WALTHAM, Mass., Oct. 07, 2026 (GLOBE NEWSWIRE) — Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company advancing therapies for patients living with autoimmune and inflammatory diseases, today announced that it will present seven posters at the 10th Joint ACTRIMS-ECTRIMS Meeting (MSToronto2026) taking place October 21-23, 2026, in Toronto, Canada.

The Company will also host a Symposium featuring a panel of Multiple Sclerosis (MS) experts discussing the evolving science and clinical potential of BTK inhibition in progressive MS.

Symposium Details:

Title: BTK Inhibition in MS: An Emerging Approach to Disability Progression
Participants: Amit Bar-Or, MD, FRCPC, Maria Pia Sormani, PhD, Robert Fox, MD, Benjamin Greenberg, MD, MHS
Date & Time: Wednesday, October 21; 5:30-6:30pm ET
Location: Lecture Hall 718

Poster Presentation Details:

Title: Pharmacokinetics of Orelabrutinib in a Phase 2 Study in Relapsing Remitting Multiple Sclerosis
Presenting Author: Mary Hughes, MD, MBA – Neurologist, University of South Carolina School of Medicine Greenville
Session: ePoster
Poster Number: EP2593

Title: Orelabrutinib in Non-Active Secondary Progressive Multiple Sclerosis: Design of the Monarch Phase 3 Randomized Controlled Trial
Presenting Author: Robert J. Fox, MD – Neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic
Session: ePoster
Poster Number: EP2594

Title: Orelabrutinib in Primary Progressive Multiple Sclerosis: Design of the PriMroSe Phase 3 Randomized Controlled Trial
Presenting Author: Robert J. Fox, MD – Neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic
Session: ePoster
Poster Number: EP2602

Title: Effect of Obexelimab on Serum Biomarkers and MS Disease Activity Score: Results from the Phase 2 MoonStone Trial in Relapsing Multiple Sclerosis
Presenting Author: Annette Okai, MD, FAAN – Director of Neuroimmunology and Multiple Sclerosis Research at North Texas Institute of Neurology, Rheumatology & Headache
Session: Paper Poster Session 2: Therapy – Immunomodulation/Immunosuppression
Session Date & Time: Thursday, October 22; 4:30pm-6:30pm ET
Poster Number: P1411
Location: Exhibit Hall DE

Title: Obexelimab Demonstrated Reduction in Disease Activity in Relapsing Multiple Sclerosis: 24-Week Results from the MoonStone Phase 2 Trial
Presenting Author: Darin Okuda, MD – Professor in the Department of Neurology at UT Southwestern Medical Center
Session: Paper Poster Session 2: Therapy – Immunomodulation/Immunosuppression
Session Date & Time: Thursday, October 22; 4:30pm-6:30pm ET
Abstract Number: P1417
Location: Exhibit Hall DE

Title: Pharmacokinetics and Pharmacodynamics of Obexelimab in Patients with Relapsing Multiple Sclerosis: Results from the Phase 2 MoonStone Trial
Presenting Author: Regina Berkovich, MD, PhD – Assistant Professor of Clinical Neurology at Keck School of Medicine of USC
Session: Paper Poster Session 2: Therapy – Immunomodulation/Immunosuppression
Session Date & Time: Thursday, October 22; 4:30pm-6:30pm ET
Abstract Number: P1455
Location: Exhibit Hall DE

Title: Efficacy and Safety of Orelabrutinib in Relapsing-Remitting Multiple Sclerosis: 24-Week Results of the 80 mg Dose from a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study
Presenting Author: Mary Hughes, MD, MBA – Neurologist, University of South Carolina School of Medicine Greenville
Session: Paper Poster Session 2: Therapy – Immunomodulation/Immunosuppression
Session Date & Time: Thursday, October 22; 4:30pm-6:30pm ET
Abstract Number: P1446
Location: Exhibit Hall DE

About Multiple Sclerosis
Multiple Sclerosis (MS) is a chronic, autoimmune-mediated disorder of the Central Nervous System (CNS). According to the Multiple Sclerosis International Federation, approximately 2.9 million people worldwide are currently living with MS. The disease disproportionately affects females, and its highest prevalence is observed in North America, Europe and Australia. MS onset typically occurs between 20 and 40 years of age, making MS the leading cause of non-traumatic neurological disability in young adults. MS is categorized into three main subtypes, Relapsing Multiple Sclerosis (RMS), Secondary Progressive Multiple Sclerosis (SPMS) and Primary Progressive Multiple Sclerosis (PPMS); all three subtypes are associated with ongoing neuroaxonal loss from the earliest stages of the disease, even in the absence of overt clinical progression. Delays in diagnosis and treatment accelerate disability accumulation, reduce quality of life and increase socioeconomic burden. Consequently, early intervention with highly effective therapies is a key objective in disease management to slow or halt inflammatory and neurodegenerative processes and stop disability progression.

Approximately 85% of patients are initially diagnosed with RMS, and approximately 20-30% of those treated patients transition to SPMS, defined by continuous disability progression with or without relapses. Currently, there are no approved therapies for non-relapsing SPMS in the U.S. PPMS represents 10-15% of all MS diagnoses and is characterized by a steady increase in disability without relapses from disease onset. Currently there is only one approved therapy for PPMS.

About Orelabrutinib
Orelabrutinib is a late-stage, potentially best-in-class, highly selective central nervous system (CNS)-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor. Orelabrutinib’s mechanism of action targets pathogenic B cells in both the periphery and the CNS. Additionally, it directly modulates macrophages and microglial cells in the CNS, with the potential to address compartmentalized inflammation and disease progression in multiple sclerosis (MS). In MS, Zenas is advancing PriMroSe, a Phase 3 trial in Primary Progressive MS (PPMS), and Monarch, a Phase 3 trial in non-active Secondary Progressive MS (naSPMS). Orelabrutinib is approved for B cell malignancies in mainland China and Singapore, marketed by our partner InnoCare.

About Obexelimab
Obexelimab is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique inhibitory mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively modulate the pathogenic role of the B cell lineage in chronic autoimmune disease.

Obexelimab has been evaluated in nine clinical trials in a total of 667 subjects, including MoonStone. Obexelimab was well tolerated and demonstrated clinical activity across these clinical trials.

Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE) topline results expected in 4Q 2026.

About Zenas BioPharma
Zenas is a clinical-stage global biopharmaceutical company focused on the development and commercialization of therapies for autoimmune diseases and inflammatory conditions. Zenas combines our experienced leadership team with a disciplined global product candidate acquisition approach to identify, acquire and develop product candidates with the potential to deliver clinically meaningful benefits to patients. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind CD19 and FcγRIIb to inhibit the activity of B cells implicated in many autoimmune diseases without depleting them. Zenas believes that the unique mechanism of action of obexelimab and its self-administered, subcutaneous injection regimen may enable sustained control across multiple chronic autoimmune diseases. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule BTK inhibitor. Orelabrutinib’s mechanism of action targets pathogenic B cells not only in the periphery but also within the CNS. Additionally, it directly modulates macrophages and microglial cells in the CNS, with the potential to address compartmentalized inflammation and disease progression in MS. Zenas’ earlier stage programs include ZB021, a novel, clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor, ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor, and ZB014, a preclinical, half-life extended anti-CD19 and FcγRIIb monoclonal antibody. For more information about Zenas BioPharma, please visit https://zenasbio.com/ and follow us on LinkedIn.

Forward-Looking Statements
This press release contains “forward-looking statements.” In some cases, forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward looking statements include, but are not limited to, the anticipated timing or likelihood of regulatory submissions and approvals, and the outcome of interactions with regulatory authorities; the therapeutic potential of the Company’s product candidates, including the potential of BTK inhibition in progressive MS; the Company’s expectations regarding the potential commercialization, estimated market size and market opportunities of its product candidates; and the timing of reporting the topline results of obexelimab in SLE. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results, performance or achievements to differ materially from those anticipated in the forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development; potential competition, including from large and specialty pharmaceutical and biotechnology companies; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements; the Company’s ability to obtain regulatory approval to commercialize its product candidates; risks related to the manufacturing of the Company’s product candidates and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the its license obligations; significant political, trade, and regulatory developments, including changes in relations between the U.S. and China; risks related to the operations of the Company’s suppliers, many of which are located outside of the United States, including the Company’s current sole contract manufacturing organization for obexelimab drug substance and drug product, WuXi Biologics (Hong Kong) Limited, and our partner, InnoCare, both of which are located in China; the risk that the Company’s indebtedness could adversely affect the Company’s financial condition or restrict the Company’s future operations; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as supplemented from time to time by our subsequent filings with the Securities and Exchange Commission (the “SEC”), as well as other information we file with the SEC. The forward-looking statements in this press release are based upon information available to the Company as of the date of this press release and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete. Because forward-looking statements are inherently subject to risks and uncertainties, these forward-looking statements should not be relied upon as guarantees of future events. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

The Zenas BioPharma word mark, logo mark, and the “lightning bolt” design are trademarks of Zenas BioPharma, Inc. or its affiliated companies. All rights reserved.

Contacts:

Investors:
Argot Partners
Zenas@argotpartners.com

Media:
Kristin Ainsworth
SVP, U.S. Commercial Strategy & Corporate Affairs
612.839.6748

WARSAW, Ind., Oct. 07, 2026 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced the expansion of its OrthoPediatrics Specialty Bracing (“OPSB”) portfolio with a new product launch, the OPSB® Knee ‘TractorFIX contracture management orthosis.

Knee ‘TractorFIX is a first-of-its-kind pediatric bracing solution intended to treat knee contractures, pre-existing or developing, in pediatric patients approximately 2 to 21 years of age who are undergoing tibial treatment with an external fixator. The brace connects directly to the external fixator to support contracture management during tibial treatment. The bracing system was developed to address the significant clinical challenges caused by pediatric knee contractures, which can include limited range of motion, complicated rehabilitation, prolonged treatment, and negatively impacted functional outcomes.

“Knee ‘TractorFIX is a perfect example of how OrthoPediatrics creates value across our portfolio by connecting our product lines for the children and families we serve,” commented Joe Hauser, President of OrthoPediatrics Specialty Bracing and Trauma & Deformity. “Providers have historically relied on custom-built solutions that are time-intensive to make and fit. Knee ‘TractorFIX offers a standardized, pediatric-focused alternative. By pairing a dedicated contracture management solution with our ORTHEX® External Fixation platform, we can support surgeons, orthotists, patients, and families throughout the treatment journey. This collaboration addresses an important unmet clinical need while also integrating products across divisions to deliver more comprehensive pediatric orthopedic solutions, demonstrating the interconnectedness of our innovation super cycle.”

Knee ‘TractorFIX expands OPSB’s lower extremity bracing portfolio while addressing a clinical indication with limited pediatric-specific options. The bracing system adds to a growing offering of specialty bracing technologies, including products such as DF2®, TRAXIO, and PediHip®.

About OrthoPediatrics Corp.

Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such, it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets over 90 systems that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and over 75 countries outside the United States. For more information, please visit www.orthopediatrics.com. For more information about the OrthoPediatrics Specialty Bracing portfolio, please visit www.opsb.com.

Investor Contact
Philip Taylor
Gilmartin Group
philip@gilmartinir.com
415-937-5406

Company to engage with wound-care professionals and meet with existing and prospective distribution partners

WINNIPEG, Manitoba, Oct. 07, 2026 (GLOBE NEWSWIRE) — Kane Biotech Inc. (TSX-V:KNE) (the “Company”, “Kane” or “Kane Biotech”), a biotechnology company commercializing and developing technologies and products that address microbial biofilms, today announced that it will attend the Symposium on Advanced Wound Care (“SAWC”) Fall 2026, taking place October 15–18, 2026, in Las Vegas, Nevada.

On Saturday, October 17, 2026, from 6:15 p.m. to 7:30 p.m. PDT, Dr. Robert Huizinga will present three scientific posters at SAWC Fall 2026 describing the clinical and health-economic findings associated with revyve®. The presentations address the modeled economic impact of moving chronic wounds toward healing trajectories, compatibility with hypochlorous acid irrigation and standard wound-care practices, and the relationship between changes in tissue oxygenation and wound-area reduction. The posters are authored by a multidisciplinary team of clinical and scientific collaborators, including Kane Biotech.

Kane will also host Booth #544 in the SAWC Fall exhibit hall, where it will showcase its revyve product line and engage with clinicians, researchers and other wound-care professionals. Kane plans to meet with its existing distributors and prospective new distributors to discuss opportunities to expand product awareness and commercial reach in the United States and other markets.

U.S. FDA 510(k) cleared and Health Canada approved revyve Antimicrobial Wound Gel and revyve Antimicrobial Wound Gel Spray

U.S. FDA 510(k) cleared and Health Canada approved revyve Antimicrobial Wound Gel and revyve Antimicrobial Wound Gel Spray

“As adoption of revyve continues to grow, SAWC Fall provides an important venue to connect directly with clinicians and distribution partners across the wound-care community,” said S. Kay Watkins Weaver, Vice President, Commercial Operations, U.S. at Kane Biotech. “We look forward to discussing our latest clinical findings, showcasing the revyve platform and exploring opportunities to expand access to these products in both existing and new markets.”

SAWC Fall is a four-day, multidisciplinary educational conference that brings together the wound-care community to advance healing, strengthen collaboration and improve patient care. The 2026 program features practical education addressing chronic wounds, limb salvage, pressure-injury prevention, mobile wound care, reimbursement, compliance and emerging technologies. For more information, visit the SAWC Fall conference website.

Kane’s revyve portfolio currently includes U.S. FDA 510(k) cleared revyve Antimicrobial Wound Gel, revyve Antimicrobial Wound Gel Spray and revyve Antimicrobial Skin and Wound Cleanser. The wound gel and wound gel spray are also approved by Health Canada. Kane is ISO 13485:2016 certified under the Medical Device Single Audit Program.

About Kane Biotech Inc. (TSX-V:KNE)

Kane Biotech is commercializing and developing novel wound care treatments that disrupt biofilms and transform healing outcomes. Biofilms are one of the main contributors to antibiotic resistance in wounds, resulting in serious clinical outcomes and significant cost. revyve addresses both biofilms and wound bacteria. revyve Antimicrobial Wound Gel, revyve Antimicrobial Wound Gel Spray and revyve Antimicrobial Skin and Wound Cleanser are all U.S. FDA 510(k) cleared. revyve Antimicrobial Wound Gel and revyve Antimicrobial Wound Gel Spray are also Health Canada approved. To learn more, visit revyvegel.com or revyvegel.ca.

Join Kane’s Distribution List & Social Media:

To stay informed on the latest developments, sign up for the Company’s email distribution list.

Kane Biotech on LinkedIn

Website & Corporate Presentation:

kanebiotech.com

Disrupting Biofilms to Save Limbs and Transform Wound Care

For more information:

Dr. Robert Huizinga Ray Dupuis
Interim CEO Chief Financial Officer
Kane Biotech Inc. Kane Biotech Inc.
rhuizinga@kanebiotech.com rdupuis@kanebiotech.com
(780) 970-1100 (204) 298-2200
   

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Caution Regarding Forward-Looking Information

This press release contains certain statements regarding Kane Biotech Inc. that constitute forward-looking information under applicable securities law. These statements reflect management’s current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, risks relating to the Company’s: (a) financial condition, including lack of significant revenues to date and reliance on equity and other financing; (b) business, including its early stage of development, government regulation, market acceptance for its products, rapid technological change and dependence on key personnel; (c) intellectual property including the ability of the Company to protect its intellectual property and dependence on its strategic partners; and (d) capital structure, including its lack of dividends on its common shares, volatility of the market price of its common shares and public company costs. Further information about these and other risks and uncertainties can be found in the disclosure documents filed by the Company with applicable securities regulatory authorities, available at www.sedarplus.ca. The Company cautions that the foregoing list of factors that may affect future results is not exhaustive.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1e960731-845e-4b9d-9e81-28fcac23fc86

Albion Crown VCT PLC
Annual Report and Financial Statements for the year ended 30 June 2026
LEI Code: 213800SYIQPA3L3T1Q68

Albion Crown VCT PLC (the “Company”) – Annual results announcement
The Company’s Directors are pleased to attach the Company’s Annual Report and Financial Statements for the year ended 30 June 2026. A summary of the information includes:

Ordinary shares

  • Increase in total shareholder value of 0.47 pence per Ordinary share (1.55% total gain on opening net asset value) (2025: decrease of 0.28 pence per share).
  • Net asset value of £139.2 million, being 29.29 pence per Ordinary share (2025: £117.4 million and 30.33 pence per Ordinary share).
  • Dividends paid of 1.51 pence per Ordinary share in the year (2025: 1.59 pence per Ordinary share).
  • Dividend declared of 0.73 pence per Ordinary share to be paid on 31 December 2026 to Ordinary shareholders on the register on 4 December 2026.

C shares*

  • Increase in total shareholder value of 1.31 pence per C share (3.27% total gain on the net asset value on opening net asset value) (2025: decrease of 0.67 pence per share).
  • Net asset value of £50.5 million, being 39.40 pence per C share (2025: £52.8 million and 40.09 pence per C share).
  • Dividends paid of 2.00 pence per C share in the year (2025: 1.08 pence per C share).

* The C shares 2025 period is from the date of merger on 19 December 2024 to 30 June 2025.

In accordance with the Articles of Association, approved by shareholders and adopted by the Company at the General Meeting on 11 December 2024, the C shares will convert into Ordinary shares based on their respective net asset values at 30 June 2026. The C shares will convert on the basis that each holder of a C share will hold 1.34520994 new Ordinary shares for each C share held, effective from 16 October 2026. As such, current holders of C shares, who are on the register on 4 December 2026, will receive a dividend of 0.73 pence per Ordinary share held post conversion, paid on 31 December 2026, as mentioned above.

The Annual Report and Financial Statements for the year ended 30 June 2026, including the Notice of Annual General Meeting, are attached to this announcement. Alternatively, copies are available on the Company’s webpage on the Manager’s website at: www.albion.vc/CRWN30Jun2026

In accordance with the UK Listing Rules, a copy of the report will be submitted to the National Storage Mechanism and will shortly be available for inspection at: https://data.fca.org.uk/#/nsm/nationalstoragemechanism.

For further details about the Company, please visit the Company’s webpage on the Manager’s website at: www.albion.vc/vct/funds/CRWN.

Vikash Hansrani
Operations Partner
AlbionVC LLP
Telephone: 020 7601 1850

7 October 2026

Attachment

  • Late-breaking data from positive Phase III REMODEL-1/-2 trials will show efficacy and safety profile of remibrutinib in RMS 
  • Novartis to hold virtual investor event highlighting REMODEL data and remibrutinib in MS
  • Phase III NEOS late-breaker will expand evidence for Kesimpta® (ofatumumab) in pediatric MS, where current approved treatment options remain limited
  • New Kesimpta data from STHENOS study in treatment-naive relapsing MS and from KATHAROS breastfeeding study will be presented

Basel, October 07, 2026 – Novartis will present new data from its multiple sclerosis (MS) portfolio with 46 abstracts at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting. Among these is a late-breaking abstract featuring the Phase III REMODEL-1/-2 results, underscoring the potential of remibrutinib and reinforcing the company’s long-standing commitment to advancing care for people living with MS.

A second late-breaking abstract will present new Kesimpta® (ofatumumab) data in pediatric MS, where significant treatment needs remain. Additional presentations will further expand the Kesimpta evidence base, including research on pregnancy outcomes and breastfeeding that aims to inform family planning decisions, as well as the use of Kesimpta versus disease-modifying therapies commonly used as first-line treatments in treatment-naïve patients.

“For decades, Novartis has helped shape the treatment landscape for people living with multiple sclerosis through scientific innovation,” said Nazem Atassi, Global Head, Neuroscience and Gene Therapy Development, Novartis. “At MSToronto2026, we are sharing Phase III results from REMODEL-1 and REMODEL-2 evaluating remibrutinib, an oral BTK inhibitor, alongside new evidence across our MS portfolio. Together, these data reflect our continued commitment to addressing unmet needs across different stages of life and disease.”

Investor call on remibrutinib in MS
Following the presentation of the REMODEL data at MSToronto2026, Novartis will host a conference call for investors to provide updates on the data and the potential for remibrutinib in MS.

Key abstracts include: 

Abstract Title  Presentation Details 
Remibrutinib 
Efficacy and Safety of Remibrutinib vs Teriflunomide in Relapsing Multiple Sclerosis: Results of the Phase 3 REMODEL-1/-2 Trials  Presentation ID O139
Oral Presentation
October 23, 11:25 – 11:35 a.m. ET
Kesimpta (ofatumumab) 
Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Multiple Sclerosis: The Innovative Phase 3 NEOS Study Presentation ID O138
Oral Presentation
October 23, 11:15 – 11:25 a.m. ET
Ofatumumab Versus Physicians’ Choice of Disease Modifying Therapy in Treatment-Naive People Living With Relapsing Multiple Sclerosis: Final Efficacy Results of The Phase 3b STHENOS Study Presentation ID P0390
Poster Session 1 
October 21, 4:30 – 6:30 p.m. ET
Ofatumumab Versus Physicians’ Choice of Disease-Modifying Therapy in Treatment-Naive People Living With Relapsing Multiple Sclerosis: Final Safety and Tolerability Results of The Phase 3b STHENOS Study Presentation ID EP2632
ePoster 
 
Ofatumumab Versus Physicians’ Choice of Disease Modifying Therapy in Treatment-Naive People Living With Relapsing Multiple Sclerosis: Final Healthcare Resource Utilization Results of the Phase 3b STHENOS Study  Presentation ID EP2625
ePoster 
 
Evaluating Ofatumumab Excretion in Breastmilk of Women Living With Relapsing Multiple Sclerosis: Interim Results of the Phase 4 KATHAROS Study Presentation ID EP2565
ePoster
Pregnancy and Infant Outcomes in Women With Relapsing Multiple Sclerosis Following Exposure to Ofatumumab: Latest Evidence From the PRIM Study  Presentation ID P1139
Poster Session 2 
October 22, 4:30 – 6:30 p.m. ET
 


About Novartis Neuroscience

Neurological diseases are deeply personal, affecting people of any age, from newborns to seniors, often striking in the prime of life. In multiple sclerosis (MS), Novartis has helped shape the treatment landscape for decades through scientific innovation and leadership in advancing care for people living with MS. We remain focused on addressing unmet needs and pursuing new approaches that may improve outcomes for people across the MS journey. Building on this foundation, we’re doubling down on our commitment to neurology, expanding our legacy of innovation in MS and spinal muscular atrophy (SMA) to work in neuroimmunology, neurodegeneration, and neuromuscular diseases. Our goal is to protect people’s health across their lifespan, developing more treatment options that lead to better outcomes.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” or similar expressions, or by express or implied discussions regarding: potential new products; potential new indications for existing products; potential product launches or potential future revenues from any such products; results of ongoing clinical trials; or potential future, pending or announced transactions; potential future sales or earnings; strategy, plans, expectations or intentions, including discussions regarding our continued investment into new R&D capabilities and manufacturing; or our capital structure. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations could be affected by, among other things, uncertainties concerning: global healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; the success of our key products, commercial priorities and strategy; research and development of new products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; the development or adoption of new technologies, including artificial intelligence, and new business models; potential significant breaches of information security or disruptions of our information technology systems; actual or potential legal proceedings, including regulatory actions or delays or government regulation related to the products and pipeline products described in this press release; safety, quality, data integrity, or manufacturing issues; major macroeconomic and geo- and socio-political developments, including the impact of any potential tariffs on our products or the impact of war in certain parts of the world; future global exchange rates; future demand for our products; and other risks and factors referred to in Novartis AG’s most recently filed Form 20-F and in subsequent reports filed with, or furnished to, the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide.

Reimagine medicine with us: Visit us at www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

# # #

Novartis Media Relations
E-mail: media.relations@novartis.com
 
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com
 

– Data showed improvements in an objective measure of impaired eye movement associated with Parkinson’s disease, with a correlation between reductions in LRRK2 cerebrospinal fluid (CSF) biomarkers to these changes in oculomotor function and changes in synaptic biomarkers –

– Findings support continued evaluation of ARV-102 as a potential therapeutic approach for neurodegenerative diseases associated with LRRK2 dysregulation –

NEW HAVEN, Conn., Oct. 07, 2026 (GLOBE NEWSWIRE) — Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today presented novel data from a Phase 1 clinical trial of ARV-102, an investigational PROteolysis TArgeting Chimera (PROTAC) degrader designed to specifically target and degrade leucine-rich repeat kinase 2 (LRRK2). Final data from this trial were presented as late-breaking oral and poster presentations at the 2026 International Congress of Parkinson’s Disease and Movement Disorders® (MDS) in Seoul, Korea.

“These final data from our Phase 1 study in patients with Parkinson’s disease provide further evidence that ARV-102 reaches the central nervous system, degrades LRRK2, and modulates biological pathways relevant to neurodegenerative disease,” said Ilaria Conti, MD, Ph.D., Vice President, Clinical Research at Arvinas. “Although this study was not designed to assess clinical efficacy, we are encouraged by the exploratory dose-related changes in ocular saccadic hypometria and their associations with LRRK2 degradation and changes in pathway biomarkers. These findings support further clinical evaluation of ARV-102.”

The data presented augment Phase 1 clinical trial results shared earlier this year at AD/PD (The 2026 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders) showing brain penetration and reductions of LRRK2 variant and expression-dependent endolysosomal and neuroinflammatory biomarkers, which have been shown to be elevated in neurodegenerative diseases, in the CSF.

The trial evaluated oral doses of ARV-102 ranging from 20 mg to 80 mg, as well as placebo, for 28 days, in a total of 24 patients with Parkinson’s disease. Notable findings include:

  • Dose-dependent increases in amplitude of saccadic hypometria (ASH) observed after 28 days of ARV-102 treatment compared with placebo, reflecting less severe hypometria;
  • Decreases in biomarkers associated with endolysosomal function and neuroinflammation;
  • Increases in biomarkers of synaptic integrity and axonal guidance; and
  • Associations between reductions in CSF LRRK2 protein levels and improvements in both oculomotor function and changes in pathway biomarkers of endolysosomal, neuroinflammatory, and synaptic function.

Additional detail on the ARV-102 data presentations at MDS 2026 follows below:

Presentation Title: Phase 1 Study of ARV-102, a PROTAC LRRK2 Degrader, in Parkinson’s Disease: Oculomotor and Biomarker Data
Session Number: 12
Session Title: Late-Breaking Abstracts: Parkinson’s Disease
Session Type: Oral
Session Location: Conference Room E3, 3rd Floor
Presentation Number: LBA 15
Presentation Order: 3
Presentation Duration: 5 minutes
Date: Wednesday, October 7
Session Time: 12:30 – 13:30 ET

Presentation Title: Phase 1 Study of ARV-102, a PROTAC LRRK2 Degrader, in Parkinson’s Disease: Oculomotor and Biomarker Data
Session Type: E-Poster
Session Location: E-Poster Hall, online
Presentation Number: LBA 15

About ARV-102
ARV-102 is an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) designed to cross the blood-brain barrier and specifically target and degrade leucine-rich repeat kinase (LRRK2), a large, multidomain scaffolding kinase with GTPase activity. Increased activity and over expression of LRRK2 have been implicated in the pathogenesis of neurological diseases, including LRRK2 genetic and idiopathic Parkinson’s disease and progressive supranuclear palsy (PSP). ARV-102 has been evaluated in a Phase 1 clinical trial in healthy volunteers and in patients with Parkinson’s disease.

About Parkinson’s Disease
Parkinson’s disease is a progressive brain disease that damages dopamine-producing neurons, leading to progression of symptoms including motor-related symptoms like tremors and limb stiffness, as well as non-motor symptoms including depression, sleep disorders, cognitive decline, and more. LRRK2 activity is abnormally increased in Parkinson’s disease – and both experimental studies and recent clinical data suggest that degrading LRRK2 may positively affect endolysosomal function, neuroinflammation, and synaptic function.  

About Arvinas
Arvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROteolysis TArgeting Chimera (PROTAC) protein degrader platform, Arvinas is pioneering the development of protein degradation therapies designed to harness the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas, with its partner Pfizer, developed the first U.S. Food and Drug Administration (FDA)-approved PROTAC, a type of heterobifunctional protein degrader, which has been outlicensed to Rigel Pharmaceuticals, Inc. for exclusive global development, manufacturing, and commercialization.

Arvinas is currently progressing multiple investigational drugs through clinical development programs, including ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; ARV-102, targeting LRRK2 for neurodegenerative disorders; ARV-027, targeting the polyglutamine-expanded androgen receptor, or polyQ-AR, in skeletal muscle for spinal-bulbar muscular atrophy, also known as Kennedy’s disease; and ARV-6723, targeting HPK1 for advanced solid tumors. Arvinas has also advanced ARV-806, targeting KRAS G12D for solid tumors, in the clinic, and previously announced plans to seek an out-licensing agreement for any additional clinical trials of ARV-806, including dose expansion or combination clinical trials. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit www.arvinas.com and connect on LinkedIn and X.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding: the potential of ARV-102, including its degradation of leucine-rich repeat kinase 2 (“LRRK2”), and its potential treatment of neurodegenerative diseases associated with LRRK2 dysregulation; oculomotor and biomarker data from the Phase 1 clinical trial of ARV-102 in Parkinson’s disease supporting continued evaluation of ARV-102 as a potential therapeutic approach for neurodegenerative diseases associated with LRRK2 dysregulation; whether degrading LRRK2 may positively affect endolysosomal function, neuroinflammation, and synaptic function; and Arvinas’ plans with respect to its clinical development programs. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas’ strategy, development plans, future operations, prospects, plans, and objectives of management and the statements identified in the prior paragraph, are forward-looking statements. The words “ability,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “target,” “goal,” “aim,” “whether,” “will,” “would,” “could,” “reliance,” “should,” “look forward,” “seek,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Arvinas may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: whether Arvinas will be able to successfully conduct and complete development for its product candidates, including ARV-102, on its current timelines or at all; risks related to clinical trial results and the interpretation thereof, including with respect to ARV-102; Arvinas’ ability to protect its intellectual property portfolio; Arvinas’ reliance on third parties; whether Arvinas will be able to raise capital when needed; whether Arvinas’ cash and cash equivalents will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the “Risk Factors” section of Arvinas’ Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent other reports filed with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas’ current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas’ views as of any date subsequent to the date of this release.

Contacts
Investors:
Jeff Boyle
+1 (347) 247-5089
jeff.boyle@arvinas.com

Media:
Kirsten Owens
+1 (203) 584-0307
Kirsten.Owens@arvinas.com

MONTRÉAL, Oct. 07, 2026 (GLOBE NEWSWIRE) — OR Royalties Inc. (“OR Royalties” or the “Company”) (OR: TSX & NYSE) is pleased to announce its third quarter 2026 preliminary deliveries, revenues and cash margin, as well as to provide an update on its cash and debt positions as at September 30, 2026. All monetary amounts included in this report are expressed in United States dollars, unless otherwise noted.

PRELIMINARY Q3 2026 RESULTS

OR Royalties earned 20,237 attributable gold equivalent ounces1 (“GEOs”) in the third quarter of 2026. OR Royalties recorded preliminary revenues from royalties and streams of $90.2 million during the third quarter and preliminary cost of sales (excluding depletion) of $2.9 million, resulting in a quarterly cash margin2 of approximately $87.3 million (96.8%).

As at September 30, 2026, OR Royalties’ cash position was approximately $76.7 million, after repurchases of common shares made under the normal course issuer bid of $29.1 million (C$40.8 million) during the third quarter. The La Verde royalty transaction with Hot Chili Limited closed during the third quarter for a total amount of $15.0 million and was financed using cash available on the balance sheet.

OR Royalties’ revolving credit facility was drawn by $228.2 million at September 30, 2026, leaving $621.8 million of available capacity, plus an uncommitted accordion of up to $350.0 million.

Q3 2026 RESULTS CONFERENCE AND WEBCAST CALL DETAILS

Results Release: Wednesday, November 11th, 2026 after market close

Conference Call: Thursday, November 12th, 2026 at 10:00 am ET

Dial-in Numbers:
(Option 1)
North American Toll-Free: 1 (800) 717-1738
Local – Montreal: 1 (514) 400-3792
Local – Toronto: 1 (289) 514-5100
Local – New York: 1 (646) 307-1865
Conference ID: 75234

Webcast link:
(Option 2)

https://viavid.webcasts.com/starthere.jsp?ei=1777759&tp_key=f1a0b01c30
Replay (available until Saturday, December 12th, 2026 at 11:59 PM ET): North American Toll-Free: 1 (888) 660-6264
Local – Toronto: 1 (289) 819-1325
Local – New York: 1 (646) 517-3975
Playback Passcode: 75234#

  Replay also available on our website at www.ORroyalties.com

Notes

The figures presented in this press release, including the cash and debt balances, and the revenues and costs of sales, have not been audited and are subject to change. As the Company has not yet finished its quarter end procedures, the anticipated financial information presented in this press release is preliminary, subject to quarter end adjustments, and may change materially.

(1) Gold Equivalent Ounces

GEOs are calculated on a quarterly basis and include royalties and streams. Silver and copper earned from royalty and stream agreements are converted to gold equivalent ounces by multiplying the silver ounces or copper tonnes earned by the average silver price or copper price for the period and dividing by the average gold price for the period. Cash royalties and other metals and commodities are converted into gold equivalent ounces by dividing the associated revenue earned by the average gold price for the period.

Average Metal Prices

  Three months ended
September 30
 
    2026     2025  
         
Gold (i) $ 4,262   $ 3,457  
Silver (ii) $ 62.59   $ 39.40  
Copper (iii) $ 14,104   $ 9,797  
             

(i)     The London Bullion Market Association’s pm price in U.S. dollars per ounce.
(ii)    The London Bullion Market Association’s price in U.S. dollars per ounce.
(iii)   The London Metal Exchange’s price in U.S. dollars per tonne.

(2) Non-IFRS Measures

Cash margin in dollars and in percentage of revenues are non-IFRS financial measures. Cash margin (in dollars) is defined by OR Royalties as revenues less cost of sales (excluding depletion). Cash margin (in percentage of revenues) is obtained by dividing the cash margin (in dollars) by the revenues.

Management uses cash margin in dollars and in percentage of revenues to evaluate OR Royalties’ ability to generate positive cash flow from its royalty, stream and other interests. Management and certain investors also use this information, together with measures determined in accordance with IFRS Accounting Standards such as gross margin and operating cash flows, to evaluate OR Royalties’ performance relative to peers in the mining industry who present these measures on a similar basis. Cash margin in dollars and in percentage of revenues are only intended to provide additional information to investors and analysts and should not be considered in isolation or as a substitute for measures of performance prepared in accordance with IFRS Accounting Standards. They do not have any standardized meaning under IFRS Accounting Standards and may not be comparable to similar measures presented by other issuers.

A reconciliation of the cash margin (in thousands of dollars and in percentage of revenues) is presented below:

  Three months ended
September 30
 
    2026       2025  
       
Revenues $ 90,205      $ 71,625   
Less: Cost of sales (excluding depletion) $ (2,917 )   $ (2,367 )
Cash margin (in dollars) $ 87,288      $ 69,258   
Cash margin (in percentage of revenues)   96.8%       96.7%  


About OR Royalties Inc.

OR Royalties is a precious metals royalty and streaming company focused on Tier-1 mining jurisdictions defined as Canada, the United States, and Australia. OR Royalties commenced activities in June 2014 with a single producing asset, and today holds a portfolio of over 200 royalties, streams and similar interests. OR Royalties’ portfolio is anchored by its cornerstone asset, the 3-5% net smelter return royalty on Agnico Eagle Mines Limited’s Canadian Malartic Complex, one of the world’s largest gold mines.

OR Royalties’ head office is located at 1100 Avenue des Canadiens-de-Montréal, Suite 300, Montréal, Québec, H3B 2S2.

For further information, please contact OR Royalties Inc.:
Grant Moenting
Vice President, Capital Markets
Cell: (365) 275-1954
Email: gmoenting@ORroyalties.com
Heather Taylor
Vice President, Sustainability and Communications
Tel: (647) 477-2087
Email: htaylor@ORroyalties.com


Forward-Looking Statements

Certain statements contained in this press release may be deemed “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended and “forward-looking information” within the meaning of applicable Canadian securities legislation. Forward-looking statements are statements other than statements of historical fact, that address, without limitation, future events, that preliminary financial information presented in this press release may be subject to quarter-end adjustments, and the availability of the uncommitted accordion of the credit facility. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential”, “scheduled” and similar expressions or variations (including negative variations), or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors, most of which are beyond the control of OR Royalties, and actual results may accordingly differ materially from those in forward-looking statements. Such risk factors include, without limitation, (i) with respect to properties in which OR Royalties holds a royalty, stream or other interest (collectively an “Interest”); risks related to: (a) the operators of the properties, (b) timely development, permitting, construction, commencement of production, ramp-up (including operating and technical challenges), (c) differences in rate and timing of production from Mineral Resource Estimates or production forecasts by operators, (d) differences in conversion rate from Mineral Resources to Mineral Reserves and ability to replace Mineral Resources, (e) the unfavorable outcome of any challenges or litigation relating to title, permits or licenses, (f) hazards and uncertainty associated with the business of exploration, development and mining including, but not limited to unusual or unexpected geological and metallurgical conditions, slope failures or cave-ins, flooding and other natural disasters or civil unrest or other uninsured risks, (ii) with respect to other external factors: (a) fluctuations in the prices of the commodities that drive royalties, streams, offtakes and investments held by OR Royalties, (b) a trade war or new tariff barriers, (c) fluctuations in the value of the Canadian dollar relative to the U.S. dollar, (d) regulatory changes by national and local governments, including permitting and licensing regimes and taxation policies, regulations and political or economic developments in any of the countries where properties in which OR Royalties holds an Interest are located or through which they are held, (e) continued availability of capital and financing and general economic, market or business conditions, and (f) responses of relevant governments to infectious diseases outbreaks and the effectiveness of such response and the potential impact of such outbreaks on OR Royalties’ business, operations and financial condition; (iii) with respect to internal factors: (a) business opportunities that may or not become available to, or are pursued by OR Royalties, (b) the integration of acquired assets or (c) the determination of OR Royalties’ PFIC status. The forward-looking statements contained in this press release are based upon assumptions management believes to be reasonable, including, without limitation: the absence of significant change in OR Royalties’ ongoing income and assets relating to determination of its PFIC status, and the absence of any other factors that could cause actions, events or results to differ from those anticipated, estimated or intended and, with respect to properties in which OR Royalties holds an Interest, (i) the ongoing operation of the properties by the owners or operators of such properties in a manner consistent with past practice and with public disclosure (including forecast of production), (ii) the accuracy of public statements and disclosures made by the owners or operators of such underlying properties (including expectations for the development of underlying properties that are not yet in production), (iii) no adverse development in respect of any significant property, (iv) that statements and estimates relating to mineral reserves and resources by owners and operators are accurate and (v) the implementation of an adequate plan for integration of acquired assets.

For additional information on risks, uncertainties and assumptions, please refer to the most recent Annual Information Form of OR Royalties filed on SEDAR+ at www.sedarplus.ca and EDGAR at www.sec.gov which also provides additional general assumptions in connection with these statements. OR Royalties cautions that the foregoing list of risk and uncertainties is not exhaustive. Investors and others should carefully consider the above factors as well as the uncertainties they represent and the risk they entail. OR Royalties believes that the assumptions reflected in those forward-looking statements are reasonable, but no assurance can be given that these expectations will prove to be accurate as actual results and prospective events could materially differ from those anticipated under such forward-looking statements and such forward-looking statements included in this press release are not a guarantee of future performance and should not be unduly relied upon. In this press release, OR Royalties relies on information publicly disclosed by other issuers and third parties pertaining to its assets and, therefore, assumes no liability for such third-party public disclosure. These statements speak only as of the date of this press release. OR Royalties undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by applicable law.

NEW YORK, Oct. 07, 2026 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it will report its financial results for the third quarter of 2026 on Monday, November 2, 2026, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update.

To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at www.axsome.com. A replay of the conference call will be available on the Company’s website for approximately 30 days following the live event.

About Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple early- to late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

Forward Looking Statements

Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Investors:
Ashley Dong
Senior Director, Investor Relations
(929) 687-1614
adong@axsome.com

Media:
Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
dopland@axsome.com

TORONTO, Oct. 07, 2026 (GLOBE NEWSWIRE) — Premier American Uranium Inc. (“PUR”, the “Company” or “Premier American Uranium”) (TSXV: PUR) (OTCQB: PAUIF) is pleased to report another positive update on mid-season results from the 2026 exploration drilling program at the Company’s wholly-owned Kaycee Project (“Kaycee” or the “Project”), located in the Powder River Basin of northeastern Wyoming. Initial drilling at the West Diane target has intersected uranium mineralization in six of eight holes, including 10 ft grading 0.064% eU₃O₈ in drillhole WD26-012. Following encouraging results at Rustler, PUR secured an additional 1,883 acres of mineral rights, extending the target area north and west, connecting the Rustler and Stampede claim blocks, and bringing its total land package to 31,724 acres.

As of September 25, 2026, PUR has completed 80 conventional mud-rotary drillholes for a total of 65,620 ft (30 holes and 23,660 ft since our last reporting), representing approximately 66% of the planned 100,000-ft program. Drilling is currently focused on West Diane, with a return to Rustler planned following completion of the West Diane campaign.

2026 Program Highlights

  • Encouraging initial results at West Diane: Six of 8 drillholes, totaling 7,360 ft, encountered uranium mineralization at grades of 0.02% eU₃O₈ or higher (Table 1). Notably, drillhole WD26-012 intercepted 10 ft of 0.064% eU₃O₈, including 5.5 ft of 0.076% and 2 ft of 0.092% eU₃O₈ (Figure 2).
  • West Diane drilling tests extensions of known mineralization: Historical drilling identified two discrete sandstone host target units within the Fort Union Formation, one of two historically productive host formations in the Smith Ranch-Highland area of the Powder River Basin. Current drilling focuses on the upper unit to better define the trend and extent of the paleochannel partially delineated by historic drilling. Infill, step-out, and confirmation holes are all planned to verify and expand areas of known uranium mineralization.
  • Additional uranium intercepts at Rustler: Six of the 22 newly reported drillholes intersected uranium mineralization grading at least 0.02% eU₃O₈, including 2.5 ft grading 0.063% eU₃O₈ in RT26-121 and 3.5 ft grading 0.037% eU₃O₈ in RT26-116 (see Table 1 and Figure 3).
  • Rustler mineral rights expanded by 1,883 acres: Encouraging drilling results prompted PUR to secure additional mineral rights immediately north and west of the existing claim block, extending the target area and connecting the Rustler and Stampede claim blocks.
  • Two mineralized sandstone units identified at Rustler: Drilling has identified two mineralized sandstone host units, both within the lower Wasatch Formation. Uranium mineralization has been encountered in both sands, and gamma results, which indicate possible stacked roll fronts in the upper unit.
  • Rustler drilling to resume across expanded target area: Drilling was paused after 45 holes while PUR secured adjacent mineral rights. With those rights now secured, drilling is expected to resume after the West Diane campaign, weather permitting.

Colin Healey, CEO of PUR commented, “Our 2026 program continues to deliver encouraging results across Kaycee. Drilling at the West Diane target has returned uranium mineralization in six of our first eight holes, including 10 ft grading 0.064% eU₃O₈, the thickest mineralized interval reported from this year’s program to date. These results provide a strong basis for follow-up drilling to test extensions of known mineralization. At Rustler, encouraging results prompted us to secure an additional 1,883 acres to the north and west, positioning us to test further exploration opportunities. With approximately two-thirds of the planned drilling complete, we look forward to advancing West Diane and returning to our expanded Rustler target area.”

Michael Harrison, Chairman, commented, “Kaycee represents one of the largest grassroots uranium exploration programs in the United States, with an expanded land package spanning approximately 31,724 acres in Wyoming’s prolific Powder River Basin. Our ongoing drilling is demonstrating the potential of this extensive land position, while the addition of strategically located mineral rights connecting the Rustler and Stampede claim blocks strengthens our exploration footprint. PUR is focussed on adding essential uranium resources in the United States.”

Table 1. Kaycee Significant Intercepts – August 18 to September 25, 2026

Target
Area
Drillhole Intercept From
(ft)
To
(ft)
Thickness
(ft)
eU₃O₈%
Rustler

RT26-106 intersected 412.5 413 0.5 0.022
RT26-112 intersected 386.5 387.5 1 0.021
  and 700 701 1 0.032
RT26-115 intersected 648 650.5 2.5 0.023
RT26-116 intersected 416 419.5 3.5 0.037
RT26-119 intersected 401.5 402.5 1 0.023
  and 426 427 1 0.022
RT26-121 intersected 427.5 430 2.5 0.063
  including 428 429.5 1.5 0.081
  including 428.5 429 0.5 0.1
West Diane

WD26-011 intersected 898.5 901.5 3 0.081
  including 899 901 2 0.108
  including 899.5 900.5 1 0.141
  and 902 904 2 0.039
  including 902.5 903.5 1 0.053
WD26-012 intersected 859.5 869.5 10 0.064
West Diane

  including 860.5 862 1.5 0.078
  including 863 868.5 5.5 0.076
  including 864 866 2 0.092
  including 864.5 865 0.5 0.102
WD26-013 intersected 826 831 5 0.063
  including 826.5 828.5 2 0.096
  including 827 828 1 0.119
  and 839 840.5 1.5 0.02
WD26-014 intersected 833.5 835 1.5 0.025
WD26-015 intersected 814 815 1 0.021
WD26-018 intersected 618 620 2 0.033
  and 633 635 2 0.031

Notes: Drill holes reported here encountered uranium mineralization at or above a cut-off grade of 0.02% eU₃O₈. Uranium grades cited were calculated from gamma-ray logs measured by Hawkins CBM Logging of Casper, Wyoming, and the cited grades are “equivalent” (“e”) grades of U3O8. Hawkins CBM Logging’s geophysical probe was calibrated at the US Department of Energy’s Casper, Wyoming test pits in August 2026. No corrections were made for radiometric disequilibrium. Numerous comparisons of eU₃O₈ and chemical assays of PRB core samples indicate that eU₃O₈ is a reasonable indicator of the actual uranium assay. All drill holes are vertical in orientation and the geologic units hosting the uranium mineralization are generally very flat lying, therefore reported thicknesses are considered to approximate or modestly exceed true thicknesses.

Figure 1. Kaycee Project Key Targets in 2026

Kaycee Project Key Targets in 2026

Figure 2. West Diane 2026 Drill Holes 

West Diane 2026 Drill Holes

Figure 3. Rustler 2026 Drill Holes

Rustler 2026 Drill Holes


Kaycee Project

The Kaycee Project in Wyoming’s Powder River Basin (PRB) consists of over 42 square miles of mineral rights over a 36-mile mineralized trend hosting more than 110 miles of identified roll fronts (Figure 4). The Project is believed to be the only project in the PRB where all three known historically productive sandstone formations (Wasatch, Fort Union, and Lance) are mineralized and potentially accessible for ISR extraction. PUR’s exploration team are undertaking the largest grass-roots ISR drill program in the United States, with upwards of 400,000 ft of drilling completed since 2023.

PUR anchors one of the strongest exploration portfolios in Wyoming, combining its Cyclone Project in the Great Divide Basin with Kaycee to drive one of the largest ongoing drilling programs in the state and significantly expand its presence in both of the state’s major ISR-amenable uranium districts.

Figure 4. PUR’s Wyoming exploration portfolio, highlighting the Kaycee Project in the Powder River Basin and the Cyclone Project in the Great Divide Basin.

PUR’s Wyoming exploration portfolio, highlighting the Kaycee Project in the Powder River Basin and the Cyclone Project in the Great Divide Basin.


Qualified Person Statement

The scientific and technical information contained in this news release was reviewed and approved by J.J. Brown, P.G., SME-RM, PUR’s Vice President Exploration, who is a “Qualified Person” as defined by National Instrument 43-101 – Standards of Disclosure for Mineral Projects. Ms. Brown has verified the data disclosed in this news release, including sampling, analytical, and test data underlying the information contained herein.

The drilling results cited in this news release were derived from conventional mud rotary drill holes and continuously recorded geophysical responses (gamma-ray, spontaneous-potential, and single point resistivity) from a borehole geophysical probe. All drill holes are vertical in orientation and the geologic units hosting the uranium mineralization are generally very flat lying, therefore reported thicknesses are considered to approximate or modestly exceed true thicknesses. Grades of mineralization reported were calculated from the gamma-ray logs following a procedure that was first developed in the early 1960s and is standard practice in the uranium industry. The borehole geophysical logging was carried out by Hawkins CBM of Casper, Wyoming, a highly experienced and skilled geophysical contractor with a well-established history of providing reliable and accurate data.

Other information regarding the Company’s Kaycee Project, including with respect to the Quality Assurance and Quality Control measures applied during the work program can be referenced from the “Technical Report for NI 43-101 Kaycee Uranium Project, Johnson County, Wyoming USA”, dated September 21, 2025, which is available under the Company’s profile on SEDAR +, at www.sedarplus.ca.

About Premier American Uranium Inc.

Premier American Uranium is focused on consolidating, exploring, and developing uranium projects across the United States to strengthen domestic energy security and advance the transition to clean energy. The Company’s extensive land position spans five of the nation’s top uranium districts, with active work programs underway in New Mexico’s Grants Mineral Belt and Wyoming’s Great Divide and Powder River Basins.

Backed by strategic partners including Sachem Cove Partners, IsoEnergy Ltd., Mega Uranium Ltd., and other leading institutional investors, PUR is advancing a portfolio supported by defined resources and high-priority exploration and development targets. Led by a distinguished team with deep expertise in uranium exploration, development, permitting, operations, and uranium-focused M&A, the Company is well positioned as a key player in advancing the U.S. uranium sector.

For More Information, Please Contact:

Premier American Uranium Inc.
Colin Healey, CEO

info@premierur.com
Toll-Free: 1-833-223-4673
Twitter: @PremierAUranium
www.premierur.com

Neither TSX Venture Exchange nor its Regulations Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

Cautionary Statement Regarding Forward-Looking Information

This news release contains “forward-looking information” within the meaning of applicable Canadian securities laws. Forward-looking information includes, but is not limited to, statements with respect to, additional exploration activities planned for 2026, the anticipated results thereof and the anticipating timing for reporting of such results; future prospects for exploration; expectations regarding the transition to clean energy in the US; and other activities, events or developments that are expected, anticipated or may occur in the future. Generally, but not always, forward-looking information and statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or the negative connotation thereof or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved” or the negative connotation thereof.

Forward-looking information and statements are based on our current expectations, beliefs, assumptions, estimates and forecasts about PUR’s business and the industry and markets in which it operates. Such forward-information and statements are based on numerous assumptions, including among others, that the results of planned exploration activities are as anticipated, the price of uranium, the anticipated cost of planned exploration activities, the completion, timing and results of planned exploration activities being consistent with expectations, the anticipated mineralization being consistent with expectations, that general business and economic conditions will not change in a material adverse manner, that financing will be available if and when needed and on reasonable terms, that third party contractors, equipment and supplies and governmental and other approvals required to conduct the Company’s planned exploration activities will be available on reasonable terms and in a timely manner. Although the assumptions made by PUR in providing forward-looking information or making forward-looking statements are considered reasonable by management at the time, there can be no assurance that such assumptions will prove to be accurate.

Forward-looking information and statements also involve known and unknown risks and uncertainties and other factors, which may cause actual results, performances and achievements of Premier American Uranium to differ materially from any projections of results, performances and achievements of Premier American Uranium expressed or implied by such forward-looking information or statements, including, among others: limited operating history, negative operating cash flow and dependence on third party financing, uncertainty of additional financing, delays or failure to obtain required permits and regulatory approvals, changes in mineral resources, no known mineral reserves, aboriginal title and consultation issues, reliance on key management and other personnel; potential downturns in economic conditions; availability of third party contractors; availability of equipment and supplies; failure of equipment to operate as anticipated; accidents, effects of weather and other natural phenomena and other risks associated with the mineral exploration industry; changes in laws and regulation, competition, and uninsurable risks and the risk factors with respect to Premier American Uranium set out in the documents of PUR filed with the Canadian securities regulators and available under PUR’s profile on SEDAR+ at www.sedarplus.ca.

Although PUR has attempted to identify important factors that could cause actual actions, events or results to differ materially from those contained in the forward-looking information or implied by forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking statements or information. PUR undertakes no obligation to update or reissue forward-looking information as a result of new information or events except as required by applicable securities laws.

Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8aa9df2a-b315-44eb-b746-7f0ccdd22b0e

https://www.globenewswire.com/NewsRoom/AttachmentNg/b52dd8f3-0f2d-4c7b-8f3f-2ac6c3be6a62

https://www.globenewswire.com/NewsRoom/AttachmentNg/b7f75b68-d17c-400e-8b57-50bd8581b452

https://www.globenewswire.com/NewsRoom/AttachmentNg/e25898c5-c279-47f5-9c44-601fa374885b

Head-to-head comparison shows 94% concordance with tumor-informed ctDNA testing, with the clinical ground-truth in all discordant cases supporting Northstar Response

MENLO PARK, Calif., Oct. 07, 2026 (GLOBE NEWSWIRE) — BillionToOne, Inc. (Nasdaq: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, announced the publication of the first peer-reviewed head-to-head study comparing Northstar Response®, a tissue-free, methylation-based liquid biopsy assay utilizing patented single-molecule counting technology to measure the absolute number of circulating tumor DNA (ctDNA) molecules, with a commercially available tumor-informed ctDNA assay for advanced cancer patients undergoing treatment. The study found that Northstar Response tracked disease dynamics on par with or better than the tumor-informed comparator, without requiring tissue sequencing.

The retrospective real-world study, published in The Journal of Liquid Biopsy, evaluated 169 paired samples from 61 patients, with 71 samples from 36 patients that had sequential concurrent draws for the two assays collected within seven days of each other. Quantitative results, after patient-specific baseline normalization, across repeated measurements were shown to be closely aligned (conditional R² = 0.97). Across evaluable sequential pairs, the two approaches reached the same conclusion of the change in tumor burden direction in 94% of cases (67 of 71).

Importantly, in all of the divergent cases, Northstar Response results were concordant with the ground truth substantiated by imaging and/or biopsy, indicating that the tumor-informed results were either false-positives or false-negatives. For instance, Northstar Response detected progression in cases where the tumor had evolved since the original biopsy, including a case of hormone receptor conversion in advanced breast cancer. Together, the cases illustrate the particular value of tumor-agnostic monitoring to track tumor burden and evolution.

“The ability to combine cancer-associated methylation with single-molecule precision to track changing tumor signal directly from blood is game-changing, as so many patients in the clinic will benefit,” said Vaia Florou, MD, MS, Associate Professor Division of Oncology at the Huntsman Cancer Institute at the University of Utah. “These results showing that a standardized assay can deliver precise longitudinal monitoring without tissue dependency are incredibly relevant for those of us practicing on the frontlines of cancer care.”

Since Northstar Response is not limited to alterations selected from an earlier tissue sample at a fixed point in time, it can capture clinically meaningful changes in disease biology that emerge under treatment pressure. Northstar Response’s simplified workflow can also significantly accelerate the start of molecular monitoring of treatment, potentially by weeks, and enable testing when tissue is unavailable, inadequate, or difficult to biopsy.

“Not only does Northstar Response deliver highly accurate insight into how disease is evolving during treatment, but it also has the added advantage of a streamlined and efficient workflow that can bring molecular testing to more patients,” said Allen Chen, MD, Vice President of Oncology Clinical Development and Medical Affairs at BillionToOne. “Treatment monitoring must be both reliable and practical for it to be effective in routine oncology care. These results show that clinicians do not need to compromise one for the other.”

About Northstar Response

Northstar Response is BillionToOne’s tissue-free, methylation-based ctDNA assay purpose-built for treatment response monitoring in patients with cancer. Powered by the company’s patented QCT™ molecular counting platform — the only multiplex technology capable of counting DNA molecules at the single-molecule level — Northstar Response quantifies tumor burden through serial blood draws with no dependence on tumor tissue at any stage of the patient journey.

About BillionToOne

Headquartered in Menlo Park, California, BillionToOne is a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all. The company’s proprietary single-molecule next-generation sequencing (smNGS) platform is the only multiplex technology that can detect and precisely quantify genetic targets at the physical limit of detection, down to the single DNA molecule. Enabled by Quantitative Counting Templates™ (QCTs™), the platform quantifies disease-related DNA fragments with single base-pair resolution, providing absolute quantification. For more information, visit www.billiontoone.com.

Disclaimer

Northstar Response may produce false-positive or false-negative results. Test results are not a guarantee of the presence or absence of disease or treatment response and should not be used as the sole basis for medical decision-making. Results should be interpreted in conjunction with the patient’s clinical presentation, radiographic findings, and other diagnostic information. Northstar Response is intended to complement, not replace, standard clinical and radiographic assessment of disease status. Northstar Response is a laboratory-developed test (LDT) performed in a CLIA-certified and CAP-accredited laboratory. The test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Test performance may vary based on factors including cancer type, disease burden, treatment, and specimen characteristics.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of federal securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Forward-looking statements in this press release include, but are not limited to, statements regarding the clinical performance of Northstar Response. These statements are based on management’s current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, some of which are beyond BillionToOne’s control. These and additional risks and uncertainties could affect BillionToOne’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. These risks and uncertainties include, but are not limited to, those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in BillionToOne’s Annual Report on Form 10K, most recently filed Quarterly Report on Form 10-Q, and other filings we make with the Securities and Exchange Commission from time to time. The forward-looking statements in this press release are based on information available to BillionToOne as of the date hereof, and BillionToOne disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing BillionToOne’s views as of any date subsequent to the date of this press release.

Reference

Choksi A, Varga MG, Farmer T, et al. Concordance of tumor-informed and tumor-agnostic ctDNA assays for treatment response monitoring in advanced solid tumors. The Journal of Liquid Biopsy. Volume 14, 2026, 100669.

Media Contact

Rachel Ford Hutman
rachel@fordhutmanmedia.com

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