Month: September 2026

John Chambers, PhD, and Nilanjana Sadhu, PhD, to share early insights from pioneering population-scale proteomic study of 10,000 participants in Singapore

REDWOOD CITY, Calif., Sept. 23, 2026 (GLOBE NEWSWIRE) — Seer, Inc. (Nasdaq: SEER) today announced that researchers from Nanyang Technological University will present early findings from the PRECISE-SG100K study at the 2026 Human Proteome Organization (HUPO) World Congress, taking place September 27 to October 1 at the Suntec Singapore Convention & Exhibition Centre.

Led by John Chambers, PhD, Chief Scientific Officer of PRECISE and Lead PI of PRECISE-SG100K, the study represents an ambitious effort to bring deep molecular characterization to population health at unprecedented scale. By integrating proteomic data with genomic, clinical and phenotypic information from Singapore’s multi-ethnic population, PRECISE-SG100K is creating a uniquely rich resource for understanding how biological and population-level differences contribute to health and disease.

As the PRECISE-SG100K program evolved, the investigators expanded its proteomic strategy to include deep, unbiased mass spectrometry-based profiling in 10,000 participants. This complementary arm of the study combines Seer’s Proteograph® Product Suite with high-performance liquid chromatography-mass spectrometry (LC-MS), enabling researchers to interrogate the circulating proteome across a broad dynamic range and at peptide-level resolution. The approach provides an important discovery dimension to the study, allowing investigators to look beyond predefined protein targets and explore biological signals that may not have been anticipated at the outset.

In April 2026, Seer announced that the Proteograph Product Suite had been selected for this 10,000-participant component of PRECISE-SG100K. By enriching proteins across the enormous dynamic range of plasma before mass spectrometry analysis, Proteograph can increase the depth of protein coverage by approximately 7 to 10-fold compared with direct plasma analysis on leading mass spectrometry platforms. That additional depth brings into view lower-abundance proteins and potential biomarkers that can otherwise go undetected, while preserving the peptide-level information needed to investigate protein variants and other molecular differences.

For population-scale studies, depth alone is not enough. Biological signals must also be measured robustly and reproducibly across thousands of samples. The Proteograph workflow is designed to deliver consistent sample processing and high-quality proteomic data at scale, helping investigators distinguish meaningful biological variation from technical variability and increasing confidence in the signals identified across the cohort.

“As biology enters the AI era, the value of our models will ultimately depend on the richness and resolution of the biological data we can generate,” said Omid Farokhzad, Chair and Chief Executive Officer of Seer. “Proteins are the functional layer of biology, yet the plasma proteome spans an extraordinary dynamic range, and many potentially important disease signals are present at low abundance. Proteograph changes what mass spectrometry can see. John Chambers and the PRECISE-SG100K team have created a pioneering study that brings together population scale, diversity and deep, peptide-resolved proteomics in a way that can uncover biology that might otherwise remain hidden.”

“The combination of Proteograph enrichment and high-performance mass spectrometry has allowed us to interrogate the circulating proteome with a level of depth, consistency and reproducibility, and to bring deep biological resolution to population-scale analysis,” said John Chambers, PhD, Chief Scientific Officer of PRECISE and Lead PI of the PRECISE-SG100K study. “The proteomic data generated using this technology are already revealing proteogenomic and epidemiological signals and show strong potential to accelerate biomarker discovery and broaden the reach of precision medicine.”

Seer Breakfast Symposium

Mass Spectrometry-based Proteomics in Asian Cohort Studies: Opportunities and Challenges

Date: Monday, September 28, 2026 | Time: 7:45-8:45 a.m. SGT | Location: Room 330, Level 3

Speakers:

John Chambers, PhD, Professor, Nanyang Technological University, Singapore; Chief Scientific Officer of PRECISE and Lead PI of the PRECISE-SG100K study

Nilanjana Sadhu, PhD, Research Assistant Professor, Nanyang Technological University, Singapore; Proteomic Working Group Lead of the PRECISE-SG100K study

The PRECISE-SG100K study is a landmark effort in precision health, designed to capture genetic, molecular, clinical and phenotypic diversity across Singapore’s multi-ethnic population. As part of its broader proteomic strategy, the study incorporated the Seer Proteograph workflow combined with Thermo Scientific Orbitrap Astral™ mass spectrometry to deeply characterize the circulating proteome of 10,000 individuals. Early proteogenomic and epidemiological findings will provide a first look at the additional biological insights enabled by deep, unbiased, mass spectrometry-based proteomics at population scale.

Seer Poster Presentation

From Peaks to Power: Context-Driven Determinants of Accuracy in Large-Scale Proteomics

Date: Wednesday, September 30, 2026 | Time: 1:15 p.m. SGT | Location: Exhibit Hall | Session: PS03.002

Presenter: Lee Cantrell, Bioinformatics Scientist III, Seer

Authors: Lee Cantrell, Seth Just, Serafim Batzoglou

Population-scale proteomics creates the opportunity to make statistically powered, in-depth biological observations across large cohorts. Realizing that opportunity requires more than depth alone: quantitative fidelity and reproducibility must be maintained as studies scale. This poster examines the acquisition context required to preserve biological signal across large numbers of samples and what those requirements mean for the design of large clinical and population studies.

Together, the presentations illustrate both the scientific ambition and the technical requirements of a new generation of population proteomics studies. PRECISE-SG100K demonstrates what becomes possible when deep, peptide-resolved mass spectrometry is incorporated into a richly characterized, multi-ethnic population cohort, while From Peaks to Power examines what is required to preserve quantitative fidelity as studies reach this scale. Together, they point toward proteomic datasets with the breadth, depth and reproducibility needed to support biomarker discovery, population health research and increasingly data-intensive approaches to biology.

For more information, please visit Booth #232 at the HUPO World Congress.

About Seer, Inc.

Seer, Inc. (Nasdaq: SEER) sets the standard in deep, unbiased proteomics, delivering insights with scale, speed, precision and reproducibility previously unattainable. Seer’s Proteograph® Product Suite integrates proprietary engineered nanoparticles, streamlined automation instrumentation, optimized consumables and advanced analytical software to overcome the limitations of traditional proteomic methods. Seer’s products are for research use only and are not intended for diagnostic procedures. For more information, visit www.seer.bio.

About PRECISE-SG100K Study

The PRECISE-SG100K study is a landmark, long-term research project that has completed recruitment of over 100,000¹ participants from Singapore’s diverse, multi-ethnic population. The study has collected extensive baseline health information and biological specimens and will continue to monitor long-term health outcomes and the environmental, lifestyle and genetic factors associated with diseases such as diabetes, hypertension and cancer. As one of the largest population health studies in Southeast Asia, PRECISE-SG100K is designed to advance precision medicine and improve health outcomes for diverse populations worldwide.

For more information, visit www.npm.sg.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on Seer’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause Seer’s actual results, performance, or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding Seer’s expectations about the PRECISE-SG100K collaboration, population-scale proteomics studies, and the impact of Seer’s products. These and other risks are described more fully in Seer’s filings with the Securities and Exchange Commission and other documents that Seer subsequently files with the Securities and Exchange Commission from time to time. Except to the extent required by law, Seer undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Media Contact

Patrick Schmidt
pr@seer.bio

Investor Contact

Marissa Bych
investor@seer.bio

______________________________
¹ NTD: Above we say 10,000 individuals. Confirm this 100,000 figure is distinct.

NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

VANCOUVER, British Columbia, Sept. 23, 2026 (GLOBE NEWSWIRE) — Grey Matters Health Inc. (the “Company” or “Grey Matters”) (CSE: GREY) (FRANKFURT: AGW0) (OTC: AGNPF), a Canadian healthcare company, is pleased to announce the increase and closing of the second and final tranche (the “Second Tranche”) of its private placement (the “Offering”) previously announced on August 20, 2026. Gross proceeds from the Second Tranche totalled CAD $520,000, consisting of $270,000 from the sale of 675,000 units at $0.40 (the “Equity Units”) and $250,000 from the sale of unsecured convertible debenture units (the “Debenture Units”). The private placement of Equity Units and Debenture Units is collectively referred as the Offering. The first tranche of the Offering closed on September 9, 2026 totalling CAD $600,000, consisting of $285,000 from the sale of 712,500 Equity Units and $315,000 from the sale of Debenture Units. With the closing of the Second Tranche, the Offering has now closed for total proceeds of $1,120,000.

Each Equity Unit, at an issue price of CAD $0.40, consists of one Class A common share in the capital of the Company (a “Common Share“) and one Common Share purchase warrant (a “Warrant“). Each Warrant entitles the holder to acquire one Common Share (a “Warrant Share“) at an exercise price of CAD $0.60 (the “Exercise Price“) per Warrant Share for a period of 36 months from the issuance date (the “Expiry Date“).

Each Debenture Unit consists of one debenture (a “Convertible Debenture”) in the principal amount of CAD $1,000 and 2,198 common share purchase warrants (a “Debenture Warrant”). The Convertible Debentures carry interest at a rate of 10% per annum from the closing date, payable semi-annually in arrears until the maturity date, which will be 24 months from the closing date of the Convertible Debentures or the conversion date of the Debentures. The outstanding principal and interest can be converted, at the option of the Convertible Debenture holder, into Common Share at a fixed price of CAD $0.455 per Common Share on or before the maturity date of the Convertible Debenture. The Company may from time to time, in its sole discretion, prepay all or a part of the principal amount and accrued interest without penalty. Each Debenture Warrant entitles the holder to acquire one Common Share (a “Debenture Warrant Share”) at an exercise price of CAD $0.55 per Debenture Warrant Share for a period of 36 months from the date of issuance.

The Company did not pay any cash finder’s fees or issue finders warrants to eligible finders in regards to the Second Tranche of the Offering.

The Company will use the proceeds of the Offering to advance its Alzheimer’s Disease program towards the opening of U.S. brain-specific neuroimaging clinic, general and administrative expenses, and for working capital purposes.

The securities issued and issuable, described in this and the previous news releases from August 20, 2026, September 10, 2026 and September 16, 2026, will be subject to a statutory hold period of four months plus a day from the date of issuance in accordance with applicable Canadian securities legislation.

The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state securities laws, and may not be offered or sold within the United States or to, or for the account or benefit of, “U.S. persons” (as such term is defined in Regulation S under the U.S. Securities Act) absent registration under the U.S. Securities Act and applicable state securities laws, or an exemption from such registration.

For more information please contact:

Christopher J. Moreau
CEO
Grey Matters Health Inc.
604.398.4175 Ext 701

cjmoreau@greymatters-health.com
info@greymatters-health.com
www.greymatters-health.com

About Grey Matters  

Grey Matters is a Canadian healthcare company focused on the provision of brain dedicated PET scanning services through a planned network of new neuroimaging clinics in the U.S. for the early-stage detection of Alzheimer’s Disease and other forms of neurodegenerative diseases, including frontotemporal dementia, Lewy body dementia, and will additionally offer other select neuro-oncology imaging applications too.

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: This news release contains forward-looking statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

TORONTO, Sept. 23, 2026 (GLOBE NEWSWIRE) — Today, Loblaw released the latest edition of its Food Inflation Report, following Statistics Canada’s release of August CPI data. While grocery inflation slowed to 2.8% year over year, falling below overall inflation for the first time in more than a year, affordability remains a significant challenge for many Canadians. 

This month’s report examines several emerging pressures that could influence food costs in the months ahead, including El Niño, commodity volatility, seafood supply constraints and the latest Canada-U.S. tariff measures. It also outlines how Loblaw is responding by helping customers identify tariff-affected products, highlighting Canadian-made and Canadian-prepared products where possible, and continuing to source competitively to deliver value. 

For more information, contact pr@loblaw.ca.

• All primary endpoints of the study were met, with ACI-7104 shown to be generally safe and well tolerated
• Strong immunogenicity demonstrated, with 100% response rate after three immunizations
• Clear antibody penetration into the cerebrospinal fluid (CSF) and signals for target engagement
• Discussions with FDA regarding future development path planned for early 2027
• AC Immune to host webcast & conference call today at 10:00am EDT / 16:00 CEST details below

Lausanne, Switzerland, September 23, 2026 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company developing targeted therapeutics for neurodegenerative diseases, today announced positive safety and immunogenicity results through week-100 in Part 1 of VacSYn, its randomized, double-blind, placebo-controlled Phase 2 trial of ACI-7104 in patients with early-stage Parkinson’s disease (PD). The study is being conducted in two parts with the aim for Part 1 being to show safety, tolerability and immunogenicity while Part 2 is designed to provide evidence of clinical activity as the basis for a Phase 3 decision. The Part 1 data reported today includes results from all 34 patients randomized into the study (25 patients receiving ACI-7104 and nine receiving placebo).

The primary endpoints for Part 1 of the VacSYn trial of ACI-7104 were safety, tolerability and immunogenicity, all of which were met. ACI-7104 was generally safe and well-tolerated and shown to be strongly immunogenic, with 100% of patients developing antibodies against the immunizing a-syn target antigen PD01 after three immunizations. Antibody reactivity against the aggregated species of a-syn was also demonstrated. Robust antibody penetration into the cerebrospinal fluid (CSF) was observed in all patients.

Part 1 of VacSYn was not designed for biomarker or clinical outcomes evaluation; however, additional exploratory analyses included monitoring the impact of ACI-7104 treatment on certain biomarkers (such as total a-syn and Neurofilament Light chain in the CSF), as well as clinical measures of disease activity. A signal was observed for total a-syn in the CSF, providing preliminary evidence consistent with target engagement. Exploratory correlation analyses identified trends suggesting an association between immunogenicity (antibody levels) and disease activity measures. While the sample size in Part 1 was limited, these observations provide a clear basis for further investigation.

The VacSYn trial of ACI-7104 in early-stage Parkinson’s disease continues in Part 1 (2-year extension) and is advancing toward the initiation of Part 2 (expansion). The final design of Part 2 is being consolidated and will be submitted to the FDA for review, with meetings expected early in 2027.

Martin Zügel, Interim CEO of AC Immune SA, commented: “The results from the complete data set at week-100 in Part 1 are encouraging, with all primary endpoints met, strong immunogenicity demonstrated, and a 100% response rate. This program is one of our strongest active immunotherapies, with ACI-7104-induced antibodies demonstrating preferential binding to aggregated a-syn species. We will now refine our approach to the next development steps in the program and discuss our plans with regulators before embarking on an expanded Phase 2 trial designed to provide evidence of clinical activity as the basis for entry into Phase 3.”

Günther Staffler, Executive Vice President, Development at AC Immune SA, commented: “We are pleased to have observed strong and boostable immune responses, with significant antibody penetration into the CSF and signals for target engagement. Together with the favorable safety profile through week-100, and exploratory correlations between antibody titers and disease activity measures, we are confident that these results provide a strong foundation for the continued development of ACI-7104 into Part 2.”

Conference call details:
Participants may call the following numbers, 10 – 15 minutes before conference start

Switzerland / Europe:    +41 (0) 58 310 50 00

United Kingdom:           +44 (0) 203 059 58 63

United States:               +1 (1) 631 570 56 13

HD Web Phone™:        Click Here

Other international numbers available HERE

Webcast link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=lUHjSJWK

A live and archived webcast will also be accessible in the Investors section of the Company’s website at https://www.acimmune.com/.

Ends

For further information, please contact:

SVP, Investor Relations & Corporate Communications Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com
International Media Optimum Strategic Communications Nick Bastin, Joshua Evans, Aoife Minihan, Ben Cowe Phone: +44 (0) 20 4566 8543 Email: acimmune@optimumcomms.com

About VacSYn

VacSYn (ClinicalTrials.gov: NCT06015841) is an adaptive, randomized, double-blind, placebo-controlled, and biomarker-based Phase 2 study in patients with early PD, consisting of two parts. Part 1 includes 34 patients randomized 3:1 to receive ACI-7104 or placebo, respectively. The results reported today include data from all participants 100 weeks since initiation of treatment. The study is being conducted in two parts with the aim for Part 1 being to show safety, tolerability and immunogenicity while Part 2 is designed to provide evidence of clinical activity and support a Phase 3 decision.

About ACI-7104

ACI-7104.056 is an optimized formulation of its clinically validated anti-a-syn predecessor active immunotherapy that generated a target-specific antibody response against pathological oligomeric a-syn to inhibit spreading and downstream neurodegeneration in early Parkinson’s disease. The accumulation of alpha-synuclein protein aggregates has been shown to cause inflammatory stress in cells and contribute to the degeneration of neurons in the brain. It has been known to play a key role in the development of neurodegenerative diseases such as Parkinson’s Disease.

About AC Immune SA 

AC Immune (NASDAQ: ACIU) is a clinical-stage biopharmaceutical company developing a pipeline of products, including both active immunotherapies and small molecules, targeting key misfolded proteins and pathways for the treatment of multiple neurodegenerative diseases. The company has a growing focus on its wholly owned proprietary clinical-stage programs, including: ACI-7104, an active immunotherapy targeting α-synuclein (α-syn) in Parkinson’s disease; and ACI-19764, a small molecule inhibitor of the NLRP3 inflammasome. In addition, an early-stage small molecule development program targeting intracellular a-syn is advancing towards the clinic.

ACIU has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding and >$4.5 billion in potential milestone payments, plus royalties from sales. ACIU’s pharma-partnered programs, all in Alzheimer’s disease, include: a collaboration on ACI-24, an active immunotherapy targeting Abeta; a collaboration on ACI-35 targeting phospho-Tau; and a collaboration developing brain-penetrant small molecule drugs targeting intracellular pathologic Tau.

All trademarks used or mentioned in this release are protected by law. The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release.

Forward looking statements

This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

Attachment

• FINAL__ACIU ACI-7104 Part 1 week 100 VacSYn Phase 2 results PR

• Immunovant’s proof-of-concept study of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus (CLE) did not achieve statistical significance on the primary endpoint of Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) percent change from baseline at Week 12
• Positive trends were observed on multiple endpoints, with deeper IgG reductions resulting in improved clinical outcomes, but the study did not meet Immunovant’s internal bar to continue development of IMVT-1402 in CLE
• IMVT-1402 demonstrated a favorable safety and tolerability profile, consistent with prior studies
• All other clinical development timelines remain on track

BASEL, Switzerland and LONDON and NEW YORK, Sept. 23, 2026 (GLOBE NEWSWIRE) — Roivant (Nasdaq: ROIV) today announced topline results from Period 1 of Immunovant’s proof-of-concept trial evaluating IMVT-1402 (imeroprubart) for the treatment of cutaneous lupus erythematosus (CLE).

The study did not achieve statistical significance on its primary endpoint of percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 12. Numerical trends favoring IMVT-1402 over placebo were observed across multiple endpoints, and patients who achieved deeper IgG reductions from baseline were more likely to achieve improved clinical responses. However, due to the competitive landscape and the clinical results observed, Immunovant plans to stop development in CLE.

“On behalf of everyone at Immunovant, I want to thank the patients living with CLE who volunteered for this study and the investigators and clinical site teams who conducted it with such care. Their contributions advance our understanding of FcRn inhibition in autoimmune disease and will inform our work going forward,” said Eric Venker, M.D., Pharm.D., Chief Executive Officer of Immunovant.

Immunovant remains focused on rapidly advancing the clinical development of IMVT-1402 across multiple autoimmune diseases with significant unmet need, including Graves’ disease, difficult-to-treat rheumatoid arthritis, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjogren’s disease.

About the Proof-of-Concept Study of IMVT-1402 in CLE
The proof-of-concept clinical study (NCT06980805) of IMVT-1402 (imeroprubart) in CLE is a randomized, double-blind, placebo-controlled, global trial that assessed the safety and efficacy of IMVT-1402 in adult patients with CLE. The study enrolled 57 patients. In Period 1, patients were randomized to IMVT-1402 vs. placebo for a 12-week treatment period. The primary endpoint was the percent change from Period 1 baseline in CLASI-A score at Week 12.

About Immunovant
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases and is a majority-owned subsidiary of Roivant (Nasdaq: ROIV). As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com.

About Roivant
Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA^™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com.

Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.

Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product and product candidates, the availability and success of topline results from our ongoing clinical trials, any commercial potential of our product and product candidates following applicable regulatory approvals and the outcome of any pending litigation. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors.

Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:
Investors
Keyur Parekh
keyur.parekh@roivant.com
Media
Stephanie Lee
stephanie.lee@roivant.com

PRINCETON, N.J., Sept. 23, 2026 (GLOBE NEWSWIRE) — ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), for Everolimus Tablets for Oral Suspension 2mg, 3mg and 5mg. ANI’s Everolimus Tablets for Oral Suspension are the generic version of the reference listed drug (RLD) Afinitor Disperz^®.

“The FDA approval of Everolimus Tablets for Suspension is another example of our R&D team’s continued execution on technically demanding formulations, and the launch adds further momentum to our commercial portfolio.  Our U.S. focused generics business continues to produce outstanding results, and we remain on track to launch at least 15 new generics this year,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

U.S. annual sales for Everolimus Tablet for Oral Suspension totaled approximately $123 million, based on July 2026 moving annual total (MAT) IQVIA data.

About ANI Pharmaceuticals, Inc.

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives” by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit https://www.anipharmaceuticals.com.

Forward-Looking Statements

To the extent any statements made in this release relate to information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the Company’s strategy; its plans with respect to the commercialization and potential sales of the Company’s products, including the launch of Everolimus; its efforts to bring limited-competition products to market and ensure that is high-quality products are readily accessible to its customers and patients in need; expansion plans for the Company’s Rare Disease, Generics and Brands businesses; and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” the negatives thereof, or other words of similar meaning, derivations of such words and the use of future dates.

Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: the ability of the Company’s approved products to achieve commercialization at levels of market acceptance that will allow the Company to maintain profitability; delays and disruptions in the production of the Company’s approved products; delays or failure to obtain or maintain approvals by the FDA of the Company’s products; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies; risks that the Company may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of the Company’s products from both domestic and overseas sources due to supply chain disruptions or for any other reason; the limited number of suppliers for active pharmaceuticals ingredients for our products; the ability of the Company’s manufacturing partners to meet its product demands and timelines; the level of competition the Company faces and the legal, regulatory and/or legislative strategies employed by its competitors to prevent or delay competition from generic alternatives to branded products; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the Company’s ability, and that of its suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; legal proceedings and product liability claims relating to our products and our business; and general business and economic conditions, such as inflationary pressures and geopolitical conditions.

More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, and other periodic reports, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Relations:
Irina Koffler, Vice President, Investor Relations
T: 917-734-7387
E: Irina.koffler@anipharmaceuticals.com

Media Relations:
Argot Partners
T: 212-600-1494
E: ani@argotpartners.com

Source: ANI Pharmaceuticals, Inc.