Tag: GlobeNewswire

Bid procedure, 2026-11-06
Bonds	SWEDEN I/L BOND: 3104. SE0000556599. 2028-12-01 SWEDEN I/L BOND: 3111, SE0007045745, 2032-06-01
Bid date	2026-11-06
Bid times	09.00-10.00 (CET/CEST) on the Bid date
Offered volume (corresponding nominal amount)	3104: 200 million SEK +/-200 million SEK 3111: 200 million SEK +/-200 million SEK
Highest permitted bid volume (corresponding nominal amount)	3104: 200 million SEK per bid 3111: 200 million SEK per bid
Lowest permitted bid volume (corresponding nominal amount)	SEK 10 million per bid
Expected allocation time	Not later than 10.15 (CET/CEST) on the Bid date
Delivery and payment date	2026-11-10
Settlement amount	To be paid to the Riksbank’s account in Euroclear Sweden AB’s securities settlement system SWIFT: VPCSSESSXXX Account: 1 4948 6383 CTM BIC: RIKSSESS ALERT acronym: RIKSBANK

Stockholm, 2026-10-30

This is a translation of the special terms and conditions published on www.riksbank.se. In the case of any inconsistency between the English translation and the Swedish language version, the Swedish language version shall prevail. Complete terms and conditions can be retrieved at www.riksbank.se.

CALGARY, Alberta, Oct. 30, 2026 (GLOBE NEWSWIRE) — Black Diamond Group Limited (“Black Diamond” or the “Company”) (TSX: BDI) today announced the appointment of Michael Chan to its Board of Directors (the “Board”), effective Thursday, October 29^th, 2026.

“We are very pleased to welcome Michael to our Board,” said Trevor Haynes, Chairman and CEO of Black Diamond Group. “He brings over 30 years of investment industry experience and a deep understanding of public markets, capital allocation and the factors that drive long-term value creation. His experience and perspective will complement the strengths of our Board as we execute against our long-range strategy, serve our customers and deliver compounding shareholder value.”

Mr. Chan brings more than three decades of asset management industry experience, including 25 years managing institutional public equity mandates at Fiera Capital, Sceptre Investment Counsel and UBS Global Asset Management. He began his career as an equity analyst at Sun Life Investments, developing research expertise across a broad range of sectors, including financial services, industrials, resources, technology and consumer discretionary.

In 2001, Mr. Chan progressed to Portfolio Manager in Canadian Small/Mid Cap equities and has since managed one of the largest pools of capital in Canada. Over the course of his career, he has received numerous industry recognitions, including being named a Top Gun Investment Mind by Brendan Wood International for his insights into companies, management, strategies and markets.

Mr. Chan is a CFA charterholder and holds an MBA from Queen’s University, as well as a Bachelor of Industrial Engineering and Bachelor of Science in Mathematics from Dalhousie University.

“I am pleased to join Black Diamond’s Board and look forward to working with Trevor, my fellow Directors and the Management Team,” said Michael Chan. “I spent my career evaluating businesses, management teams and strategies from an investor’s perspective, and I look forward to bringing that experience to the Board as the Company continues to execute on its proven growth strategies and track record of strong performance.”

About Black Diamond        

Black Diamond is an industrial services and asset management company with two operating business units – MSS and WFS. We operate in Canada, the United States, and Australia.

MSS through its principal brands, BOXX Modular, CLM, and Schiavi, owns a large rental fleet of modular buildings of various types and sizes. Its network of local branches rent, sell, service, and provide ancillary products and services to a diverse customer base in the construction, industrial, education, financial, and government sectors.

WFS, through its principal brands Black Diamond Lodging and Accommodations, Royal Camp Services and Summit Camps, owns a large rental fleet of modular accommodation assets of various types. Its regional operating terminals rent, sell, service, and provide ancillary products and services including turn-key operated camps with premium integrated catering and hospitality services to a wide array of customers in the resource, infrastructure, construction, disaster recovery, and education sectors.

In addition, WFS includes LodgeLink, which operates a digital marketplace for business-to-business crew accommodation, travel, and logistics in North America, Australia and the Asia-Pacific region. This proprietary digital platform enables customers to efficiently manage the full travel cycle through a rapidly growing network of hotels, remote lodges, and travel partners. LodgeLink solves the unique challenges associated with workforce crew travel and is complemented by Spencer Corporate Travel’s high-touch boutique corporate travel management service.

Learn more at www.blackdiamondgroup.com.

Investor and Media Inquiries
Emma Covenden at 403-888-1666 or investor@blackdiamondgroup.com

To sign up for news alerts please go to www.blackdiamondgroup.com/investor/subscription/

LIVONIA, Mich., Oct. 30, 2026 (GLOBE NEWSWIRE) — Alta Equipment Group Inc. (NYSE: ALTG) (“Alta” or “the Company”), a leading provider of premium material handling, construction and environmental processing equipment and related services, today announced that it will report its financial results for the third quarter ended September 30, 2026, after the U.S. markets close on Monday, November 9, 2026. In conjunction with this announcement, Alta management will host a conference call and webcast on Tuesday, November 10, at 8:00 a.m. Eastern Time to discuss and answer questions about the Company’s financial results. Prior to the conference call and webcast, Alta will issue a press release and supplementary presentation slides reporting these results on the Investors portion of the Company’s website, https://investors.altaequipment.com.

Conference Call Details:
What: Alta Equipment Group Third Quarter Earnings Call and Webcast
Date: Tuesday, November 10, 2026
Time: 8:00 a.m. Eastern Time
Live call: (833) 461-5787
International: International Dial-In Numbers
Meeting ID: 500034146
Webcast: https://events.q4inc.com/attendee/500034146

The webcast replay will be archived through November 10, 2027.

About Alta Equipment Group Inc.
Alta owns and operates one of the largest integrated equipment dealership platforms in North America. Through its branch network, the Company sells, rents, and provides parts and service support for several categories of specialized equipment, including lift trucks and other material handling equipment, heavy and compact earthmoving equipment, crushing and screening equipment, environmental processing equipment, cranes and aerial work platforms, concrete and asphalt paving equipment, other construction equipment and allied products. Alta has operated as an equipment dealership for 42 years and has over 80 total locations across Michigan, Illinois, Indiana, Ohio, Pennsylvania, Massachusetts, Maine, Connecticut, New Hampshire, Vermont, Rhode Island, New York, Virginia, Nevada and Florida, and the Canadian provinces of Ontario, New Brunswick, and Quebec. Alta offers its customers a one-stop shop for their equipment needs through its broad, industry-leading product portfolio. More information can be found at www.altg.com.

Contacts

Investors:

Kevin Inda

SCR Partners, LLC

kevin@scr-ir.com

(225) 772-0254

NEW YORK, Oct. 30, 2026 (GLOBE NEWSWIRE) — OTC Markets Group Inc. (OTCQX: OTCM), operator of regulated markets for trading 12,000 U.S. and international securities, today announced Pacifica Silver Corp. (CSE: PSIL; OTCQX: PAGFF), a mineral exploration company, has qualified to trade on the OTCQX® Best Market. Pacifica Silver Corp. upgraded to OTCQX from the OTCQB® Venture Market.

Pacifica Silver Corp. begins trading today on OTCQX under the symbol “PAGFF.” U.S. investors can find current financial disclosure and Real-Time Level 2 quotes for the company on www.otcmarkets.com.

Pacifica Silver Corp. is a Canadian resource company led by a proven management team with decades of mining and exploration experience in Mexico. The company is currently focused on its 100% owned Claudia Project located in Mexico’s Sierra Madre Occidental—one of the world’s most prolific epithermal precious metal belts.

The OTCQX Market is designed for established, investor-focused U.S. and international companies. To qualify for OTCQX, companies must meet high financial standards, follow best practice corporate governance, and demonstrate compliance with applicable securities laws. Graduating to the OTCQX Market from the OTCQB Market marks an important milestone for companies, enabling them to demonstrate their qualifications and build visibility among U.S. investors.

“Graduating to the OTCQX Best Market is a meaningful milestone for Pacifica Silver as we continue to broaden our presence across North America,” said Todd Anthony, Chief Executive Officer of Pacifica Silver. “Trading on OTCQX will provide greater visibility and more convenient access for U.S. investors as we advance our Claudia Project in Durango State, Mexico.”

Trading in non-U.S. North American securities on OTC Markets reached $29.38B in the third quarter of 2026, representing an 84.22% increase over Q3 2025. OTC Markets recorded $203.47B in total dollar volume in Q3. North America ranked among the top home markets by trading volume during the quarter, highlighting sustained U.S. investor demand for internationally listed names.

About Pacifica Silver Corp.
Pacifica Silver Corp. is a mineral exploration company with the high-grade Claudia Silver-Gold Project in Durango, Mexico, situated along the mineral-rich Sierra Madre Occidental belt, near major mines. The project spans 11,876 hectares, with over 30 km of known veins, of which less than 10% has been drill tested. The Company has also identified at least nine historic mines on the Claudia Project property. The project encompasses multiple previously identified mineralized zones, including Santiaguera, Mina de Oro, Mina Vieja, El Grullo, Noche Buena, Tres Reyes, Aguilareña, Guadalupana, La Concepción, Don Cose, El Cristo, and the Lizeth Vein Swarm.

About OTC Markets Group Inc.
OTC Markets Group Inc. (OTCQX: OTCM) operates regulated markets for trading 12,000 U.S. and international securities. Our data-driven disclosure standards form the foundation of our public markets: OTCQX® Best Market, OTCQB® Venture Market, OTCID™ Basic Market and Pink Limited™ Market. Our OTC Link® Alternative Trading Systems (ATSs) provide critical market infrastructure that broker-dealers rely on to facilitate trading. Our innovative model offers companies more efficient access to the U.S. financial markets.

OTC Link ATS, OTC Link ECN, OTC Link NQB, OTC Overnight® and MOON ATS® are each an SEC regulated ATS, operated by OTC Link LLC, a FINRA and SEC registered broker-dealer, member SIPC.

To learn more about how we create better informed and more efficient markets, visit www.otcmarkets.com.

Media Contact:
OTC Markets Group Inc., +1 (212) 896-4428, media@otcmarkets.com

NEW YORK, Oct. 30, 2026 (GLOBE NEWSWIRE) — Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that Michael A. Metzger, Chief Executive Officer, as well as members of the Syndax management team, will participate in the following upcoming investor conferences:

• Guggenheim 3rd Annual Healthcare Innovation Conference in Boston, MA with a fireside chat on Tuesday, November 10, 2026, at 11:00 a.m. ET.
• Stifel 2026 Healthcare Conference in New York, NY with a fireside chat on Thursday, November 12, 2026, at 9:20 a.m. ET.
• UBS Global Biopharma Conference 2026 in London, UK with a fireside chat on Tuesday, November 17, 2026, at 12:00 p.m. GMT / 7:00 a.m. ET.
• Jefferies London Healthcare Conference in London, UK with a fireside chat on Thursday, November 19, 2026, at 12:30 p.m. GMT / 7:30 a.m. ET.

A live webcast of the fireside chats will be available in the Investor section of the Company’s website at www.syndax.com, where a replay will also be available for a limited time.

About Syndax

Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include Revuforj^® (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com or follow the Company on X and LinkedIn.

Syndax Contacts

Sharon Klahre
Syndax Pharmaceuticals, Inc.
sklahre@syndax.com
Tel 781.684.9827

SNDX-G

SANTIAGO, Chile, Oct. 30, 2026 (GLOBE NEWSWIRE) — Banco Santander Chile (NYSE: BSAC; SSE: Bsantander) announced today its results¹ for the nine-month period ended September 30, 2026, and third quarter 2026 (3Q26).

Solid financial performance with a ROAE² of 24.5% in 3Q26³ and profit growth of 11.9% YoY⁴.

As of September 30, 2026, net income attributable to the Bank’s owners totaled $893 billion (US$4.74 per share and US$1.94 per ADR). Compared to the same period of the previous year, net income increased by 11.9%, reaching a ROAE of 24.5% in 9M26⁵ versus 24.0% in 9M25⁶. This is mainly due to higher net interest income resulting from higher inflation in the readjustment income line, as the UF variation was 3.3% in 9M26 compared to 2.8% in 9M25. Higher results from financial transactions and lower operating expenses also contributed to this improvement.

Furthermore, at the shareholders’ meeting in April 2026, it was agreed to distribute dividends of 60% of the profits from the 2025 fiscal year. This is a dividend of $3.35 per share and a yield of 4.5%.

In the third quarter of 2026, net income attributable to the Bank’s owners totaled $237 billion ($1.30 per share and US$0.50 per ADR). Compared to the previous quarter (2Q26), it decreased 38.0% QoQ⁷ and 4.2% compared to 3Q25, primarily due to lower net income from readjustments in a quarter with lower inflation (0.6% in 3Q26⁸ vs. 2.5% in 2Q26 and 0.6% in 3Q25), as well as lower fee income and higher provisions during the quarter. Despite these factors, ROAE reached 19.1% in 3Q26.

Total equity increased 5.7% during the year, including a dividend distribution provision of 70%.

Total equity reached $5,114,925 million as of September 30, 2026, a 5.7% increase compared to December 31, 2025. This growth is primarily due to reserves resulting from higher profits in fiscal year 2025. Additionally, as of September 2026, the Bank increased its dividend provision from 60% to 70% of 2026 profits. The Bank maintains a stable CET1 ratio⁹ of 10.9% with a capital adequacy ratio¹⁰ of 16.3% as of September 2026.

Customer funds grow 3.7% in the quarter.

The Bank’s total deposits increased by 9.0% as of December 31, 2025, driven by an 18.1% growth in time deposits. This was partially offset by a slight contraction in demand deposits, associated with the usual seasonality compared to the previous year-end; however, demand deposits have increased by 5.5% compared to September 2025. We have also seen increased demand for mutual funds, which grew by 15.5% YTD¹¹. Overall, client funds have grown by 11.1% as of December 31, 2025.

In the third quarter (3Q26), total deposits increased by 2.8% QoQ. With lower expectations of cuts to the Monetary Policy Rate, time deposits grew by 5.6%, while demand deposits decreased slightly by 0.8% QoQ. Meanwhile, mutual funds increased by 5.5% QoQ. Overall, customer funds grew by 3.7% QoQ.

Total loans grew 1.8% QoQ, driven by higher demand for loans from large companies

Total loans at amortized cost increased by 3.0% compared to December 31, 2025 and by 1.8% QoQ, driven by growth in commercial, mortgage, and auto loans.

During the second and third quarters, incipient signs of recovery in commercial loans began to appear, with growth of 5.5% since December 31, 2025, and 4.0% QoQ. This trend was primarily driven by increased demand for financing for foreign trade loans and the depreciation of the Chilean peso against the US dollar since December 2025. Secondly, it was also influenced by improved growth in non-trade-export commercial loans to large companies.

Within consumer loans is the auto financing business, Santander Consumer, which has maintained positive trends with an increase of 6.3% since December 31, 2025 and an increase of 2.1% QoQ thanks to greater commercial agreements with car dealerships.

Best-in-Class in the industry, with an efficiency¹² of 33.0% in 9M26 with operating expenses contracting YoY.

The Bank’s efficiency ratio reached 33.0% as of September 30, 2026, an improvement over the 35.9% recorded in the same period of the previous year, and the efficiency ratio stood at 36.1% in 3Q26. In line with this, the cost-to-asset ratio decreased to 1.4% in the first nine months of 2026.

Operating expenses (which include other expenses) decreased by 4.2% compared to 9M25, primarily due to lower administrative costs. It’s worth noting that during the first quarter of 2025, the Bank completed a significant milestone with Project Gravity, which involved migrating from the mainframe to the cloud. During that period, both systems operated in parallel, resulting in higher costs. Furthermore, the transition to the new cloud infrastructure generated higher amortization and depreciation expenses associated with legacy systems.

During 3Q26, operating expenses decreased by 1.4% compared to 2Q26 and by 4.0% compared to 3Q25, explained by lower other operating expenses in the quarter.

Net interest income and readjustments increased 7.0% YoY with a NIM¹³ of 4.1% in 9M26.

Net interest and readjustment income accumulated to September 30, 2026 increased by 7.0% compared to the same period in 2025. This growth was driven by a 21.8% increase in readjustment income, favored by a UF variation of 3.3% in 9M26 compared to 2.8% in the same period in 2025.

In 3Q26, total net interest and readjustment income decreased by 18.1% compared to 2Q26, mainly due to a sharp contraction in readjustment income of 64.6% in 3Q26, where the variation of the UF decreased from 2.5% in 2Q26 to 0.6% in 3Q26. Meanwhile, interest income in the quarter remained stable compared to the previous quarter.

As a result of these inflationary dynamics, the net interest margin (NIM) reached 3.8% in 3Q25, 4.7% in 2Q26 and 3.8% in 3Q26. In cumulative terms, the NIM increased from 4.0% in 9M25 to 4.1% in 9M26.

Customer base expansion continues, with total customers increasing by 7.5% YoY.

The strategy of strengthening digital products has led to continued growth in our customer base, reaching over 4.9 million customers, of which 2.7 million are active. The Bank’s market share in current accounts remained strong, reaching 20.4% as of July 2026. Likewise, the increased use of digital platforms continued to drive fee income, with YoY growth of 13% in mutual fund brokerage and insurance. As a result, the recurrence ratio (total net fees divided by structural support expenses) reached 60.8% YTD as of September 2026, demonstrating that almost two-thirds of the Bank’s expenses are financed by fees generated by customers.

Banco Santander Chile is one of the companies with the highest risk ratings in Latin America, with an A2 rating from Moody’s, A- from Standard & Poor’s, A+ from the Japan Credit Rating Agency, and AA- from HR Ratings. All ratings have a stable outlook as of the date of this report.

As of September 30, 2026, the Bank has total assets of CLP 78,140,567 million (US$ 84,835 million), total gross loans (including interbank loans) at amortized cost of CLP 42,153,512 million (US$ 45,765 million), total deposits of CLP 33,308,102 million (US$ 36,152 million), and shareholders’ equity of CLP 4,943,285 million (US$ 5,367 million). The capital adequacy ratio is 16.3%, with a core capital ratio of 10.9%. As of September 30, 2026, Santander Chile employs 8,188 people and has 219 branches throughout Chile.

CONTACT INFORMATION
Cristian Vicuña
Chief Strategy Officer and Head of Investor Relations
Banco Santander Chile
Bandera 140, 20^th Floor
Santiago, Chile
Email: irelations@santander.cl Website: www.santander.cl

---

1 The information contained in this report is presented in accordance with Chilean Bank GAAP as defined by the Financial Markets Commission (FMC).
2 Net profit attributable to shareholders of the Bank annualized divided by the average equity attributable to shareholders.
3 Third quarter of 2026.
4 Year-on-year.
5 The nine months ending on September 30, 2026.
6 The nine months ending on September 30, 2025.
7 Quarter vs. quarter. (2Q26 vs 1Q26).
8 Third quarter of 2025.
9 Common Equity Tier 1 divided by risk-weighted assets, under Chilean regulation.
10 Tier 1 + Tier 2 capital divided by risk-weighted assets, under Chilean regulation.
11 Year-to-date
12 Operating expenses including impairment and other operating expenses/ margin+commissions+ financial transactions and other net operating income.
13 NIM: Net interest margin. Annualized accumulative net interest income and readjustments divided by the average of interest-earning assets.

Mount Laurel, NJ., Oct. 30, 2026 (GLOBE NEWSWIRE) —  J & J Snack Foods Corp. (Nasdaq: JJSF) today announced that it will release financial results for its fourth quarter and fiscal year ended September 26, 2026, before the stock market opens on Wednesday, November 18, 2026. The Company will hold a conference call and webcast to discuss the results at 10:00 a.m. Eastern Time that same day.

Investors interested in participating in the live call can pre-register by clicking on this Registration Link to receive the dial-in number and a personal PIN, which are required to access the conference call.  The live audio webcast will be accessible on the Company’s investor relations website at https://www.jjsnack.com/investors/ or directly at here.  

About J & J Snack Foods Corp.

J & J Snack Foods Corp. is a leader and innovator in the snack food industry, providing innovative, niche, and affordable branded snack foods and beverages to foodservice and retail supermarket outlets. Manufactured and distributed nationwide, our principal products include SUPERPRETZEL, the #1 soft pretzel brand in the world, as well as internationally known ICEE and SLUSH PUPPIE frozen beverages, DIPPIN’ DOTS ice cream, LUIGI’S Real Italian Ice, MINUTE MAID* frozen ices, WHOLE FRUIT sorbet and frozen fruit bars, HOLA! CHURROS, and THE FUNNEL CAKE FACTORY funnel cakes and several bakery brands within DADDY RAY’S, COUNTRY HOME BAKERS and HILL & VALLEY. For more information, please visit http://www.jjsnack.com.

*MINUTE MAID is a registered trademark of The Coca-Cola Company.

Investor Contact:
Reed Anderson, ICR
(646) 277-1260
reed.anderson@icrinc.com

— Topline data show that ALTITUDE-AD did not meet the primary endpoint of change from baseline in cognitive and functional decline as measured by the Integrated Alzheimer’s Disease Rating Scale (iADRS) at 18 months compared to placebo at either dose; key secondary endpoints, including CDR-SB, also did not achieve statistical significance —

— Acumen to cease clinical development of sabirnetug, preserve cash and explore strategic options —

NEWTON, Mass., Oct. 30, 2026 (GLOBE NEWSWIRE) — Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (“Acumen” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics that target toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced that initial topline data from its Phase 2 ALTITUDE-AD clinical trial of sabirnetug (ACU193) in participants with early AD did not meet its primary endpoint of change from baseline in cognitive and functional decline as measured by the Integrated Alzheimer’s Disease Rating Scale (iADRS) at 18 months compared to placebo at either the 35 mg/kg or the 50 mg/kg dose. The trial also failed to achieve statistical significance on key secondary efficacy endpoints, including the Clinical Dementia Rating – Sum of Boxes (CDR-SB), and did not show any meaningful difference between either sabirnetug treatment arm and the placebo arm. Sabirnetug was generally well tolerated, with amyloid-related imaging abnormalities – edema (ARIA-E) observed in ~10% of sabirnetug-treated participants. An analysis of change in amyloid plaque load, as measured by positron emission tomography (PET) SUVr, demonstrated statistically significant amyloid plaque reduction for both dose levels at week 36 and week 76.

Acumen expects to receive and analyze additional data from ALTITUDE-AD in the coming weeks, including fluid biomarker and additional imaging data, but does not expect these data to change the efficacy conclusions of the trial.

Based on the initial topline results, Acumen plans to cease development of sabirnetug, including the open-label extension portion of the ALTITUDE-AD trial, and to evaluate its strategic options, including its Enhanced Brain Delivery™ (EBD®) program. In the interim, the Company plans to take steps to implement cash conservation measures and explore strategic options to maximize shareholder value.

“While we are disappointed the trial did not meet its primary endpoint, we express our compassion and hope for future therapeutic options for patients with Alzheimer’s disease and their families,” said Daniel O’Connell, Chief Executive Officer of Acumen. “We have tremendous gratitude toward the patients, caregivers, investigators and clinical trial sites, as well as all Acumen employees, who worked so diligently over many years on this program.”

About Sabirnetug (ACU193) 

Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble AβOs, which are a highly toxic and pathogenic form of Aβ, relative to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AβOs, sabirnetug aims to address the hypothesis that soluble AβOs are an early and persistent underlying cause of the neurodegenerative process in AD. Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S. Food and Drug Administration and was evaluated in the Phase 2 ALTITUDE-AD clinical trial in patients with early AD.

About ALTITUDE-AD (Phase 2)

Initiated in 2024, ALTITUDE-AD is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of sabirnetug (ACU193) infusions administered once every four weeks in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer’s disease. The study has enrolled 542 individuals with early Alzheimer’s disease (mild cognitive impairment or mild dementia due to AD) at multiple investigative sites located in the United States, Canada, the European Union and the United Kingdom. More information can be found on www.clinicaltrials.gov, NCT identifier NCT06335173. 

About Acumen Pharmaceuticals, Inc. 

Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapeutics that target toxic soluble AβOs for the treatment of AD. Acumen’s scientific founders pioneered research on AβOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen’s lead investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AβOs, was evaluated in the Phase 2 ALTITUDE-AD clinical trial (NCT06335173) in early symptomatic Alzheimer’s disease patients, following positive results in its Phase 1 trial INTERCEPT-AD. Acumen is also investigating a subcutaneous formulation of sabirnetug using Halozyme’s proprietary ENHANZE^® drug delivery technology. Acumen is also collaborating with JCR Pharmaceuticals to develop an Enhanced Brain Delivery™ (EBD^®) therapy for Alzheimer’s disease utilizing a transferrin-receptor-targeting blood-brain barrier-penetrating technology. The company is headquartered in Newton, Mass. For more information, visit www.acumenpharm.com.

Forward-Looking Statements

This press release contains forward-looking statements.  Any statement describing Acumen’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Words such as “believes,” “expects,” “anticipates,” “could,” “should,” “would,” “seeks,” “aims,” “plans,” “potential,” “will,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning the therapeutic potential of Acumen’s product candidate, sabirnetug (ACU193); the anticipated receipt and analysis of additional data from ALTITUDE-AD and Acumen’s expectation that such data will not change the clinical trial’s efficacy conclusions; Acumen’s plans to cease development of sabirnetug; and Acumen’s plans to evaluate its strategic options and take steps to implement cash conservation measures and explore strategic options to maximize shareholder value. These statements are based upon the current beliefs and expectations of Acumen’s management, and are subject to certain factors, risks and uncertainties, including the risk that additional data or further analyses from ALTITUDE-AD may differ from, or change the interpretation of, the topline results, and particularly those inherent in the process of discovering, developing and commercializing safe and effective human therapeutics. Such risks may be amplified by the impacts of geopolitical events and macroeconomic conditions. These and other risks concerning Acumen’s programs are described in additional detail in Acumen’s filings with the Securities and Exchange Commission (“SEC”), including in Acumen’s most recent Quarterly Report on Form 10-Q, Annual Report on Form 10-K, and in subsequent filings with the SEC. Copies of these and other documents are available from Acumen.  Additional information will be made available in other filings that Acumen makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Acumen expressly disclaims any obligation to update or revise any forward-looking statement, except as otherwise required by law, whether, as a result of new information, future events or otherwise.

Investors:
Alex Braun
abraun@acumenpharm.com

Media: 
Robyn Moxon
rmoxon@acumenpharm.com

• Preservative-Free Ketamine is an American-manufactured presentation of ketamine that contains no benzethonium chloride (BZT), a toxic antimicrobial preservative that is not Generally Recognized as Safe (GRAS) by the FDA. Current law requires preservatives and other inactive ingredients of drugs, foods, and cosmetics to be GRAS or demonstrated to be unsafe.
• Benzethonium Chloride is known to be toxic to the cells that line the body’s organs (epithelial cells) and is banned from new drugs, consumer hand cleansers, wipes, healthcare or surgical hand rubs ^1,2
• Ketamine, originally formulated in 1970 is one of the last remaining sterile drugs to contain Benzethonium Chloride.
• NRx aims to return sterile, injectable drug manufacture to the United States and to end the current shortage of traditional glass-bottled ketamine through modern, high-volume “blow-fill-seal” technology, manufactured in the United States with Nephron Pharmaceuticals in West Columbia, South Carolina.
• This approval demonstrates that sterile, injectable drug manufacturing can be reshored to the United States from current overseas sources of supply using modern technology for the benefit of American patients, workers, and their families.
• The Company will host a conference call Friday, October 30, at 8:30 a.m. ET.

WILMINGTON, Del., Oct. 30, 2026 (GLOBE NEWSWIRE) — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, “NRx” or “the Company”), a commercial biopharmaceutical company developing medicines that target depression, PTSD, and suicidality today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Abbreviated New Drug Application (ANDA) for Preservative-Free Ketamine. The approval comes ahead of the FDA-announced November 10, approval goal date.

“We are excited to bring Preservative-Free Ketamine to market and to give patients and their physicians an option for repeat treatments without the potential dangers of a preservative that has been classified as unacceptable for inclusion in multiple product categories by the US Food and Drug Administration,” said Jonathan Javitt, MD, MPH, the company’s Chairman and Chief Executive Officer. “Ketamine injection has been in short supply since 2018 and currently appears on the FDA drug shortage list with some manufacturers discontinuing production. The Secretary of Health and FDA Commissioner have previously identified ketamine as a strategic drug whose supply in the US must be assured. With manufactured commercial supply on hand, we can now label our product and supply American hospitals and clinics. In those settings, ketamine is used primarily for anesthesia and pain control, including in labor and delivery, where it is the only IV anesthetic that minimizes suppression of breathing in the baby. We are pleased to work with our partners at Nephron Pharmaceuticals in West Columbia, South Carolina, who have helped us prove that sterile, preservative-free injectables can be made in America.”

Currently all available ketamine injection products contain benzethonium chloride (BZT). According to current regulation, inactive ingredients in drugs (including preservatives) must be Generally Recognized as Safe (“GRAS”) or proven not to be unsafe. The FDA has declined to designate Benzethonium Chloride as GRAS. Under current FDA policy, benzethonium chloride cannot be included in new drugs, consumer hand cleansers, wipes, healthcare or surgical hand rubs nor in intravenous formulations above a threshold concentration for toxicological reasons.^1,2 Ketamine is one of the few remaining old drugs, initially formulated in 1970 to contain BZT. Prior to NRx’s novel formulation, it was widely believed that BZT was required for long-term stability and sterility of ketamine.

The Company has filed a Citizen Petition with FDA seeking to have BZT removed from ketamine and an expert Toxicology report is available to the public on the FDA docket. That report, compiled by a Board-Certified Toxicologist under the supervision of a leading Regulatory Law Firm, documents that patients receiving ketamine at dosages routinely used in hospitals and clinics for labeled indications may be exposed to levels of BZT that exceed the published FDA maximum daily exposure of 1 milligram.²

Federal policymakers have addressed the threat to the United States of a sterile injectable drug supply that is largely manufactured offshore. Traditional, labor-intensive, glass bottle manufacturing of these drugs has not been economically viable in the United States for decades. NRx’s presentation of Ketamine demonstrates that manufacture of old-line sterile, injectable drugs can be reshored to the United States for the benefit of American patients, workers, and investors.

The approval of Ketamine ahead of its Generic Drug User Fee Act (GDUFA) goal date by the FDA Office of Generic Drugs demonstrates FDA’s commitment to timely and efficient approval of drug-shortage drugs.

Conference Call Details

The Company will host a conference call at 8:30 a.m. ET on Friday, October 30, 2026, to discuss the FDA approval of Preservative-Free Ketamine. A live webcast of the conference call will be available on the Company’s website at https://ir.nrxpharma.com/events. Participants that are unable to join the webcast can access the conference call via telephone by dialing domestically 1-800-717-1738 or internationally 1-646-307-1865.

About NRx Pharmaceuticals, Inc.

NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA receptor platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company has been awarded a Abbreviated New Drug Approval (ANDA) for Preservative-Free Ketamine and is seeking New Drug Approval for a presentation of intravenous ketamine (NRX-100) with approved claims for treating depression and suicidality.

In October 2026 the Defense Advanced Research Projects Agency awarded an $11.25 million contract to NRx to conduct a phase 3 trial of its oral drug NRX-101, (D-cycloserine/lurasidone) combined with Robotic Neuronavigated Transcranial Magnetic Stimulation as a one-day treatment for patients with depression. NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression.

Notice Regarding Forward-Looking Statements

The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “look forward,” and other similar expressions among others. These statements relate to future events or to the Company’s future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company’s current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company’s operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Brian Korb
Managing Partner, astr partners
(917) 653-5122
brian.korb@astrpartners.com

Media Contact:
Victoria Verdeja
RXMD
(305) 904-1038
vverdeja@rxmedny.com

References

1. U.S. Food and Drug Administration. (2019). Safety and effectiveness of consumer antiseptic rubs; topical antimicrobial drug products for over-the-counter human use. Federal Register, 84(71), 14847–14864.
2. U.S. Food and Drug Administration. (n.d.). Inactive ingredient search for approved drug products: Benzethonium chloride. Retrieved October 29, 2026, from https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
3. https://www.regulations.gov/document/FDA-2025-P-3577-0004

• Patent milestones build on positive REMAIN-1 six-month pivotal results and patient research supporting interest in a one-time procedure for post-GLP-1 weight maintenance
• New catheter patent provides protection extending to 2042; broader portfolio includes issued duodenum treatment-method claims not limited to any specific energy modality
• Fractyl’s IP portfolio includes 39 granted U.S. patents, approximately 40 pending U.S. applications and more than 50 issued international patents

BURLINGTON, Mass., Oct. 30, 2026 (GLOBE NEWSWIRE) — Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced additions to its U.S. patent portfolio that strengthen the intellectual property foundation for investigational Revita® as the Company advances toward a planned U.S. Food and Drug Administration (FDA) De Novo marketing submission for post-GLP-1 weight maintenance.

The patent developments build on positive six-month results from the REMAIN-1 Pivotal Cohort and recently announced market research identifying patient interest in a one-time procedural approach to maintaining weight loss after GLP-1 therapy. Together, these advances support Fractyl’s strategy to develop Revita as a potential new treatment option for patients seeking to preserve the weight loss they achieved with medication.

The U.S. Patent and Trademark Office (USPTO) has issued a patent covering aspects of Revita’s single-use catheter and allowed a patent application covering how the system controls thermal energy during treatment. These developments complement an existing console patent and broader issued treatment-method claims that are not limited to any specific energy modality.

“The positive six-month REMAIN-1 results and our patient research strengthen our confidence in Revita’s potential to address a substantial unmet need in post-GLP-1 weight maintenance by targeting the duodenum,” said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. “As we build the clinical evidence and prepare for potential commercialization, we are also strengthening protection for the innovations behind Revita. Our portfolio spans key device components and duodenal treatment methods, including claims that are not limited to any specific energy modality. We believe this breadth is an important foundation for Revita’s potential long-term commercial value.”

Protecting the technology behind a potential one-time treatment

U.S. Patent No. 12,740,821, issued September 22, 2026, covers specific design features of the Revita catheter designed to help it navigate the duodenum—the first part of the small intestine—and position the treatment element for duodenal ablation.

The single-use catheter is a key component of the Revita system. The patent’s term extends to November 28, 2042, adding long-term protection for the claimed catheter technology.

The USPTO has also issued a Notice of Allowance for U.S. Patent Application No. 18/988,800, directed to Revita’s thermal dosing method. The allowed claims cover separately controlling heated and cooling fluids within the treatment element to regulate the thermal dose delivered to the duodenal lining. This method is part of the hydrothermal ablation approach being evaluated in the ongoing REMAIN-1 Pivotal Cohort.

Treatment-method claims not limited to any specific energy modality

Fractyl’s intellectual property strategy extends beyond the specific hardware and hydrothermal technology used in Revita to include methods of treating duodenal tissue that are not limited to a particular ablation modality.

U.S. Patent No. 12,471,979 includes an independent method claim that is not limited to any specific energy modality. The claim addresses a defined sequence of positioning an expandable treatment device, delivering energy to duodenal mucosal tissue, and repeating treatment at additional locations. Dependent claims expressly address electrical or thermal energy.

These claims provide an additional layer of treatment-method protection alongside patents covering Revita’s catheter, console and thermal dosing technology. Their scope is defined by the device features and procedural steps required by the claims.

Building the foundation for potential commercialization

The catheter patent and allowed thermal-dosing application complement U.S. Patent No. 12,690,909, issued July 28, 2026, which covers a heater design for the Revita console.

Together, these recent patent developments strengthen issued and allowed claims across the system that powers the procedure, the single-use catheter and the treatment method. Fractyl believes this combination supports its preparations for potential commercialization while protecting innovations developed through years of investment in duodenal treatment technology.

Fractyl’s intellectual property portfolio currently includes 39 granted U.S. patents, approximately 40 pending U.S. applications, and more than 50 issued patents outside the United States. The portfolio includes patents with terms extending into 2042, although individual patent terms vary.

About Revita

The Revita® DMR System is Fractyl’s lead product candidate, designed to remodel the duodenal lining via a single, minimally invasive endoscopic procedure intended to restore healthy nutrient sensing and signaling disrupted by chronic metabolic disease. By targeting duodenal dysfunction, Revita is designed to address an underlying driver of obesity and enable durable weight maintenance following GLP-1 discontinuation. Revita has received FDA Breakthrough Device Designation for weight maintenance in people with obesity who discontinue GLP-1 therapies. Revita is for investigational use only in the United States and is CE marked in the European Union and United Kingdom.

About Fractyl Health

Fractyl is a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes. The Company’s lead product candidate, Revita, is an endoscopic procedural therapy in pivotal development for post-GLP-1 weight maintenance. Fractyl’s goal is to change the course of metabolic disease, advancing treatment from chronic management toward prevention and reversal of disease. Fractyl is headquartered in Burlington, Massachusetts.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact are forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words.

Forward-looking statements in this press release include, without limitation, statements regarding: the scope, duration, enforceability and potential benefits of the Company’s intellectual property protection, including the potential application of treatment-method claims to technologies using different energy modalities; the anticipated issuance of allowed patent applications and growth of the Company’s patent portfolio; the potential protection afforded by patents covering the Revita console, catheter and treatment methods; the potential contribution of the Company’s intellectual property portfolio to Revita’s long-term commercial value; the promise and potential impact of the Company’s clinical trial data, market research and product candidates, including Revita’s potential for maintaining weight loss following GLP-1 therapy discontinuation; the potential patient population, patient interest and commercial opportunity for Revita; the Company’s regulatory strategy, including the timing of any potential De Novo marketing application submission and the potential use and benefits of the De Novo pathway; the potential receipt of FDA marketing authorization; the potential launch or commercialization of the Company’s product candidates; the Company’s strategic and product development objectives and goals; and the timing of any of the foregoing.

These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, without limitation, the risk that pending or allowed patent applications may not issue as patents; that issued patents may be challenged, invalidated, circumvented or found unenforceable, or may not provide the anticipated scope or duration of protection; that the Company may be unable to obtain or maintain adequate intellectual property protection for its product candidates; that clinical results may not support regulatory authorization or commercial adoption; that stated patient preferences may not translate into actual demand; and risks related to clinical development, regulatory review, financing and commercialization. These and other risks are discussed more fully in the Company’s filings with the Securities and Exchange Commission (the SEC), including the “Risk Factors” section of its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 24, 2026, and other documents it subsequently files with or furnishes to the SEC, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on August 10, 2026.

These forward-looking statements are based on management’s current estimates and expectations. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change.

Contact
Brian Luque, Head of Investor Relations and Corporate Development
IR@fractyl.com, 951.206.1200