Amicus Therapeutics Announces Full-Year 2025 Financial Results and Corporate Updates




Amicus Therapeutics Announces Full-Year 2025 Financial Results and Corporate Updates

2025 Total Revenue of $634M, up 17% Year-over-Year at CER

Cash Position of $294M, a $44M Increase in 2025

Proposed Acquisition by BioMarin Expected to Close in Q2 2026, Subject to Closing Conditions

PRINCETON, N.J., Feb. 20, 2026 (GLOBE NEWSWIRE) — Amicus Therapeutics (Nasdaq: FOLD), a leading, global biotechnology company with a clear and compelling mission to develop and deliver transformative medicines for people living with rare diseases, today announced financial results for the full year ended December 31, 2025.

Full-Year 2025 Financial Highlights:

• Total revenues for the full year 2025 were $634.2 million, reflecting strong operational growth measured at constant exchange rates (CER)¹ of 17% and a currency tailwind of ~$14 million. Fourth quarter total revenues were $185.2 million up 24%, or 20% at CER¹.

• Galafold (migalastat) net product sales for the full year 2025 were $521.7 million, representing a year-over-year increase of 14%, or 12% at CER¹. Fourth quarter net product sales were $150.2 million. Growth was driven by continued commercial execution in all markets, net new patient starts, and strong compliance.
• Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) net product sales for the full year 2025 were $112.5 million, representing a year-over-year increase of 60%, or 56% at CER¹. Fourth quarter net product sales were $35.0 million. Growth was driven by high commercial demand from established and newly launched countries.
• Total GAAP operating expenses of $528.5 million for the full year 2025 increased by 17% as compared to $450.5 million for the full year 2024. Total non-GAAP operating expenses² were up 24% to $431.9 million for the full year 2025 as compared to $347.8 million for the full year 2024.
• GAAP net loss of $27.1 million, or $0.09 per share basic and diluted, was achieved in the full year 2025, compared to a GAAP net loss of $56.1 million, or $0.18 per share basic and diluted, for the full year 2024. GAAP net income was $1.7 million, or $0.01 per share basic and diluted, for the fourth quarter 2025, compared to a net income of $14.7 million, or $0.05 per share basic and diluted, for the fourth quarter 2024.
• Non-GAAP net income^2,3 was $96.8 million, or $0.31 per share basic and diluted, for the full year 2025, compared to non-GAAP net income of $73.9 million, or $0.24 per share basic and diluted, for the full year 2024. Non-GAAP net income was $31.6 million, or $0.10 per share basic and diluted, for the fourth quarter 2025, compared to a net income of $29.2 million, or $0.10 per share basic and $0.09 per share diluted, for the fourth quarter 2024.
• Cash, cash equivalents, and marketable securities increased to $293.5 million at December 31, 2025, as compared to $249.9 million at December 31, 2024.

Corporate Updates:

• Proposed acquisition of Amicus by BioMarin. In December 2025, Amicus entered into a definitive agreement to be acquired by BioMarin Therapeutics for $14.50 per share in an all-cash transaction for a total equity value of approximately $4.8 billion. The agreement has been unanimously approved by the Boards of Directors of both companies and the Amicus Board of Directors unanimously recommended that Amicus’ stockholders vote to adopt the agreement. The transaction is expected to close in the second quarter of 2026, subject to regulatory clearances, approval by the stockholders of Amicus and other customary closing conditions.
• On January 21, 2026, Amicus and BioMarin each filed a Premerger Notification and Report Form under the HSR Act with the Antitrust Division of the U.S. Department of Justice and the U.S Federal Trade Commission (the “FTC”) in connection with the Merger. On February 11, 2026, the FTC granted early termination of the waiting period under the HSR Act.
• Two oral presentations and 19 posters highlighting Amicus’ development programs in Fabry disease and Pompe disease presented at the 22^nd Annual WORLDSymposium™. New data from clinical and real world evidence studies support the growing body of evidence for Galafold and Pombiliti + Opfolda.

¹ In order to illustrate underlying performance, Amicus discusses its results in terms of constant exchange rate (CER) growth. This represents growth calculated as if the exchange rates had remained unchanged from those used in the comparative period.
² Full reconciliation of GAAP results to the Company’s non-GAAP adjusted measures for all reporting periods appear in the tables to this press release.
³ Amicus defines non-GAAP Net (Loss) Income as GAAP Net (Loss) Income excluding the impact of share-based compensation expense, changes in fair value of contingent consideration, loss on impairment of assets, depreciation and amortization, acquisition related income (expense), loss on extinguishment of debt, restructuring charges and income taxes.

Conference Call and Webcast
Given the pending acquisition of Amicus by BioMarin, Amicus is not providing financial guidance for 2026 and will not be hosting its quarterly conference call to discuss its financial results. Earnings materials are available publicly on the Investor Relations page of its website at ir.amicusrx.com.

About Galafold
Galafold^® (migalastat) 123 mg capsules is an oral pharmacological chaperone of alpha-Galactosidase A (alpha-Gal A) for the treatment of Fabry disease in adults who have amenable galactosidase alpha gene (GLA) variants. In these patients, Galafold works by stabilizing the body’s own dysfunctional enzyme so that it can clear the accumulation of disease substrate. Globally, Amicus Therapeutics estimates that approximately 35 to 50 percent of people living with Fabry disease may have amenable GLA variants, though amenability rates within this range vary by geography. Galafold is approved in more than 40 countries around the world, including the U.S., EU, U.K., and Japan.

U.S. INDICATIONS AND USAGE
Galafold is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.

This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

U.S. IMPORTANT SAFETY INFORMATION

ADVERSE REACTIONS: The most common adverse reactions reported with Galafold (≥10%) were headache, nasopharyngitis, urinary tract infection, nausea and pyrexia. USE IN SPECIFIC POPULATIONS: There is insufficient clinical data on Galafold use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Advise women of the potential risk to a fetus. It is not known if Galafold is present in human milk. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Galafold and any potential adverse effects on the breastfed child from Galafold or from the underlying maternal condition. Galafold is not recommended for use in patients with severe renal impairment or end-stage renal disease requiring dialysis. The safety and effectiveness of Galafold have not been established in pediatric patients. To report Suspected Adverse Reactions, contact Amicus Therapeutics at 1-877-4AMICUS or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For additional information about Galafold, including the full U.S. Prescribing Information, please visit https://www.amicusrx.com/pi/Galafold.pdf.

About Pombiliti + Opfolda
Pombiliti + Opfolda, is a two-component therapy that consists of cipaglucosidase alfa-atga, a bis-M6P-enriched rhGAA that facilitates high-affinity uptake through the M6P receptor while retaining its capacity for processing into the most active form of the enzyme, and the oral enzyme stabilizer, miglustat, that’s designed to reduce loss of enzyme activity in the blood.

U.S. INDICATIONS AND USAGE
POMBILITI in combination with OPFOLDA is indicated for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT).

SAFETY INFORMATION

HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS: Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available. If a severe hypersensitivity reaction occurs, POMBILITI should be discontinued immediately and appropriate medical treatment should be initiated. INFUSION-ASSOCIATED REACTIONS (IARs): If severe IARs occur, immediately discontinue POMBILITI and initiate appropriate medical treatment. RISK OF ACUTE CARDIORESPIRATORY FAILURE IN SUSCEPTIBLE PATIENTS: Patients susceptible to fluid volume overload, or those with acute underlying respiratory illness or compromised cardiac or respiratory function, may be at risk of serious exacerbation of their cardiac or respiratory status during POMBILITI infusion. See PI for complete Boxed Warning. CONTRAINDICATION: POMBILITI in combination with Opfolda is contraindicated in pregnancy. EMBRYO-FETAL TOXICITY: May cause embryo-fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for at least 60 days after the last dose. Adverse Reactions: Most common adverse reactions ≥ 5% are headache, diarrhea, fatigue, nausea, abdominal pain, and pyrexia. Please see full PRESCRIBING INFORMATION, including BOXED WARNING, for POMBILITI (cipaglucosidase alfa-atga) LINK and full PRESCRIBING INFORMATION for OPFOLDA (miglustat) LINK.

About Amicus Therapeutics
Amicus Therapeutics (Nasdaq: FOLD) is a leading, global biotechnology company with a clear and compelling mission: to develop and deliver transformative medicines for people living with rare diseases. With extraordinary patient focus, Amicus strives to redefine expectations in rare disease. For more information please visit the company’s website at www.amicusrx.com, and follow on LinkedIn.

Non-GAAP Financial Measures
In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted financial measures that we believe provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information. These adjusted financial measures are non-GAAP measures and should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We use these non-GAAP measures as key performance measures for the purpose of evaluating operational performance and cash requirements internally. We typically exclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other companies may define these measures in different ways. When we provide our expectation for non-GAAP operating expenses and profitability on a forward-looking basis, a reconciliation of the differences between the non-GAAP expectation and the corresponding GAAP measure generally is not available without unreasonable effort due to potentially high variability, complexity and low visibility as to the items that would be excluded from the GAAP measure in the relevant future period, such as unusual gains or losses. The variability of the excluded items may have a significant, and potentially unpredictable, impact on our future GAAP results.

Forward Looking Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the proposed acquisition of Amicus by BioMarin (the “Transaction”), prospects and timing of the potential regulatory and pricing approval of our products, and commercialization plans. The inclusion of forward-looking statements should not be regarded as a representation by us that any of our plans will be achieved or that the conditions to the consummation of the Transaction will be satisfied. Any or all of the forward-looking statements in this press release may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. For example, statements regarding the goals, progress, timing, and outcomes of discussions with regulatory authorities and pricing and reimbursement authorities, are based on current information. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation: uncertainties as to the ability to obtain stockholder approval for the Transaction; the possibility that competing offers will be made; the possibility that various closing conditions for the Transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the Transaction; the effects of the Transaction on relationships with employees, other business partners or governmental entities; the potential that regulatory authorities may not grant or may delay approval for our product candidates; the potential that required regulatory inspections may be delayed or not be successful and delay or prevent product approval; the potential that we may not be successful in negotiations with pricing and reimbursement authorities; the potential that we may not be successful in commercializing Galafold and/or Pombiliti and Opfolda in Europe, the UK, the US and other geographies; the potential that the Dimerix license agreement for DMX-200 may not be successful, including without limitation expectations of the timing of the Phase 3 clinical trial evaluating DMX-200; the likelihood of success of such clinical trial; the prospects for FDA approval of DMX-200 for FSGS or other indications; the estimated prevalence of FSGS; the achievement of any milestone and timing of any payments associated with milestones and the success of any efforts to commercialize DMX-200, including any projections of future financial performance or payments; the potential that we may not be able to manufacture or supply sufficient commercial products; and the potential that we will need additional funding to complete the manufacturing and commercialization of our products. With respect to statements regarding corporate financial guidance and financial goals and the expected attainment of such goals and projections of the Company’s revenue, GAAP and non-GAAP profitability and cash position, actual results may differ based on market factors and the Company’s ability to execute its operational and budget plans. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2025, to be filed today. These risks, as well as other risks associated with the Transaction, are further discussed in the Proxy Statement filed with the U.S. Securities and Exchange Commission on February 2, 2026, in connection with the Transaction. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this news release to reflect events or circumstances after the date hereof.

CONTACT:

Investors:
Amicus Therapeutics
Andrew Faughnan
Vice President, Investor Relations
afaughnan@amicusrx.com
(609) 662-3809

Media:
Amicus Therapeutics
Brendan McEvoy
Executive Director, External Communications
bmcevoy@amicusrx.com
(609) 662-5005

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Eupraxia Pharmaceuticals Announces Closing of US$63.2 Million Public Offering Including Full Exercise of Underwriter Option




Eupraxia Pharmaceuticals Announces Closing of US$63.2 Million Public Offering Including Full Exercise of Underwriter Option

VICTORIA, British Columbia, Feb. 20, 2026 (GLOBE NEWSWIRE) — Eupraxia Pharmaceuticals Inc. (“Eupraxia” or the “Company”) (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology designed to optimize local, controlled drug delivery for applications with significant unmet need, is pleased to announce the successful closing of its previously announced public offering (the “Offering”) of 7,607,145 common shares of the Company (the “Common Shares”), which includes the full exercise of the option to purchase additional shares granted to the underwriters, at a price to the public of US$7.00 per Common Share, and pre-funded warrants to purchase up to 1,428,571 Common Shares in lieu thereof (the “Pre-Funded Warrants”) at a price of US$6.99999 per Pre-Funded Warrant, which equals the public offering price per Common Share less the C$0.000001 per share exercise price of each Pre-Funded Warrant, for gross proceeds of approximately US$63.2 million, before deducting the underwriting commissions and estimated expenses incurred in connection with the Offering.

“We are pleased to complete this financing, allowing us to significantly expand our pipeline, reach several additional development milestones with EP-104GI for eosinophilic esophagitis, and make meaningful progress towards commercial readiness,” said James Helliwell, CEO of Eupraxia. “We appreciate the support from both existing and new investors as we execute our mission and pursue the next phase of growth for Eupraxia.”

Cantor and LifeSci Capital acted as joint book-running managers for the Offering. Bloom Burton and Craig-Hallum also acted as co-managers for the Offering.

As previously stated, the Company intends to use the net proceeds from the Offering primarily for the continued advancement of EP-104GI for Eosinophilic Esophagitis, including the completion of ongoing preclinical studies, and Phase 2 clinical trials, preparations for a Phase 3 clinical trial including the related regulatory submissions, and manufacturing activities, and to undertake the necessary commercial/market development activities to prepare for the eventual product launch. The Company also intends to use a portion of the proceeds to accelerate and expand its plans to pursue clinical studies with EP-104GI in multiple additional gastrointestinal indications, including in esophageal strictures and fibrostenotic Crohn’s disease. A portion of the proceeds will be allocated to research and development of additional pipeline candidates, business development initiatives, and general corporate purposes, which may include but are not limited to employee salaries, working capital, leases for facilities, administrative expenses, and capital expenditures. The Company may also use a portion of the proceeds to expand its intellectual property portfolio and strengthen its corporate infrastructure to support future growth.

The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on February 7, 2024, and the Company’s existing Canadian short form base shelf prospectus, (the “Base Prospectus”) dated February 5, 2024. A preliminary prospectus supplement and a final prospectus supplement (the “Supplement”) relating to and describing the terms of the Offering were filed with the securities commissions in all of the provinces and territories of Canada, except Quebec, and with the SEC in the United States. The Supplement and accompanying Base Prospectus contain important detailed information about the Offering.

The Supplement and accompanying Base Prospectus can be found on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying Base Prospectus may also be obtained from Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at prospectus@cantor.com, from LifeSci Capital LLC at 1700 Broadway, 40^th Floor, New York, New York 10019, or by email at compliance@lifescicapital.com, or from Bloom Burton Securities Inc. at ecm@bloomburton.com, or from Craig-Hallum Capital Group LLC, Attention: Equity Capital Markets, 323 North Washington Ave., Suite 300, Minneapolis, MN 55401, or by telephone at (612) 334-6300, or by email at prospectus@chlm.com.

This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

About Eupraxia Pharmaceuticals Inc.

Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. Diffusphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs.

Notice Regarding Forward-looking Statements and Information

This news release includes forward-looking statements and forward-looking information within the meaning of applicable securities laws. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “is expected”, “expects”, “suggests”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes”, “potential” or variations (including negative and grammatical 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. Forward-looking statements in this news release include statements regarding the anticipated use of proceeds from the Offering; expectations around the expansion of the Company’s pipeline, additional development milestones with EP-104GI for eosinophilic esophagitis, and meaningful progress towards commercial readiness; expected capitalization into the first quarter of 2028; and the potential for the Company’s technology to impact the drug delivery process. Such statements and information are based on the current expectations of Eupraxia’s management, and are based on assumptions, including but not limited to: future research and development plans for the Company proceeding substantially as currently envisioned; industry growth trends, including with respect to projected and actual industry sales; the Company’s ability to obtain positive results from the Company’s research and development activities, including clinical trials; and the Company’s ability to protect patents and proprietary rights. Although Eupraxia’s management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including, but not limited to: risks and uncertainties related to the Company’s limited operating history; the Company’s novel technology with uncertain market acceptance; if the Company breaches any of the agreements under which it licenses rights to its product candidates or technology from third parties, the Company could lose license rights that are important to its business; the Company’s current license agreement may not provide an adequate remedy for its breach by the licensor; the Company’s technology may not be successful for its intended use; the Company’s future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; the Company’s clinical trials may fail to demonstrate adequately the safety and efficacy of its product candidates at any stage of clinical development; the Company may be required to suspend or discontinue clinical trials due to side effects or other safety risks; the Company completely relies on third parties to provide supplies and inputs required for its product candidates and services; the potential impact of tariffs on the cost of the Company’s active pharmaceutical ingredients and clinical supplies of EP-104IAR and EP-104GI; the Company relies on external contract research organizations to provide clinical and non-clinical research services; the Company may not be able to successfully execute its business strategy; the Company will require additional financing, which may not be available; any therapeutics the Company develops will be subject to extensive, lengthy and uncertain regulatory requirements, which could adversely affect the Company’s ability to obtain regulatory approval in a timely manner, or at all; the impact of health pandemics or epidemics on the Company’s operations; the Company’s restatement of its consolidated financial statements, which may lead to additional risks and uncertainties, including loss of investor confidence and negative impacts on the Company’s common share price; and other risks and uncertainties described in more detail in Eupraxia’s public filings on SEDAR+ (sedarplus.ca) and EDGAR (sec.gov). Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement or information can be guaranteed. Except as required by applicable securities laws, forward-looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward-looking statement or information, whether as a result of new information, future events or otherwise.

For investor and media inquiries, please contact:
James Meikle, Eupraxia Pharmaceuticals Inc.
236.330.7084
jmeikle@eupraxiapharma.com

or

Kevin Gardner, on behalf of:
Eupraxia Pharmaceuticals Inc.
617.283.2856
kgardner@lifesciadvisors.com

SOURCE Eupraxia Pharmaceuticals Inc.

U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-‘749) for the Once-Monthly Treatment of Schizophrenia in Adults




U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-‘749) for the Once-Monthly Treatment of Schizophrenia in Adults

• Olanzapine long-acting injectable (LAI) suspension (TEV-‘749) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation¹
• If approved, TEV-‘749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations¹
• Teva is committed to advancing this innovative treatment option and further building on its differentiated LAI franchise and scientific leadership in complex neurological conditions as it drives forward its Pivot to Growth strategy

PARSIPPANY, N.J. and TEL AVIV, Israel and PARIS, Feb. 20, 2026 (GLOBE NEWSWIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for olanzapine extended-release injectable suspension (TEV-‘749) for the treatment of schizophrenia in adults. TEV-‘749 is designed to improve real-world treatment adherence and help patients maintain long-term stability, with the goal of addressing a critical treatment gap for people living with schizophrenia.

Currently, there is no long-acting olanzapine formulation without an FDA-required Risk Evaluation and Mitigation Strategy (REMS), which mandates administration in a certified healthcare facility and requires a 3-hour post-injection monitoring period. In the Phase 3 SOLARIS trial, TEV-‘749 administered as a once-monthly subcutaneous injection demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations and showed no evidence for the need for post-injection monitoring.

“Treatment adherence remains a major challenge and unmet need for people living with schizophrenia, including many who rely on oral forms of olanzapine. TEV-‘749, our investigational subcutaneously delivered olanzapine LAI, has the potential to help provide stability by offering the proven efficacy and safety of olanzapine as a once-monthly treatment,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “For too long, the lack of a viable long-acting olanzapine formulation has limited the options available to these individuals, and we look forward to working with the FDA on the review of this NDA for TEV-‘749 to help address this gap in care.”

“Daily olanzapine is one of the most widely prescribed antipsychotics for people living with schizophrenia, and this long‑acting formulation may better fit into their lives,” said Christophe Douat, CEO of Medincell. “As experience with long‑acting injectables continues to grow, they are increasingly recognized as an important treatment option in serious psychiatric conditions. The potential reach of a practical long‑acting option is significant.”

The NDA for TEV-‘749 is based on results from the Phase 3 SOLARIS trial, including Week 56 results studying its efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia.¹ The results demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations.¹

TEV-‘749 is an investigational once-monthly subcutaneous LAI of the second-generation atypical antipsychotic olanzapine. It is not approved by any regulatory authority for any use at this time.

TEV-‘749 utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine.

About Subcutaneous OLAnzapine Extended-Release Injection Study (SOLARIS)
SOLARIS is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-64 years) with schizophrenia.¹ For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (TEV-‘749) (low, medium or high dose) or placebo in a 1:1:1:1 ratio.¹ For period two (next 48 weeks), patients who completed period one were randomized and equally allocated to one of the three olanzapine LAI (TEV-‘749) treatment groups.¹ The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively.¹ The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of olanzapine LAI (TEV-‘749) in adult patients with schizophrenia.¹ A key secondary objective was to further evaluate the efficacy of olanzapine LAI (TEV-‘749) based on additional parameters in adult patients with schizophrenia.¹ A secondary objective of period two of the study was to evaluate the safety and tolerability of olanzapine LAI (TEV-‘749) in adult patients with schizophrenia.¹

About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.² Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.^2,3,4 Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 3.5 million people in the U.S. are currently diagnosed with the condition.^3,4 Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women.⁴ The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization.⁴ Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.^5,6,7 Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.^2,3,4,5,6,7

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements
This Press Release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop olanzapine LAI (TEV-‘749) for the treatment of adult patients diagnosed with schizophrenia and to obtain regulatory FDA approval; our ability to successfully compete in the marketplace, including our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

1. Data on file. Parsippany, NJ: Teva Neuroscience, Inc.
2. Substance Abuse and Mental Health Services Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia. Accessed February 2026.
3. Velligan DI, Rao S. The Epidemiology and Global Burden of Schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.
4. Wander C. (2020). Schizophrenia: Opportunities to Improve Outcomes and Reduce Economic Burden Through Managed Care. The Am J Manag Care. 26(3 Suppl), S62–S68. https://doi.org/10.37765/ajmc.2020.43013.
5. Emsley, R., & Kilian, S. (2018). Efficacy and safety profile of paliperidone palmitate injections in the management of patients with schizophrenia: an evidence-based review. Neuropsychiatric Dis. Treat., 14, 205–223.
6. Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The nature of relapse in schizophrenia. BMC Psychiatry 13, 50.
7. Andreasen, N. C., et al. (2013). Relapse duration, treatment intensity, and brain tissue loss in schizophrenia: a prospective longitudinal MRI study. The Am J Psychiatry, 170(6), 609–615.

Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquires
TevaIR@Tevapharm.com

About Medincell

Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY® (BEPO® technology is licensed to Teva under the name SteadyTeq™). We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, Medincell currently employs more than 140 people representing more than 25 different nationalities.

Contact: communication@medincell.com

Vistin Pharma ASA: Mandatory notification of trade




Vistin Pharma ASA: Mandatory notification of trade

Magnus Tolleshaug, Chief Executive Officer in Vistin Pharma ASA, and a primary insider, has on 20’th of February 2026 purchased 30.000 shares in Vistin Pharma ASA at an average price of NOK 21,10 per share. Following this purchase Magnus Tolleshaug holds 105.000 shares in Vistin Pharma ASA.

Attachment

• Notification of trade_skjema – Magnus Tolleshaug

ADARx Pharmaceuticals to Present Onvuzosiran (ADX-324) Phase 1/2 Clinical Data and Phase 3 Design at the 2026 AAAAI Annual Meeting




ADARx Pharmaceuticals to Present Onvuzosiran (ADX-324) Phase 1/2 Clinical Data and Phase 3 Design at the 2026 AAAAI Annual Meeting

SAN DIEGO, Feb. 20, 2026 (GLOBE NEWSWIRE) — ADARx Pharmaceuticals, Inc. (ADARx), a late-stage clinical biotechnology company developing next-generation RNA therapeutics, announced today that it will present Phase 1/2 clinical data and Phase 3 design for its onvuzosiran (also known as ADX-324) program, an investigational small interfering RNA (siRNA) therapeutic candidate being evaluated in a Phase 3 clinical trial for the treatment of hereditary angioedema (HAE). The poster presentation will be given at the 2026 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) being held February 27 – March 2, 2026, in Philadelphia, PA.

Presentation details:

• “ADX-324, A Semi-Annual SC Investigational siRNA Targeting Prekallikrein for HAE Attack Prevention” (Poster number: 089) on Friday, February 27, 2026 from 2:45 – 3:45 pm EST in the Pennsylvania Convention Center, Level 2, Hall E

About HAE and Onvuzosiran (ADX-324)
HAE is a rare genetic disorder characterized by recurrent, unpredictable attacks of swelling that can be painful, disabling, and life-threatening. These attacks result from dysregulation of the kallikrein-kinin system (KKS), which regulates blood pressure, inflammation, coagulation and pain. Prekallikrein (PKK) is a critical protein in the plasma kallikrein pathway that activates a second protein called kallikrein, which, if present, produces bradykinin, a potent vasodilator. A dysfunctional KKS leads to excessive release of bradykinin which causes the swelling attacks in HAE.

Onvuzosiran is an investigational siRNA therapy designed to inhibit PKK generation at the mRNA level and reduce the production of plasma PKK, thereby averting bradykinin generation and potentially preventing HAE attacks. Compared to currently approved prophylactic treatments, Onvuzosiran is expected to decrease PKK to a greater degree, offering the potential for greater and more durable control of kallikrein activity, which is expected to result in a higher proportion of patients remaining attack-free with a less frequent dosing regimen. Onvuzosiran is currently being evaluated in the Phase 3 STOP-HAE clinical trial (https://stophae.com) and has received Orphan Drug Designation for the treatment of patients with HAE from the U.S. Food and Drug Administration (FDA).

About ADARx Pharmaceuticals
ADARx Pharmaceuticals, Inc. is a late-stage biotechnology company dedicated to transforming cutting-edge science into next-generation RNA medicines across a wide range of therapeutic areas. We have developed technology to control the expression of specific disease drivers with highly selective RNA targeted therapies with the goal of delivering life-changing treatments for patients with urgent unmet medical needs. ADARx is focused on advancing and expanding a deep pipeline of highly potent, durable and selective RNA-targeted therapeutic candidates, developing product candidates for the treatment of complement-mediated, genetic, cardiovascular, thrombosis, central nervous system and metabolic (obesity) diseases. In addition to our wholly-owned programs, we have entered into a collaboration and license option agreement with AbbVie to develop small interfering RNA (siRNA) therapeutics across multiple disease areas, including neuroscience, immunology and oncology. Follow ADARx on LinkedIn.

CONTACT: Contacts
Investors: ir@adarx.com
Media: teri@redhousecomms.com

Nasus Pharma to Participate in Upcoming Investor Conferences




Nasus Pharma to Participate in Upcoming Investor Conferences

TEL AVIV, Feb. 20, 2026 (GLOBE NEWSWIRE) — Nasus Pharma Ltd. (NYSE: NSRX) (“Nasus Pharma” or the “Company”), a clinical-stage pharmaceutical company focused on the development of innovative intranasal products, today announced that Company management will participate in upcoming investor conferences in February and March.

Oppenheimer 36th Annual Healthcare Life Sciences Conference

• Date and time: February 25, 2026, 1:20 p.m. ET
• Location: Virtual (register here: https://event.summitcast.com/view/CTtthLh2Bi2D9aYoKpvtEv/KoYPJS8x3zqMuXPHfEHoSY)
• Format: Company presentation
• Speaker: Dan Teleman, Chief Executive Officer

BIO Investment & Growth Summit

• Date and time: March 2, 2026, 10:15 a.m. ET
• Location: Miami, FL
• Format: Company presentation
• Speaker: Dan Teleman, Chief Executive Officer

Citizens Life Sciences Conference

• Date and time: March 11, 2026, 3:25 p.m. ET
• Location: Miami, FL
• Format: Company presentation
• Speaker: Dan Teleman, Chief Executive Officer

Nasus management will be available for one-on-one meetings during the conferences. Interested parties should contact their conference representative to arrange a meeting.

About Nasus Pharma
Nasus Pharma is a clinical-stage pharmaceutical company developing a number of intranasal powder products addressing acute medical conditions in the community. NS002, Nasus’ intranasal powder Epinephrine product candidate is being developed as a needle-free alternative to Epinephrine autoinjectors for patients with anaphylaxis. Intranasal administration is most suitable for those situations in which rapid drug delivery is required and offers needle-free, easy-to-use alternatives. Nasus’ proprietary powder-based intranasal (“PBI”) technology is designed for rapid and reliable drug delivery, leveraging the nasal cavity’s rich vascular network for quick absorption. The PBI formulation uses uniform spherical powder particles for broad dispersion and potentially faster, higher absorption compared to liquid-based nasal products. For further information about the Company, please visit www.nasuspharma.com or follow on Twitter (X) or LinkedIn.

Company Contact
Nasus Pharma Ltd.
info@nasuspharma.com

Investor Contact
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com

Syncx Accelerates the Future of Locums Staffing with Major Platform Enhancements and Rapid AI Expansion




Syncx Accelerates the Future of Locums Staffing with Major Platform Enhancements and Rapid AI Expansion

ATLANTA, Feb. 20, 2026 (GLOBE NEWSWIRE) — Syncx today announced a major wave of platform enhancements and AI-driven capabilities that are available starting February 23rd and rolling out through March. These investments reinforce Syncx’s position as one of the fastest, most intelligent, and most scalable VMS and MSP platforms in the Locums market – built to help health systems and staffing partners fill roles faster and operate with greater efficiency.

The latest updates include a fully refreshed Syncx VMS interface paired with significant performance improvements. The modernized UI delivers a cleaner, more intuitive experience while preserving existing workflows. At the same time, platform optimizations have increased speeds by up to 60 percent in key locations, enabling users to move through critical workflows faster without retraining or disruption. The refreshed interface also establishes a scalable foundation for continued feature expansion.

Syncx is rapidly expanding its embedded AI capabilities through Felix, its platform-wide AI assistant. Felix is now being embedded across the Locums lifecycle, with new capabilities and functionality coming online in the weeks ahead. These enhancements enable users to streamline daily operational tasks such as job creation, candidate evaluation, scheduling, and real-time data discovery all within a single platform.

AI-powered candidate risk assessments are now available to provide early risk insights when candidates enter the workflow, supporting faster and more confident decision-making. Felix also delivers real-time summaries and contextual insights to reduce cognitive load and accelerate reviews.

Beyond AI, Syncx is introducing expanded platform integrations that bridge permanent and Locums hiring. Health systems can now open permanent roles to Locums and Perm agencies directly from their ATS, with unified workflows designed to reduce friction and shorten time-to-fill.

Operational speed remains a core focus. Accelerated onboarding now enables new customers to go live in as little as two weeks, while upcoming unified notifications, and advanced analytics will further enhance visibility, responsiveness, and workforce optimization.

“These investments reflect our commitment to delivering meaningful innovation at speed,” said Doug Shaener, CEO at Syncx. “This release represents a major step forward, and it’s part of a disciplined roadmap that will continue to deliver meaningful platform advancements on a regular cadence for our customers.”

About Syncx
Syncx is a leading VMS and MSP platform for the Locums market, delivering advanced technology, embedded AI, and high-touch service to health systems and staffing partners nationwide.

Media Contact
Syncx Communications
https://hellosyncx.com
support@hellosyncx.com

AltruBio Announces Formation of Inflammatory Bowel Disease Clinical Advisory Board




AltruBio Announces Formation of Inflammatory Bowel Disease Clinical Advisory Board

World-renowned medical experts with extensive experience in treating patients with inflammatory bowel disease join AltruBio to support clinical advancement of ALTB-268 for the treatment of ulcerative colitis

SAN FRANCISCO, Feb. 20, 2026 (GLOBE NEWSWIRE) — AltruBio Inc. (“AltruBio” or “the Company”), a clinical stage biotech company developing novel immune checkpoint enhancers to address the unmet need in immunological and inflammatory diseases, with a lead candidate in ulcerative colitis (UC), today announced the formation of its inflammatory bowel disease clinical advisory board (IBD CAB), comprising esteemed physicians and Professors David T. Rubin, MD, Walter Reinisch, MD, PhD, Bruce Sands, MD, and Britta Siegmund, MD, PhD.

The IBD CAB will collaborate closely with AltruBio’s leadership team to support clinical initiatives in IBD, including advancing its novel immune checkpoint enhancer PSGL-1 agonist antibody, ALTB-268, which is currently being tested in an open-label, dose exploration Phase 2a study in participants with moderately to severely active UC who are refractory to advanced therapy (ASCEND-UC 2a; NCT06109441). The IBD CAB will also offer guidance to shape long-term clinical development strategies as AltruBio progresses towards initiating a randomized, placebo-controlled, global Phase 2b study (ASCEND-UC 2b) in participants with moderately to severely active UC who are refractory to either conventional or advanced therapy in 2026.

“We are honored to welcome Professors Rubin, Reinisch, Sands, and Siegmund to our Clinical Advisory Board focused on inflammatory bowel disease,” said Dr. Judy Chou, President and Chief Executive Officer of AltruBio. “Their extensive experience in treating patients with ulcerative colitis will be instrumental in guiding the clinical path forward for ALTB-268 in this chronic and biologically diverse disease. This CAB of distinguished physicians adds significant credibility to AltruBio’s approach and the potential of our novel therapies in IBD. Their expertise will be invaluable to our clinical progress in ulcerative colitis, and we look forward to collaborating to further advance our science and pipeline for patients in need.”

Professor David T. Rubin, Chair of the Board, added, “I am particularly excited about the opportunity to support AltruBio’s novel science and approach for ALTB-268 in ulcerative colitis, especially after the promising results we saw with the company’s first-generation molecule in UC. The highly differentiated mechanism of action of ALTB-268 that targets PSGL-1 to downregulate chronically activated late-stage effector T cells, has the potential to be a groundbreaking therapy for patients with limited effective options, and I look forward to working together with my colleagues on this CAB to help shape its clinical development pathway.”

AltruBio’s IBD Clinical Advisory Board is comprised of the following members:

David T. Rubin, MD, Chair of the Board
Professor David T. Rubin is the Joseph B. Kirsner Professor of Medicine, Professor of Pathology, Chief of the Section of Gastroenterology, Hepatology & Nutrition and Director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine. He is associate faculty member at the MacLean Center for Clinical Medical Ethics, associate investigator at the University of Chicago Comprehensive Cancer Center and a member of the University of Chicago Committee on Clinical Pharmacology and Pharmacogenomics. He is the immediate past Chair of the National Scientific Advisory Committee of the Crohn’s & Colitis Foundation and Chair of the International Organization for the Study of IBD. Professor Rubin’s research is focused on disease modification in IBD including clinical trial designs, novel measures of inflammation and prevention of adverse outcomes, and quality of life in IBD. He has twice received the ACG’s Governor’s Award of Excellence in Clinical Research (2003 and 2013), and in 2020, Professor Rubin received the Sherman Prize for Excellence in Crohn’s and Colitis. In 2023, he received both the UChicago Michael Reese Lectureship Award (for outstanding faculty who have developed novel teaching and clinical research that advances healthcare) and the distinguished UChicago Arthur H. Rubenstein Mentorship in Academic Medicine Award. Professor Rubin is currently a senior editor of the 12th edition of Sleisenger and Fordtran’s Gastrointestinal and Liver Disease, and an author on more than 600 articles on management of IBD, including the 2025 ACG Guidelines for ulcerative colitis. He earned a medical degree with honors at The University of Chicago Pritzker School of Medicine where he also completed his residency in internal medicine and fellowships in gastroenterology and clinical medical ethics.

Walter Reinisch, MD, PhD
Professor Walter Reinisch is the Director of the Inflammatory Bowel Disease Study Group at the Medical University of Vienna, Austria. He is a founding member of the European Crohn’s and Colitis Organisation and was assigned as an honorary member after having contributed in various positions. He is also a member of the International Organisation for the Study of Inflammatory Bowel Disease. Professor Reinisch was an active member of the Scientific and Public Affairs Committee of the United European Gastroenterology organisation and headed the Austrian Inflammatory Bowel Disease Study Group. Previously, he held the Audrey Campbell Chair in Ulcerative Colitis Research at McMaster University, Ontario, Canada from 2013 to 2016. Professor Reinisch has also either written or made contributions to ~ 500 publications on IBD and remains active in all aspects of IBD research. Professor Reinisch graduated at the Medical University of Vienna, where he finished his training in Internal Medicine and Gastroenterology.

Bruce Sands, MD
Professor Bruce Sands is the Dr. Burrill B. Crohn Professor of Medicine at the Ichan School of Medicine at Mount Sinai. Previously, he was Medical Co-Director of the Crohn’s & Colitis Center at Massachusetts General Hospital in Boston, where he also served as the hospital’s Acting Chief of the Gastrointestinal Unit as well as Associate Professor of Medicine at Harvard Medical School. Professor Sands is an American Gastroenterological Association Fellow and a fellow of the American College of Gastroenterology. In 2006 he was named Humanitarian of the Year by the New England Chapter of the Crohn’s and Colitis Foundation of America, and the Massachusetts General Physician Organization honored him for “Excellence in Action” in recognition of his distinguished patient care. He has authored more than 250 original manuscripts, including as lead investigator of the landmark studies ACCENT 2, UNIFI and VARSITY, published in the New England Journal of Medicine, and SEAVUE in the Lancet. Professor Sands served as an Associate Editor for the field’s leading journal, Gastroenterology, from 2011 to 2016. Professor Sands received his medical degree at Boston University School of Medicine in Massachusetts and completed a residency in internal medicine at the Hospital of the University of Pennsylvania in Philadelphia. He then completed clinical and research fellowships at the Massachusetts General Hospital. In 2001 Professor Sands also earned a Master of Science in Epidemiology at Harvard School of Public Health.

Britta Siegmund, MD, PhD
Professor Britta Siegmund is a leading gastroenterologist with extensive experience in both clinical and translational research in inflammatory diseases, including IBD. Professor Siegmund currently works as a Professor and Director of the Department of Gastroenterology, Infectious Disease and Rheumatology at the University Hospital Charite in Berlin, Germany. Professor Siegmund is widely recognized for her contributions to the field of gastroenterology and has published over 480 scientific publications. She is actively involved in various professional organizations and is President-Elect of the European Crohn’s and Colitis Organisation. Professor Siegmund received her MD at the Ludwig Maximilians University in Munich and continued her training as postdoc in the lab of Charles Dinarello in Denver, USA and completed her training for gastroenterology at the Charité – Universitätsmedizin Berlin.

About AltruBio Inc.
AltruBio is a clinical-stage biotechnology company developing novel therapies leveraging immune checkpoint agonism to address unmet medical needs in immunological and inflammatory diseases. The Company’s lead candidate, ALTB-268, acts as an immune checkpoint enhancer, designed to activate natural pathways that downregulate a chronically overactivated immune system to restore balance. ALTB-268 operates through a unique mechanism of action, targeting PSGL-1, a key immune checkpoint regulator. It preferentially targets and downregulates chronically activated late-stage effector T cells, leading to their exhaustion and apoptosis. Currently being evaluated in a Phase 2 trial in ulcerative colitis, ALTB-268 holds the potential to be a pipeline in a product to address a range of inflammatory diseases, which AltruBio plans to explore in upcoming Phase 2 trials. Led by an expert team with successful track records in drug development and commercialization in immunology, AltruBio is dedicated to delivering safer, more effective, and durable biologic treatments to improve the lives of patients.

Contacts

AltruBio Inc:
+1-415-655-6603
info@altrubio.com

Media Contact:
LifeSci Communications
Luke Shiplo
lshiplo@lifescicomms.com

Beyond Air® Comments on Landmark Independent Review Article Highlighting the Antimicrobial Effects of High-Dose Inhaled Nitric Oxide and its Therapeutic Potential for Treating Respiratory Infections




Beyond Air® Comments on Landmark Independent Review Article Highlighting the Antimicrobial Effects of High-Dose Inhaled Nitric Oxide and its Therapeutic Potential for Treating Respiratory Infections

GARDEN CITY, N.Y., Feb. 20, 2026 (GLOBE NEWSWIRE) — Beyond Air, Inc. (NASDAQ: XAIR) (“Beyond Air” or the “Company”), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, today commented on the publication of an independent review article providing the most comprehensive overview to date of high‑dose inhaled nitric oxide (iNO) delivered at concentrations well above the FDA‑approved 20 ppm, and presenting mounting evidence that high‑dose iNO may function as a novel broad‑spectrum antimicrobial therapy for a wide range of respiratory infections. Titled “The therapeutic potential of high‑dose inhaled nitric oxide for antimicrobial effects: a narrative review and future directions,” the article was published in Intensive Care Medicine Experimental (ICMx), a peer-reviewed, open-access journal of the European Society of Intensive Care Medicine, published by Springer Nature Switzerland AG.

The article reviews the emerging clinical evidence supporting the safe administration of iNO at concentrations far exceeding the traditional doses currently used for vasodilation. Its authors synthesized clinical and mechanistic data from 27 studies conducted in both in-hospital and at-home settings– including early‑phase clinical trials in pneumonia, COVID‑19, bronchiolitis, and nontuberculous mycobacteria (NTM) – to illustrate the breadth of ongoing research. The paper highlights the unique multimodal activity of high‑dose iNO, including direct microbial killing, biofilm disruption, antiviral effects, inflammation reduction, and enhanced mucociliary clearance. It also outlines a potential roadmap for future research, emphasizing opportunities in hospital‑acquired pneumonia, ventilator‑associated pneumonia, tuberculosis, post‑viral fibrosis, and in immunocompromised patients, among others – areas where new therapeutic tools are urgently needed.

“We are excited to see the scientific community increasingly recognize high‑dose iNO as a potential game‑changing antimicrobial platform for respiratory infections,” said Steve Lisi, Chief Executive Officer of Beyond Air. “A growing collection of studies shows that high‑dose iNO can address pathogens and clinical challenges that current therapies are unable to treat. This most recent article builds on the momentum of our own clinical programs that have demonstrated promising signals in NTM, bronchiolitis, community‑acquired pneumonia (VCAP), and COVID-19. We believe the publication of this article will serve as a catalyst for new scientific research and accelerate the clinical development of high‑dose iNO as a potential transformative treatment modality for pulmonary indications.”

About Beyond Air^®, Inc.
Beyond Air is a commercial-stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The Company has received FDA approval and CE Mark for its first system, LungFit PH, for the treatment of term and near-term neonates with hypoxic respiratory failure. Beyond Air is currently advancing its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19) and nontuberculous mycobacteria (NTM).

Additionally, Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit www.beyondair.net.

About LungFit *
Beyond Air’s LungFit is a cylinder-free, phasic flow generator and delivery system designated as a medical device by the U.S. Food and Drug Administration (FDA). The ventilator-compatible version of the device can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 ppm to 80 ppm. The LungFit system could potentially replace large, high-pressure NO cylinders, providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall safety by eliminating NO2 purging steps, and offering other operational benefits.

LungFit can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting (e.g., COVID-19, bronchiolitis) and chronic, refractory lung infections in the home setting (e.g., NTM). With the elimination of cylinders, Beyond Air intends to offer NO treatment in the home setting.

*Beyond Air’s LungFit PH is approved for commercial use in the United States, European Union, and many other countries around the world. Beyond Air’s other LungFit systems are not approved for commercial use and are for investigational use only. Beyond Air is not suggesting NO use over 80 ppm or use at home.

Forward Looking Statements
This press release contains “forward-looking statements” concerning the potential safety and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “appears,” “expects,” “plans,” “anticipates,” “believes” “expects,” “intends,” “looks,” “projects,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect views as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to the ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for our product candidates; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; the ability to fund and the results of further pre-clinical studies and clinical trials of our product candidates; obtaining, maintaining and protecting intellectual property utilized by products; obtaining regulatory approval for products; competition from others using similar technology and others developing products for similar uses; dependence on collaborators; and other risks, which may, in part, be identified and described in the “Risk Factors” section of Beyond Air’s most recent Annual Report on Form 10-K and other of its filings with the Securities and Exchange Commission, all of which are available on Beyond Air’s website. Beyond Air and Beyond Cancer undertake no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law.

CONTACTS:
Investor Relations contacts

Corey Davis, Ph.D.
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577

Calidi Biotherapeutics Presents Data on its New Approach to Bispecific T-Cell Engagers (BiTEs) Using its RedTail Platform at the 2026 AACR-IO Conference




Calidi Biotherapeutics Presents Data on its New Approach to Bispecific T-Cell Engagers (BiTEs) Using its RedTail Platform at the 2026 AACR-IO Conference

SAN DIEGO, Feb. 20, 2026 (GLOBE NEWSWIRE) — Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, today presented data on its novel approach to the use of BiTEs in solid tumors by utilizing its systemically delivered RedTail platform at the AACR Immuno-Oncology (AACR-IO) conference being held in Los Angeles, California. A link to the poster is available here and on the company’s website.

RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the tumor microenvironment (TME), and enable high-level expression of therapeutic genetic payloads directly within the tumor. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL‑15 superagonist (IL-15 SA), a known T-cell activator, in the TME.

In data presented at the meeting, Calidi demonstrated RedTail viruses that could express both a functional BiTE, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous alteration of the TME and T-cell activation and introduction into the TME of a solid-tumor targeting BiTE. BiTEs have shown exceptional efficacy in hematological malignancies but have failed to show clinical benefit in solid tumors where the TME inhibits T-cell activity. By remodeling the TME and driving T-cell activation while expressing a tumor-localized BiTE, RedTail may overcome the historical limitations of BiTEs in solid tumors.

“The RedTail platform allows for the systemic and targeted delivery of genetic payloads to distal sites of disease,” said Eric Poma, PhD, Chief Executive Officer of Calidi. “Once at the target, RedTail can induce high levels of expression of one or more genetic payloads, representing a major advance in the delivery of genetic medicines.”

“The data presented today highlight the ability of the RedTail platform to functionally overexpress complex biologics likes BiTEs and cytokines directly within the tumor microenvironment,” said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. “Simultaneous tumor-localized expression of a T-cell activator and BiTE via RedTail can remodel the TME to allow for T-cell engagement precisely where it is needed.”

Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. The company anticipates submitting an Investigational New Drug (IND) application for CLD-401 by the end of 2026. The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

About Calidi 

Calidi Biotherapeutics (NYSE American: CLDI) is a biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. The company’s proprietary Redtail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent genetic medicine(s) to metastatic locations.

CLD-401, the lead candidate from the Redtail platform, currently in IND-enabling studies, targets non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need. Calidi continues to advance its pipeline utilizing the Redtail platform including its novel approach to incorporate BiTEs in solid tumors.

Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com or view Calidi’s Corporate Presentation here.

Forward-Looking Statements

This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning key milestones, including certain pre-clinical data, planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s annual report filed with the SEC on Form 10-K on March 31, 2025, as may be amended or supplemented by other reports we file with the SEC from time to time. We disclaim any obligation to update any forward-looking statement to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

For Investors:

Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
CLDI@redchip.com