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Biotech & pharma

2,208 press releases in English indexed under biotech & pharma.

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Biotech & pharma

Ionis partner GSK announces Hibsago (bepirovirsen) approved in the U.S. for the treatment of chronic hepatitis B (CHB)

– Approval based on Phase 3 data showing unprecedented functional cure rates compared to standard of care – – Six-month treatment with option of at-home administration after first dose – – CHB affects approximately 1.7 million people in the U.S. – CARLSBAD, Calif., October 21, 2026--Ionis Pharmaceutic

Oct 21 · 01:20Business Wire
Finance · Healthcare

Disc Medicine Announces Pricing of $450 Million Upsized Public Offering of Common Stock

WATERTOWN, Mass., Oct. 20, 2026 -- Disc Medicine, Inc. (NASDAQ: IRON) (Disc), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced the pricing of an upsized underwritten public offering of shares of its common stock. Disc is selling 6,000,000 shares of common stock at a public offering price of $75.00 per share. In addition, Disc has granted the underwriters a 30-day option to purchase up to an additional 900,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. The aggregate gross proceeds to Disc from this offering are expected to be $450 million, before deducting underwriting discounts and commissions and other offering expenses, assuming no exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on October 22, 2026, subject to the satisfaction of customary closing conditions.

Oct 21 · 00:52GlobeNewswire
Finance · Biotech & pharma

Wolf Popper LLP Continues Investigation on Behalf of Xenon Pharmaceuticals Inc. Investors

NEW YORK, Oct. 20, 2026 -- Wolf Popper LLP is continuing its investigation into potential claims on behalf of purchasers of Xenon Pharmaceuticals Inc. (“Xenon”) common stock (NASDAQ: XENE).

Oct 21 · 00:50GlobeNewswire
Finance · Biotech & pharma

HUTCHMED Announces Closing of KRAS-EGFR-Antibody Conjugate Therapy License to GSK Outside China

HONG KONG, SHANGHAI and FLORHAM PARK, N.J., Oct. 20, 2026 -- HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM:HCM; HKEX:13) today announces that further to its announcement on September 3, 2026  and following the completion of customary closing conditions including antitrust regulatory reviews, the exclusive development and license agreement between HUTCHMED Limited (a subsidiary of the Company) and a subsidiary of GSK plc (“GSK”) has closed. The agreement grants the GSK subsidiary worldwide rights excluding Mainland China, Hong Kong, Macau and Taiwan to develop and commercialize HMPL-A830.

Oct 21 · 00:00GlobeNewswire
Finance · Biotech & pharma

Hibsago (bepirovirsen) Approved in the US for the Treatment of Chronic Hepatitis B (CHB)

Approval based on phase III data showing unprecedented functional cure rates compared to standard of care Six-month treatment with option of self-administration after first dose CHB affects approximately 1.7 million people in the US1 PHILADELPHIA, October 20, 2026--GSK plc (LSE/NYSE: GSK) today announc

Oct 20 · 23:58Business Wire
Healthcare · Biotech & pharma

Ascentage Pharma’s Lisaftoclax Granted Breakthrough Therapy Designation in China for Treatment-Naïve CLL/SLL

Lisa granted breakthrough designation for Lisa in China

Oct 20 · 23:30GlobeNewswire
Biotech & pharma

Unicycive Therapeutics, Inc. Investors Have Until November 2nd to Contact Bragar Eagel & Squire, P.C. Seeking Lead Plaintiff Role

Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In Unicycive (UNCY) To Contact Him Directly To Discuss Their Options

Oct 20 · 23:01GlobeNewswire
Finance · Biotech & pharma

Telix Reports Third Quarter 2026 Financial Performance

MELBOURNE, Australia and INDIANAPOLIS, Oct. 21, 2026 -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) provides a financial update on its commercial and operational performance for the quarter ended September 30, 2026 (Q3 2026).

Oct 20 · 22:10GlobeNewswire
Finance · Biotech & pharma

Atrium Therapeutics Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

SAN DIEGO, Oct. 20, 2026 -- Atrium Therapeutics, Inc. (Nasdaq: RNA) (the "Company") today announced it awarded inducement grants on October 20, 2026 under the Company's 2026 Employment Inducement Incentive Award Plan (the "2026 Inducement Plan") as a material inducement to...

Oct 20 · 21:23PR Newswire
Healthcare · Education

BioVersys Announces Publication of BV100 Lung Penetration and Drug Interaction Data in two Leading Peer-reviewed Antimicrobial Journals

International Journal of Antimicrobial Agents publishes data showing that BV100 reaches concentrations in lung fluid and alveolar macrophages approximately 35-fold and over 300-fold higher, respectively, than in plasma, providing a strong pharmacological rationale for BV100 use in severe CRAB pneumonia Journal of Antimicrobial Chemotherapy publishes data showing BV100 is a mild CYP3A inducer and a mild substrate for CYP3A inhibitors, a milder drug interaction profile than rifampicin, supporting its use alongside the many medicines given to critically ill patients Both Phase 1 datasets form part of the clinical solid pharmacology foundation of RIV-TARGET, the ongoing Phase 3 registration trial of BV100 in hospital- and ventilator-associated bacterial pneumonia caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC); trial enrollment is ongoing, with topline data read-out anticipated for early 2028 BASEL, SWITZERLAND - October 20, 2026 - BioVersys AG (SIX: BIOV), a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (MDR) bacteria, announced today the publication of two Phase 1 clinical pharmacology studies of BV100, its lead clinical asset, in two leading peer-reviewed journals in the field of antimicrobial therapy: the International Journal of Antimicrobial Agents, the official journal of the International Society of Antimicrobial Chemotherapy, and the Journal of Antimicrobial Chemotherapy, the official journal of the British Society for Antimicrobial Chemotherapy. Dr. Glenn Dale, Chief Development Officer of BioVersys and co-author of the publications, commented: "These two papers address the questions that matter most for an intravenous antibiotic in critically ill pneumonia patients. BV100 has very good distribution in lung fluid and alveolar macrophages, and its drug-interaction profile is mild and manageable. We are pleased to share these data with the infectious disease and critical care community as we continue to enroll patients in our Phase 3 study RIV-TARGET." Dr. Marc Gitzinger, Chief Executive Officer and founder of BioVersys, added: "Carbapenem-resistant Acinetobacter baumannii represents one of the highest medical needs in infectious disease, and patients fighting these life-threatening infections have very few options. These data continue to strengthen the growing scientific basis for BV100 therapy in CRABC pneumonia and bring us a step closer to delivering a much-needed new treatment option to patients and the physicians who care for them." International Journal of Antimicrobial Agents: lung penetration study The paper, entitled "Pulmonary Penetration of Intravenous Rifabutin in Healthy Participants: A Multiple-Dose Pharmacokinetic Study," was published in the International Journal of Antimicrobial Agents (DOI: 10.1016/j.ijantimicag.2026.108014). In 36 healthy male participants receiving BV100 (intravenous rifabutin) 300 mg every 12 hours for four days, concentrations of rifabutin in lung fluid and alveolar macrophages exceeded plasma concentrations at every time point, with median penetration ratios of approximately 35-fold and over 300-fold, respectively, and repeated dosing was well tolerated. The authors conclude that these pulmonary exposures provide a strong pharmacological rationale for further clinical evaluation of BV100 in severe CRAB pneumonia. Journal of Antimicrobial Chemotherapy: drug-drug interaction studies The paper, entitled "BV100 (rifabutin IV) drug interaction studies in healthy subjects with index CYP450 3A probes midazolam and itraconazole," was published in the Journal of Antimicrobial Chemotherapy (DOI: 10.1093/jac/dkag317). Across two Phase 1 studies, BV100 was shown to be a mild CYP3A inducer, reducing midazolam exposure by approximately 47%, and a mild substrate for CYP3A inhibitors, with rifabutin exposure increasing 1.3- to 1.7-fold with itraconazole. This is a milder interaction profile than that of rifampicin, a strong CYP3A inducer, and BV100 was safe and well tolerated in both studies. BV100 is currently studied in two clinical trials: the pivotal Phase 3 global registrational trial, RIV-TARGET and the open-label Phase 2b differentiation trial, RIV-CARE in collaboration with ADVANCE-ID. In September 2026, BV100 was granted Fast Track Designation by the US FDA, under the Qualified Infectious Disease Product (QIDP) Designation received in 2019. About BioVersys BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 3), and tuberculosis (alpibectir, Phase 2, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland. About BV100 BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, BV100 allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including carbapenem-resistant ABC (CRABC) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted US FDA Fast Track Designation in 2026 and QIDP Designation in May 2019, making BV100 eligible for priority FDA review and a five-year extension of market exclusivity upon approval of the first QIDP indication. About Acinetobacter baumannii Acinetobacter baumannii calcoaceticus complex (ABC) are Gram-negative bacteria found in the environment (e.g., in soil and water) and an opportunistic pathogen in humans, typically infecting critically ill and immunocompromised patients, that can result in severe pneumonia and bloodstream infections in addition to affecting other parts of the body. ABC is considered a significant worldwide threat in the healthcare setting given its ability to survive for prolonged periods on surfaces, combined with its ability to develop or acquire resistance to standard of care antibiotics, e.g. carbapenems. Carbapenem-resistance as well as multi-drug resistance (MDR) rates for ABC are among the highest recorded for any bacteria in current times (The Lancet 2022; 399: 629–55). Incidence and resistance rates for ABC are trending upwards and COVID-19 has exacerbated this significantly. BioVersys forecasts the annual number of carbapenem-resistant A. baumannii infections in hospitals to have surpassed one million globally and due to the limited treatment options, such infections come with high (up to 50%) mortality rates. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning BioVersys and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioVersys to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioVersys is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. BioVersys contact  Anca Cighi, Head of IR and Communications, Tel. +41 79 949 33 09; Mail: anca.cighi@bioversys.com For IR: IR@bioversys.com;  Website: www.bioversys.com

Oct 20 · 21:15NewMediaWire
Healthcare · Biotech & pharma

Zoetis Receives FDA Approval for Convenia® RTU for Dogs (cefovecin injectable suspension), Helping More Medium and Large Dogs Access Single-Injection Treatment

Convenia RTU for Dogs can provide up to 14 days of antibiotic treatment of susceptible bacterial skin infections in dogs in a single injection by a veterinary professional Pyoderma – a bacterial skin infection—is one of the top 5 reasons for vet visits for dogs.1 Administration at the veterinary clinic helps dog owners av

Oct 20 · 20:42Business Wire
Healthcare · Biotech & pharma

Alcon Acquires Neurotech and ENCELTO, the Only FDA-Approved Treatment for MacTel Type 2

Expands Alcon's retina portfolio with ENCELTO, an encapsulated cell therapy intended for surgical implantation in the eye for patients with MacTel Type 2, a rare retinal disease Alcon's established presence and expertise in surgical retina is expected to accelerate commercialization and patient access Broadens Alcon's off

Oct 20 · 20:35Business Wire