AUCATZYL® will be available through routine commissioning by the UK National Health Service (NHS)LONDON, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces that the National Institute for Health and Care Excellence (NICE) has published draft guidance1 recommending AUCATZYL® (obecabtagene autoleucel, or “obe-cel”)2 for use in the National ...

LONDON, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces that the National Institute for Health and Care Excellence (NICE) has published draft guidance1 recommending AUCATZYL® (obecabtagene autoleucel, or “obe-cel”)2 for use in the National Health Service (NHS) in England and Wales as a treatment option for adult patients (≥26 years) wi ...

Core Insights - Junshi Biosciences announced that its JS001sc-002-III-NSCLC study has met its primary endpoints, indicating a successful Phase 3 clinical trial for its subcutaneous formulation of toripalimab in treating recurrent or metastatic non-squamous non-small-cell lung cancer [1][5] - The company plans to submit a new drug application (NDA) to regulatory authorities soon, aiming to enhance treatment accessibility and convenience for patients [1][6] Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery, development, and commercialization of novel therapies [8] - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas, including cancer, autoimmune, metabolic, neurological, and infectious diseases [8] - It has received approvals for five products in China and international markets, including toripalimab, which is China's first domestically produced anti-PD-1 monoclonal antibody [9] Industry Context - In 2022, China reported 1.06 million new lung cancer cases, with non-small-cell lung cancer (NSCLC) being the predominant subtype, accounting for approximately 85% of cases [2] - Immunotherapy, particularly anti-PD-1 monoclonal antibodies, has become a cornerstone treatment for various cancers, including lung cancer, addressing a significant clinical need for more convenient administration methods [3][4]

Core Insights - Junshi Biosciences announced that its JS001sc-002-III-NSCLC study has met its primary endpoints, indicating a successful Phase 3 clinical trial for its subcutaneous formulation of toripalimab in treating recurrent or metastatic non-squamous non-small-cell lung cancer (NSQ-NSCLC) [1][5] - The company plans to submit a new drug application (NDA) to regulatory authorities soon, aiming to enhance treatment accessibility and convenience for patients [1][6] Company Overview - Junshi Biosciences, founded in December 2012, is an innovation-driven biopharmaceutical company focused on discovering, developing, and commercializing novel therapies, with a diverse R&D pipeline of over 50 drug candidates [8][10] - The company has five therapeutic focus areas: cancer, autoimmune, metabolic, neurological, and infectious diseases, and has received approvals for five products in China and international markets [9][8] Clinical Study Details - The JS001sc-002-III-NSCLC study is a multi-center, open-label, randomized Phase 3 clinical trial led by Professor Lin WU from Hunan Cancer Hospital, marking the first Phase 3 study of a domestic anti-PD-1 monoclonal antibody subcutaneous formulation [4][7] - The study results showed that the drug exposure of JS001sc was non-inferior to that of the intravenous formulation, with comparable efficacy and safety profiles [5][6] Market Context - In 2022, China reported 1.06 million new lung cancer cases, with non-small-cell lung cancer (NSCLC) being the predominant subtype, accounting for approximately 85% of cases [2] - Immunotherapy, particularly anti-PD-1 monoclonal antibodies, has become a cornerstone treatment for various cancers, highlighting the urgent need for more convenient administration methods [3][6]

Core Insights - Zymeworks Inc. is a biotechnology company focused on developing innovative biotherapeutics and is participating in two major investor conferences in Miami [1] - The company is advancing its portfolio of licensed healthcare assets, particularly zanidatamab, through strategic partnerships to optimize future cash flows [2] - B. Riley upgraded Zymeworks' stock to a "Buy" rating with a price target increase from $30 to $40, reflecting positive market sentiment [3] Company Developments - Zymeworks has formed partnerships with BeOne Medicines Ltd. and Jazz Pharmaceuticals Ireland Limited for the development and commercialization of zanidatamab [2] - The stock has shown resilience with a 52-week high of $26.19 and a low of $9.03, indicating strong investor interest [4] - The company’s market capitalization is approximately $1.88 billion, with current trading at $24.96, reflecting a 3.91% increase [3][4] Market Position - Zymeworks is well-positioned in the biotechnology sector, focusing on multifunctional biotherapeutics for diseases such as cancer and autoimmune disorders [4] - The company’s integrated drug development engine and therapeutic platforms allow for precise engineering of antibody-based therapeutics [4] - Partnerships with global biopharmaceutical companies enhance Zymeworks' capabilities to target novel pathways in areas with significant unmet medical needs [4]

Largest prospective clinical trial to-date in a rare subtype of GIST ROCKVILLE, Md. and SUZHOU, China, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International Inc. (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced the publication of clinical and translational data from a Phase Ib study (NCT03594422) on the ...

Core Insights - iBio, Inc. will participate in the 8th Annual Evercore Healthcare Conference from December 2-4, 2025, in Miami, highlighting its focus on advancing its next-generation obesity pipeline [1][2]. Company Overview - iBio is an AI-driven biotech company specializing in precision antibody therapies for cardiometabolic diseases, obesity, cancer, and other challenging conditions [4]. - The company utilizes proprietary 3D modeling and innovative drug discovery platforms to develop breakthrough antibody treatments aimed at significant unmet medical needs [4]. Key Events - Martin Brenner, CEO and Chief Scientific Officer of iBio, will engage in a fireside chat on December 4, 2025, discussing the promising non-human primate data for IBIO-610, a potential first-in-class Activin E antibody [2]. - Felipe Duran, CFO of iBio, will be available for one-on-one meetings during the conference, providing opportunities for direct engagement with investors [3]. Additional Information - A livestream of the conference will be available, and a replay will be posted on the Investor section of the iBio website [3].

SAN DIEGO--(BUSINESS WIRE)--Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced that management is scheduled to participate in a fireside chat at the 8th Annual Evercore Healthcare Conference in Miami on Wednesday, December 3, 2025 at 1:20 p.m. ET. An audio webcast of the fireside chat can be acc. ...

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 24, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced that management will be participating in a fireside chat at the 8th Annual Evercore Healthcare Conference on Wednesday, December 3, 2025, at 11:15 a.m. ET. Management will also be participating in one-on-one meetings. The webcast of the fireside chat discuss ...

BOSTON, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system (CNS) disorders driven by neuronal excitation-inhibition imbalance, today announced they will present the latest preclinical and clinical data and progress on trials across its precision epilepsy pipeline at the American Epilepsy Society Annual (AES) Meeting, December 5-9, 2025, in Atlanta, Georgia. “The A ...