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Altimmune Appoints Industry Veteran Christophe Arbet-Engels, M.D., PhD as Chief Medical Officer to Drive Next Phase of Clinical Development of Pemvidutide
Globenewswire· 2025-09-29 11:30
Seasoned clinical leader to oversee Phase 3 development of pemvidutide in MASH Dr. Arbet-Engels has led late-stage development, regulatory approvals and commercial launches for multiple successful franchises GAITHERSBURG, Md., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced the appointment of Christophe Arbet-Engels, MD, PhD as Chief Medical Of ...
IO Biotech Provides Update Following Pre-BLA Meeting with FDA
Globenewswire· 2025-09-29 11:05
FDA recommends that IO Biotech not submit a Biologics License Application (BLA) based on the data from the IOB-013 clinical trial Company plans to design new registrational study for Cylembio for the treatment of first-line patients with advanced melanomaCompany implementing a restructuring, reducing its workforce by approximately 50 percent NEW YORK, Sept. 29, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf th ...
Inventiva's Financial and Clinical Progress Amid Challenges
Financial Modeling Prep· 2025-09-29 11:00
The company's financial metrics indicate a challenging environment. With a price-to-earnings (P/E) ratio of approximately -1.46, Inventiva is experiencing negative earnings. The price-to-sales ratio of about 33.51 suggests that investors are paying $33.51 for every dollar of sales. Additionally, the enterprise value to sales ratio is approximately 28.92, reflecting the company's valuation relative to its sales. Inventiva's debt-to-equity ratio is about -0.51, indicating more liabilities than equity. The cur ...
RedHill Wins New York Supreme Court Appeal, Upholding $10 Million Summary Judgment Against Kukbo
Prnewswire· 2025-09-29 11:00
Accessibility StatementSkip Navigation The New York Supreme Court has, on appeal, upheld its original summary judgment ruling in favor of RedHill The New York Supreme Court unequivocally dismissed Kukbo Co. Ltd's ("Kukbo") defense again, further ruling that RedHill had fulfilled its agreement obligations even after Kukbo's breach RedHill has been granted approximately $10 million in total awards comprised of the $8.25 million original award and a subsequent $1.82 million award for legal costs and expenses ( ...
Applied Therapeutics Provides Update Following Meeting with FDA
Globenewswire· 2025-09-29 11:00
NEW YORK, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the Company), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, today announced that the Company completed a meeting with the U.S. Food and Drug Administration (FDA) to discuss the potential new drug application (NDA) submission for govorestat for the treatment of Charcot-Marie-Tooth Sorbitol Dehydrogenase (SORD) Deficiency (CMT-SORD) in the third quarter of 202 ...
Larimar Therapeutics Announces Positive Data from Ongoing Long-term Open Label Study and Updates to Nomlabofusp Program for Friedreich's Ataxia
Globenewswire· 2025-09-29 11:00
In 4 completed studies and the ongoing OL study, 65 participants received at least 1 dose of nomlabofusp, including 39 in the OL study, with 14 on treatment for at least 6 months and 8 for over 1 year in the OL studyIncreases in skin FXN levels with short- and long-term daily nomlabofusp; 10/10 participants with data at 6 months achieved skin FXN levels over 50% of median levels in healthy volunteers (which is similar to levels in asymptomatic carriers)Consistent directional improvement across 4 key clinica ...
Climb Bio Announces CLYM116 Preclinical Data Highlighting Potential for Best-In-Class Therapeutic for IgAN
Globenewswire· 2025-09-29 11:00
New preclinical data demonstrate deeper IgA reduction and a longer half-life compared to first-generation anti-APRIL monoclonal antibody CLYM116 Phase 1 trial initiation expected in Q4 2025, with initial biomarker and dosing interval data anticipated mid-year 2026 Company to host R&D Spotlight Webcast today, September 29, 2025 WELLESLEY HILLS, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical-stage biotechnology company developing therapeutics for immune-mediated diseases, ...
MannKind Appoints Dr. Ajay Ahuja as Executive Vice President and Chief Medical Officer
Globenewswire· 2025-09-29 10:05
公司人事任命 - MannKind Corporation任命Ajay Ahuja博士为首席医疗官 该任命自2025年9月29日起生效[1] - Ahuja博士将直接向首席执行官Michael Castagna博士汇报 并加入公司高管领导团队[1] 新任高管专业背景 - 拥有超过20年生物制药行业领导经验 涵盖初创公司及跨国药企 从业时间自2003年起[2] - 曾任Kardigan Bio公司晚期DNA疗法的开发与上市负责人 该公司专注心脏病学领域[2] - 在Idorsia Pharmaceuticals组建美国医学部门并推动多个新化合物上市[3] - 在Allergan担任全球医学事务主管 管理超100人团队 覆盖美国及国际市场[3] - 曾在武田制药担任心血管代谢产品线全球医学主管 专注糖尿病和心血管疾病领域[3] - 早期职业经历包括在辉瑞、诺华和Tepha公司担任重要职务[3] 高管资质与学术背景 - 获得华盛顿大学医学院医学博士学位 在西北大学完成住院医师培训 在哈佛医学院完成专科培训[4] - 持有哈佛商学院MBA学位[4] - 拥有超过十年波士顿儿童医院执业医师经验 为委员会认证医师[4] 公司战略方向 - 专注内分泌及罕见肺病领域创新吸入疗法及设备的开发与商业化[5] - 通过干粉制剂和吸入装置技术实现药物快速递送至肺部 针对局部或全身性治疗[6] - 当前产品管线涵盖糖尿病、非结核分枝杆菌肺病、肺纤维化及肺动脉高压等领域[6] 管理层评价 - 首席执行官强调Ahuja博士在医学事务、临床开发和全球战略方面的专业经验将推动管线进展[2] - 特别指出其心血管代谢领域经验对公司未来发展具有关键价值[2] - Ahuja博士表示认司创新理念与患者中心解决方案 期待推动变革性疗法发展[4]
RAPT Therapeutics Announces FDA Clearance of IND Application to Proceed to Phase 2b Trial of RPT904 in Food Allergy
Globenewswire· 2025-09-29 09:00
SOUTH SAN FRANCISCO, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared RAPT’s Investigational New Drug (IND) Application to proceed to a Phase 2b clinical trial of RPT904 for the treatment of patients with ...
盘前暴涨超38%!80亿美元!Genmab官宣收购Merus
美股IPO· 2025-09-29 08:51
当地 时间 2 0 2 5 年 9 月 2 9 日 清早 , Genmab 官宣 将 收购 Merus N.V. ( 以下简称 为 " Merus " ) 。 根据协议,Genmab 将 以每股97.00美元的现金收购Merus的全部股份, 交易价值 约80亿美元 。这是 Genmab自成立以来最大的一笔收购( 去年收购普方生物总价为18 亿美元) 。 图片来源 : Genmab 官网 Merus最早创立于2003年,总部位于荷兰 , 核心 资产 是 一 款 EGFR / LGR5双抗 —— petosemtamab ( M C L A - 1 5 8 ) 。 2 0 2 5 年 A S C O 上 , Merus公布 了 petosemtamab 联合 K 药 对比 K 药 单药 一线 治 疗 局部晚期头颈部鳞状细胞癌 (HNSCC) 的 I I 期 临床数据 。 具体 来看 , 这项 I I 期 研 究 共 纳入 4 5 名 局部 晚期 HNSCC 患者 。 最 终 4 3 名 可 评估 患者 数据 显示 , 联合 用药 组 经实体瘤反应评估标准 的 总体缓解率 ( O R R ) 达 6 3 % (27 ...