Data Safety Monitoring Committee approves advancing to a higher dose of 90mCi The first two Cohorts’ patients show tumor uptake and a favourable safety profile SYDNEY, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced the completion of enrollment for the second cohort of patients in the ...

协议核心内容 - Chiesi集团与艾伯维全资子公司Aliada Therapeutics达成一项独家许可协议 [1] - 协议旨在推进针对溶酶体贮积症的跨血脑屏障平台技术 以解决存在高度未满足需求的疾病领域 [1] - Chiesi集团获得全球独家、需支付特许权使用费的许可 以开发和商业化利用Aliada专有平台技术的某些酶替代疗法 [2] - Chiesi集团将负责全球范围内所有的研究、开发及后续商业化活动并承担全部费用 [2] 协议财务与商业条款 - Aliada将获得一笔预付款 并有资格获得基于开发和销售额的里程碑付款以及潜在销售的分级特许权使用费 [2] - 该协议源于2023年8月开始的现有研究合作 该合作专注于利用Aliada的MODEL™平台修饰多种酶货物 [3] 公司战略与研发重点 - 协议体现了公司致力于为多种罕见病中认知和神经系统症状的重大未满足需求创造潜在解决方案的持续承诺 [2] - 研发目标超越症状管理 旨在直接解决根本的神经系统负担 [2] - 合作得到令人鼓舞的临床前数据支持 为识别溶酶体贮积症的治疗途径打开了大门 [3] 公司背景信息 - Chiesi集团是一家以研发为导向的国际生物制药集团 专注于呼吸健康、罕见病和专科治疗领域的创新疗法 [4] - Chiesi全球罕见疾病是集团的一个业务部门 旨在为罕见病患者提供创新疗法和解决方案 [7] - 公司总部位于意大利帕尔马 在全球拥有31家分公司和超过7,500名员工 [6] - 集团在帕尔马设有研发中心 并在法国、美国、加拿大、中国、英国和瑞典设有6个其他重要研发中心 [6]

APR-1051 (WEE1 kinase inhibitor): In ongoing Phase 1 ACESOT-1051dose-escalation trial, 3 out of 4 patients at Dose Level 6 (100 mg once daily) achieved stable disease, per RECIST v1.1, in heavily pretreated gastrointestinal and gynecologic malignanciesATRN-119 (ATR kinase Inhibitor): RP2D of 1,100 mg once daily identified in ABOYA-119 dose-escalation studyPosters on APR-1051 and ATRN-119 featured at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics DOYLESTOWN, Pa., Nov. 1 ...

Results of Clinical Trials Provide Evidence Supporting Significant Radiographic Response and Potential Long-Term Survival in Recurrent Grade III/IV IDH1-Mutant Astrocytoma Treated with Intranasal NEO100CALABASAS, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (NTHI) (“NeOnc” or the “Company”), a multi–Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers today announced updated clinical results from its current Phase ...

BELTSVILLE, Md., Nov. 12, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to developing novel therapies to treat cancer, today announced that it has entered into definitive agreements with the participation of certain institutional and accredited investors, including Ikarian Capital, Squadron Capital Management, Affinity Healthcare Fund, LP., Exome Asset Management as well as other healthcare focused funds, for the purchase and sale of an aggregat ...

NEW YORK, Nov. 12, 2025 (GLOBE NEWSWIRE) -- LB Pharmaceuticals, Inc (“LB Pharmaceuticals” or the “Company”) (Nasdaq: LBRX), a clinical-stage biopharmaceutical company developing novel therapies for schizophrenia, bipolar depression, and other neuropsychiatric diseases, today announced the appointment of Kaya Pai Panandiker as Chief Commercial Officer. Ms. Pai Panandiker is a seasoned commercial and operating leader with more than 20 years of global biopharmaceutical experience, including extensive leadershi ...

Phase 1a Single Ascending Dose trial remains on track for initial clinical data to be reportedby year end 2025 Phase 1b/2 Multiple Ascending Dose trial currently enrolling, intended to inform dose selection for potential Phase 3 development program; initial clinical data expected in 2H 2026 Recent significant corporate milestones include the selection of a CDMO, CFO hire, and opening of corporate headquarters Cash, cash equivalents and short-term investments of $77.0M as of September 30, 2025, expected to ...

MALVERN, Pa., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today provided corporate updates and third quarter 2025 financial results. "The past quarter delivered breakthrough progress on every front," said Maria Maccecchini, Ph.D., President and CEO of Annovis. "Our pivotal Phase 3 Alzhe ...

Business development: Secures royalty economic interests in two early stage partnered assets through XOMA Royalty’s announced expected acquisition of LAVA Therapeutics. Company acquisitions: •Completed XOMA Royalty’s acquisitions of Turnstone Biologics and HilleVax; • announced acquisitions of LAVA Therapeutics and Mural Oncology; • acted as structuring agent for XenoTherapeutics’ acquisition of ESSA Pharma. Key Pipeline advancements: • Zevra Therapeutics submitted a Marketing Authorization Application (MA ...

Face-to-Face Pre-NDA Meeting with the FDA Scheduled for Early December; NDA Submission for D-PLEX₁₀₀ On Track for Early 2026 Advancements in Discussions with Potential U.S. Partners Following Positive Phase 3 Trial Results Company Continues to Advance Towards Commercial Manufacturing Readiness with Successful Completion of IMOH GMP Inspection Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, Nov. 12, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a l ...