临床开发合作 - Cellectar Biosciences与合同研究组织Evestia Clinical达成协议，Evestia将为Cellectar的CLR 125治疗三阴性乳腺癌的1b期临床试验提供全面的CRO服务 [1] - 该合作将利用Evestia Clinical在肿瘤学领域的专业知识和全球能力，其经验涵盖超过300项涉及实体瘤和血液恶性肿瘤的研究 [2] - Cellectar计划于2025年第四季度在梅奥诊所启动针对三阴性乳腺癌的1b期临床试验 [1] 试验药物与方案 - CLR 125是一种靶向实体瘤的碘-125奥杰电子发射候选药物，其靶向适应症包括三阴性乳腺癌、肺癌和结直肠癌 [1] - Cellectar已选择梅奥诊所网络站点作为1b期临床试验的治疗中心，并任命Pooja Advani博士为首席研究员，确保患者由经验丰富的临床专家治疗 [3] 公司战略与背景 - Cellectar Biosciences是一家晚期临床生物制药公司，专注于利用其专有的磷脂药物偶联物平台开发靶向癌细胞的下一代治疗方法 [7] - 公司产品管线包括已获FDA突破性疗法认定的iopofosine I 131、基于锕-225的CLR 121225项目以及CLR 121125等项目 [8] - Evestia Clinical是一家全球专业CRO，通过近期与Atlantic Research Group合并，增强了其治疗专业知识和美国市场布局，能为肿瘤等复杂治疗领域提供定制化服务 [2][3] 疾病背景与市场机会 - 三阴性乳腺癌是一种侵袭性乳腺癌亚型，其特征在于缺乏雌激素受体、孕激素受体和HER2蛋白表达，使其治疗选择有限 [4] - 在美国，约12%的乳腺癌诊断属于三阴性乳腺癌，研究表明约25%（40,540例）的病例在标准治疗后会出现复发，存在对创新靶向疗法的迫切需求 [4]

Sapu003 Designed to Overcome Limitations of Afinitor®, FDA-Approved Oral Everolimus, by Delivering Full Strength of the Drug via Intravenous InjectionSAN DIEGO, Sept. 24, 2025 (GLOBE NEWSWIRE) -- via IBN -- Sapu Nano, developer of Deciparticle™, today announced that it has received approval from Australia’s Human Research Ethics Committee (HREC) to begin enrolling patients in a Phase 1 human clinical trial of Sapu003—an injectable form of Everolimus—for the treatment of breast cancer. Sapu Nano is part of t ...

Accessibility StatementSkip Navigation MENIN inhibitors are a promising class of targeted oncology drugs in development for acute leukemias and certain solid tumors, but their use is often limited by severe dermatological side effects. HT-001 aims to address these toxicities, helping patients remain on therapy and realize the full benefit of treatment. Key Highlights NEW YORK, Sept. 24, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing next-g ...

Suitability Petition is required for shift from multidose packaging of ketamine to single-patient dose preservative free ketamineGranting of Suitability Petition enables re-filing of Abbreviated New Drug Application (ANDA) for NRx’s patent-pending preservative-free ketamine product WILMINGTON, Del., Sept. 24, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq:NRXP), a clinical-stage biopharmaceutical company, announced that it was notified yesterday by the United States Food and Drug Administration ...

公司活动安排 - 公司首席科学官John Kastelein与投资者关系主管Matthew Philippe将于2025年9月30日美东时间上午11点参加Stifel 2025虚拟心脏代谢论坛的炉边谈话[1] - 活动将通过公司投资者关系网站进行直播并提供回放服务[2] 公司业务定位 - 公司为晚期临床生物制药企业 专注于开发口服非他汀类药物 针对现有疗法效果不足或耐受性差的心血管疾病高风险人群[3] - 致力于为代谢疾病人群提供安全耐受且便捷的LDL-C降低疗法 解决显著未满足的医疗需求[3] 研发管线进展 - 核心产品obicetrapib为口服低剂量每日一次CETP抑制剂 目前正在进行多项三期临床试验[3] - 试验方案包含单药治疗及与依折麦布固定剂量组合疗法 作为他汀类药物的辅助治疗手段[3]

Engagement Will Expand Daré’s Engagement in Advancing Women’s Health Innovation and Provide Insights into One of the Most Significant Unmet Needs in Maternal CareSAN DIEGO, Sept. 24, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company with a sole focus of closing the gap in women's health between promising science and real solutions, today announced it has entered into an agreement with the Gates Foundation under which it will receive up to approximately $499,000 from ...

SAN DIEGO, Sept. 24, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that management is scheduled to participate in the following investor conference. UBS Virtual Oncology DayWednesday, October 1, 20252:30 p.m. ET / 11:30 a.m. PT A live audio webcast will be available in the Investors section of Kura’s website at https://kuraoncology.com/, with an arc ...

Program to Provide Support of Communications and Outreach for Patient Advocacy Organizations Focused on Cardiovascular Diseases Deadline for Applications is November 3rd, 2025 SOUTH SAN FRANCISCO, Calif., Sept. 24, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced a call for proposals for the eighth annual Cytokinetics Communications Grant Program. The program will award five grants to patient advocacy organizations serving the hypertrophic cardiomyopathy (HCM) and heart fai ...

FG-3246 Phase 2 dose optimization trial to enroll 75 patients with metastatic castration-resistant prostate cancer (mCRPC) in the post-androgen receptor signaling inhibitor (ASRI) and pre-chemotherapy setting FG-3180 to be evaluated in the Phase 2 trial as a companion PET imaging agent and a potential predictive patient selection biomarker Interim analysis expected in 2H 2026 SAN FRANCISCO, Sept. 24, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the initiation of the Phase 2 monothe ...

SAN MATEO, Calif., Sept. 24, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced its participation in a drug development panel at Fierce Biotech Week taking place October 7-9, 2025 in Boston, MA. Panel Title:How Biotechs are Leveraging Artificial Intelligence (AI)/Machine Learning (ML) to Drive Efficiency and ROIPresenter: Marie O’Farrell, P ...