CAN-2409 improved disease-free survival in patients with intermediate-to-high-risk, localized prostate cancer compared to placebo in patients treated with either conventional or moderate hypofractionated radiotherapy with curative intent, independent of the specific modality of radiation therapy used NEEDHAM, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immuno ...

KETAFREE™ to provide innovative, preservative-free IV ketamine formulation, eliminating toxic preservatives, in keeping with current HHS priorities to eliminate toxic preservatives from foods and drugsFiling is based on FDA interaction and approval of Suitability Petition for NRx’s proposed strength of preservative-free ketamineThis presentation of ketamine represents a reshoring of a strategically important drug to the US, in keeping with the Presidential Executive Order signed on May 5, 2025. Ketamine fac ...

-- Study did not meet primary endpoint of complete healing of PCED at Week 8; secondary endpoints also did not achieve statistical significance -- -- KPI-012 was well-tolerated with no treatment-related serious adverse events observed -- -- KALA to cease clinical development of KPI-012, preserve cash and explore strategic options -- ARLINGTON, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commerci ...

公司研发进展 - Provectus Biopharmaceuticals宣布启动其主导研究药物PV-10在膀胱癌原位模型中的临床前研究 [1] - 该研究由Translational Drug Development LLC (TD2) 执行 旨在评估PV-10在不同治疗组中的表现 包括口服和膀胱内单药治疗以及与抗PD-1检查点抑制剂的联合治疗 [2] - 研究结果预计在2026年第一季度公布 [1] 研究目标与意义 - 该研究旨在生成转化数据 为PV-10未来在膀胱癌领域的临床开发提供信息 并支持口服PV-10在实体瘤癌症中更广泛的免疫肿瘤学应用 [2] - 研究目标是将成功的小鼠模型数据转化为PV-10膀胱癌临床试验的基础 关键是为给药剂量和给药途径的确定提供证据基础 [3] - 成功的临床前研究结果将使公司能够扩大PV-10的研究性新药申请 涵盖局部给药和全身给药 [3] 公司背景与药物平台 - Provectus是一家临床阶段的生物技术公司 开发基于孟加拉玫瑰红钠的免疫疗法药物管线 [4] - PV-10由公司药用级孟加拉玫瑰红钠活性药物成分制成 [1] - 公司的临床项目涵盖肿瘤学、皮肤病学和眼科学 并在血液学、伤口愈合、传染病和组织修复领域拥有额外的概念验证项目 [4]

CARMEL, Ind., Sept. 29, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced that Kent Hawryluk, President and Chief Executive Officer, and Sam Azoulay, MD, Chief Medical Officer, will participate in a fireside chat at the Stifel 2025 Virtual Cardiometabolic Forum on September 30. Stifel 2025 Virtual Cardiome ...

SAN DIEGO, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, today announced that its management will participate in the second annual Oncology Venture, Innovation, and Partnering Summit being held September 29-30, 2025, at the Westin Boston Seaport in Boston, MA. Eric Poma, Ph.D., ...

业绩总结 - VELA项目在第16周的主要终点显示出统计学显著性，p值小于0.001[9] - VELA-1和VELA-2的HiSCR75反应率分别为35%和36%[9] - VELA-1的所有主要和关键次要终点均达到了统计学显著性[10] - VELA项目的总筛查人数为639人，其中421人被随机分配，完成第16周的患者分别为130人（94%）和128人（91%）[15] - VELA-1和VELA-2的患者特征在基线时保持平衡，女性比例分别为61.5%和53.6%[16] - VELA-1和VELA-2的HiSCR75反应率在第16周的观察结果显示出持续的改善[24] 用户数据 - Sonelokimab 120mg在VELA-1和VELA-2试验中，HiSCR75反应率为34.4%和34.1%，相较于安慰剂组的17.5%和24.9%分别提高了16.9%和9.2%[39] - HiSCR50反应率在VELA-1和VELA-2中分别为51.0%和55.6%，相较于安慰剂组的30.3%和43.0%提高了20.7%和13.4%[39] - 在疼痛NRS-3评分中，Sonelokimab 120mg组的反应率为28.4%和29.1%，相比安慰剂组的11.5%和14.9%提高了16.9%和14.1%[39] - HiSQOL评分的变化从基线到治疗后，Sonelokimab 120mg组的LSM CfB为-9.4和-8.3，显著优于安慰剂组的-3.1和-3.5[39] - DLQI评分的变化显示，Sonelokimab 120mg组的反应率为56.8%和58.1%，相比安慰剂组的36.2%和38.1%提高了20.6%和19.0%[39] 未来展望 - MLTX预计在2024年5月3日开始进行Hidradenitis suppurativa的VELA-1和VELA-2临床试验[51] - VELA-1和VELA-2的结果预计在2025年第三季度和2026年第二季度分别公布[51] - MLTX计划在2026年第三季度提交VELA-1和VELA-2的注册申请，预计在2027年中期获得批准[51] - PsA（银屑病关节炎）相关的IZAR-1和IZAR-2试验预计在2024年11月3日开始，结果将在2026年上半年公布[51] - MLTX计划在2027年第三季度提交PsA的补充生物制剂申请（sBLA），预计在2028年第三季度获得批准[51] 新产品和新技术研发 - VELA项目的安全性良好，采用方便的皮下给药方案，注射次数较少且剂量较低[10] - Sonelokimab的安全性良好，任何不良事件发生率为67.3%，而安慰剂组为55.6%[40] - 任何严重不良事件在Sonelokimab组的发生率为2.5%，安慰剂组为1.8%[40] - Sonelokimab在临床试验中未发现新的安全信号，包括缺乏IBD和肝脏事件的信号[41] 其他新策略和有价值的信息 - 公司相信HS的治疗方案基于现有的SLK数据（包括VELA和MIRA试验数据）是可批准的[55] - MLTX正在寻求FDA的指导，以确认注册路径[55] - SLK显示出差异化的特征，匹配疗效、疼痛和生活质量的影响、安全性和便利性[55] - 公司对HS的未来发展持乐观态度，认为有明确的前进路径[52] - MLTX将在2025年10月31日至11月2日的第十届Hidradenitis Suppurativa进展年会中展示VELA的顶线数据[53]

TORONTO, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (Upstream: QNTM) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development, is pleased to announce today the results of its annual general and special meeting ...

Strengthening Leadership to Accelerate iNKT Therapies into Immune-Mediated Disease, Pulmonary Disorders, and Global Health Security Colonel (Ret.) John B. Holcomb, MD Colonel (Ret.) John B. Holcomb, MD NEW YORK, Sept. 29, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (Nasdaq: INKT), a clinical-stage biopharmaceutical company pioneering invariant natural killer T (iNKT) cell therapies, today announced the appointment of Colonel (Ret.) John B. Holcomb, MD, FACS to its Board of Directors. Dr. Holcomb is ...

Additional Data from MAPLE-HCM Show Aficamten Significantly Improves Measures of Maximaland Submaximal Exercise Capacity and Recovery Compared to Metoprolol 96-Week Analyses from FOREST-HCM SupportLong-Term Efficacy and Tolerability of Aficamten in Patients with Non-Obstructive HCM SOUTH SAN FRANCISCO, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional data related to aficamten were presented in a Late Breaking Clinical Research session at th ...