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Annexon Announces Completion of Enrollment in Pivotal Phase 3 ARCHER II Trial of Vonaprument (formerly ANX007) for Dry Age-Related Macular Degeneration (AMD) with Geographic Atrophy
GlobeNewswire News Room· 2025-07-24 19:00
Expedited Enrollment Surpassing 630 Targeted Participants Underscores the Strong Demand for a Therapy Focused on Vision Preservation Phase 3 ARCHER II Trial Design and Rationale to Be Presented at ASRS, a Leading Meeting for Retina Science and Innovation Topline Pivotal Phase 3 Data Expected in the Second Half of 2026 Potential for Vonaprument to Be the First Treatment Approved in Europe and the U.S. for Dry AMD with Geographic Atrophy Based on Protection of Visual Acuity and Structural Measures BRISBANE, C ...
Ligand to Report Second Quarter 2025 Financial Results on August 7, 2025
GlobeNewswire· 2025-07-24 19:00
JUPITER, Fla., July 24, 2025 (GLOBE NEWSWIRE) -- Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced that it will report second quarter 2025 financial results on Thursday, August 7, 2025. The company will hold a conference call beginning at 8:30 a.m. ET to discuss the results and provide a general business update. Ligand is a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, l ...
MediciNova Provides Enrollment Update for Ongoing ALS and Hypertriglyceridemia Clinical Trials
Globenewswire· 2025-07-24 18:00
MN-166 COMBAT ALS trial down to single digit required enrollment while MN-001 hypertriglyceridemia trial in type 2 diabetes patients requires final two patientsLA JOLLA, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875) (the “Company”), today provides an update on the enrollment of two key ongoing clinical trials for the Company’s developmental compou ...
Akeso Announces First Patient Enrollment in Phase III Trial of Ivonescimab for Pancreatic Cancer
Prnewswire· 2025-07-24 09:14
临床试验进展 - 公司宣布首例患者入组关键性/注册III期临床试验(AK112-310/HARMONi-GI2),评估ivonescimab(PD-1/VEGF双抗)联合化疗±ligufalimab(CD47单抗)一线治疗转移性胰腺癌的疗效 [1] - 该试验是公司解决全球肿瘤领域重大未满足临床需求战略的关键组成部分 [3] 胰腺癌治疗现状 - 胰腺癌治疗难度大,现有免疫疗法作为一线治疗的III期研究大多失败,目前尚无免疫疗法获批一线治疗转移性胰腺癌 [2] - 2022年全球新发胰腺癌约51.1万例,死亡46.7万例,80%患者确诊时已处于晚期,现有化疗方案中位总生存期不足1年 [4] 药物作用机制 - Ivonescimab可同时阻断PD-1和VEGF信号通路,增强免疫细胞杀伤肿瘤能力 [5] - Ligufalimab通过阻断CD47-SIRPα相互作用增强吞噬作用,与ivonescimab联用有望协同增强抗肿瘤活性 [5] 公司背景 - 公司拥有50多个创新药物管线,其中24个进入临床试验阶段(含15个双抗/多抗及双抗ADC),7个新药已商业化,2个新药及2个新适应症正在审评中 [10] - 公司建立了从研发到商业化的全产业链平台,包括ACE研发平台、Tetrabody双抗技术和GMP生产体系 [10]
Palisade Bio Announces Exercise of Previously Issued Warrants for $3.9 Million
GlobeNewswire News Room· 2025-07-24 08:00
Carlsbad, CA, July 23, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today announced an agreement between the Company and several accredited investors to exercise certain existing warrants (the “Existing Warrants”) to purchase up to an aggregate of 4,318,905 shares of common stock. The Existing ...
Vanda Pharmaceuticals to Announce Second Quarter 2025 Financial Results on July 31, 2025
Prnewswire· 2025-07-24 04:45
公司财务报告发布安排 - 公司将于2025年7月31日美股开盘前发布2025年第二季度财务业绩 [1] - 公司计划在2025年7月31日美国东部时间上午8点举行电话会议,讨论第二季度财务业绩及其他公司活动 [2] 投资者参与方式 - 电话会议参与号码:美国境内拨打1-800-715-9871,国际拨打1-646-307-1963,密码9430387 [2] - 电话会议将在公司官网同步直播并存档,投资者需提前15分钟注册并安装必要音频软件 [3] - 电话会议回放时间为2025年7月31日上午11点至8月7日晚上11点59分,回拨号码美国境内1-800-770-2030,国际1-609-800-9909,密码9430387 [4] 公司背景 - 公司是全球领先的生物制药企业,专注于开发创新疗法以满足高度未满足的医疗需求并改善患者生活 [5] - 公司官网为www.vandapharma.com,社交媒体账号为X平台@vandapharma [5] 公司联系人 - 首席财务官Kevin Moran,联系电话202-734-3400,邮箱[email protected] [6] - 媒体联系人Jim Golden/Jack Kelleher/Dan Moore,邮箱[email protected] [6]
Viking Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Prnewswire· 2025-07-24 04:05
核心观点 - Viking Therapeutics在2025年第二季度及上半年取得显著临床进展,重点推进VK2735治疗肥胖症的III期临床试验,并完成口服制剂VK2735的II期试验入组 [2][3][4] - 公司现金储备充足,截至2025年6月30日持有8.08亿美元现金及短期投资,为III期临床试验提供资金保障 [5][16] - 财务方面,2025年第二季度研发支出同比增加153%至6020万美元,净亏损扩大至6560万美元,主要因临床项目投入增加 [10][12] 临床管线进展 VK2735皮下注射剂 - 基于II期VENTURE试验阳性结果(体重平均减少最高达14.7%)及FDA反馈,启动III期VANQUISH项目,包含两项研究:VANQUISH-1计划入组4500名肥胖患者,VANQUISH-2计划入组1100名肥胖合并2型糖尿病患者 [3][4] - III期主要终点为治疗78周后体重变化百分比,次要终点包括体重降低≥5%/10%/15%/20%的患者比例 [5][6] VK2735口服制剂 - 口服制剂II期VENTURE-Oral试验完成280名患者入组,预计2025年下半年公布顶线数据,I期数据显示28天治疗体重平均减少最高8.2% [6][7][8] - 口服制剂设计允许患者从皮下注射过渡至口服治疗,可能提升用药便利性 [6] 双胰淀素和降钙素受体激动剂(DACRA)项目 - 临床前数据显示单次皮下给药可减少啮齿类动物摄食量,计划2025年第四季度提交IND申请 [8][9] 财务数据 - 2025年第二季度研发支出6020万美元(2024年同期2380万美元),管理费用1440万美元(2024年同期1030万美元) [10][11] - 上半年净亏损1.112亿美元(2024年同期4960万美元),主要因临床项目投入增加 [13][15] - 现金及短期投资从2024年底9.03亿美元降至8.08亿美元,主要支撑临床开发 [16] 行业活动 - 公司管理层将参与2025年7月至9月期间的多场医疗健康投资会议,包括BTIG生物技术会议、摩根士丹利全球医疗会议等 [9]
Galapagos Bolster Leadership Team with Seasoned Life Sciences Executives to Accelerate Business Transformation
Globenewswire· 2025-07-24 04:03
Appoints Sooin Kwon as Chief Business Officer and Dan Grossman as Chief Strategy Officer Both executives possess proven track records in strategic execution and deal-making and will help drive long-term value creation at Galapagos Mechelen, Belgium; July 23, 2025, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced the appointments of Ms. Sooin Kwon as Chief Business Officer (CBO) and Mr. Dan Grossman as Chief Strategy Officer (CStO), effective August 4, 2025, further strengthening the Company ...
Galapagos Welcomes Seasoned Pharmaceutical Executives Dawn Svoronos and Jane Griffiths to Its Board of Directors
GlobeNewswire News Room· 2025-07-24 04:02
New Directors bring deep commercial, operational, and transaction experience to the Board Mechelen, Belgium; July 23, 2025, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced the appointments by way of co-optation of Dawn Svoronos and Jane Griffiths as Non-Executive Independent Directors to its Board of Directors, effective July 28, 2025. Dawn Svoronos and Jane Griffiths will replace Peter Guenter and Simon Sturge, who will step down from the Board on July 28, 2025. Jérôme Contamine, Chair o ...
Arcutis to Report Second Quarter 2025 Financial Results and Host Conference Call on August 6, 2025
GlobeNewswire News Room· 2025-07-24 04:00
WESTLAKE VILLAGE, Calif., July 23, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will report second quarter 2025 financial results and provide a business update on Wednesday, August 6, 2025 after the U.S. financial markets close. The Company will also host a conference call and webcast the same day at 4:30 p.m. ET. A live webcast of the call and th ...