The Company’s investigational small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”), BMF-650, demonstrated potent weight loss and good tolerability in obese cynomolgus monkeys A Phase I study of BMF-650 in healthy obese patients is currently enrolling with data expected first half of 2026In a rodent model of type 2 diabetes (“T2D”), icovamenib in combination with low dose semaglutide promoted enhanced glycemic control and body weight reduction with preservation of lean mass, outperforming ...

Advances diabetes and obesity programs with icovamenib demonstrating durable 52-Week Phase II data and with BMF-650, Biomea’s next-generation, oral small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”), dosing its first patient in a Phase I clinical trialPresented preclinical activity of icovamenib in combination with semaglutide in type 2 diabetes (“T2D”) animal model at EASD Annual Meeting, demonstrating enhanced glycemic control and body weight reduction with preservation of lean massR ...

SAN CARLOS, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced that it will present poster presentations at ObesityWeek® 2025, taking place November 4-7, 2025 in Atlanta, Georgia. The presentations will highlight preclinical data for BMF-650, Biomea’s next-generation oral small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”), and combination data for icovamenib, the company’s fir ...

SAN CARLOS, Calif., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that it will participate in Citi’s SMID Biotech C-Suite Fireside Chat Series on Thursday, October 23, 2025, at 8:00 a.m. Pacific Time / 11:00 a.m. Eastern Time. A live audio webcast of the discussion will be available here or by visiting the Investors & Media section of Biomea’s website at https://investors.biomeafusion.com/news-events/events. A ...

PresentationLadies and gentlemen, please stand by. Ladies and gentleman, please remain on line, your conference will begin shortly.I would now like to hand the conference over to your speaker today, Ramses Erdtmann, President and Chief Operating Officer. Please go ahead.Ramses ErdtmannCo-Founder, President, COO & Director Perfect. Okay. All the other speakers that have dialed in, we're going to go live. Maybe you can let Juan Pablo now. Okay. Thank you, operator, and welcome, everyone, to this conference ca ...

会议基本信息 - 本次会议为Biomea公司电话会议 [3] - 会议由公司总裁兼首席运营官Ramses Erdtmann主持 [1][3] 临床研究进展 - 公司公布了COVALENT-111研究的52周结果 [3] - 该研究是一项随机双盲、安慰剂对照的二期临床试验 [3] - 试验旨在评估icovamenib在二型糖尿病患者中的安全性和耐受性 [3] - 试验同时包含探索性疗效终点 [3]

公开增发详情 - 公司进行公开增发，包括1120万股普通股及附带购买等量股份的认股权证[1] - 部分投资者将获得购买最多100万股普通股的预先融资认股权证及额外购买100万股的认股权证[1] - 承销商拥有30天期权，可额外购买最多183万股及相应认股权证[1] - 普通股和预先融资认股权证的发行附带行权价为2.50美元的认股权证[2] - 此次增发预计募集总额约2500万美元，预计于10月8日完成[2] - Jefferies担任独家账簿管理人，H.C. Wainwright & Co.担任牵头管理人[2] 股价表现与市场反应 - 公司股价在增发定价后大幅下跌，截至周二最后报价为1.76美元，跌幅达33.9%[7] - 股价下跌可能由对股份稀释的担忧驱动，新股的发行可能降低现有持股价值[3] - 每股2.05美元的发行价低于股票先前市场价值，可能被视为折价出售的信号[3] - 附带行权价2.50美元的认股权证以及公司临床试验被暂停等持续挑战加剧了市场的负面反应[3] 临床试验进展 - 公司公布其II期COVALENT-111研究52周结果，评估icovamenib对2型糖尿病患者的疗效和安全性[4] - 在FDA实施临床暂停后，分析聚焦于163名完成至少80%治疗的患者[4] - 在严重胰岛素缺乏患者中，icovamenib实现持久HbA1c降低1.2%，接受12周治疗的患者效果最佳（降低1.5%）[4] - 接受GLP-1疗法治疗的患者显示HbA1c降低1.3%[5] - icovamenib保持良好安全性，无严重不良事件或停药情况，总体耐受性良好[5] 未来研发计划 - 食物效应研究（COVALENT-121）正在进行，旨在优化icovamenib的给药标准，数据预计于2025年12月完成[8] - 针对严重胰岛素缺乏2型糖尿病患者的IIb期试验（COVALENT-211）预计于2025年第四季度启动[8] - 联合GLP-1基础疗法治疗2型糖尿病患者的II期试验（COVALENT-212）预计于2025年第四季度启动[8] - 公司口服GLP-1 RA（BMF-650）在肥胖健康志愿者中的I期试验（GLP-131）正在进行中，数据预计在2026年上半年获得[8]

Biomea Fusion (NASDAQ:BMEA) shares rose after reporting positive results from its mid-stage study testing icovamenib in individuals with type 2 diabetes over a 52-week period. The stock closed up 24% on Monday. The study found that icovamenib provided lasting treatment ...

Icovamenib showed a sustained treatment benefit at Week 52 (9 months past the end of treatment) in the severe insulin-deficient diabetes patient population taking one or more antihyperglycemic medications at baseline, with a 1.8% placebo adjusted mean reduction in HbA1c (Arm B)Type 2 diabetes patients on a GLP-1-based therapy failing to achieve their target HbA1c also showed a clinically meaningful response from only 12 weeks of icovamenib treatment with a mean placebo adjusted HbA1c reduction of 1.8% (Arms ...

SAN CARLOS, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced that on September 24, 2025, the compensation committee of Biomea’s board of directors granted one new employee non-qualified stock options to purchase 48,000 shares of the Company’s common stock. The shares underlying each employee’s stock options will vest 1/16 on a quarterly basis over four years, subject to such empl ...