NasdaqGS - Nasdaq Real Time Price • USD Biomea Fusion, Inc. (BMEA) Follow Compare 5.85 +0.21 (+3.72%) At close: December 16 at 4:00:01 PM EST 6.85 +1.00 (+17.09%) After hours: 7:59:30 PM EST All News Press Releases SEC Filings All SEC Filings Corporate Changes & Voting Matters Periodic Financial Reports Proxy Statements Tender Offer/Acquisition Reports Offering Registrations Biomea Fusion to Host Conference Call to Announce Topline Results from Phase II COVALENT-111 Study in Patients with Type 2 Diabetes (T2D) Tuesday, December 17, 2024 at 8:00 am ESTREDWOOD CITY, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that it will host a conference call and webcast on Tuesday, December 17, 2024 at 8:00 am EST to present topline results from CO Biomea Fusion Announces Oral and Poster Presentations of Icovamenib at the 22nd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) In preclinical experiments, icovamenib enhanced beta cell function and responsiveness of human islets to GLP-1-based therapies. These effects were associated with an increase in the expression levels of both the GLP-1 receptor (GLP-1R) as well as intracellular insulin.Overall results showed synergy of the combination therapy, which may allow lower doses of GLP-1-based therapies to achieve glycemic targets, potentially reducing side effects and improving tolerability of GLP-1 based therapies. RED Biomea Fusion Announces Preliminary Data from Ongoing COVALENT-103 Study of Investigational Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia Preliminary data supports BMF-500’s potential as a transformative therapy for patients with FLT3 mutated relapsed or refractory (R/R) acute leukemiaBMF-500 showed a favorable safety and tolerability profile, with no dose-limiting toxicities observed across all dose levelsPharmacokinetic and pharmacodynamic data confirmed on-target FMS-like tyrosine kinase 3 (FLT3) inhibition, demonstrating dose-proportional activity and good compartmental penetrationPreliminary Phase I data for BMF-500 in R/R ac Biomea Fusion to Host Conference Call to Present initial Clinical Data from Phase I COVALENT-103 Study of BMF-500, a Covalent FLT3 Inhibitor, in Relapsed or Refractory Acute Leukemia REDWOOD CITY, Calif., Dec. 06, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that it will host a conference call and webcast on Monday, December 9, 2024 at 4:30 pm EST to present data from COVALENT-103, the company’s Phase I trial of BMF-500, an Biomea Fusion, Inc. Reports Inducement Grant under Nasdaq Listing Rule 5635(c)(4) REDWOOD CITY, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA) (“Biomea” or the “Company”), a clinical stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that on December 2, 2024, the compensation committee of Biomea’s board of directors granted one new employee non-qualified stock options to purchas Late-Breaker Oral Presentation Showing New Analysis from the Escalation Portion of COVALENT-111 Presented at the 1st Annual Asian Conference on Innovative Therapies for Diabetes Management (ATTD-ASIA 2024) Icovamenib Achieves a Mean Reduction in HbA1c Greater than 1% at Week 26 Following 4 Weeks of Dosing in Type 2 Diabetes Patients Characterized by Insulin Deficiency 32 patients from the 100mg and 200mg cohorts, doses selected for the expansion phase, were characterized based on baseline biomarkers and analyzed for efficacy. Patients identified as insulin deficient (approx. 50% of the broader patient population) and insulin resistant were compared to examine the mean reduction in HbA1c at Week 26 We're A Little Worried About Biomea Fusion's (NASDAQ:BMEA) Cash Burn Rate There's no doubt that money can be made by owning shares of unprofitable businesses. For example, although... Biomea Fusion Presents Preclinical Data Showing Icovamenib (BMF-219) Enhanced Effectiveness of GLP-1-Based Therapies and Introduces BMF-650, a Next-Generation, Oral Small-Molecule GLP-1 Receptor Agonist Candidate Preclinical data from ex vivo human islet experiments showed that icovamenib (BMF-219) was able to enhance the activity of glucagon-like peptide-1 (GLP-1)-based therapies, potentially leading to increased insulin secretion and improved glycemic control in patients with diabetesPhase II study (COVALENT-211), combining icovamenib with a GLP-1-based therapy, planned to begin in 2025BMF-650, an investigational next-generation, oral small-molecule GLP-1 receptor agonist (GLP-1 RA), demonstrated posit Biomea Fusion Reports Third Quarter 2024 Financial Results and Corporate Highlights U.S. Food and Drug Administration (FDA) lifted Clinical Hold on COVALENT-111 (Type 2 Diabetes) & COVALENT-112 (Type 1 Diabetes) trialsCOVALENT-111 Phase 2b 26-week topline data of the dose expansion cohorts expected in December 2024COVALENT-112 Phase 2a 26-week topline data of the open label portion expected in December 2024On track to announce our third clinical candidate, BMF-650, for the treatment of diabetes and obesity – a next-generation, oral small-molecule GLP-1 receptor agonist (GLP-1 R Biomea Fusion Announces Approval of “icovamenib” as International Nonproprietary Name for BMF-219 Icovamenib is an oral covalent menin inhibitor in clinical development to investigate its impact on the function of insulin-producing beta cellsREDWOOD CITY, Calif., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that the World Health Or Biomea Fusion to Host Conference Call and Webcast on Wednesday, October 30th at 4:30 pm ET to Announce Our Lead Clinical Candidate, BMF-650, a Next-Generation, Oral Small-Molecule GLP-1 Receptor Agonist and Preclinical Data Combining BMF-219 with a GLP-1 RA-Based Therapy REDWOOD CITY, Calif., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that it will host a conference call and webcast on Wednesday, October 30th at 4:30 pm ET to announce our lead clinical candidate, BMF-650 – a next-generation, potent, s Morning Movers: Arcadium Lithium surges after deal to be acquired Check out this morning’s top movers from around Wall Street, compiled by The Fly. HIGHER – Arcadium Lithium (ALTM) up 30% after Rio Tinto (RIO) and the company announced a definitive agreement under which Rio Tinto will acquire Arcadium in an all-cash transaction for $5.85 per share Clearside Biomedical (CLSD) up 10% after announcing that the ODYSSEY Phase 2b clinical trial of CLS-AX, or axitinib injectable suspension, for the treatment of neovascular age-related macular degeneration achieved bo Biomea Fusion to Present at the 1st Annual Asian Conference on Innovative Therapies for Diabetes Management (ATTD-ASIA 2024) BMF-219 is an investigational oral covalent menin inhibitor developed to regenerate insulin-producing beta cells Two trial-in-progress oral presentations to feature Phase II study design of oral covalent menin inhibitor BMF-219 in patients with type 2 diabetes (COVALENT-111) and in patients with type 1 diabetes (COVALENT-112)One late breaker oral presentation to highlight two case studies assessing BMF-219 in persons with poorly controlled severe insulin-deficient (SIDD) type 2 diabetes REDWOOD Independent Director of Biomea Fusion Michael J. Hitchcock Buys 200% More Shares Potential Biomea Fusion, Inc. ( NASDAQ:BMEA ) shareholders may wish to note that the Independent Director, Michael J... Biomea Announces Formation of Global Scientific Advisory Board with 22 World-Renowned Diabetes Experts International diabetes pioneers and thought leaders from 11 countries will work with Biomea leadership to unlock the potential of menin science and beta cell biology to advance BMF-219 and Biomea’s evolving pipelineREDWOOD CITY, Calif., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with metabolic diseases, FDA Removes Clinical Hold On Biomea Fusion's Early-Stage Trials For Potential Diabetes Candidate Friday, the FDA lifted the clinical hold on Biomea Fusion, Inc.’s (NASDAQ:BMEA) ongoing Phase 1/2 clinical trials of the company’s investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112), respectively. “The in-depth review of the clinical data to date reconfirms our confidence in BMF-219 as a novel, first-in-class agent for the treatment of diabetes,” stated Thomas Butler, Biomea Fusion’s CEO and Chairman. “We are encouraged from the safety Biomea’s stock bounces back as FDA lifts clinical hold on diabetes trials The FDA placed a full clinical hold on two diabetes trials for Biomea’s menin inhibitor after reports of liver toxicity. BMEA Stock Up 9% as FDA Lifts Clinical Hold on 2 Diabetes Studies Biomea stock rises 9% after the FDA lifts clinical hold on two phase I/II studies evaluating the company's lead candidate, BMF-219, for diabetes. FDA Lifts Clinical Hold on BMF-219 in Type 2 and Type 1 Diabetes Trials REDWOOD CITY, Calif., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or the “Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Biomea’s ongoing Phase I/II clinical trials of the Company’s investig With 51% institutional ownership, Biomea Fusion, Inc. (NASDAQ:BMEA) is a favorite amongst the big guns Key Insights Significantly high institutional ownership implies Biomea Fusion's stock price is sensitive to their... Performance Overview Trailing total returns as of 12/16/2024, which may include dividends or other distributions. Benchmark is S&P 500 Return BMEA S&P 500 YTD -59.71% +27.34% 1-Year -58.72% +28.71% 3-Year -29.43% +28.97%