Biomea Fusion(BMEA)

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Biomea Fusion(BMEA) - 2024 Q3 - Quarterly Results
2024-10-29 21:06
Exhibit 99.1 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) & COVALENT112 (Type 1 Diabetes) trials • COVALENT-111 Phase 2b 26-week topline data of the dose expansion cohorts expected in December 2024 • COVALENT-112 Phase 2a 26-week topline data of the open label portion expected in December 2024 • On track to announce our third clinical candidate, BMF-650, for the treatment o ...
Biomea Fusion Reports Third Quarter 2024 Financial Results and Corporate Highlights
GlobeNewswire News Room· 2024-10-29 20:46
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 RA) - and pre ...
Biomea Fusion Announces Approval of “icovamenib” as International Nonproprietary Name for BMF-219
GlobeNewswire News Room· 2024-10-21 13:00
REDWOOD 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 Organization (WHO) has approved “icovamenib” as the International Nonproprietary Name (INN) for its lead product candidate BMF-219, and that the United States ...
Biomea Fusion to Present at the 1st Annual Asian Conference on Innovative Therapies for Diabetes Management (ATTD-ASIA 2024)
GlobeNewswire News Room· 2024-10-07 13:00
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 CITY, Calif ...
BMEA Stock Up 9% as FDA Lifts Clinical Hold on 2 Diabetes Studies
ZACKS· 2024-09-27 13:51
Shares of Biomea Fusion (BMEA) gained 9.1% on Thursday after the FDA lifted the clinical hold it had earlier placed on the company's ongoing early to mid-stage studies evaluating its lead candidate, BMF-219, for treating type 2 and type 1 diabetes (T2D and T1D). The update follows a thorough review of the clinical data on the candidate, to date. Biomea's BMF-219 is an investigational novel covalent menin inhibitor that has been developed using the company's proprietary FUSION System. Recent Regulatory Updat ...
FDA Lifts Clinical Hold on BMF-219 in Type 2 and Type 1 Diabetes Trials
GlobeNewswire News Room· 2024-09-26 18:00
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 investigational cova ...
Wall Street Analysts Think Biomea Fusion (BMEA) Could Surge 317.86%: Read This Before Placing a Bet
ZACKS· 2024-08-14 14:56
Biomea Fusion, Inc. (BMEA) closed the last trading session at $5.71, gaining 2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $23.86 indicates a 317.9% upside potential. The mean estimate comprises seven short-term price targets with a standard deviation of $20.63. While the lowest estimate of $5 indicates a 12.4% decline from the current price level, the most optimistic analyst ...
Biomea Fusion, Inc. Reports Inducement Grant under Nasdaq Listing Rule 5635(c)(4)
Newsfilter· 2024-08-01 20:05
REDWOOD CITY, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA) ("Biomea" or the "Company"), a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases, today announced that on June 1, 2024, the compensation committee of Biomea's board of directors granted one new employee non-qualified stock options to purchase an aggregate of 25,000 shares of the Company ...
Biomea Fusion(BMEA) - 2024 Q2 - Quarterly Report
2024-07-31 20:14
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.0001 par value BMEA The Nasdaq Global Select Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commissio ...
Biomea Fusion(BMEA) - 2024 Q2 - Quarterly Results
2024-07-31 20:13
Exhibit 99.1 Biomea Fusion Reports Second Quarter 2024 Financial Results and Corporate Highlights • COVALENT-111 Phase 2b on track for Q4 2024 readout • COVALENT-112 Phase 2a on track for Q4 2024 readout • Announcement of the third program in obesity on track for Q3 2024 REDWOOD CITY, Calif., July 31, 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 trea ...