Biomea Fusion(BMEA)

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After Plunging -19.32% in 4 Weeks, Here's Why the Trend Might Reverse for Biomea Fusion (BMEA)
ZACKS· 2025-04-01 14:35
A downtrend has been apparent in Biomea Fusion, Inc. (BMEA) lately with too much selling pressure. The stock has declined 19.3% over the past four weeks. However, given the fact that it is now in oversold territory and Wall Street analysts are majorly in agreement about the company's ability to report better earnings than they predicted earlier, the stock could be due for a turnaround. However, like every investing tool, RSI has its limitations, and should not be used alone for making an investment decision ...
Biomea Fusion(BMEA) - 2024 Q4 - Annual Report
2025-03-31 20:23
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40335 Biomea Fusion, Inc. (Exact name of Registrant as specified in its Charter) Delaware 82-2520134 (State or other jurisdiction of ...
Biomea Fusion(BMEA) - 2024 Q4 - Annual Results
2025-03-31 20:17
"2024 was a transformative year for Biomea, marked by the advancement of icovamenib into late-stage development and compelling clinical data that reinforced our confidence in its potential to reshape diabetes treatment, particularly for patients with severe insulin deficiency," said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. "As we move into this next phase, the Board made a strategic decision to align leadership with the company's evolution, and I'm honored to ...
Biomea Fusion Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Highlights
GlobeNewswire· 2025-03-31 20:10
REDWOOD CITY, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, reported fourth quarter and full year 2024 financial results and corporate highlights. "2024 was a transformative year for Biomea, marked by the advancement of icovamenib into late-stage development and compelling clinical data that reinforced our confidence in its potential to reshape diabetes treatment, particul ...
After Plunging -20.42% in 4 Weeks, Here's Why the Trend Might Reverse for Biomea Fusion (BMEA)
ZACKS· 2025-03-31 14:36
Technically, every stock oscillates between being overbought and oversold irrespective of the quality of their fundamentals. And the beauty of RSI is that it helps you quickly and easily check if a stock's price is reaching a point of reversal. Biomea Fusion, Inc. (BMEA) has been on a downward spiral lately with significant selling pressure. After declining 20.4% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement am ...
Biomea Fusion Announces Leadership Transition
Newsfilter· 2025-03-25 23:00
Executive Leadership Change - Biomea Fusion, Inc. announced the appointment of Mick Hitchcock as interim CEO, replacing Thomas Butler, effective immediately [2][4] - Hitchcock has been a board member since 2021 and has extensive experience in pharmaceutical research and development [3] Clinical Development Progress - The company is focused on developing a novel therapy for diabetes, with recent positive Phase II data for icovamenib in insulin-deficient patients marking a significant milestone [3] - Biomea is advancing late-stage development efforts and preparing for regulatory engagement [3] Company Mission and Strategy - Biomea aims to cure diabetes through innovative covalent therapies, utilizing its proprietary FUSION™ System to develop next-generation small-molecule medicines [5][6] - The company emphasizes the advantages of covalent small molecules, including greater target selectivity and the potential for deeper, more durable responses [5]
Icovamenib Treatment in Patients with Severe Insulin-Deficient Diabetes Led to a Significant Improvement in Pancreatic Beta-cell Function with a 53% Mean Increase in C-peptide Levels 3 Months After Last Dose
GlobeNewswire· 2025-03-24 12:30
Core Insights - Biomea Fusion, Inc. presented promising preclinical and clinical data on icovamenib at the ATTD 2025 Conference, indicating its potential as a first-in-class, disease-modifying therapy for diabetes by targeting beta-cell restoration and enhancing insulin secretion [1][2][3] Company Overview - Biomea Fusion is a clinical-stage company focused on developing oral covalent small molecules aimed at improving the lives of patients with diabetes, obesity, and metabolic diseases [18] - The company utilizes its proprietary FUSION™ System to discover and develop next-generation covalent-binding small-molecule medicines [19] Product Insights - Icovamenib is an investigational covalent menin inhibitor designed to restore pancreatic beta-cell mass and function, which are critical in insulin-deficient diabetes [3][17] - The therapy demonstrated a significant increase in C-peptide production, indicating improved beta-cell function, with effects lasting beyond the treatment period [2][4][14] - A strong correlation was observed between C-peptide increase and HbA1c reduction, supporting icovamenib's proposed mechanism of action [6][14] Clinical Findings - Patients with severe insulin-deficient diabetes showed a 53% mean increase in C-peptide index levels by Week 26 after receiving icovamenib [14] - The treatment resulted in a statistically significant placebo-adjusted mean reduction in HbA1c of 1.47% at Week 26 [6] - Icovamenib enhanced the responsiveness of human islets to GLP-1-based medicines, suggesting potential for combination therapy [6][14] Market Context - Severe insulin-deficient diabetes is an underserved patient population, estimated to affect over 100 million people worldwide [6] - The findings from icovamenib's studies could address a significant unmet need in diabetes treatment, particularly for patients with poor beta-cell function [2][4][10]
Biomea Fusion, Inc. Reports Inducement Grant under Nasdaq Listing Rule 5635(c)(4)
GlobeNewswire· 2025-03-03 13:00
Core Points - Biomea Fusion, Inc. granted non-qualified stock options to a new employee for a total of 25,000 shares, vesting quarterly over four years [1][2] - The stock option award is part of Biomea's 2023 Inducement Equity Plan, adopted on November 17, 2023 [2] - Biomea is focused on developing oral covalent small molecules for diabetes, obesity, and metabolic diseases, aiming to improve patient outcomes [3][4] Company Overview - Biomea Fusion is a clinical-stage company dedicated to discovering and developing innovative medicines for diabetes and obesity [3] - The company utilizes its proprietary FUSION™ System to create next-generation covalent-binding small-molecule medicines [4] - Biomea aims to provide significant clinical benefits and potentially cure diseases for the patients it serves [4]
Biomea Fusion to Unveil New Icovamenib Data at the 18th International Conference on Advanced Technologies & Treatments for Diabetes
GlobeNewswire· 2025-02-27 13:00
Core Insights - Biomea Fusion, Inc. will present new clinical data from the COVALENT-111 study at the ATTD 2025 conference, highlighting advancements in diabetes care [1][2] - The presentations will focus on the efficacy of icovamenib, a novel treatment aimed at enhancing beta cell function and glycemic control in type 2 diabetes patients [2][3] Presentation Details - Biomea will feature two oral presentations and one poster presentation, along with a symposium at the ATTD 2025 conference scheduled for March 19-22, 2025, in Amsterdam [1][4] - The oral presentations will cover the exploration of icovamenib in severe insulin-deficient type 2 diabetes and its combination with GLP-1 receptor agonists [4] - A poster presentation will evaluate the long-term efficacy and safety of short-term icovamenib treatment in type 2 diabetes patients [4] Clinical Findings - New clinical findings from the Expansion Phase of the COVALENT-111 study indicate that icovamenib treatment can lead to sustained improvements in glycemic control, even 14 weeks post-treatment [2][3] - Previous studies showed that 12 weeks of icovamenib treatment resulted in statistically significant reductions in HbA1c levels among insulin-deficient type 2 diabetes patients [3] Mechanism of Action - Icovamenib is designed to inhibit menin, which may enhance beta cell function and promote the regeneration of insulin-producing cells [7][10] - The mechanism of action suggests that icovamenib could serve as a first-in-class, disease-modifying therapy for type 1 and type 2 diabetes [10][11] Industry Context - Type 2 diabetes is a significant global health issue, affecting over 100 million adults worldwide, with a pressing need for effective treatments [3][9] - The economic burden of diabetes care is substantial, with one in four healthcare dollars in the U.S. spent on diabetes-related expenses [9]
Biomea Fusion to Become a Diabetes & Obesity Medicines Company
Newsfilter· 2025-01-13 14:00
Icovamenib & BMF-650 (oral small molecule GLP-1) are the cornerstones of the metabolic franchiseBiomea preparing icovamenib for late-stage clinical development2025 corporate update to be presented at the 43rd Annual J.P. Morgan Healthcare Conference REDWOOD CITY, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to improve ...