Welcome to our dedicated page for Biomea Fusion news (Ticker: BMEA), a resource for investors and traders seeking the latest updates and insights on Biomea Fusion stock.
Biomea Fusion, Inc. (BMEA) is a clinical-stage biopharmaceutical company pioneering oral covalent small molecule therapies for genetically defined cancers and metabolic disorders. This page provides investors and researchers with timely updates on the company's scientific advancements, clinical trial progress, and strategic initiatives.
Access authoritative updates on Biomea Fusion's pipeline developments, including its lead candidate icovamenib (menin inhibitor) and explore how its proprietary FUSION™ System drives innovation in precision oncology and diabetes research. Stay informed about material events such as clinical data readouts, regulatory milestones, and partnership announcements.
Key updates include progress in Phase I/II studies for oncology targets, metabolic disorder therapeutic breakthroughs, and peer-reviewed research publications. All content is curated to meet investor needs for decision-critical information while maintaining compliance with financial disclosure standards.
Bookmark this page for direct access to Biomea Fusion's latest press releases, SEC filings, and objective third-party analyses. Check regularly for developments in covalent inhibitor research and the company's contributions to advancing targeted therapies for complex diseases and metabolic conditions.
Biomea Fusion (NASDAQ: BMEA) presented significant preclinical findings for icovamenib, their investigational covalent menin inhibitor, at the 22nd WCIRDC. The research demonstrated that icovamenib enhanced beta cell function and improved responsiveness to GLP-1-based therapies in human islets. Key findings showed increased expression of GLP-1 receptors and intracellular insulin, with synergistic effects when combined with therapies like semaglutide and tirzepatide.
The data suggests that icovamenib's ability to increase beta cell mass could potentially allow for lower doses of GLP-1-based therapies while maintaining glycemic targets, potentially reducing side effects. Clinical case studies indicated that short-term icovamenib treatment was well-tolerated with no significant adverse events or hypoglycemia reported.
Biomea Fusion (BMEA) announced preliminary data from its Phase I COVALENT-103 study of BMF-500, a covalent FLT3 inhibitor for relapsed or refractory acute leukemia. The study enrolled 20 patients, including 13 with confirmed FLT3-mutations, who had previously failed gilteritinib treatment.
Key findings include: no dose-limiting toxicities across all dose levels, favorable safety profile, and demonstrated FLT3 inhibition with bone marrow penetration. Clinical activity was observed with one complete response with incomplete hematologic recovery (CRi) at 100mg twice daily dosing, and bone marrow blast reductions in 5 of 6 evaluable FLT3 mutated patients.
The highlighted case study showed a CRi in a 61-year-old patient with R/R AML who had failed four prior treatment regimens.
Biomea Fusion (NASDAQ: BMEA) has announced a conference call and webcast scheduled for December 9, 2024, at 4:30 pm EST. The presentation will reveal initial clinical data from the Phase I COVALENT-103 study of BMF-500, their investigational covalent FLT3 inhibitor, in patients with relapsed or refractory acute leukemia.
BMF-500 was developed using Biomea's proprietary FUSION™ System. The webcast will be accessible to registered attendees through the company's investor relations website, with a replay available after the event.
Biomea Fusion announced that its compensation committee granted stock options to one new employee on December 2, 2024. The grant includes options to purchase 30,000 shares of common stock, which will vest quarterly over four years at a rate of 1/16. The grant was made under Biomea's 2023 Inducement Equity Plan, adopted on November 17, 2023, and serves as an inducement for employment in accordance with Nasdaq Listing Rule 5635(c)(4).
Biomea Fusion presented new analysis from COVALENT-111 trial at ATTD-ASIA 2024, showing promising results for icovamenib in Type 2 Diabetes (T2D) treatment. The study revealed that insulin-deficient patients (approximately 50% of the population) showed a greater mean HbA1c reduction (-1.23% vs -0.48%) compared to insulin-resistant patients at Week 26, following 4 weeks of dosing.
Notable case studies included a 29-year-old patient achieving a 2.5% HbA1c reduction and a 45-year-old patient showing a 1.1% reduction, both with significant improvements in HOMA-B and C-peptide levels. The company expects topline results from the Phase IIb expansion portion, involving over 200 T2D patients, in December.
Biomea Fusion announced that its compensation committee granted stock options to one new employee on November 1, 2024. The grant includes options to purchase 6,500 shares of common stock, which will vest quarterly over four years at a rate of 1/16. The award was made under Biomea's 2023 Inducement Equity Plan and granted as an inducement for employment in accordance with Nasdaq Listing Rule 5635(c)(4).
Biomea Fusion presented preclinical data showing that icovamenib (BMF-219) enhanced the effectiveness of GLP-1-based therapies in diabetes treatment. Ex vivo human islet experiments demonstrated increased insulin secretion when icovamenib was combined with tirzepatide or semaglutide. The company plans to initiate a Phase II study (COVALENT-211) combining icovamenib with GLP-1-based therapy in 2025.
Additionally, Biomea introduced BMF-650, a next-generation oral small-molecule GLP-1 receptor agonist candidate, which showed promising preclinical results including improved glucose-stimulated insulin secretion, better glucose control, and appetite suppression in cynomolgus monkeys.
Biomea Fusion reported Q3 2024 financial results and corporate updates. The FDA lifted clinical holds on COVALENT-111 (Type 2 Diabetes) and COVALENT-112 (Type 1 Diabetes) trials. The company expects topline data from both studies in December 2024. Cash position stood at $88.3 million as of September 30, 2024. Q3 net loss was $32.8 million, with R&D expenses at $27.2 million and G&A expenses at $6.8 million. The company plans to announce its third clinical candidate, BMF-650, an oral GLP-1 receptor agonist for diabetes and obesity treatment.
Biomea Fusion (Nasdaq: BMEA) announced that the World Health Organization (WHO) has approved "icovamenib" as the International Nonproprietary Name (INN) for its lead product candidate BMF-219. The United States Adopted Name Council has also adopted this name as the United States Adopted Name (USAN). Icovamenib is an oral covalent menin inhibitor in clinical development, investigating its impact on insulin-producing beta cells.
The suffix '-menib' denotes a menin inhibitor. INNs and USANs are unique, globally recognized names for pharmaceutical drugs or active ingredients, ensuring safety, consistency, and logic in medication naming. Biomea will use "icovamenib" in future presentations, publications, and public statements as it advances the clinical development of this product candidate.
Biomea Fusion (Nasdaq: BMEA) has announced a conference call and webcast scheduled for Wednesday, October 30th at 4:30 pm ET. The event will focus on two key announcements:
1. Introduction of BMF-650, their lead clinical candidate, described as a next-generation, potent, selective, oral small-molecule GLP-1 receptor agonist (GLP-1 RA).
2. Presentation of preclinical study results examining the synergistic benefits of combining BMF-219 with a GLP-1 RA-based therapy.
The webcast will be accessible to registered attendees through Biomea's investor website. A replay will be available after the event.
FAQ
What is the current stock price of Biomea Fusion (BMEA)?
What is the market cap of Biomea Fusion (BMEA)?
