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Biomea Fusion Updates on Diabetes and Obesity Pipeline, Financial Outlook
BMEA
New Projects/Investments
Guidance Update
- Biomea Fusion is advancing two key assets: Covamenib for diabetes and BMF-650 for weight loss.
- Covamenib demonstrated a 1.5% reduction in A1C at 52 weeks (placebo-adjusted) in the Covalent 111 study, with the effect persisting post-treatment. Two Phase 2 studies, Covalent 211 and Covalent 212, are slated for first patient enrollment in 1Q 2026, with 26-week data readouts expected in 4Q 2026.
- The oral GLP-1 receptor agonist BMF-650 achieved a 15% reduction in body weight in a 28-day monkey study. 28-day weight loss results from its ongoing Phase 1 study are anticipated in 2Q 2026.
- The company reported approximately $70 million in cash at the end of Q3 2025, with a quarterly spend of about $12 million, providing a cash runway into early 2027.
Jan 15, 2026, 1:15 AM
Biomea Fusion Updates on Diabetes and Obesity Programs at JPMorgan Healthcare Conference
BMEA
New Projects/Investments
Guidance Update
- Biomea Fusion is developing two main assets: Covamenib, a menin inhibitor for diabetes, and BMF-650, an oral GLP-1 receptor agonist for weight loss.
- Covamenib demonstrated a durable reduction in A1C for up to 52 weeks after a 3-month dosing period in patients with severe insulin-deficient type 2 diabetes and GLP-1 failures, with a favorable safety profile.
- The company plans to enroll the first patients in two parallel studies for Covamenib, Covalent 211 and Covalent 212, in Q1 2026, with 26-week data readouts expected in Q4 2026.
- For BMF-650, the Phase 1 study is progressing to the multiple ascending dose portion, with 28-day weight loss results anticipated in Q2 2026.
- Biomea Fusion reported a cash position of approximately $70 million at the end of Q3 2025, including a $27 million raise, with a quarterly burn rate of around $12 million, providing a runway into early 2027.
Jan 15, 2026, 1:15 AM
Biomea Fusion provides clinical and financial updates at JPMorgan Healthcare Conference
BMEA
New Projects/Investments
Guidance Update
- Biomea Fusion is currently developing two assets focused on diabetes and obesity: Icovamenib for Type 2 diabetes and BMF-650, an oral GLP-1 receptor agonist for weight loss.
- Clinical data for Icovamenib from the COVALENT-111 study showed a 1.5 reduction in A1C at 52 weeks and continued improvement in GLP-1 failures, with a favorable safety profile.
- The company plans first patient enrollment in Q1 2026 for two new Icovamenib studies, COVALENT-211 and COVALENT-212, with 26-week data readouts expected in Q4 2026.
- For BMF-650, 28-day weight loss results from the ongoing Phase I study are anticipated in Q2 2026.
- Biomea Fusion reported a cash position of approximately $70 million at the end of Q3 (after a $27 million raise), with a quarterly spend of around $12 million, providing a runway into early 2027.
Jan 15, 2026, 1:15 AM
Biomea Fusion Provides Updates on Icovamenib and BMF-650 Clinical Programs
BMEA
Product Launch
New Projects/Investments
Guidance Update
- Biomea Fusion's icovamenib, an oral menin inhibitor for Type 2 Diabetes (T2D), demonstrated a durable treatment effect in severe insulin-deficient patients, showing a -1.2% mean change in HbA1c (P=0.01) for icovamenib versus 0.3% for placebo 9 months after a 12-week dosing period, and also increased insulin secretion.
- The company plans to initiate first patient enrollment for two Phase II trials of icovamenib, COVALENT-211 and COVALENT-212, in 1Q 2026, with 26-week readouts expected in 4Q 2026.
- BMF-650, an oral GLP-1 receptor agonist for weight loss, showed promising preclinical results, with obese cynomolgus monkeys experiencing up to a -15.2% body weight reduction.
- The ongoing Phase 1 GLP-131 study for BMF-650 is expected to provide 28-day weight loss study results in 2Q 2026. Both icovamenib and BMF-650 have demonstrated a favorable safety profile in their respective studies to date.
Jan 15, 2026, 1:15 AM
Biomea Fusion Updates Corporate Presentation with Clinical Trial Progress and Future Milestones
BMEA
New Projects/Investments
Guidance Update
- Biomea Fusion, Inc. (BMEA) updated its corporate presentation on January 14, 2026, detailing its pipeline of oral therapies for metabolic diseases.
- The company's lead candidate, icovamenib, a selective menin inhibitor for Type 2 Diabetes (T2D), demonstrated durable clinical activity in the COVALENT-111 Phase II study, showing a 1.2% mean HbA1c reduction in insulin-deficient T2D patients and a 1.3% mean HbA1c reduction in T2D patients not controlled on GLP-1-based therapies, both maintained through Week 52 after only 12 weeks of dosing.
- First patient enrollment for the COVALENT-211 Phase IIb trial (insulin-deficient T2D) and COVALENT-212 Phase II trial (T2D patients not controlled on GLP-1-based therapies) is planned for 1Q 2026, with 26-week readouts expected in 4Q 2026.
- Biomea Fusion is also developing BMF-650, an oral GLP-1 receptor agonist for obesity, with 28-day weight loss study results from its Phase I GLP-131 trial expected in 2Q 2026. Preclinical data for BMF-650 demonstrated significant body weight reduction in obese cynomolgus monkeys and favorable liver safety.
Jan 14, 2026, 9:02 PM
Biomea Fusion Provides Updates on Diabetes Programs and Oral GLP-1 Development
BMEA
New Projects/Investments
Guidance Update
- Biomea Fusion Inc. (BMEA) is focused on curing diabetes with its Menin inhibitor, which has shown early clinical data demonstrating A1C reduction in insulin-deficient patients, with effects lasting nine months off-drug.
- The company plans to initiate two Phase II studies (COVALENT-211 and COVALENT-212) for its Menin inhibitor in Q1, targeting Severe Insulin Deficient and GLP-1 responder patient groups.
- Biomea is also developing an oral GLP-1 (BMF-650), currently in Phase I, designed for improved tolerability over existing options; results are anticipated in Q2 2026.
- Safety concerns regarding liver enzyme elevation at higher doses of the Menin inhibitor were addressed, with the 100mg dose deemed safe by the FDA, and future dosing will involve titration.
- The company has a financial runway into 2027 and is actively exploring business development partnerships for its GLP-1 program.
Dec 3, 2025, 12:30 PM
Biomea Fusion Updates on Diabetes and Obesity Drug Pipeline Progress
BMEA
New Projects/Investments
Guidance Update
- Biomea Fusion (BMEA) is developing a Menin inhibitor (COVALENT-111) for diabetes, with early clinical data showing A1C reduction in Severe Insulin Deficient (SID) patients, maintaining effects nine months off-drug.
- The company expects to enroll the first patients in two Phase 2 studies (COVALENT-211 and COVALENT-212) in Q1 , focusing on specific diabetic subpopulations and a 100 mg dose with titration to ensure long-term safety.
- Biomea Fusion is also advancing an oral GLP-1 (BMF-650), currently in Phase 1, designed for better tolerability than Orforglipron, with results anticipated in Q2 2026.
- The company's financial runway extends into 2027, and it is exploring partnering discussions for its GLP-1 program.
Dec 3, 2025, 12:30 PM
BMEA Discusses Clinical Progress for Diabetes and Obesity Treatments
BMEA
New Projects/Investments
Guidance Update
- BMEA is developing COVALENT-111, a Menin inhibitor, for Type 2 diabetes, with early clinical data showing sustained A1C reduction in Severe Insulin Deficient (SID) patients, who remained off-drug for nine months after 12 weeks of dosing.
- The company plans to initiate two Phase 2 studies (COVALENT-211 and COVALENT-212) in Q1 2026, targeting SID and GLP-1 responder subgroups of Type 2 diabetes patients.
- BMEA addressed previous liver enzyme elevation concerns, with the FDA clearing 100mg dosing for COVALENT-111, and future studies will use titration.
- An oral GLP-1 (BMF-650) is in Phase 1 development, designed for better tolerability than Lilly's Orforglipron, with initial results anticipated in Q2 2026.
- The company has a financial runway into 2027 and is open to partnering discussions for its GLP-1 program.
Dec 3, 2025, 12:30 PM
Biomea Fusion Provides Update on Icovamenib and BMF-650 Programs
BMEA
New Projects/Investments
Guidance Update
- Biomea Fusion is developing icovamenib, an oral menin inhibitor for diabetes, and BMF-650, an oral GLP-1 agonist.
- Icovamenib has shown up to 1.8% placebo-adjusted A1C reduction in insulin-deficient patients after 12 weeks of dosing, with 52-week data and C-peptide data expected to be presented this Friday at the World Congress for Insulin Resistance and Diabetes Care.
- BMF-650 is an oral GLP-1 designed for improved tolerability and efficacy, with initial 28-day efficacy data and 6-week follow-up data from its GLP-131 study anticipated in the first half of 2026.
- The company has cash until the first quarter of 2027 and is open to partnerships for the development of BMF-650 due to the high costs associated with its development pathway.
Dec 2, 2025, 1:00 PM
Biomea Fusion Provides Updates on Icovaminib and Oral GLP-1 BMF-650 Development
BMEA
New Projects/Investments
M&A
- Biomea Fusion is developing icovaminib, an oral menin inhibitor for diabetes, which has demonstrated up to 1.8% placebo-adjusted A1C reduction in insulin-deficient patients after 12 weeks of dosing, with sustained effects. The company is scheduled to present 52-week data and C-peptide data for icovaminib at an upcoming congress.
- The company's oral GLP-1 agonist, BMF-650, is designed for improved tolerability and efficacy compared to existing options, with 28-day efficacy data expected in the first half of 2026 from an ongoing study in obese individuals.
- Biomea is exploring the potential to combine icovaminib with GLP-1s to reduce side effects such as muscle loss and enhance weight reduction.
- The company has cash until the first quarter of 2027 and is open to partnerships for the costly development of BMF-650.
Dec 2, 2025, 1:00 PM
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