This section highlights FDA-related milestones and regulatory updates for drugs developed by Biomea Fusion (BMEA).
Over the past two years, Biomea Fusion has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BMF-219, BMF-500, BMF-650, COVALENT-111, and icovamenib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BMF-219 - FDA Regulatory Timeline and Events
BMF-219 is a drug developed by Biomea Fusion for the following indication: Diffuse Large B-Cell Lymphoma, Multiple Myeloma, and Several KRAS Mutant Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BMF-219
- Announced Date:
- October 7, 2024
- Indication:
- Diffuse Large B-Cell Lymphoma, Multiple Myeloma, and Several KRAS Mutant Solid Tumors
Announcement
Biomea Fusion, Inc. announced the attendance at the 1st Asian Conference on Innovative Therapies for Diabetes Management (ATTD-ASIA 2024), taking place in Singapore, 18-20 November 2024.
AI Summary
Biomea Fusion, Inc. has announced it will attend the 1st Asian Conference on Innovative Therapies for Diabetes Management (ATTD-ASIA 2024) in Singapore from November 18 to 20, 2024. The company, focused on developing oral covalent small molecules for treating diabetes and obesity, plans to showcase key clinical trial results related to its investigational oral covalent menin inhibitor BMF-219. During the conference, Biomea Fusion will present data from its trials studying the drug’s effects in both type 2 (COVALENT-111) and type 1 (COVALENT-112) diabetes. The presentations include a long oral session and two short oral sessions that will discuss trial designs and case studies, including work on patients with poorly controlled severe insulin-deficient type 2 diabetes.
Additional details regarding the presentations will be released in line with ATTD-ASIA’s abstract embargo policies.
Read Announcement- Drug:
- BMF-219
- Announced Date:
- September 27, 2024
- Indication:
- Diffuse Large B-Cell Lymphoma, Multiple Myeloma, and Several KRAS Mutant Solid Tumors
Announcement
Biomea Fusion announced that FDA lifted the clinical hold , Inc. 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.
AI Summary
Biomea Fusion announced that the FDA has lifted the clinical hold on its ongoing Phase I/II clinical trials of BMF-219, an innovative covalent menin inhibitor being tested for type 2 diabetes (COVALENT-111) and type 1 diabetes (COVALENT-112). This decision paves the way for the company to resume its studies focused on evaluating the safety, efficacy, and dosage of BMF-219 in treating both diabetes types.
The FDA’s review showed that safety signals observed in earlier phases did not develop into confirmed serious liver injuries in the larger Phase 2b Expansion Study. With this clearance, Biomea Fusion is confident in pushing forward with its development plans. The company, which is developing oral covalent small molecules for metabolic diseases and cancers, looks forward to further validating BMF-219’s potential as a first-in-class treatment for diabetes.
Read Announcement- Drug:
- BMF-219
- Announced Date:
- September 26, 2024
- Indication:
- Diffuse Large B-Cell Lymphoma, Multiple Myeloma, and Several KRAS Mutant Solid Tumors
Announcement
Biomea Fusion, Inc. 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 covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112), respectively.
AI Summary
Biomea Fusion, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its ongoing Phase I/II trials for the investigational covalent menin inhibitor BMF-219. These trials, known as COVALENT-111 for type 2 diabetes and COVALENT-112 for type 1 diabetes, will now continue without interruption. The FDA’s review confirmed that the safety issues observed in the earlier Phase 2a study did not carry over to a larger group of patients in the Phase 2b Expansion Study. Notably, the elevated lab values seen previously did not lead to any confirmed cases of serious liver injury or liver impairment. With the hold lifted, Biomea Fusion expressed confidence in BMF-219 as a novel, first‐in‐class treatment for diabetes and looks forward to further developing the therapeutic in these clinical trials.
Read Announcement
BMF-500 - FDA Regulatory Timeline and Events
BMF-500 is a drug developed by Biomea Fusion for the following indication: Orally Bioavailable Covalent Inhibitor of FLT3.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BMF-500
- Announced Date:
- June 13, 2025
- Indication:
- Orally Bioavailable Covalent Inhibitor of FLT3
Announcement
Biomea Fusion, Inc. announced updated preliminary clinical data from the ongoing Phase I COVALENT-103 trial of BMF-500 in adults with relapsed or refractory ("R/R") acute leukemia ("AL"). The results will be presented in a poster presentation at the European Hematology Association ("EHA") 2025 Congress in Milan, Italy.
AI Summary
Biomea Fusion, Inc. announced updated preliminary results from its ongoing Phase I COVALENT-103 trial evaluating BMF-500 in adults with relapsed or refractory acute leukemia. The trial focuses on safety, pharmacokinetics, and early signs of clinical activity in heavily pretreated patients, many with FLT3 mutations. Significant data include bone marrow blast reductions in several patients, with some achieving a complete remission with incomplete hematologic recovery or a morphologic leukemia-free state. These encouraging early outcomes suggest that BMF-500 may offer a new treatment option for patients who have exhausted other therapies.
The findings will be presented in a poster session at the European Hematology Association (EHA) 2025 Congress in Milan, Italy. Dr. Farhad Ravandi of The University of Texas MD Anderson Cancer Center will showcase these emerging results and discuss the potential of BMF-500 as a selective, covalent FLT3 inhibitor in this challenging patient population.
Read Announcement- Drug:
- BMF-500
- Announced Date:
- May 14, 2025
- Indication:
- Orally Bioavailable Covalent Inhibitor of FLT3
Announcement
Biomea Fusion, Inc. announced that preliminary clinical data from the Phase I COVALENT-103 trial of BMF-500 in adults with acute leukemia (AL) were selected for a poster presentation at the European Hematology Association (EHA) 2025 Congress, taking place June 12–15 in Milan, Italy.
AI Summary
Biomea Fusion, Inc. announced that preliminary clinical data from its Phase I COVALENT-103 trial of BMF-500 in adults with acute leukemia was selected for a poster presentation at the European Hematology Association (EHA) 2025 Congress in Milan, Italy, taking place June 12–15, 2025. The trial focuses on BMF-500, a covalent FLT3 inhibitor, evaluating its safety, pharmacokinetics, pharmacodynamics, and clinical activity in patients with relapsed or refractory disease, including those with FLT3 mutations who have previously been treated with other FLT3 inhibitors.
Early results show that BMF-500 was well-tolerated and many patients experienced reductions in bone marrow blasts, with survival outcomes already comparing favorably to historical data. This promising data will be shared at the congress as the company discusses strategic partnerships to further advance BMF-500 for patients with very limited treatment options.
Read Announcement- Drug:
- BMF-500
- Announced Date:
- December 9, 2024
- Indication:
- Orally Bioavailable Covalent Inhibitor of FLT3
Announcement
Biomea Fusion, Inc announced preliminary data from the ongoing Phase I COVALENT-103 study evaluating BMF-500, the company's investigational covalent FLT3 inhibitor developed using the proprietary FUSION™ System.
AI Summary
Biomea Fusion, Inc. recently announced promising preliminary results from its ongoing Phase I COVALENT-103 study of BMF-500, an investigational covalent FLT3 inhibitor developed using the proprietary FUSION™ System. The study has enrolled 20 patients with relapsed or refractory acute leukemia, including 13 with FLT3 mutations, all of whom had previously failed treatment with gilteritinib. Early data shows that BMF-500 has a favorable safety profile with no dose-limiting toxicities observed at any dosage. Pharmacokinetic and pharmacodynamic evaluations confirmed that the drug effectively targeted FLT3, demonstrating dose-proportional activity and reaching meaningful levels in the bone marrow. Notably, signs of clinical efficacy were observed, with some patients showing significant reductions in bone marrow blast counts and one achieving a complete response with incomplete hematologic recovery (CRi). These initial results support the potential of BMF-500 as a transformative therapy for this challenging patient group.
Read Announcement
BMF-650 - FDA Regulatory Timeline and Events
BMF-650 is a drug developed by Biomea Fusion for the following indication: GLP-1 receptor agonist.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BMF-650
- Announced Date:
- June 18, 2025
- Indication:
- GLP-1 receptor agonist
Announcement
Biomea Fusion, Inc. announced new preclinical findings from a 28-day weight loss study in obese non-human primates evaluating BMF-650, the Company's investigational, next-generation oral small molecule glucagon-like peptide-1 receptor agonist (GLP-1 RA).
AI Summary
Biomea Fusion, Inc. recently shared promising preclinical data for its investigational drug BMF-650, a next-generation oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) for obesity treatment. In a 28-day study with 15 obese cynomolgus monkeys, BMF-650 was administered orally at 10 mg/kg and 30 mg/kg. Researchers observed a clear, dose-dependent reduction in daily food intake and progressive weight loss, with the lower and higher doses achieving approximately 12% and 15% weight reduction from baseline, respectively. These results highlight the drug’s potential to replicate potent metabolic benefits while offering improved oral bioavailability and consistent plasma exposure. Given that the GLP-1 receptors in monkeys are functionally similar to those in humans, the findings support further clinical development of BMF-650 as a promising, patient-friendly treatment for obesity.
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COVALENT-111 - FDA Regulatory Timeline and Events
COVALENT-111 is a drug developed by Biomea Fusion for the following indication: To treat and improve the lives of patients with genetically defined cancers and metabolic diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- COVALENT-111
- Announced Date:
- November 18, 2024
- Indication:
- To treat and improve the lives of patients with genetically defined cancers and metabolic diseases,
Announcement
Biomea Fusion, Inc. announced its presentations at the 1st Annual Asian Conference on Innovative Therapies for Diabetes Management (ATTD-ASIA 2024) taking place in Singapore, 18-20 November 2024.
AI Summary
Biomea Fusion, Inc. has announced that it will present multiple sessions at the 1st Annual Asian Conference on Innovative Therapies for Diabetes Management (ATTD-ASIA 2024) in Singapore, from November 18-20, 2024. The company will showcase three oral presentations and participate in an industry symposium. Among the highlights are updates on the Phase 2 COVALENT-111 trial, which studies the oral menin inhibitor icovamenib in type 2 diabetes patients, and a late-breaker session focusing on case studies for patients with poorly controlled insulin-deficient type 2 diabetes. Biomea will also present preliminary information on the Phase 2 COVALENT-112 trial investigating icovamenib in type 1 diabetes patients. These presentations aim to demonstrate icovamenib’s potential benefits in improving glycemic control by targeting beta-cell function, and they offer insights into innovative future strategies in diabetes management.
Read Announcement
icovamenib - FDA Regulatory Timeline and Events
icovamenib is a drug developed by Biomea Fusion for the following indication: For 2 diabetes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- icovamenib
- Announced Date:
- June 23, 2025
- Indication:
- For 2 diabetes
Announcement
Biomea Fusion, Inc. announced the presentation of new preclinical and clinical data for icovamenib, the company's investigational oral menin inhibitor, at the 85th Scientific Sessions of the American Diabetes Association (ADA) June 20–23, 2025 in Chicago.
AI Summary
Biomea Fusion, Inc. presented fresh preclinical and clinical findings for its investigational oral menin inhibitor, icovamenib, at the 85th Scientific Sessions of the American Diabetes Association in Chicago. The new data show that when icovamenib is combined with low-dose semaglutide, it significantly enhances glycemic control and promotes extra weight loss. In a rodent type 2 diabetes model, the combination led to better blood glucose reduction and fat loss while fully preserving lean body mass compared to semaglutide alone.
Clinical results from the Phase II COVALENT-111 trial revealed a 1.0% placebo-adjusted HbA1c reduction and a 55% increase in C-peptide levels three weeks after the last dose, suggesting improvement in beta cell function. These findings indicate that icovamenib may work through a novel mechanism to restore beta cells and, when paired with other therapies, could offer a promising approach to diabetes care.
Read Announcement- Drug:
- icovamenib
- Announced Date:
- January 7, 2025
- Indication:
- For 2 diabetes
Announcement
Biomea Fusion, Inc. announce compelling results from in vivo studies of icovamenib in combination with semaglutide.
AI Summary
Biomea Fusion, Inc. announced compelling preclinical results from in vivo studies using icovamenib combined with semaglutide. The study, conducted on a diabetic rat model, showed that the combination led to an 11.5% greater reduction in body weight and a 43% increase in lean muscle mass compared to semaglutide alone. Researchers also found that the combination therapy doubled C-peptide production per unit of glucose, leading to a 60% more effective reduction in fasting blood glucose levels. These results indicate that icovamenib can enhance the benefits of GLP-1-based treatments like semaglutide, improving glycemic control and potentially lowering the necessary dose of semaglutide. Biomea Fusion’s Chief Medical Officer highlighted that these findings could pave the way for better management of diabetes, offering hope for improved treatment regimens and fewer side effects for patients. Further data will be presented at the upcoming J.P. Morgan Conference.
Read Announcement- Drug:
- icovamenib
- Announced Date:
- December 17, 2024
- Indication:
- For 2 diabetes
Announcement
Biomea Fusion, Inc. announced positive topline results from the ongoing COVALENT-111 study, evaluating the efficacy, safety and tolerability of icovamenib in patients with type 2 diabetes (T2D).
AI Summary
Biomea Fusion recently announced promising topline results from the ongoing COVALENT-111 study testing icovamenib, an oral covalent inhibitor, in patients with type 2 diabetes (T2D). The study met its primary endpoint by achieving a statistically significant, placebo-corrected reduction in HbA1c levels. In particular, patients with beta-cell deficiency who were already on one or more antidiabetic agents experienced a notable 1.47% reduction in HbA1c after 12 weeks of dosing with 100 mg of icovamenib. These results suggest that the treatment can effectively lower blood sugar levels and improve glycemic control in this subgroup of patients.
Icovamenib was also well tolerated, with no adverse-event-related discontinuations, hypoglycemic events, or serious adverse events reported during the study. The favorable safety and efficacy data highlight the potential of icovamenib as a new treatment option for T2D, and the company plans to further develop this novel approach to diabetes care.
Read Announcement
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