Biomea Fusion (BMEA)
NASDAQ:BMEA
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Icovamenib 100Mg
Type 2 Diabetes
Phase II
Recruiting
Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets
Mar 26, 2026
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Icovamenib 100 Mg
Type 2 Diabetes
Phase II
Recruiting
Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy
Mar 26, 2026
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Icovamenib, Icovamenib Hpmc, Bmf-219
Healthy Volunteer
Phase I
Completed
Food Effect Study in Healthy Volunteers
Oct 10, 2025
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Bmf-500
Acute Myeloid Leukemia
Phase I
Active Not Recruiting
A Phase 1 Study of BMF-500 in Adults With Acute Leukemia
May 18, 2023
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Bmf-219
Colorectal Cancer, Pancreatic Cancer, Non Small Cell Lung Cancer, Nsclc, Stage Iv Pancreatic Cancer, Stage Iv Non-Small Cell Lung Cancer, Refractory Cancer, Pdac, Crc, Relapsed Cancer, Stage Iii Pancreatic Cancer, Stage Iii Non-Small Cell Lung Cancer, Stage Iii Colorectal Cancer, Stage Iv Colorectal Cancer, Stage Iii Nsclc, Stage Iv Nsclc, Kras Mutation-Related Tumors
Phase I
Terminated
Study of Covalent Menin Inhibitor BMF-219 in Adult Patients With KRAS Driven Non-Small Cell Lung Cancer, Pancreatic Cancer, and Colorectal Cancer
Nov 04, 2022
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Bmf-219
Multiple Myeloma, Acute Myeloid Leukemia, Cancer, Chronic Lymphocytic Leukemia, Lymphoma, Non-Hodgkin, Small Lymphocytic Lymphoma, Diffuse Large B Cell Lymphoma, Lymphoma, Acute Lymphoblastic Leukemia, Plasma Cell Myeloma, Myeloma, Plasma-Cell, Myelomatosis, Acute Mixed-Phenotype Leukemia, Refractory, Progression
Phase I
Terminated
Study of BMF-219, a Covalent Menin Inhibitor, in Adult Patients With AML, ALL (With KMT2A/ MLL1r, NPM1 Mutations), DLBCL, MM, and CLL/SLL
Nov 30, 2021
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Bmf-219
Type 2 Diabetes Mellitus
Phase I/II
Completed
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Biomea Fusion (BMEA) have in its pipeline
BMEA is currently developing the following drugs: Icovamenib 100Mg, Icovamenib 100 Mg, Bmf-650. These drug candidates are in various stages of clinical development as the company works toward FDA approval.