Biomea Fusion Announces First Patient Dosed with Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia in Phase I Clinical Trial (COVALENT-103)
17. Oktober 2023 08:30 ET
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Biomea Fusion, Inc.
BMF-500, a novel 3rd generation oral covalent inhibitor of FMS-like tyrosine kinase 3 (FLT3), is the second product candidate discovered and developed by Biomea’s proprietary FUSION™ System to enter...
Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for BMF-219 in Type 1 Diabetes
05. Oktober 2023 08:30 ET
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Biomea Fusion, Inc.
The FDA has cleared the initiation of COVALENT-112, a Phase II clinical trial of BMF-219 in adults with type 1 diabetes (T1D).The randomized, double-blind, placebo-controlled (N=150) trial in adults...
Biomea Fusion Announces FDA and Health Canada Clearance of the Expansion Cohorts of the Ongoing COVALENT-111 Phase II Study
28. September 2023 08:30 ET
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Biomea Fusion, Inc.
The FDA and Health Canada have cleared the initiation of the expansion portion of COVALENT-111, which will evaluate BMF-219 administered at 100 mg and 200 mg, with dosing durations up to 12 weeks in...
Biomea Fusion Announces Appointment of Juan Pablo Frías, M.D. as Chief Medical Officer
31. August 2023 08:30 ET
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Biomea Fusion, Inc.
Industry veteran and prominent diabetes clinical development expert to oversee Biomea’s progressing clinical development of novel covalent menin inhibitor BMF-219 in type 2 and type 1 diabetesSteve...
Biomea Fusion Reports Second Quarter 2023 Financial Results and Corporate Highlights
31. Juli 2023 16:01 ET
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Biomea Fusion, Inc.
Reported additional positive clinical data at ADA 83rd Scientific Sessions from the first two cohorts of patients with type 2 diabetes from ongoing Phase I/II study (COVALENT-111) evaluating BMF-219...
BMF-219 Induces Complete Responses in Target Acute Myeloid Leukemia (AML) Patient Population
24. Juli 2023 09:00 ET
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Biomea Fusion, Inc.
Initial topline data from COVALENT-101 trial revealed 2 complete responses (CRs) out of 5 relapsed/refractory AML patients carrying menin-dependent mutations treated at Dose Level 4Dose Level 4...
Biomea Fusion Presents Positive Clinical Data from the Initial Cohorts of the Ongoing Phase II Study (COVALENT-111) of BMF-219 in Patients with Type 2 Diabetes Mellitus at the American Diabetes Association (ADA) 83rd Scientific Sessions; 100 mg Cohort 3 Demonstrated a 90% Response Rate and 70% Maintained or Improved Time in (Normal Glucose) Range, While Off-Treatment
23. Juni 2023 21:54 ET
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Biomea Fusion, Inc.
Eight weeks after completing treatment with BMF-219, patients with type 2 diabetes (T2D) showed an increase of C-peptide and an improvement of HOMA-B, measured during oral glucose tolerance testing...
Biomea Fusion to Present Late Breaking Data from Ongoing Phase II Trial, COVALENT-111, Evaluating BMF-219 in Patients with Type 2 Diabetes at ADA 2023
20. Juni 2023 16:30 ET
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Biomea Fusion, Inc.
New clinical data from COVALENT-111 will be unveiled during a late-breaking poster presentation at ADA’s Scientific SessionsBMF-219, an orally delivered novel covalent menin inhibitor, is designed to...
Biomea Fusion Reports First Quarter 2023 Financial Results and Corporate Highlights
02. Mai 2023 16:01 ET
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Biomea Fusion, Inc.
Reported initial positive clinical data from first two cohorts of Phase II of ongoing Phase I/II study (COVALENT-111) of BMF-219, Biomea’s lead investigational, orally administered covalent menin...
Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia
01. Mai 2023 08:30 ET
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Biomea Fusion, Inc.
BMF-500, a novel 3rd generation covalent inhibitor of fms-like tyrosine kinase 3 (FLT3), is the second investigational compound, discovered and developed by Biomea’s FUSION™ System, to advance to the...