09/28/23 8:30 AMNasdaq : BMEA clinical trialhigh shortlow floatBiomea Fusion Announces FDA and Health Canada Clearance of the Expansion Cohorts of the Ongoing COVALENT-111 Phase II StudyThe 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 type 2 diabetes patients The expansion portion will consist of approximately 300 patients and willRHEA-AIneutral
08/31/23 8:30 AMNasdaq : BMEA managementhigh shortlow floatBiomea Fusion Announces Appointment of Juan Pablo Frías, M.D. as Chief Medical OfficerIndustry 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 diabetes Steve Morris, M.D., will transition to the role of Chief Development Officer, continuing to lead clinicalRHEA-AIpositive
07/31/23 4:01 PMNasdaq : BMEA earningshigh shortlow floatBiomea Fusion Reports Second Quarter 2023 Financial Results and Corporate HighlightsReported additional positive clinical data at ADA 83 rd Scientific Sessions from the first two cohorts of patients with type 2 diabetes from ongoing Phase I/II study (COVALENT-111) evaluating BMF-219 as a novel, potentially disease-modifying treatment candidate for patients with type 2 diabetes NewRHEA-AIneutral
07/24/23 9:00 AMNasdaq : BMEA high shortlow floatBMF-219 Induces Complete Responses in Target Acute Myeloid Leukemia (AML) Patient PopulationInitial 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 4 Dose Level 4 exposure correlates with initial activity seen in BMF-219’s pre-clinical studies Safety profile ofRHEA-AIneutral
06/23/23 9:54 PMNasdaq : BMEA clinical trialhigh shortlow floatBiomea 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-TreatmentEight 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 (OGTT), supporting improved beta cell function for these patients Observations of durable andRHEA-AIneutral
06/20/23 4:30 PMNasdaq : BMEA conferencesclinical trialhigh shortlow floatBiomea Fusion to Present Late Breaking Data from Ongoing Phase II Trial, COVALENT-111, Evaluating BMF-219 in Patients with Type 2 Diabetes at ADA 2023New clinical data from COVALENT-111 will be unveiled during a late-breaking poster presentation at ADA’s Scientific Sessions BMF-219, an orally delivered novel covalent menin inhibitor, is designed to regenerate, preserve, and reactivate healthy, insulin-producing beta cells Biomea to holdRHEA-AInegative
05/02/23 4:01 PMNasdaq : BMEA high shortlow floatBiomea Fusion Reports First Quarter 2023 Financial Results and Corporate HighlightsReported 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 inhibitor, as a novel, potentially disease-modifying treatment for patients with type 2 diabetesRHEA-AIneutral
05/01/23 8:30 AMNasdaq : BMEA high shortlow floatBiomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute LeukemiaBMF-500, a novel 3 rd 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 clinic. Phase I study (COVALENT-103) of BMF-500 will examine its safety and efficacy in patientsRHEA-AIneutral
04/19/23 8:30 AMNasdaq : BMEA conferenceshigh shortlow floatBiomea Fusion to Present Late Breaking Data from Ongoing Phase II Trial, COVALENT-111, Evaluating BMF-219 in Patients with Type 2 Diabetes, at the ADA 83rd Scientific Sessions 2023 in JuneBiomea Fusion, Inc. (“Biomea”) (Nasdaq:RHEA-AIneutral
04/13/23 4:30 PMNasdaq : BMEA conferenceshigh shortlow floatBiomea Fusion To Present Two Preclinical Posters at the 114th AACR Annual MeetingAbstract 473 highlights the dose dependent reduction of menin target genes in ex vivo chronic lymphocytic leukemia (CLL) patient samples treated with BMF-219, an investigational covalent inhibitor. BMF-219 showed greater potency and ability to achieve >98% growth inhibition in these CLL patientRHEA-AIneutral