BMEA - Earnings announcements

A 52% increase from baseline in mean C-peptide AUC at Week 12 in patients diagnosed within 0–3 years (n=5) receiving icovamenib 200 mg, with a clear dose response observed vs 100 mg (n=6)Persistence observed through Week 52, with mean C-peptide AUC largely preserved in 200 mg group (~7% decline from baseline) following only 12 weeks of dosingPreservation of C-peptide also observed in patients diagnosed between 3-15 years (n=9)Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52 Comprehensive dataset to be presented at the American Diabetes Association's (ADA) Scientific Sessions (abstract is preliminary un

Icovamenib showed a sustained treatment benefit at Week 52 (9 months past the end of treatment) in the severe insulin-deficient diabetes patient population taking one or more antihyperglycemic medications at baseline, with a 1.8% placebo adjusted mean reduction in HbA1c (Arm B)Type 2 diabetes patients on a GLP-1-based therapy failing to achieve their target HbA1c also showed a clinically meaningful response from only 12 weeks of icovamenib treatment with a mean placebo adjusted HbA1c reduction of 1.8% (Arms A, B, and C combined) at Week 52Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52 Phase II trials

Icovamenib met the primary endpoint, displaying a meaningful statistically significant placebo-corrected mean reduction in HbA1c in the prespecified per protocol patient populationBest response achieved in target, beta-cell deficient patients on one or more antidiabetic agents at baseline, showing a placebo-adjusted mean reduction of 1.47% in HbA1c at Week 26 with statistical significance, after only 12 weeks of dosing icovamenib with 100 mgIcovamenib was well-tolerated, with no adverse-event related discontinuations, no hypoglycemic events and no serious adverse events REDWOOD CITY, Calif., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company

REDWOOD CITY, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that it will host a conference call and webcast on Tuesday, December 17, 2024 at 8:00 am EST to present topline results from COVALENT-111, the company's Phase II trial of icovamenib in patients with type 2 diabetes. Conference Call and Webcast Details Webcast of Biomea's investor update on Tuesday, December 17, 2024, at 8:00 am EST will be available to reg

Preliminary data supports BMF-500's potential as a transformative therapy for patients with FLT3 mutated relapsed or refractory (R/R) acute leukemiaBMF-500 showed a favorable safety and tolerability profile, with no dose-limiting toxicities observed across all dose levelsPharmacokinetic and pharmacodynamic data confirmed on-target FMS-like tyrosine kinase 3 (FLT3) inhibition, demonstrating dose-proportional activity and good compartmental penetrationPreliminary Phase I data for BMF-500 in R/R acute leukemia patients with FLT3 gene mutations having failed gilteritinib indicated clinical activity with evidence of responses, including a first complete response with incomplete hematologic recove

REDWOOD CITY, Calif., Dec. 06, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that it will host a conference call and webcast on Monday, December 9, 2024 at 4:30 pm EST to present data from COVALENT-103, the company's Phase I trial of BMF-500, an investigational covalent FLT3 inhibitor developed using the proprietary FUSION™ System, in adult patients with relapsed or refractory acute leukemia. Conference Call and Webcast DetailsWebcast of B

Preclinical data from ex vivo human islet experiments showed that icovamenib (BMF-219) was able to enhance the activity of glucagon-like peptide-1 (GLP-1)-based therapies, potentially leading to increased insulin secretion and improved glycemic control in patients with diabetesPhase II study (COVALENT-211), combining icovamenib with a GLP-1-based therapy, planned to begin in 2025BMF-650, an investigational next-generation, oral small-molecule GLP-1 receptor agonist (GLP-1 RA), demonstrated positive early preclinical activity, including improved glucose-stimulated insulin secretion, reduction in blood glucose concentration, and appetite suppression in cynomolgus monkeys REDWOOD CITY, Calif.,

U.S. Food and Drug Administration (FDA) lifted Clinical Hold on COVALENT-111 (Type 2 Diabetes) & COVALENT-112 (Type 1 Diabetes) trialsCOVALENT-111 Phase 2b 26-week topline data of the dose expansion cohorts expected in December 2024COVALENT-112 Phase 2a 26-week topline data of the open label portion expected in December 2024On track to announce our third clinical candidate, BMF-650, for the treatment of diabetes and obesity – a next-generation, oral small-molecule GLP-1 receptor agonist (GLP-1 RA) - and preclinical data combining icovamenib (BMF-219) with a GLP-1 RA-based therapy on October 30thAnnounced formation of Biomea's Global Scientific Advisory Board with 22 world-renowned diabetes e

REDWOOD CITY, Calif., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that it will host a conference call and webcast on Wednesday, October 30th at 4:30 pm ET to announce our lead clinical candidate, BMF-650 – a next-generation, potent, selective, oral small-molecule GLP-1 receptor agonist (GLP-1 RA) and to share results of preclinical studies investigating the synergistic benefits of combining BMF-219 with a GLP-1 RA-based therapy.

REDWOOD CITY, Calif., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or the "Company") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today 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. "We greatly appreciate FDA's review of our data, and the swift resolution of the

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 (OGTT), supporting improved beta cell function for these patientsObservations of durable and continued improvement in glycemic control were seen in follow-up visits through Week 12 compared to Week 4, eight weeks after the last dose of BMF-219: 70% of Cohort 3 (n=10) patients (100 mg BMF-219 without food) maintained or improved their time in range during continuous glucose monitoring (CGM), while off treatment50% of Cohort 3 patients showed continued improvement in their HbA1c levels while being

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 regenerate, preserve, and reactivate healthy, insulin-producing beta cellsBiomea to hold in-person KOL investor event at the Scientific Sessions in San Diego on Saturday, June 24th at 5:30 pm PTBiomea to hold conference call and webcast on Monday, June 26th at 5:30 am PT REDWOOD CITY, Calif., June 20, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules t

In Cohort 3, after 4 weeks of once-daily 100 mg dosing with the investigational, oral covalent menin inhibitor, BMF-219, 89% of patients achieved a reduction in A1c, 78% of patients achieved at least a 0.5% reduction in A1c, and 56% achieved at least a 1% reduction in A1c.Initial observations of continued glycemic control were seen in follow up visits in patients that had already reached week 8 in the study (4 weeks after the last BMF-219 dose) at the time of this publication.BMF-219 demonstrated a well-tolerated safety profile. No patients on BMF-219 discontinued dosing and all patients completed 4 weeks of treatment.Biomea continues dose escalation of BMF-219 in COVALENT-111 and plans to e

REDWOOD CITY, Calif., March 23, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced that it will host a conference call and webcast to discuss the initial clinical data from the first two cohorts of the Phase II portion of COVALENT-111 on Tuesday, March 28th at 8:30 am ET. Conference Call and Webcast Details Webcast of Biomea's investor update on Tuesday, March 28th at 8:30 am ET will be available to registered attendees under the Investors an

COVALENT-111, a Phase I/II clinical trial in patients with type 2 diabetes, already underway in Canada, will now activate sites in the USAs previously reported, the Phase I portion of COVALENT-111 has been completed, with BMF-219 demonstrating a favorable safety, pharmacokinetics (PK) and pharmacodynamics (PD) profile  Ongoing Phase II portion is evaluating BMF-219's long-term glycemic control by restoring the pool and health of beta cells in type 2 diabetes patientsInitial data from the Phase II portion of the study is expected in the first half of 2023Company to host conference call on Thursday, December 15 at 4 PM EST featuring the BMF-219 clinical program in type 2 diabetes REDWOOD