Icovamenib & BMF-650 (oral small molecule GLP-1) are the cornerstones of the metabolic franchiseBiomea preparing icovamenib for late-stage clinical development2025 corporate update to be presented at the 43rd Annual J.P. Morgan Healthcare Conference REDWOOD CITY, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to improve the lives of patients announced today that the company will become a diabetes and obesity medicines company. Based on the most recent clinical trial results, the strategic focus for ico

New in vivo preclinical data announced today, demonstrate that icovamenib, in combination with semaglutide showed additional 11.5% body weight reduction and 43% increase in lean muscle mass compared to semaglutide aloneIcovamenib, in combination with semaglutide, approximately doubled C-peptide production per unit of glucose compared to semaglutide alone leading to a 60% improved reduction of fasting blood glucoseEx vivo human islet experiments previously presented in October, showed that icovamenib enhanced the activity of glucagon-like peptide-1 (GLP-1)-based therapies, leading to substantial increase in insulin secretionTopline data from the COVALENT-111 study showed that 12 weeks of dail

REDWOOD CITY, Calif., Jan. 06, 2025 (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 today that Thomas Butler, Chief Executive Officer and Chairman of the Board, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025, at 1:30 PM Pacific Time / 4:30 PM Eastern Time. Additionally, Biomea's management team will be hosting one-on-one meetings throughout the conference, taking place from January 13 to January 16

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

In preclinical experiments, icovamenib enhanced beta cell function and responsiveness of human islets to GLP-1-based therapies. These effects were associated with an increase in the expression levels of both the GLP-1 receptor (GLP-1R) as well as intracellular insulin.Overall results showed synergy of the combination therapy, which may allow lower doses of GLP-1-based therapies to achieve glycemic targets, potentially reducing side effects and improving tolerability of GLP-1 based therapies. REDWOOD CITY, Calif., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to discov

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

REDWOOD CITY, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (NASDAQ:BMEA) ("Biomea" or the "Company"), a clinical stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to treat and improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced that on December 2, 2024, the compensation committee of Biomea's board of directors granted one new employee non-qualified stock options to purchase an aggregate of 30,000 shares of the Company's common stock. The shares underlying the employee's stock options will vest 1/16 on a quarterly basis over four years, subject to the employee's contin

Icovamenib Achieves a Mean Reduction in HbA1c Greater than 1% at Week 26 Following 4 Weeks of Dosing in Type 2 Diabetes Patients Characterized by Insulin Deficiency 32 patients from the 100mg and 200mg cohorts, doses selected for the expansion phase, were characterized based on baseline biomarkers and analyzed for efficacy. Patients identified as insulin deficient (approx. 50% of the broader patient population) and insulin resistant were compared to examine the mean reduction in HbA1c at Week 26, following 4 weeks of dosing. 83% of patients with insulin deficiency responded to icovamenib, and showed a greater mean HbA1c reduction at Week 26 compared to baseline, than those that were found

4 - Biomea Fusion, Inc. (0001840439) (Issuer)

4 - Biomea Fusion, Inc. (0001840439) (Issuer)

SC 13G/A - Biomea Fusion, Inc. (0001840439) (Subject)

SC 13G/A - Biomea Fusion, Inc. (0001840439) (Subject)

SC 13G - Biomea Fusion, Inc. (0001840439) (Subject)

SC 13G/A - Biomea Fusion, Inc. (0001840439) (Subject)

SC 13G/A - Biomea Fusion, Inc. (0001840439) (Subject)

SC 13G/A - Biomea Fusion, Inc. (0001840439) (Subject)

SC 13G/A - Biomea Fusion, Inc. (0001840439) (Subject)

SC 13G/A - Biomea Fusion, Inc. (0001840439) (Subject)

SC 13G - Biomea Fusion, Inc. (0001840439) (Subject)

SC 13G - Biomea Fusion, Inc. (0001840439) (Subject)

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

Demonstrated durable HbA1c lowering in the escalation portion of ongoing Phase II study in type 2 diabetes (COVALENT-111), with 84% of all patients showing a reduction of HbA1c after 4 weeks dosing and 74% after another 8 weeks off-treatment periodExpansion portion of COVALENT-111 cleared and actively enrolling in the U.S. and Canada; expected to enroll approximately 200 adults with type 2 diabetesInvestigational new drug (IND) application cleared for Phase II clinical trial of BMF-219 in type 1 diabetes (COVALENT-112); enrollment of 150 adults with type 1 diabetes anticipated to begin in Q4 2023Dosed first relapsed/refractory AML patient with BMF-500, Biomea's novel third generation investi

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 Morris, M.D., will transition to the role of Chief Development Officer, continuing to lead clinical development of Biomea's oncology portfolio, including BMF-219, BMF-500 and research-stage assets REDWOOD CITY, Calif., Aug. 31, 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 metabo

Renowned physician-scientist's groundbreaking work led to the discovery and characterization of multiple oncogenes, including anaplastic lymphoma kinase (ALK)Dr. Morris will lead clinical development of BMF-219, an irreversible covalent menin inhibitor currently in a Phase I clinical trial, and additional planned clinical programsCompany plans to initiate clinical development of BMF-219 in up to seven distinct tumor types, as well as diabetes, in 2022 REDWOOD CITY, Calif., Feb. 01, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and im

Completed investigational new drug ("IND") enabling studies for lead program, BMF-219, an irreversibly binding menin inhibitor. On track to complete IND submission for Phase I/II study of BMF-219 as treatment for patients with menin-dependent acute myeloid leukemia ("AML") and acute lymphocytic leukemia ("ALL") during the second half of this yearContinued to advance ongoing preclinical studies of BMF-219 in a number of menin-dependent liquid and solid tumors, including Diffuse Large B Cell Lymphoma ("DLBCL"), to expand potential impact of novel drug   Initiated pathway validation studies in type 2 diabetesContinued to expand team and laboratory facilities to support long-term growth and clin

REDWOOD CITY, Calif., June 28, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a preclinical-stage biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers, announced the appointment of Franco Valle as Chief Financial Officer. Mr. Valle is an accomplished financial expert who brings extensive experiences to Biomea, in particular with building the necessary infrastructure to support clinical and operational growth within biotech companies. Mr. Valle will also assume the role of Principal Financial Officer and Principal Accounting Officer upon joining. Recently, Mr. Valle se

Edward Jones initiated coverage of Biomea Fusion with a rating of Buy and set a new price target of $128.00

Rodman & Renshaw upgraded Biomea Fusion from Neutral to Buy and set a new price target of $18.00

Truist upgraded Biomea Fusion from Hold to Buy and set a new price target of $54.00

CapitalOne initiated coverage of Biomea Fusion with a rating of Overweight and set a new price target of $25.00

Truist downgraded Biomea Fusion from Buy to Hold

Barclays downgraded Biomea Fusion from Overweight to Equal Weight and set a new price target of $5.00 from $30.00 previously

JP Morgan downgraded Biomea Fusion from Overweight to Neutral and set a new price target of $14.00 from $51.00 previously

Truist initiated coverage of Biomea Fusion with a rating of Buy and set a new price target of $55.00

Scotiabank initiated coverage of Biomea Fusion with a rating of Sector Outperform and set a new price target of $41.00

Jefferies downgraded Biomea Fusion from Buy to Hold

8-K - Biomea Fusion, Inc. (0001840439) (Filer)

S-8 - Biomea Fusion, Inc. (0001840439) (Filer)

8-K - Biomea Fusion, Inc. (0001840439) (Filer)

8-K - Biomea Fusion, Inc. (0001840439) (Filer)

10-Q - Biomea Fusion, Inc. (0001840439) (Filer)

8-K - Biomea Fusion, Inc. (0001840439) (Filer)

8-K - Biomea Fusion, Inc. (0001840439) (Filer)

10-Q - Biomea Fusion, Inc. (0001840439) (Filer)

8-K - Biomea Fusion, Inc. (0001840439) (Filer)

8-K - Biomea Fusion, Inc. (0001840439) (Filer)