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 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

REDWOOD CITY, Calif., Nov. 01, 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 November 1, 2024, the compensation committee of Biomea's board of directors granted one new employee non-qualified stock options to purchase an aggregate of 6,500 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 continu

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. 21, 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 the World Health Organization (WHO) has approved "icovamenib" as the International Nonproprietary Name (INN) for its lead product candidate BMF-219, and that the United States Adopted Name Council has adopted "icovamenib" as the United States Adopted Name (USAN) for BMF-219. The suffix ‘-menib' stands for menin inhibitor. An International Nonproprietary Name

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.

BMF-219 is an investigational oral covalent menin inhibitor developed to regenerate insulin-producing beta cells Two trial-in-progress oral presentations to feature Phase II study design of oral covalent menin inhibitor BMF-219 in patients with type 2 diabetes (COVALENT-111) and in patients with type 1 diabetes (COVALENT-112)One late breaker oral presentation to highlight two case studies assessing BMF-219 in persons with poorly controlled severe insulin-deficient (SIDD) type 2 diabetes REDWOOD CITY, Calif., Oct. 07, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small

REDWOOD CITY, Calif., Oct. 01, 2024 (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 metabolic diseases, obesity and genetically defined cancers, today announced the formation of Biomea Fusion's Global Scientific Advisory Board (SAB) with internationally renowned experts in beta cell science and diabetes therapeutics. The SAB will work closely with Biomea's leadership team as they unlock menin science and beta cell biology to design disease modifying agents that address a root cause of diabetes – beta cell dysfunc

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

REDWOOD CITY, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (NASDAQ:BMEA) ("Biomea" or the "Company"), a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with metabolic diseases and genetically defined cancers, today announced that on August 1, 2024, the compensation committee of Biomea's board of directors granted one new employee non-qualified stock options to purchase an aggregate of 7,500 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 continued employment with the Company o

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

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