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

SCHEDULE 13D/A - Biomea Fusion, Inc. (0001840439) (Subject)

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

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

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

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424B5 - 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)

Piper Sandler resumed coverage of Biomea Fusion with a rating of Overweight and set a new price target of $7.00

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

SAN CARLOS, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea," "Biomea Fusion" or the "Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity medicines company, today announced the appointment of Julianne Averill to its Board of Directors (the "Board"), effective July 22, 2025. Ms. Averill has also been appointed to serve as a member of the Audit Committee. She succeeds Bihua Chen, who has stepped down from the Board after more than four years of dedicated service. "Julianne is an accomplished leader whose extensive financial, operational, and strategic expertise in the life sciences and digital health industries will be a tremendous asset to Biomea. Her prov

Company Announces Strategic Realignment to Focus on Core Programs and Extend Cash Runway Icovamenib progressing toward the next phase of clinical development in insulin deficient type 2 diabetes patients and patients that are currently uncontrolled on a GLP-1 based therapyBiomea's next generation oral GLP-1 receptor agonist (BMF-650) filing for IND All other clinical and preclinical activities are either being partnered or closed REDWOOD CITY, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity company, today reported its financial results for the first quarter ended March 31, 202

Mick Hitchcock, Ph.D., appointed Interim Chief Executive OfficerBiomea preparing icovamenib for late-stage clinical developmentMultiple milestones anticipated in 2025 including:FDA meeting anticipated in first half 2025 to discuss icovamenib late-stage development in severe insulin deficient patientsCOVALENT-111 (T2D) 52-week data anticipated in second half 2025COVALENT-112 (T1D) open label data anticipated in second half 2025BMF-650 IND application submission planned in second half 2025 REDWOOD CITY, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity medicines company, reported

Board member Mick Hitchcock, named interim CEO replacing Thomas Butler. COO and President Ramses Erdtmann continuing at Biomea in current role. REDWOOD CITY, Calif., March 25, 2025 (GLOBE NEWSWIRE) --  Biomea Fusion, Inc. ("Biomea," or the "Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity medicines company, announced today an executive leadership change to help ensure the company realizes its full potential developing a novel therapy for diabetes. Specifically, Mick Hitchcock, a current board member since 2021, will succeed Thomas Butler as interim Chief Executive Officer. The change is effective immediately. "As a long-time member of Biomea's Board, I've had the privilege

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

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SAN CARLOS, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea," "Biomea Fusion" or the "Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity medicines company, today announced the appointment of Julianne Averill to its Board of Directors (the "Board"), effective July 22, 2025. Ms. Averill has also been appointed to serve as a member of the Audit Committee. She succeeds Bihua Chen, who has stepped down from the Board after more than four years of dedicated service. "Julianne is an accomplished leader whose extensive financial, operational, and strategic expertise in the life sciences and digital health industries will be a tremendous asset to Biomea. Her prov

In a rodent model of type 2 diabetes (T2D), icovamenib in combination with low-dose semaglutide promoted enhanced glycemic control and body weight reduction with complete preservation of lean mass, outperforming the group given semaglutide aloneIcovamenib promoted healthy myotube morphology and diminished drug-induced atrophy in ex vivo 3D-engineered human myotube culturesIn severely insulin-deficient patients from the Phase II COVALENT-111 trial, icovamenib achieved a 1.0% placebo-adjusted mean HbA1c reduction and a 55% increase in C-peptide at Week 26, three weeks after last dose SAN CARLOS, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Biomea or Biomea Fusion) (NASDAQ:

Dose-dependent, marked reductions in food intake and significant weight loss observed in obese cynomolgus monkeys BMF-650 compared favorably to published data of a leading GLP-1 RA candidate IND filing on track for the second half of 2025; with Phase I study initiation in obese, otherwise healthy volunteers anticipated late 2025 REDWOOD CITY, Calif., June 18, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea," "Biomea Fusion" or the "Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity medicines company, today announced new preclinical findings from a 28-day weight loss study in obese non-human primates evaluating BMF-650, the Company's investigational, next-generation oral

REDWOOD CITY, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage diabetes and obesity company, today announced the pricing of its previously announced underwritten public offering consisting of (i) 19,450,000 shares of its common stock and accompanying warrants to purchase an aggregate of 19,450,000 shares of common stock (or pre-funded warrants in lieu thereof) and (ii) in lieu of common stock, to certain investors, pre-funded warrants to purchase an aggregate of up to 550,000 shares of its common stock and accompanying warrants to purchase an aggregate of 550,000 shares of common stock (or pre-funded warrants in lieu thereof), at an e

REDWOOD CITY, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage diabetes and obesity company, announced today that it has commenced an underwritten public offering of shares of its common stock and accompanying warrants to purchase shares of its common stock (or pre-funded warrants in lieu thereof) and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock and accompanying warrants to purchase shares of its common stock (or pre-funded warrants in lieu thereof). In addition, Biomea intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of

REDWOOD CITY, Calif., June 13, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or the "Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity medicines company, today announced updated preliminary clinical data from the ongoing Phase I COVALENT-103 trial of BMF-500 in adults with relapsed or refractory ("R/R") acute leukemia ("AL"). The results will be presented in a poster presentation at the European Hematology Association ("EHA") 2025 Congress in Milan, Italy. The presentation by Dr. Farhad Ravandi of The University of Texas MD Anderson Cancer Center will highlight emerging safety, pharmacokinetics/pharmacodynamics, and early clinical activity data for BMF-500, a highl

REDWOOD CITY, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (NASDAQ:BMEA), a clinical-stage diabetes and obesity medicines company, today announced that preliminary clinical data from the Phase I COVALENT-103 trial of BMF-500 in adults with acute leukemia (AL) were selected for a poster presentation at the European Hematology Association (EHA) 2025 Congress, taking place June 12–15 in Milan, Italy. The presentation will highlight emerging safety, pharmacokinetics/pharmacodynamics (PK/PD), and clinical activity of BMF-500, a covalent FLT3 inhibitor, in patients with relapsed or refractory (R/R) AL, including those with FLT3 mutations (FLT3m) who have previously re

Company Announces Strategic Realignment to Focus on Core Programs and Extend Cash Runway Icovamenib progressing toward the next phase of clinical development in insulin deficient type 2 diabetes patients and patients that are currently uncontrolled on a GLP-1 based therapyBiomea's next generation oral GLP-1 receptor agonist (BMF-650) filing for IND All other clinical and preclinical activities are either being partnered or closed REDWOOD CITY, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity company, today reported its financial results for the first quarter ended March 31, 202

REDWOOD CITY, Calif., April 01, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or the "Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity medicines company, today announced that on March 23, 2025, the compensation committee of Biomea's board of directors granted two new employees non-qualified stock options to purchase an aggregate of 30,000 shares of the Company's common stock. The shares underlying each employee's stock options will vest 1/16 on a quarterly basis over four years, in each case subject to each such employee's continued employment with the Company on such vesting dates. All of the above-described awards were made under Biomea's 2023 Inducement Equity Pla

Mick Hitchcock, Ph.D., appointed Interim Chief Executive OfficerBiomea preparing icovamenib for late-stage clinical developmentMultiple milestones anticipated in 2025 including:FDA meeting anticipated in first half 2025 to discuss icovamenib late-stage development in severe insulin deficient patientsCOVALENT-111 (T2D) 52-week data anticipated in second half 2025COVALENT-112 (T1D) open label data anticipated in second half 2025BMF-650 IND application submission planned in second half 2025 REDWOOD CITY, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity medicines company, reported

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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