Biomea Fusion, Inc., a biopharmaceutical company, focuses on the discovery, development, and commercialization of irreversible small molecules to treat patients with genetically defined cancers. Its lead product candidate is BMF-219, an orally bioavailable, potent, and selective irreversible inhibitor of MENIN, a transcriptional regulator in oncogenic signaling in multiple cancers. The company was founded in 2017 and is headquartered in Redwood City, California.
IPO Year: 2021
Exchange: NASDAQ
Website: biomeafusion.com
Date | Price Target | Rating | Analyst |
---|---|---|---|
9/27/2024 | $18.00 | Neutral → Buy | Rodman & Renshaw |
9/27/2024 | $54.00 | Hold → Buy | Truist |
8/29/2024 | $25.00 | Overweight | CapitalOne |
6/11/2024 | Buy → Hold | Truist | |
6/7/2024 | $30.00 → $5.00 | Overweight → Equal Weight | Barclays |
4/2/2024 | $51.00 → $14.00 | Overweight → Neutral | JP Morgan |
2/6/2024 | $55.00 | Buy | Truist |
7/27/2023 | $41.00 | Sector Outperform | Scotiabank |
6/26/2023 | Buy → Hold | Jefferies | |
5/12/2023 | $50.00 | Overweight | Barclays |
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
COVALENT-111 Phase 2b on track for Q4 2024 readoutCOVALENT-112 Phase 2a on track for Q4 2024 readoutAnnouncement of the third program in obesity on track for Q3 2024 REDWOOD CITY, Calif., July 31, 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, reported second quarter 2024 financial results and corporate highlights. "Q2 2024 was another busy quarter for the company. The company's top priority is working with FDA to resolve the clinical hol
REDWOOD CITY, Calif., June 06, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or the "Company") (NASDAQ:BMEA), announced that the Company has received notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold has been placed 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. The Company will continue ongoing safety and efficacy data collection during the hold. "We respect the FDA's decision and agree that patient safety is paramount and our top priority. We are fully collaborating and working diligently with the FDA to p
REDWOOD CITY, Calif., June 03, 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 genetically defined cancers and metabolic diseases, today announced that on June 1, 2024, the compensation committee of Biomea's board of directors granted one new employee non-qualified stock options to purchase an aggregate of 25,000 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 continued employment with the Company on
REDWOOD CITY, Calif., May 30, 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 metabolic diseases and genetically defined cancers, today announced the completion of enrollment of the first three dose expansion arms of COVALENT-111, with a total of over 260 type 2 diabetes patients enrolled. The COVALENT-111 study is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. Phase II consists of multiple dose escalation and dose expansion cohorts including adult patients with type 2 diabete
Reported positive data from the escalation portion of Phase 1/2 study (COVALENT-111) in type 2 diabetes patients, displaying durable improved glycemic control while off therapy for 22 weeks, supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes: a loss of healthy, insulin-producing beta cellsAnnounced initial clinical data from our Phase 2 study (COVALENT-112) in type 1 diabetes from the first two type 1 diabetes patients dosed with BMF-219 and demonstrated early signs of clinical activity with improved measures of beta-cell function after initial treatment with BMF-219We expect a reduction in operating expenses in the second half of the year due to the ne
REDWOOD CITY, Calif., May 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 genetically defined cancers and metabolic diseases, today announced that on May 1, 2024, the compensation committee of Biomea's board of directors granted 8 new employees non-qualified stock options to purchase an aggregate of 80,250 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 wi
REDWOOD CITY, Calif., April 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 genetically defined cancers and metabolic diseases, today announced that on April 1, 2024, the compensation committee of Biomea's board of directors granted two new employees non-qualified stock options to purchase an aggregate of 6,500 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 employme
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8-K - Biomea Fusion, Inc. (0001840439) (Filer)
8-K - Biomea Fusion, Inc. (0001840439) (Filer)
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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
Barclays initiated coverage of Biomea Fusion with a rating of Overweight and set a new price target of $50.00
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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
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
HC Wainwright & Co. analyst Joseph Pantginis reiterates Biomea Fusion (NASDAQ:BMEA) with a Buy and maintains $15 price target.
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Truist Securities analyst Robyn Karnauskas downgrades Biomea Fusion (NASDAQ:BMEA) from Buy to Hold.
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Citigroup analyst Yigal Nochomovitz maintains Biomea Fusion (NASDAQ:BMEA) with a Buy and lowers the price target from $90 to $45.
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HC Wainwright & Co. analyst Joseph Pantginis maintains Biomea Fusion (NASDAQ:BMEA) with a Buy and lowers the price target from $50 to $15.