Biomea Fusion Inc

Biomea Fusion, Inc. is a biopharmaceutical company, which engages in the discovery, development, and commercialization of irreversible small molecules to treat patients with genetically defined cancers. The company was founded by Thomas Butler and Ramses Erdtmann in August 2017 and is headquartered in Redwood City, CA.

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Biomea Fusion, Inc. is a biopharmaceutical company, which engages in the discovery, development, and commercialization of covalent small molecule drugs to treat patients with genetically defined cancers and metabolic disorders, such as diabetes. It offers its lead product candidate, BMF-219, an orally bioavailable, potent, and selective covalent inhibitor of menin, a transcriptional regulator known to play a direct role in oncogenic signaling in multiple cancers. The company was founded by Thomas Butler and Ramses Erdtmann in August 2017 and is headquartered in Redwood City, CA.

BMF-219 is an investigational novel covalent menin inhibitor designed to regenerate insulin-producing beta cells with the aim to cure type 2 diabetes BMF-219 is an investigational novel covalent menin inhibitor designed to regenerate insulin-producing beta cells with the aim to cure type 2 diabetes

Biomea Fusion to Present New Data from Ongoing Phase II Study (COVALENT-111) of BMF-219 in Patients with Type 2 Diabetes at the World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)

REDWOOD CITY, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “the company”) (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 abstracts related to BMF-219, a novel, investigational covalent menin inhibitor, currently in Phase 1 clinical study across multiple liquid and KRAS-mutated solid tumors, and BMF-500, a novel, investigational covalent FMS-like tyrosine kinase 3 (FLT3) inhibitor currently in Phase 1 clinical study in FLT3-mutated acute leukemias, have been accepted for presentation at the upcoming American Society of Hematology (ASH) Annual Meeting, to be held in San Diego from December 9-12, 2023. Both BMF-219 and BMF-500 were originated in-house with Biomea's proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.

Biomea Fusion Announces Two Poster Presentations at Upcoming ASH Annual Meeting 2023

REDWOOD CITY, Calif., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “the Company”) (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, reported third quarter 2023 financial results and business highlights.

Biomea Fusion Reports Third Quarter 2023 Financial Results and Corporate Highlights

Biomea (BMEA) successfully doses the first patient in its phase I study of BMF-500 to treat adult patients with acute leukemia. The company's stock rises 6.7% on the news.

Biomea (BMEA) Doses First Patient in Leukemia Study, Stock Up

BMF-500, a novel 3 rd generation oral covalent inhibitor of FMS-like tyrosine kinase 3 (FLT3), is the second product candidate discovered and developed by Biomea's proprietary FUSION™ System to enter the clinic

Biomea Fusion Announces First Patient Dosed with Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia in Phase I Clinical Trial (COVALENT-103)

REDWOOD CITY, Calif., Sept. 28, 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 FDA and Health Canada clearance of the expansion portion of the ongoing COVALENT-111 Phase II study. The objective of the expansion portion is to continue to investigate BMF-219 with treatment durations up to 12 weeks.

Biomea Fusion Announces FDA and Health Canada Clearance of the Expansion Cohorts of the Ongoing COVALENT-111 Phase II Study

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 metabolic diseases, today announced the appointment of Juan Pablo Frías, M.D. as Chief Medical Officer (CMO). In his new role, Dr. Frías will leverage his deep industry and clinical investigator expertise in the development of therapeutics for the management of diabetes to oversee the clinical development of BMF-219, Biomea's novel investigational menin inhibitor, for the treatment of type 2 and type 1 diabetes. Steve Morris, M.D., will transition to the new role of Chief Development Officer (CDO), where he will continue to lead clinical development of Biomea's oncology portfolio, including BMF-219, BMF-500 and several early-stage oncology research candidates.

Biomea Fusion Announces Appointment of Juan Pablo Frías, M.D. as Chief Medical Officer

REDWOOD CITY, Calif., July 31, 2023 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “the Company”) (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, reported second quarter 2023 financial results and business highlights.

Biomea Fusion Reports Second Quarter 2023 Financial Results and Corporate Highlights

REDWOOD CITY, Calif., July 24, 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 preliminary topline data from its ongoing Phase I clinical trial, COVALENT-101, showcasing initial responses in relapsed/refractory AML patients with menin-dependent mutations.

BMF-219 Induces Complete Responses in Target Acute Myeloid Leukemia (AML) Patient Population

Biomea Fusion is a clinical-stage biotech company developing covalent small molecule inhibitors, with its lead asset BMF-219 showing promising initial phase 2 data for Type 2 diabetes. The company's core strategy is to leverage its proprietary FUSION System platform to develop covalent inhibitors for other cancer targets. The company's Phase 1/2 study for BMF-219 showed significant reductions in blood sugar levels in Type 2 diabetes patients, with the results maintained up to 12 weeks after treatment. However, some toxicity signals were present, leading to a rethinking of the dosing. Further trials are needed to validate the platform and finalize dose escalation.

Biomea Fusion: Potential Cure For Diabetes, Initiating With A Buy

NEW YORK , July 14, 2023 /PRNewswire/ -- Jakubowitz Law announces that an investigation into potential securities fraud allegations has commenced on behalf of shareholders of Biomea Fusion, Inc. (NASDAQ: BMEA) To be contacted by a member of our team, fill out the form: https://claimyourloss.com/securities/biomea-fusion-class-action-loss-submission-form/?id=42094&from=4 Further details on the investigation: On June 23, 2023, Biomea Fusion presented data for its Type 2 diabetes drug candidate BMF-219 at a meeting of the American Diabetes Association. In response to the presentation, market analysts downgraded Biomea Fusion and its stock price fell $6.25 per share, from $30.67 per share on June 23, 2023 to close at $24.42 per share on June 26, 2023.

BMEA FRAUD ALERT: Jakubowitz Law is Investigating Biomea Fusion, Inc. in Connection with Potential Violations of Federal Securities Laws

NEW YORK , July 13, 2023 /PRNewswire/ -- Levi & Korsinsky notifies investors that it has commenced an investigation of Biomea Fusion, Inc. ("Biomea Fusion") (NASDAQ: BMEA) concerning possible violations of federal securities laws. On June 23, 2023, Biomea Fusion presented data for its Type 2 diabetes drug candidate BMF-219 at a meeting of the American Diabetes Association.

BMEA INVESTOR ALERT: Levi & Korsinsky, LLP Notifies Investors of an Investigation Involving Possible Securities Fraud Violations by Officers of Biomea Fusion, Inc.

NEW YORK , July 12, 2023 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Biomea Fusion, Inc.: On June 23, 2023, Biomea Fusion presented data for its Type 2 diabetes drug candidate BMF-219 at a meeting of the American Diabetes Association. In response to the presentation, market analysts downgraded Biomea Fusion and its stock price fell $6.25 per share, from $30.67 per share on June 23, 2023 to close at $24.42 per share on June 26, 2023.

INVESTIGATION ALERT: The Gross Law Firm Notifies Shareholders of Biomea Fusion, Inc. of an Investigation and Potential Class Action Lawsuit - (NASDAQ: BMEA)

LOS ANGELES, CA / ACCESSWIRE / July 11, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Biomea Fusion, Inc. ("Biomea Fusion" or "the Company") (NASDAQ:BMEA) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTOR ACTION NOTICE: The Schall Law Firm Announces it is Investigating Claims Against Biomea Fusion, Inc. and Encourages Investors with Losses to Contact the Firm

NEW YORK , July 11, 2023 /PRNewswire/ -- The Klein Law Firm announces that it is investigating allegations that Biomea Fusion, Inc. ("Biomea Fusion") (NASDAQ: BMEA) violated federal securities laws. CURRENT INVESTIGATION DETAILS:On June 23, 2023, Biomea Fusion presented data for its Type 2 diabetes drug candidate BMF-219 at a meeting of the American Diabetes Association.

BMEA NEWS: The Klein Law Firm Initiates an Investigation Involving Possible Securities Fraud Violations by Officers of Biomea Fusion, Inc.

NEW YORK , July 10, 2023 /PRNewswire/ -- Attention Biomea Fusion, Inc. ("Biomea Fusion") (NASDAQ: BMEA) shareholders: The Law Offices of Vincent Wong announce that an investigation has commenced into Biomea Fusion and certain of its officers and directors regarding potential securities fraud. The investigation concerns, in part, the below: On June 23, 2023, Biomea Fusion presented data for its Type 2 diabetes drug candidate BMF-219 at a meeting of the American Diabetes Association.

BMEA ALERT: The Law Offices of Vincent Wong Investigate Biomea Fusion, Inc. for Potential Violations of Securities Laws

LOS ANGELES, CA / ACCESSWIRE / July 8, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Biomea Fusion, Inc. ("Biomea Fusion" or "the Company") (NASDAQ: BMEA) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

SHAREHOLDER ACTION NOTICE: The Schall Law Firm Announces it is Investigating Claims Against Biomea Fusion, Inc. and Encourages Investors with Losses to Contact the Firm

LOS ANGELES, CA / ACCESSWIRE / July 7, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Biomea Fusion, Inc. ("Biomea Fusion" or "the Company") (NASDAQ:BMEA) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTOR ACTION NOTICE: The Schall Law Firm Announces it is Investigating Claims Against Biomea Fusion, Inc. and Encourages Investors with Losses In Excess of $100,000 to Contact the Firm

A year removed from its $20 IPO of April 2021, Biomea Fusion, Inc. NASDAQ: BMEA faded into penny stock land as investors lost their appetite for high-risk biotechnology stocks. Approximately a year later, it skyrocketed more than 15 times.

Are (More) Big Gains Ahead for This Small Cap Biotech Stock?

LOS ANGELES--(BUSINESS WIRE)---- $BMEA #BMEA--The Schall Law Firm Announces it is Investigating Claims Against Biomea Fusion, Inc. and Encourages Investors with Losses to Contact the Firm.

INVESTIGATION REMINDER: The Schall Law Firm Announces it is Investigating Claims Against Biomea Fusion, Inc. and Encourages Investors with Losses to Contact the Firm

Shares of Biomea Fusion Inc. BMEA, -5.89% jumped 17% in premarket trading Monday after the clinical-stage biopharmaceutical company released new clinical data on its investigational covalent menin inhibitor for patients with type 2 diabetes. The data supports the ability of the treatment, BMF-219, to address a root cause of the disease, beta cell loss, Biomea CEO and chairman Thomas Butler said in a statement.

Biomea Fusion stock soars after release of clinical data on diabetes treatment

REDWOOD CITY, Calif., June 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 the presentation of new clinical data from the first two cohorts of patients with T2D enrolled in the Phase II portion of its ongoing Phase I/II clinical study (COVALENT-111) of BMF-219, the company's investigational oral covalent menin inhibitor.

Biomea Fusion Presents Positive Clinical Data from the Initial Cohorts of the Ongoing Phase II Study (COVALENT-111) of BMF-219 in Patients with Type 2 Diabetes Mellitus at the American Diabetes Association (ADA) 83rd Scientific Sessions; 100 mg Cohort 3 D

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 to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, today announced that it will present new clinical data from the ongoing Phase II portion of its COVALENT-111 trial, which is evaluating BMF-219 as a potential treatment for patients with type 2 diabetes, in a late-breaking poster presentation at the 2023 American Diabetes Association's (ADA's) 83rd Scientific Sessions, to be held June 23 – 26, 2023 at the San Diego Convention Center in San Diego, CA. The company will also host an in-person KOL investor event during the meeting.

Biomea Fusion to Present Late Breaking Data from Ongoing Phase II Trial, COVALENT-111, Evaluating BMF-219 in Patients with Type 2 Diabetes at ADA 2023

BMEA develops oral covalent small molecules for cancer and diabetes. Its lead asset is a menin inhibitor.

Biomea: Novel Approach To Diabetes And Cancer

REDWOOD CITY, Calif., May 02, 2023 (GLOBE NEWSWIRE) --  Biomea Fusion, Inc. (“Biomea” or “the Company”) (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, reported first quarter 2023 financial results and business highlights. “In 2023, we expect to continue to advance our clinical programs in diabetes and oncology and plan to report multiple data readouts throughout the remainder of the year, including late-breaking clinical data from COVALENT-111 at the upcoming American Diabetes Association, or ADA, Scientific Sessions,” said Thomas Butler, CEO and Chairman of Biomea. “Loss of mass and function of beta cells is an underlying cause of type 2 diabetes. There is biological precedent, reinforced by our extensive preclinical data for BMF-219, that suggests inhibiting menin may enable the proliferation, preservation, and reactivation of healthy, functional beta cells capable of producing insulin, thereby leading to long-term glycemic control in patients with type 2 diabetes. We believe that none of the currently approved therapies for diabetes adequately addresses the beta cell mass and function loss. With its intended disease-modifying mechanism of action, BMF-219 could potentially represent a monumental shift for the treatment of patients with diabetes. The initial data we reported from COVALENT-111 in the first quarter of 2023 demonstrated that after just four weeks of treatment with BMF-219, the majority of patients in our lowest dose cohorts showed HbA1c improvements, with indications of potential longer-term disease modification and control. We are excited to report additional data from COVALENT-111 to the diabetes-focused scientific community at ADA in June.”

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