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Biomea Fusion, Inc. - BMEA STOCK NEWS

Welcome to our dedicated page for Biomea Fusion news (Ticker: BMEA), a resource for investors and traders seeking the latest updates and insights on Biomea Fusion stock.

Biomea Fusion, Inc. (Nasdaq: BMEA) is a clinical-stage biopharmaceutical company established in 2017 by a team of experienced biotech executives. The company is committed to the discovery, development, and commercialization of innovative small molecule drugs, specifically targeting genetically defined cancers and metabolic diseases such as diabetes. Biomea Fusion leverages its proprietary FUSION™ System, which combines internal expertise with advanced computational drug design technology to create novel medicines aimed at improving patient outcomes.

Product Pipeline and Focus
Biomea Fusion's lead product candidate, BMF-219, is an orally bioavailable, potent, and selective irreversible inhibitor of menin, a crucial transcriptional regulator implicated in oncogenic signaling in various cancers. The company is actively exploring this candidate for its potential to regenerate insulin-producing beta cells to treat diabetes. The investigational BMF-219 is currently being evaluated in several clinical studies, including COVALENT-111 for Type 2 diabetes and COVALENT-112 for Type 1 diabetes. Another promising candidate, BMF-500, is targeted at acute leukemias and is in the early stages of clinical development.

Recent Achievements
2023 was a pivotal year for Biomea Fusion, marked by positive data readouts in both Type 2 diabetes and acute myeloid leukemia (AML). The company has also begun clinical trials for Type 1 diabetes, with dosing of the first patient in the U.S. in its ongoing Phase II study, COVALENT-112. This study aims to assess the safety, efficacy, and durability of BMF-219 in potentially restoring beta cell function in adults with Type 1 diabetes.

Current Projects and Future Directions
Biomea Fusion is diligently pursuing its goal to address the root causes of diseases, particularly diabetes, by focusing on regenerating beta cells to normalize blood sugar levels naturally. The company's ongoing and upcoming clinical trials, including the multi-arm COVALENT-112 and COVALENT-111, are designed to provide robust data to support future registrational studies. In 2024, Biomea Fusion plans to complete dosing and follow-up studies for over 200 patients, which will pave the way for late-stage clinical development in both Type 2 and Type 1 diabetes.

Partnerships and Collaborations
Biomea Fusion collaborates with global research institutions and clinical sites to advance its drug candidates. The company is dedicated to building strong relationships with stakeholders to expedite the development of its therapies and ultimately improve patient lives.

Visit the Biomea Fusion website and follow the company on LinkedIn, Twitter, and Facebook for more updates on their progress and upcoming milestones.

News

Biomea Fusion Presents Achievement of Minimal Residual Disease Negativity (MRD-neg) in First Complete Responder from Ongoing Phase I Study (COVALENT-101) of BMF-219 in Patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) at the 2023 ASH Annual Meeting

Rhea-AI Summary
Biomea Fusion, Inc. (Nasdaq: BMEA) presented positive clinical data for BMF-219, an investigational covalent menin inhibitor, in relapsed/refractory AML patients with menin-dependent mutations at the 65th American Society of Hematology (ASH) Annual Meeting. The clinical update at ASH showed that nearly half of the participants received prior Hematopoietic Stem Cell Transplant, and the median prior lines of therapy was 3. Out of 29 patients dosed in the Phase I of COVALENT-101, 2 Complete Responses (CRs) were observed with a mean time to response of 1.8 months. BMF-219 was generally well-tolerated with no dose-limiting toxicities observed and without treatment discontinuations due to toxicity.
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Biomea Fusion Announces Near Doubling the Percentage of Patients with Durable HbA1c Reduction in the 200 mg Dose Cohorts

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Biomea Fusion, Inc. (BMEA) announced top line data of the 200 mg dose cohorts from the ongoing Phase II clinical study (COVALENT-111) for BMF-219, a novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with the aim to cure diabetes. The 200 mg cohorts increased the percentage of patients to approximately 40% with durable HbA1c reduction of 1% or more, showing promising results in the treatment of diabetes.
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Biomea Fusion Presents Long-Term Follow-Up Data Showing Improved Glycemic Control after 22 Weeks Off Treatment in Ongoing Phase II Study (COVALENT-111) of BMF-219 in Adults with Type 2 Diabetes in a Poster Presentation at the World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)

Rhea-AI Summary
Biomea Fusion, Inc. (Nasdaq: BMEA) presented 26-week follow-up data from the COVALENT-111 study for BMF-219, an investigational covalent menin inhibitor for type 2 diabetes. The data showed improved glycemic control, increased insulin production, and expansion of beta cells in responders, with no severe adverse events reported.
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Biomea Fusion to Present Long-Term Follow-Up Data from Ongoing Phase II Study (COVALENT-111) of BMF-219 in Adults with Type 2 Diabetes and Results from Ex-Vivo Human Islet Experiments at the World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)

Rhea-AI Summary
Biomea Fusion, Inc. (Nasdaq: BMEA) announced the presentation of new preclinical and clinical data for BMF-219, an investigational menin inhibitor aiming to regenerate insulin-producing beta cells to cure diabetes. The data showed a sustained HbA1C reduction of ≥0.5% and ≥1.0% in 40% and 20% of patients, respectively, 22 weeks after the last dose. BMF-219 was generally well tolerated, displaying glucose-controlled beta cell proliferation in a preclinical ex-vivo human islet model. Biomea will also host a symposium at the 21st WCIRDC, presenting additional data on BMF-219's potential as a disease-modifying agent in type 2 diabetes.
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Biomea Fusion Announces Health Canada Clearance of Clinical Trial Application (CTA) for BMF-219 in Type 1 Diabetes

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Biomea Fusion, Inc. (Nasdaq: BMEA) has received clearance from Health Canada to initiate COVALENT-112, a Phase II clinical trial of BMF-219, a novel investigational covalent menin inhibitor, in adults living with type 1 diabetes. The trial will examine the safety, efficacy, and durability of BMF-219 at two oral dose levels, 100 mg and 200 mg, for 12 weeks of treatment followed by a 40-week off-treatment period. The trial will also include an open label portion, enrolling participants in the US and Canada with T1D up to 15 years since diagnosis.
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Biomea Fusion Announces Acceptance of Three Abstracts for its Novel Menin Inhibitor Highlighting Durable Glycemic Control in Diabetes Patients at the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in 2024

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Biomea Fusion, Inc. (BMEA) announces the acceptance of three abstracts presenting new clinical data from the ongoing escalation portion of its COVALENT-111 trial, evaluating BMF-219 as a potential treatment for people with type 2 diabetes at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD). The new clinical data from all dosing cohorts initiated to date from the escalation portion of COVALENT-111 will be featured during a Poster Discussion Presentation and two Poster Viewing Presentations at ATTD.
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Biomea Fusion Abstract “BMF-219: A Novel Therapeutic Agent to Reestablish Functional Beta Cells and Provide Long-term Glycemic Control" Selected as One of Six Oral Presentations at 21st World Congress Insulin Resistance, Diabetes & Cardiovascular Disease

Rhea-AI Summary
Biomea Fusion, Inc. (Nasdaq: BMEA) announced that its investigational novel covalent menin inhibitor, BMF-219, will be presented at the 21st World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) meeting. The company will share topline data results of the escalation portion of COVALENT-111, a Phase I/II study designed to regenerate insulin-producing beta cells to cure diabetes.
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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)

Rhea-AI Summary
Biomea Fusion, Inc. (Nasdaq: BMEA) announced the acceptance of abstract showing long-term 26 weeks follow-up data of the first 20 patients from the first two dosing cohorts of COVALENT-111 for the 2023 Poster Session of the 21st World Congress Insulin Resistance, Diabetes & Cardiovascular Disease. The company also revealed that topline data for the escalation portion of COVALENT-111 will be presented prior to year-end, including multiple BMF-219 dosing cohorts. The announcement includes the company's dedication to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases.
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Biomea Fusion Announces Two Poster Presentations at Upcoming ASH Annual Meeting 2023

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Biomea Fusion, Inc. announced that abstracts related to its investigational drugs, BMF-219 and BMF-500, have been accepted for presentation at the upcoming American Society of Hematology (ASH) Annual Meeting. BMF-219 is a covalent menin inhibitor being evaluated in multiple liquid and solid tumors, while BMF-500 is a covalent FLT3 inhibitor being studied in acute leukemias. The company reported positive preliminary Phase 1 data from the COVALENT-101 trial of BMF-219, showing two complete responses in acute myeloid leukemia patients with menin-dependent mutations. The clinical trials for both drugs are ongoing.
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Biomea Fusion Reports Third Quarter 2023 Financial Results and Corporate Highlights

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Biomea Fusion, Inc. reported positive results from its ongoing Phase II study in type 2 diabetes, with 84% of patients showing a reduction in HbA1c after 4 weeks of dosing. The expansion portion of the study is now enrolling participants. The company also received clearance for a Phase II clinical trial of BMF-219 in type 1 diabetes. In addition, Biomea dosed the first patient with BMF-500, its novel oral covalent inhibitor of FLT3, in relapsed/refractory AML. The company reported initial data from a Phase I trial of BMF-219 in relapsed/refractory AML, showing 2 complete responses out of 5 patients. Biomea also announced the appointment of a new Chief Medical Officer and had a cash position of $199.5 million at the end of Q3 2023.
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FAQ

What is the current stock price of Biomea Fusion (BMEA)?

The current stock price of Biomea Fusion (BMEA) is $4.23 as of December 20, 2024.

What is the market cap of Biomea Fusion (BMEA)?

The market cap of Biomea Fusion (BMEA) is approximately 147.9M.

What does Biomea Fusion, Inc. specialize in?

Biomea Fusion focuses on the discovery, development, and commercialization of innovative small molecule drugs to treat genetically defined cancers and metabolic diseases like diabetes.

What is BMF-219?

BMF-219 is an investigational orally bioavailable, potent, and selective irreversible inhibitor of menin, aimed at treating cancers and regenerating beta cells to potentially cure diabetes.

What are the key clinical trials Biomea Fusion is conducting?

Biomea Fusion is conducting several clinical trials including COVALENT-111 for Type 2 diabetes and COVALENT-112 for Type 1 diabetes, to evaluate the safety, efficacy, and durability of BMF-219.

What significant achievements has Biomea Fusion made recently?

Biomea Fusion has reported positive data in both Type 2 diabetes and AML, initiated clinical trials for Type 1 diabetes, and dosed the first patient in the U.S. in its ongoing Phase II study, COVALENT-112.

What makes Biomea Fusion's approach unique?

Biomea Fusion utilizes its proprietary FUSION™ System to combine internal expertise and computational drug design technology, aiming to develop next-generation covalent-binding small molecule medicines with higher efficacy and target selectivity.

How does BMF-219 aim to treat diabetes?

BMF-219 aims to regenerate insulin-producing beta cells, potentially restoring their function and allowing patients to naturally regulate blood glucose levels without chronic treatment.

What is the FUSION™ System?

The FUSION™ System is Biomea Fusion’s proprietary platform used to discover, design, and develop covalent-binding small molecule medicines aimed at maximizing clinical benefits for patients.

What are Biomea Fusion's future plans for its clinical programs?

Biomea Fusion plans to complete dosing and follow-up studies for over 200 patients in 2024, paving the way for late-stage clinical development and future registrational studies in diabetes and oncology.

Who founded Biomea Fusion, Inc.?

Biomea Fusion was founded in 2017 by a group of experienced biotech executives committed to developing innovative and precise therapies for patients.

Where can I find more information about Biomea Fusion's progress?

You can visit Biomea Fusion’s official website and follow them on LinkedIn, Twitter, and Facebook for the latest updates and corporate milestones.

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Biomea Fusion, Inc.

Nasdaq:BMEA

BMEA Rankings

#4117 Ranked by Market Cap
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BMEA Stock Data

147.85M
27.17M
25.02%
64.54%
25.96%
Biotechnology
Pharmaceutical Preparations
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