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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.

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, 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, 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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Biomea Fusion announces the initiation of Phase I trial for BMF-500, a covalent FLT3 inhibitor, in adult patients with relapsed or refractory acute leukemia.
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Biomea Fusion receives FDA clearance for Phase II clinical trial of BMF-219 in adults with type 1 diabetes
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Biomea Fusion has received FDA and Health Canada clearance for the expansion portion of the COVALENT-111 Phase II study, evaluating BMF-219 in type 2 diabetes patients. 84% of patients dosed with BMF-219 in the escalation portion showed a reduction in HbA1c at Week 4 and 74% at Week 12. Topline results expected in Q4 2023.
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Biomea Fusion appoints Juan Pablo Frías, M.D. as Chief Medical Officer to oversee clinical development of BMF-219 in type 2 and type 1 diabetes.
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Biomea Fusion, Inc. has announced preliminary topline data from its Phase I clinical trial, COVALENT-101, showing initial responses in relapsed/refractory AML patients with menin-dependent mutations. Two complete responses were observed in five patients treated at Dose Level 4. The safety profile of BMF-219 supports further dose escalation, and enrollment for Dose Level 5 has begun. The company plans to present additional clinical data at an upcoming conference.
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Biomea Fusion, Inc. announces positive clinical data from its Phase II study of BMF-219 in patients with type 2 diabetes. The data shows improved beta cell function and glycemic control even after treatment cessation. The company plans to explore longer treatment durations and potential utility in type 1 diabetes.
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FAQ

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

The current stock price of Biomea Fusion (BMEA) is $3.98 as of February 4, 2025.

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

The market cap of Biomea Fusion (BMEA) is approximately 145.0M.

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.
Biomea Fusion, Inc.

Nasdaq:BMEA

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144.95M
27.17M
25.02%
64.57%
33.89%
Biotechnology
Pharmaceutical Preparations
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