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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.
Biomea Fusion, a clinical-stage biopharmaceutical company focused on developing novel covalent small molecules, announced its participation in the H.C. Wainwright Global Investment Conference. The event will be held virtually, and Biomea will engage in 1x1 meetings organized by the conference. The company aims to target genetically defined cancers and metabolic diseases using its proprietary FUSION™ System to enhance therapeutic efficacy.
Biomea Fusion has announced its investigational product candidate, BMF-500, a third-generation covalent FLT3 inhibitor showcasing picomolar IC50 values against FLT3 isoforms, likely becoming the most potent inhibitor in its category. Initial in vivo studies have shown complete tumor regression in mouse models, indicating potential efficacy in treating acute myeloid leukemia (AML). BMF-500 is developed in-house through Biomea's proprietary FUSION™ System and may synergize with BMF-219, enhancing treatment options for AML patients with FLT3 mutations.
Biomea Fusion reported a net loss of $16.4 million for Q1 2022, up from $5.9 million in Q1 2021. R&D expenses surged to $11.4 million, up from $3.8 million, due to increased personnel and clinical costs for BMF-219, a novel covalent menin inhibitor. The company holds a cash position of $165.6 million. The COVALENT-101 study expands enrollment to include DLBCL and MM patients, while preclinical data supporting BMF-219's efficacy will be presented at ASCO and ADA Scientific Sessions.
Biomea Fusion (Nasdaq: BMEA), a clinical-stage biopharmaceutical company, announced that CEO Thomas Butler will participate in a fireside chat at the Bank of America Securities 2022 Healthcare Conference. This event will occur on May 11, 2022, at 4:00 PM Pacific Time. Investors can access a live webcast of the chat, which will be available for 90 days post-presentation. Biomea Fusion focuses on developing covalent small molecules targeting genetically defined cancers and metabolic diseases, aiming to enhance treatment efficacy and patient outcomes.
Biomea Fusion, a clinical-stage biopharmaceutical company, announced the acceptance of two abstracts for the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. These abstracts focus on the preclinical activity of the irreversible Menin inhibitor, BMF-219, in chronic lymphocytic leukemia (CLL), and details of the ongoing COVALENT-101 Phase I trial involving BMF-219 for various blood cancers. The ASCO meeting will take place from June 3-7, 2022, in Chicago, IL. Biomea aims to develop covalent small molecules targeting genetically defined cancers.
Biomea Fusion, Inc. (Nasdaq: BMEA) presented promising data for its covalent menin inhibitor, BMF-219, at the AACR Annual Meeting. The drug showed significant cytotoxic activity in various preclinical models, including diffuse large B-cell lymphoma and multiple myeloma. BMF-219 demonstrated superior potency compared to existing KRAS inhibitors, achieving over 90% growth inhibition in multiple cell lines. A Phase I study (COVALENT-101) is currently enrolling patients with relapsed/refractory cancers, indicating potential for treating significant unmet needs in oncology.
Biomea Fusion (Nasdaq: BMEA) announced acceptance of a late-breaking abstract detailing preclinical data from an in vivo study of BMF-219, aimed at treating type 2 diabetes, for presentation at the American Diabetes Association's 82nd Scientific Sessions, taking place June 3-7, 2022, in New Orleans. The company focuses on developing covalent small molecules for genetically defined cancers and metabolic diseases, which may offer advantages over conventional drugs. Further details on the presentation will be disclosed following ADA's embargo policies.
Biomea Fusion, a clinical-stage biopharmaceutical company, announced its participation in the Oppenheimer 32nd Annual Virtual Healthcare Conference on March 16, 2022. CEO Thomas Butler will engage in a fireside chat at 7:00 AM Pacific Time. The company focuses on developing novel irreversible covalent small molecules aimed at treating genetically defined cancers and metabolic diseases. They utilize their proprietary FUSION™ System to advance therapeutic agents targeting key oncogenic drivers.
Investors can access the audio webcast on the company's website in the Investor Relations section.
Biomea Fusion announced the acceptance of its abstract for presentation at the upcoming American Diabetes Association Scientific Sessions, scheduled for June 3-7, 2022. The presentation will focus on preclinical data for BMF-219, a novel treatment for type 2 diabetes. The company plans to initiate a Phase I/II clinical trial of BMF-219 in the second half of 2022, pending IND application clearance. Biomea aims to develop irreversible small molecules to treat genetically defined cancers and metabolic diseases, and sees significant potential in BMF-219 as an oral treatment for diabetes.
Biomea Fusion announced promising preclinical results for its lead program, BMF-219, an irreversible covalent menin inhibitor, at the AACR Annual Meeting 2022. The data showed high potency and complete growth inhibition in high-grade B-cell lymphoma and multiple myeloma patient-derived models. BMF-219 also demonstrated strong efficacy in various KRAS-mutant cancers, showcasing advantages over the KRAS-targeted inhibitor sotorasib. Biomea plans to enroll patients in clinical trials for multiple myeloma and diffuse large B-cell lymphoma in 2022, with an IND submission for KRAS-mutant tumors anticipated by Q4 2022.
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