Biomea Fusion, Inc. Stock Price, News & Analysis

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.

Biomea Fusion (BMEA) reported a net loss of $41.6 million for 2021, significantly up from $5.3 million in 2020, driven by increased R&D and G&A expenses. Research and development expenses soared to $28.0 million, primarily due to costs associated with BMF-219, an irreversible covalent menin inhibitor currently in a Phase I trial. The company plans to expand trials for BMF-219 into seven cancers and diabetes, anticipating a second clinical candidate announcement in mid-2022. As of year-end 2021, cash and equivalents totaled $175.7 million, supporting future initiatives.

Biomea Fusion has appointed Dr. Steve Morris as Chief Medical Officer, who previously served as a consultant since 2020. He will lead the clinical development of BMF-219, an irreversible covalent menin inhibitor currently in a Phase I trial aimed at treating patients with specific acute leukemias. Biomea plans to expand clinical studies for BMF-219 into seven tumor types and diabetes. Dr. Morris' extensive research background includes significant contributions to the understanding of oncogenes like ALK, enhancing the company's clinical prospects in oncology.

Biomea Fusion (Nasdaq: BMEA) has initiated a Phase I clinical trial for BMF-219, the first irreversible covalent menin inhibitor aimed at treating relapsed/refractory acute leukemias. The trial involves enrolling patients with MLL1/KMT2A gene rearrangements or NPM1 mutations across 20 clinical sites in the U.S. This milestone marks Biomea's transition to a clinical stage company, with expectations for further pipeline candidates to be announced soon. Biomea aims to leverage its FUSION™ System for developing targeted therapies in oncology and metabolic diseases.

Biomea Fusion (Nasdaq: BMEA), a clinical-stage biopharmaceutical company, announced its participation at the H.C. Wainwright BioConnect Conference held from January 10-13, 2022. CEO Thomas Butler will provide a corporate update during a fireside chat. The company is focused on developing irreversible small molecules for treating genetically defined cancers and metabolic diseases, utilizing its proprietary FUSION™ discovery platform. This innovative approach aims to offer significant advantages in drug efficacy and patient outcomes.

Biomea Fusion (BMEA) plans to initiate clinical studies for its irreversible covalent menin inhibitor, BMF-219, targeting seven cancer indications and diabetes in 2022. The company aims to file an Investigational New Drug (IND) application within 12 months for their second program. BMF-219 has shown promising results in preclinical studies, effectively inhibiting menin-dependent oncogenic signaling and normalizing glucose levels in diabetic models. Clinical trials for liquid tumors and diabetes are set to commence in 2022, reflecting Biomea's strategic focus on novel treatments for genetically defined cancers.

Biomea Fusion (Nasdaq: BMEA) announced that its irreversible menin inhibitor, BMF-219, demonstrated significant efficacy in animal models for type 2 diabetes. In studies using Zucker Diabetic Fatty rats and Streptozotocin-Induced Diabetes models, BMF-219 normalized glucose levels in most subjects after two weeks. These effects persisted even post-treatment, indicating the compound's potential as a groundbreaking diabetes treatment. Biomea plans to discuss the next steps, including a Phase 1/2 clinical trial, with regulators this quarter, showcasing the promising capabilities of BMF-219 in addressing Beta-cell dysfunction.

Biomea Fusion, Inc. (Nasdaq: BMEA) has relocated its headquarters to a new 27,000 sq. ft. facility in Redwood City, California, enhancing its operational capabilities. The move supports the company’s growth initiatives for 2022 and beyond. Additionally, Biomea is expanding its R&D Innovation Center by 18,000 sq. ft., expected to be complete in the second half of 2022, to focus on biology, medicinal chemistry, and drug research. Biomea is committed to developing irreversible small molecules for treating genetically defined cancers, aiming to be a leader in this field.