Biomea Fusion, Inc. Stock Price, News & Analysis

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.

Biomea Fusion, a clinical-stage biopharmaceutical company focused on innovative cancer treatments, announced its participation in the 40th Annual J.P. Morgan Healthcare Conference. CEO Thomas Butler will present on January 12, 2022, at 12:00 PM PT. The presentation will highlight Biomea's proprietary FUSION™ platform, aimed at developing irreversible small molecules for genetically defined cancers, offering potential advantages such as greater selectivity and durability. A live audio webcast will be available on the company's website for 30 days post-presentation.

Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company focused on irreversible small molecules for genetically defined cancers, has been added to the NASDAQ Biotechnology Index, effective December 20, 2021. This index includes NASDAQ-listed companies in the Biotechnology and Pharmaceuticals sectors that meet specific criteria. Biomea’s proprietary FUSION™ discovery platform aims to enhance treatment selection, potentially improving patient outcomes through more selective and durable drug responses.

Biomea Fusion, a clinical-stage biopharmaceutical company (Nasdaq: BMEA), announced participation in two virtual conferences. CEO Thomas Butler will present at the Jefferies London Healthcare Conference on November 18 at 3:00am ET and at the Piper Sandler 33rd Annual Virtual Healthcare Conference on November 22 at 10:00am ET. Biomea will also conduct 1x1 investor meetings during these events. The company is advancing BMF-219, an irreversible inhibitor targeting genetically defined leukemias, into a first-in-human trial.

Biomea Fusion announced the publication of preclinical data for its irreversible menin inhibitor, BMF-219, in the journal Blood. The study showed that BMF-219 disrupts menin globally, yielding potent efficacy against diffuse large B cell lymphoma (DLBCL) cell lines, achieving over 90% cell viability reduction at low dosages. The mechanism involves modulation of MYC expression, with BMF-219 demonstrating a strong impact on MYC-dependent malignancies. Plans for clinical trials in relapsed or refractory acute leukemia patients are underway.

Biomea Fusion (BMEA) announced FDA clearance for its Investigational New Drug Application (IND) for BMF-219, targeting relapsed or refractory acute leukemia. The Phase I trial enrollment will include patients with MLL/KMT2A rearrangements or NPM1 mutations. The company plans to explore BMF-219’s use in diffuse large B cell lymphoma and multiple myeloma. Biomea opened the Biomea Innovation Research Center to enhance R&D efforts. Financially, Biomea reported a net loss of $26.9 million for the first nine months of 2021, with R&D expenses rising significantly to $16.9 million.

Biomea Fusion has announced the initiation of its first-in-human (FIH) clinical trial for BMF-219, an irreversible menin inhibitor targeting relapsed or refractory acute leukemia. The FDA has cleared the Investigational New Drug application for this Phase I trial, which aims to evaluate safety and efficacy in a challenging patient population, including those with MLL/KM2TA rearrangements or NPM1 mutations. The company asserts that the aggressive nature of acute leukemia presents a significant unmet need, providing a strong rationale for its novel therapeutic approach.

Biomea Fusion (BMEA) has achieved significant milestones with its lead program, BMF-219, an irreversible menin inhibitor. The company has completed IND-enabling studies and plans to submit the IND for a Phase I/II study targeting menin-dependent acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) in the latter half of 2021. Financially, Biomea reported a net loss of $14.3 million for the first half of 2021 and increased R&D expenses of $9.0 million. As of June 30, 2021, the company holds $203 million in cash and equivalents to support ongoing initiatives.