Biomea Fusion, Inc. Stock Price, News & Analysis

Biomea Fusion announced the first patient dosing in its Phase I clinical trial, COVALENT-101, evaluating BMF-219, a covalent menin inhibitor, for relapsed/refractory multiple myeloma (MM). This marks BMF-219 as the first menin inhibitor targeting MM. The trial has expanded to include cohorts for both MM and diffuse large B-cell lymphoma (DLBCL), while patient enrollment continues for acute leukemia cohorts. Approximately 35,000 new MM cases are diagnosed annually in the U.S., with a notably low 5-year survival rate of ~56% for affected patients.

Biomea Fusion has reported promising preclinical results for BMF-219, a covalent menin inhibitor, showcasing its potential in treating type 2 diabetes. In studies involving ZDF and STZ rat models, BMF-219 demonstrated significant improvements in glycemic control and reduced HbA1c levels, outperforming standard treatments like pioglitazone and liraglutide.

The company plans to initiate a Phase I/II clinical trial in the second half of 2022, contingent on IND submission and clearance, aiming to explore BMF-219's long-term efficacy in diabetes management.

Biomea Fusion, a clinical-stage biopharmaceutical company (Nasdaq: BMEA), announced CEO Thomas Butler's participation in the Jefferies Healthcare Conference on June 8, 2022, at 2:30 PM ET. The event will feature a fireside chat where Butler will discuss the company's innovative approach to developing covalent small molecules aimed at treating genetically defined cancers and metabolic diseases. A live webcast of the chat will be available for 90 days post-event at Biomea Fusion Investors.

Biomea Fusion (Nasdaq: BMEA) announced its participation in the American Diabetes Association Scientific Sessions, presenting pre-clinical data on BMF-219, a covalent menin inhibitor, as a potential treatment for type 2 diabetes. The presentations on June 5, 2022, highlighted BMF-219's significant and durable reduction in HbA1c levels in diabetic rat models, suggesting improved beta cell function and glycemic control compared to liraglutide. A virtual investor event on June 6 will further discuss BMF-219’s therapeutic prospects.

Biomea Fusion (BMEA) announced significant findings related to BMF-219, a novel menin inhibitor effective against chronic lymphocytic leukemia (CLL). In preclinical studies, BMF-219 demonstrated over 98% cell lethality across various CLL tumor models, particularly in high-risk patient samples with TP53 alterations and NOTCH1 mutations. Moreover, BMF-219 showed superior activity compared to standard treatments like bendamustine and ibrutinib. Currently, it is undergoing a Phase I trial (COVALENT-101) for multiple hematologic malignancies, highlighting its potential to address unmet clinical needs.

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.