Biomea Fusion, Inc. - BMEA STOCK NEWS

Biomea Fusion (Nasdaq: BMEA), a biopharmaceutical company, announced investor meetings and events scheduled for March 2023. Highlights include a virtual fireside chat focusing on Type 2 diabetes treatment options on March 2 at 12:00 PM (EST) with Oppenheimer & Co. and participation in the Barclays Global Healthcare Conference on March 14, featuring a fireside chat at 4:35 PM (EST) and 1x1 meetings. Another chat is set for Oppenheimer’s 33rd Annual Healthcare Conference on March 15 at 11:20 AM (EST). Webcasts will be available on Bioema's investor page, with replays after the events.

Biomea specializes in covalent small molecules targeting genetically defined cancers and metabolic diseases.

Biomea Fusion has initiated the COVALENT-102 trial, a Phase I/Ib study of BMF-219, the first menin inhibitor targeting KRAS-mutated cancers, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC). BMF-219 has shown potential to treat a significant percentage of these cancer patients, addressing an unmet medical need. The company aims to explore BMF-219's efficacy in patients who haven't responded to existing therapies. Given KRAS mutations' prevalence in these cancers, successful outcomes could substantially impact treatment options and market dynamics for BMEA, providing a promising outlook for investors.

Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company, will showcase its corporate progress and milestones at the 41st Annual J.P. Morgan Healthcare Conference on January 11, 2023. CEO Thomas Butler highlighted the ongoing development of the clinical pipeline, including three trials for BMF-219 across eight cancer indications and Type 2 diabetes. The company anticipates initial clinical data from its Phase I/Ib studies within the first half of 2023, as well as advancing BMF-500 into the clinic. Live webcasts of the presentation will be available on Biomea’s website.

Biomea Fusion, Inc. (BMEA) has initiated the Phase II trial of COVALENT-111, evaluating BMF-219, a covalent menin inhibitor aimed at type 2 diabetes treatment. Following FDA IND clearance, the trial is now enrolling patients in a randomized, placebo-controlled study. BMF-219 may restore healthy beta cells in the pancreas, crucial for insulin production. Initial Phase II data is anticipated in the first half of 2023, potentially establishing a new treatment approach that could reduce dependence on insulin therapy.

Biomea Fusion (Nasdaq: BMEA) has received FDA clearance for its IND application for BMF-219, enabling the expansion of the COVALENT-111 study to U.S. sites. The trial evaluates BMF-219’s efficacy in treating type 2 diabetes by restoring beta cell health. The Phase I portion has been completed, showing a favorable safety and pharmacokinetics profile. Initial Phase II data is anticipated in the first half of 2023. Management will discuss the study during a conference call on December 15, 2022, at 4 PM EST, highlighting the significance of menin inhibition in diabetes treatment.

Biomea Fusion, Inc. (BMEA) has presented promising preclinical data for BMF-500, a novel covalent FLT3 inhibitor, at the 64th ASH Annual Meeting. BMF-500 exhibits picomolar affinity for FLT3 mutations and demonstrates multi-fold higher potency compared to gilteritinib. In mouse models, it led to complete tumor regression in FLT3-ITD acute myeloid leukemia, maintaining effects without continuous exposure. Biomea plans to file an IND for BMF-500 in H1 2023 and aims to initiate clinical trials soon thereafter.

Biomea Fusion, a clinical-stage biopharmaceutical company focused on covalent small molecules for genetically defined cancers and metabolic diseases, will participate in the Piper Sandler 34th Annual Healthcare Conference. This event will take place in New York, NY, on November 29, 2022, with a fireside chat scheduled for 3:30 PM ET. Investor meetings are also planned for the same day. A webcast of the fireside chat will be available on Biomea’s investor page, providing insights into their innovative therapies and development strategies.

Biomea Fusion reported its third quarter 2022 financial results, highlighting significant advancements in its clinical pipeline. The company is expanding the clinical development of BMF-219, its lead covalent menin inhibitor, now enrolling in multiple trials for liquid and solid tumors, including KRAS-mutated cancers. The cash position stood at $133.8 million. However, Biomea noted a rising net loss of $22.9 million in the quarter, up from $12.6 million in Q3 2021, primarily due to increased R&D expenses.

Biomea Fusion reported promising preclinical findings for BMF-500, its investigational covalent FLT3 inhibitor, highlighting its potential as the most potent and selective FLT3 inhibitor to date. Key results indicate that BMF-500 achieves greater cytotoxicity in acute myeloid leukemia (AML) cell lines compared to gilteritinib, and demonstrates sustained FLT3 inhibition, leading to complete tumor regression in mouse models. With around one-third of AML patients affected by FLT3 mutations, the company aims to file an IND for BMF-500 in early 2023, potentially enhancing treatment options in this critical area.