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Investing.com - H.C. Wainwright has reiterated its Buy rating and $4.00 price target on Biomea Fusion Inc. (NASDAQ:BMEA) following the disclosure of 52-week COVALENT-111 data. According to InvestingPro data, analyst targets for BMEA range from $4 to $16, with the company currently appearing undervalued based on Fair Value analysis.
BMEA stock fell approximately 30% after the data release, while the S&P Biotech ETF (XBI) remained unchanged at market close. The firm noted that while icovamenib’s durable effect could be a "game-changer," several investor concerns have emerged.
These concerns include limited statistical power due to small patient populations in the trial arms, lack of mechanistic biomarkers to validate long-term disease-modifying potential, and complications with the T2D subtype framework used for patient selection.
Additional investor issues center around icovamenib’s incompletely understood pharmacokinetic profile and food effect, plus the need for larger, well-controlled confirmatory trials in difficult-to-treat target subpopulations and in combination with GLP-1 receptor agonists.
H.C. Wainwright highlighted that Biomea remains committed to addressing these questions and advancing icovamenib’s clinical development in Type 2 diabetes, with upcoming trials expected to provide more clarity on the drug’s clinical progress.
In other recent news, Biomea Fusion , Inc. has announced the pricing of its underwritten public offering, which is expected to generate approximately $25 million in gross proceeds. This offering includes 11,195,121 shares of common stock with accompanying warrants, and pre-funded warrants for certain investors. The pricing for each share of common stock and accompanying warrant is set at $2.05, while pre-funded warrants and accompanying warrants are priced at $2.0499. Additionally, Biomea Fusion has launched this public offering with Jefferies as the sole book-running manager, granting underwriters a 30-day option to purchase up to an additional 15% of shares and/or warrants.
In another significant development, Biomea Fusion reported 52-week results from its Phase II COVALENT-111 clinical trial, evaluating the experimental diabetes drug icovamenib. The trial involved adults with type 2 diabetes who had inadequate glycemic control despite existing treatments. Results indicated that patients who received 12 weeks of treatment maintained a 1.2% reduction in HbA1c levels at Week 52, with the strongest performing group achieving a 1.5% reduction. These results highlight sustained treatment benefits for patients with severe insulin-deficient diabetes.
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