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H.C. Wainwright reiterated its Buy rating and $18.00 price target on Biomea Fusion Inc. (NASDAQ: BMEA) on Monday, following the company’s presentation of initial data from its Phase 1 COVALENT-103 trial at EHA 25. Currently trading at $2.36, the stock has experienced significant volatility, down 10% in the past week and nearly 60% over six months. According to InvestingPro analysis, BMEA appears undervalued based on its Fair Value assessment.
The trial evaluated BMF-500, Biomea’s covalent small molecule FLT3 inhibitor, in patients with relapsed/refractory acute leukemia with or without FLT3 mutations. According to the data presented, BMF-500 demonstrated favorable tolerability, with most efficacy-evaluable patients showing reduced bone marrow blasts, positive responses, and improved survival outcomes. With a market capitalization of $89 million and a beta of -0.25, BMEA shows low correlation with broader market movements. InvestingPro subscribers can access 12 additional key insights about BMEA’s financial health and market position.
As of May 19, 2025, the trial had enrolled 27 patients across two study arms: 10 patients not taking CYP3A4 inhibitors (Arm A) and 17 patients taking these inhibitors (Arm B). The participants had received a median of four prior lines of therapy, with 18 patients presenting FLT3 mutations and 9 with wild-type FLT3.
Patients in Arm A received BMF-500 at doses of 50 mg, 100 mg, or 150 mg twice daily in 28-day cycles, while those in Arm B received 25 mg, 50 mg, or 75 mg doses. The trial included patients with FLT3 mutations who had previously failed treatment with gilteritinib, a reversible FLT3 inhibitor.
Following a recent restructuring to focus fully on metabolic diseases, Biomea is actively exploring strategic partnerships to advance the BMF-500 program, according to H.C. Wainwright’s research note. The company maintains a healthy current ratio of 2.25 and holds more cash than debt on its balance sheet, though it’s currently unprofitable. For deeper insights into BMEA’s financial position and growth prospects, access the comprehensive Pro Research Report available exclusively on InvestingPro.
In other recent news, Biomea Fusion reported updated preliminary data from its Phase I COVALENT-103 trial involving BMF-500 in patients with relapsed or refractory acute leukemia. The trial showed promising results, with nine out of eleven efficacy-evaluable patients exhibiting a reduction in bone marrow blasts, and two achieving significant remission milestones. The company highlighted that the survival durations for treated patients compared favorably to historical data. In the financial realm, H.C. Wainwright adjusted Biomea Fusion’s stock target to $18 from $40, maintaining a Buy rating, following the company’s first-quarter earnings report. Biomea Fusion reported an EPS of ($0.80), which surpassed the firm’s estimate but did not meet the consensus estimate. The company also announced that it had $36.2 million in cash reserves, expected to last until the fourth quarter of 2025. Additionally, Biomea Fusion presented new data at the ATTD 2025 Conference, suggesting that its investigational drug icovamenib could potentially modify the progression of type 2 diabetes by improving beta-cell function. This data indicated that icovamenib might offer long-term benefits, particularly for patients with severe insulin deficiency.
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