Icovamenib shows sustained benefits for hard-to-treat diabetes patients

SAN CARLOS, Calif. - Biomea Fusion, Inc. (NASDAQ:BMEA), whose stock has recently shown strong momentum with a 25% gain over the past week, announced Monday that its experimental diabetes drug icovamenib demonstrated sustained treatment benefits in type 2 diabetes patients nine months after treatment ended, according to 52-week results from its Phase II COVALENT-111 study. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, though it’s currently operating at a loss.

The trial showed that patients with severe insulin-deficient diabetes who received 12 weeks of treatment maintained a 1.2% reduction in HbA1c (a measure of blood sugar control) through Week 52, with the strongest performing arm achieving a 1.5% reduction. While the clinical results appear promising, InvestingPro analysis indicates the company is rapidly burning through cash, with a current market capitalization of approximately $159 million.

Additionally, patients who were already on GLP-1-based therapies but failing to reach glycemic targets showed a 1.3% reduction in HbA1c that was maintained through the 52-week observation period.

"The 52-week durability in severe insulin-deficient patients is remarkable. These are the most difficult to treat patients, and no current therapy provides this kind of lasting benefit for them without chronic dosing," said Professor Ralph DeFronzo from the University of Texas Health Science Center, according to the company’s press release.

The drug was generally well tolerated with no treatment-related serious adverse events or discontinuations due to adverse events reported across all dosing arms.

Icovamenib works by inhibiting menin, a protein that regulates beta cell quantity and function. The company suggests this mechanism may enable the proliferation and preservation of insulin-producing beta cells, potentially addressing an underlying cause of type 2 diabetes.

Biomea Fusion plans to initiate Phase IIb trials in severe insulin-deficient diabetes patients and in diabetes patients on GLP-1 therapy in the fourth quarter of 2025.

The company will host a conference call to discuss these results on Tuesday. With analysts setting price targets ranging from $4 to $16 per share and four analysts recently revising earnings estimates upward, investors seeking deeper insights can access comprehensive financial analysis and 12 additional ProTips through InvestingPro’s detailed research reports.

In other recent news, Biomea Fusion has been highlighted by Jefferies, which initiated coverage with a Buy rating and set a price target of $5.00. The focus was on Biomea Fusion’s development of oral small molecule medicines aimed at treating diabetes and obesity. Additionally, Biomea Fusion announced the appointment of Julianne Averill to its Board of Directors, effective July 22, 2025. Averill will also serve on the company’s Audit Committee, replacing Bihua Chen, who stepped down after over four years on the board. These developments reflect ongoing changes within the company’s leadership and strategic direction.

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