FDA Removes Clinical Hold On Biomea Fusion's Early-Stage Trials For Potential Diabetes Candidate

Friday, the FDA lifted the clinical hold on Biomea Fusion, Inc.’s BMEA ongoing Phase 1/2 clinical trials of the company’s investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112), respectively.

“The in-depth review of the clinical data to date reconfirms our confidence in BMF-219 as a novel, first-in-class agent for the treatment of diabetes,” stated Thomas Butler, Biomea Fusion’s CEO and Chairman.

“We are encouraged from the safety review of the ongoing Phase 2b Expansion Study, where the concerning safety signals seen in the Phase 2a Escalation Study did not translate over to the larger Expansion Study. And most importantly, none of the elevated lab values translated to confirmed serious liver injury or liver impairment,” Butler said.

In June, the FDA placed a clinical hold on Biomea Fusion’s Phase 1/2 trials for BMF-219.

The FDA’s decision was driven by concerns over potential drug-induced hepatotoxicity observed during the Dose Escalation Phase of the trials. Elevated liver enzyme levels were noted, although most adverse events were mild to moderate, with no severe reactions reported.

During its second-quarter earnings release, the company said data readout from COVALENT-111 Phase 2b and COVALENT-112 Phase 2a trials were on track for the fourth quarter of 2024.

Biomea Fusion Stock Prediction For 2024

Equity research analysts on and off Wall Street typically use earnings growth and fundamental research as a form of valuation and forecasting. But many in trading turn to technical analysis as a way to form predictive models for share price trajectory.

Some investors look to trends to help forecast where they believe a stock could trade at a certain point in the future. Looking at Biomea Fusion, an investor could make an assessment about a stock's long term prospects using a moving average and trend line. If they believe a stock will remain above the moving average, which many believe is a bullish signal, they can extrapolate that trend into the future using a trend line. For Biomea Fusion, the 200-day moving average sits at $11.19, according to Benzinga Pro, which is above the current price of $9.93. For more on charts and trend lines, see a description here.

Traders believe that when a stock is above its moving average, it is a generally bullish signal, and when it crosses below, it is a more negative signal. Investors could use trend lines to make an educated guess about where a stock could trade at a later date if conditions remain stable.

Price Action: BMEA stock is up 3.97% at $9.95 at the last check on Friday.

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