Biomea Fusion (NASDAQ:BMEA) stock is falling hard on Friday after announcing a clinical hold has been put on its Phase I/II clinical trials of BMF-219.
This clinical hold comes from the Food and Drug Administration (FDA) and has to do with safety concerns. The regulator is worried about possible drug-induced hepatotoxicity. This comes after the trials may have led to liver enzyme elevations.
BMF-219 is Biomea Fusion’s candidate for treating Type 2 and Type 1 diabetes. The company says it will continue to collect safety and efficacy data during the clinical hold.
Biomea Fusion chairman and CEO Thomas Butler said the following about this clinical hold news:
“The results to date have supported that BMF-219 is generally well-tolerated and can restore glucose-controlled insulin production and improve glycemic control. Based on the totality of the safety and efficacy data for BMF-219 in diabetes to date, we remain committed to advancing BMF-219 with its potentially transformative profile.”
How This Affects BMEA Stock Today
With today’s news comes some 500,000 shares of BMEA stock changing hands during pre-market hours. To put that in perspective, the company’s daily average trading volume is closer to 952,000 shares.
BMEA stock is down 63% as of Friday morning. The stock was also down 23.2% year-to-date when markets closed yesterday.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
