FDA Removes Clinical Hold On Biomea Fusion's Early-Stage Trials For Potential Diabetes Candidate [Yahoo! Finance]
Biomea Fusion, Inc. (BMEA)
Company Research
Source: Yahoo! Finance
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,
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BMEA
News
- Biomea Fusion, Inc. (NASDAQ: BMEA) had its price target raised by analysts at Scotiabank from $21.00 to $41.00. They now have a "sector outperform" rating on the stock.MarketBeat
- Biomea Fusion, Inc. (NASDAQ: BMEA) had its price target raised by analysts at HC Wainwright from $15.00 to $40.00. They now have a "buy" rating on the stock.MarketBeat
- Biomea Fusion, Inc. (NASDAQ: BMEA) had its price target raised by analysts at Barclays PLC from $5.00 to $9.00. They now have an "equal weight" rating on the stock.MarketBeat
- Biomea Fusion, Inc. May Have Violated Securities Laws And The Schall Law Firm Urges Affected Shareholders To Join An Inquiry Accesswire
- Biomea Fusion, Inc. (NASDAQ: BMEA) was upgraded by analysts at Truist Financial Co. from a "hold" rating to a "buy" rating. They now have a $54.00 price target on the stock.MarketBeat
BMEA
Earnings
- 7/31/24 - In-Line
BMEA
Sec Filings
- 9/27/24 - Form 8-K
- 7/31/24 - Form 10-Q
- 7/31/24 - Form 8-K
- BMEA's page on the SEC website