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Biomea, FDA and type 2 diabetes
Biomea’s stock bounces back as FDA lifts clinical hold on diabetes trials
The US FDA placed a full clinical hold on two diabetes trials for Biomea’s menin inhibitor after reports of liver toxicity.
FDA Removes Clinical Hold On Biomea Fusion's Early-Stage Trials For Potential Diabetes Candidate
FDA has lifted the clinical hold on Biomea Fusion's BMF-219 trials for type 1 and type 2 diabetes following a safety review, allowing the ongoing studies to resume.
US FDA lifts clinical hold on Biomea’s diabetes trials after safety review
The drug BMF-219 works by increasing, preserving and reactivating patients’ own healthy insulin-producing cells. Read more at straitstimes.com.
Biomea upgraded by analysts after FDA lifts clinical hold
Biomea Fusion (NASDAQ:BMEA) has received two analyst upgrades along with bullish comments from three other firms in the wake of Thursday’s news that the FDA has lifted a clinical hold on a Phase 1/2 study of its drug BMF-219 for the treatment of type 1 and type 2 diabetes.
BMEA Stock Up 9% as FDA Lifts Clinical Hold on 2 Diabetes Studies
Biomea stock rises 9% after the FDA lifts clinical hold on two phase I/II studies evaluating the company's lead candidate, BMF-219, for diabetes.
FDA lifts hold on diabetes trials after Biomea mitigates liver toxicity risk
Biomea Fusion has escaped from the full clinical hold imposed by the FDA. | Biomea Fusion has escaped from the full clinical hold imposed by the FDA. After reviewing the data, the regulator has cleared Biomea to study its diabetes drug candidate under a revised protocol intended to mitigate liver toxicity concerns.
FDA Lifts Clinical Hold on BMF-219 in Type 2 and Type 1 Diabetes Trials
This trial also includes an open-label portion for adults with type 1 diabetes up to 15 years since diagnosis. The open-label portion (n=40) is examining the efficacy, safety, and durability of BMF-219 at two oral dose levels, 100 mg and 200 mg over 12-week treatment followed by a 40-week off treatment period.
Biomea Fusion: FDA Lifts Hold on Diabetes-Treatment Trials
Biomea Fusion said the Food and Drug Administration lifted its clinical hold on continuing clinical trials of the company's diabetes drug.
Biomea Fusion, Inc.: FDA Lifts Clinical Hold on BMF-219 in Type 2 and Type 1 Diabetes Trials
Biomea Fusion, Inc. ("Biomea" or the "Company") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing
Biomea Fusion : FDA Lifts Clinical Hold On BMF-219 For Type 1 And Type 2 Diabetes Trials; Stock Up
Biomea Fusion Inc. (BMEA) announced that the U.S. Food and Drug Administration has lifted the clinical hold on the company's ongoing
US FDA lifts clinical hold on Biomea's diabetes trials
Biomea Fusion said on Thursday the U.S. Food and Drug Administration lifted a clinical hold on ongoing studies of its experimental drug for type 1 and 2 diabetes, sending its shares up 6.9%. The decision comes as a boon for the company as the regulator placed a hold on two trials of its lead drug,
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Buy Rating Affirmed for Biomea Fusion with Promising BMF-219 Clinical and Regulatory Developments
Joseph Pantginis, an analyst from H.C. Wainwright, maintained the Buy rating on Biomea Fusion (BMEA – Research Report). The associated ...
9h
IonQ, Biomea Fusion, Rocket Lab USA And Other Big Stocks Moving Higher On Friday
Biomea Fusion, Inc. BMEA shares jumped 15.5% to $11.05. Biomea Fusion disclosed that the FDA lifted its clinical hold on ...
9h
Wynn Resorts upgraded, HP Inc. downgraded: Wall Street's top analyst calls
UBS upgraded Certara (CERT) to Buy from Neutral with an unchanged price target of $16. The firm has increased conviction that ...
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