fda-and-biotech News
Praxis Shares Hit Record High on FDA Breakthrough Nod for Tremor Drug
The U.S. regulator granted Breakthrough Therapy Designation to ulixacaltamide, expediting the path for a novel essential tremor treatment.
Ultragenyx Stock Craters Over 40% as Bone Drug Fails Phase 3 Trial
The disappointing result for setrusumab wiped out over $1.4 billion in market value and dealt a heavy blow to partner Mereo BioPharma, whose shares fell nearly 90%.
Mereo BioPharma Stock Plunges After Lead Drug Fails Phase 3 Trial
The company and partner Ultragenyx will halt spending on the bone drug program after it failed to reduce fracture rates in patients with osteogenesis imperfecta.
HUTCHMED Gains as China Grants Priority Review for Cancer Drug Fanregratinib
The Hong Kong-based biotech's treatment for a rare and aggressive liver cancer will receive an accelerated regulatory review, a key step toward commercialization.
J&J Shares Dip After Halting Mid-Stage Eczema Drug Study
The healthcare giant terminated its Phase 2b trial for an atopic dermatitis treatment after an interim analysis failed to show desired efficacy, a setback in a highly competitive market.
Omeros Stock Soars 80% on Landmark FDA Drug Approval
YARTEMLEA becomes the first and only therapy for a rare, life-threatening complication of stem-cell transplants, marking a pivotal win for the company.
Omeros Shares Double as FDA Approves Transplant Drug Yartemlea
The landmark approval for Yartemlea (narsoplimab) marks a major turnaround after a previous regulatory rejection in 2021.
Edgewise Soars 22% on Promising Heart Drug Safety Data
Phase 2 results for its hypertrophic cardiomyopathy drug show a key safety advantage over a recently approved competitor, boosting investor confidence.