fda-and-biotech News
Ultragenyx Shares Soar 15% on Landmark FDA Filing for Gene Therapy
Company completes submission for DTX401, a potential first-in-class treatment for the underlying cause of the rare metabolic disorder GSDIa.
Travere Stock Soars as FDA Eases Path for Kidney Drug Filspari
Shares trade near 52-week highs after agency cancels key meeting for Filspari's review in FSGS, signaling a clearer path to approval.
Corcept CEO Exercises Options Valued at $44M Ahead of Key FDA Decisions
Joseph Belanoff's deeply in-the-money transaction signals strong insider confidence as the company's lead drug candidate, relacorilant, faces two critical approval deadlines.
Verastem Sinks 4% After Halting Lung Cancer Drug Trial
The biotech firm is discontinuing its RAMP 203 study in a competitive cancer market, pivoting resources to its next-generation KRAS G12D inhibitor.
Greenwich LifeSciences Soars 20% as Insiders Extend Stock Lock-Up
The move is seen as a powerful vote of confidence in the company's pivotal Phase III breast cancer drug trial, aligning management with long-term investors.
Mereo BioPharma Stock Collapses 89% as Bone-Drug Trial Fails
Shares were nearly wiped out after flagship drug setrusumab, developed with partner Ultragenyx, failed to meet its primary goal of reducing fractures in patients with 'brittle bone disease'.
Ultragenyx Crashes 45% as Brittle Bone Drug Fails Key Goal
The pivotal therapy, setrusumab, missed its primary endpoint of fracture reduction in a late-stage trial, erasing over $2.6 billion in market value and forcing a strategic overhaul.
Ultragenyx Plunges 43% as Bone Drug Fails Pivotal Trial
Setrusumab, a once-promising therapy for brittle bone disease, failed to reduce fractures, prompting significant restructuring and a collapse in partner Mereo BioPharma's shares.