fda-and-biotech News
Immunome surges on Phase 3 trial success despite earnings miss
Varegacestat shows 84% disease progression reduction in desmoid tumors, NDA filing planned for Q2 2026
Scholar Rock falls 1.8% after Q4 loss exceeds estimates
Biotech maintains $367M cash position as BLA resubmission slated for 2026
Dyne shares surge on dystrophin data, BLA timeline
Positive DELIVER trial results show 5.46% dystrophin expression, regulatory submission on track for Q2 2026
Rhythm shares surge as setmelanotide shows 18.8% BMI reduction in obesity trial
Phase 3 TRANSCEND data supports potential first therapy for acquired hypothalamic obesity with March 20 FDA decision looming
Ascendis surges on FDA approval of first once-weekly achondroplasia drug
YUVIWEL's accelerated approval marks competitive milestone against BioMarin's daily treatment in rare disease market
Janux Therapeutics beats EPS estimates on $966M cash position
Biotech company reports narrower-than-expected loss, advances Bristol Myers Squibb collaboration and TRACTr platform programs
Celldex shares rise 2% as Phase 3 study completes ahead of schedule
Barzolvolimab targets $7.6bn chronic spontaneous urticaria market with topline data due Q4 2026
Pulse Biosciences surges 80% on FDA approval for atrial fibrillation study
Regulatory milestone for nanosecond pulsed field ablation technology drives stock to near 52-week high despite earnings miss