Related coverage linked through entity extraction aliases.
Aug 07, 2026
FDA approved Viridian's Lumvoa (veligrotug-vvze) for thyroid eye disease on June 26, 2026; immediate U.S. launch followed. Q2 2026 cash stood at $982 million, and elegrobart BLA submission is on track for Q1 2027.
Jun 10, 2026
TG Therapeutics reported positive Phase 1 data for subcutaneous BRIUMVI in myasthenia gravis and started a Phase 2 trial; five-year ULTIMATE data in JAMA Neurology showed sustained MS efficacy.
Apr 05, 2026
Biotech investors are closely watching cystic fibrosis drug trials, rare-disease therapies and regulatory catalysts. Sionna Therapeutics is advancing a new CF drug class, while Praxis Precision Medicines targets essential tremor. FDA staffing challenges add uncertainty to approval timelines.
May 08, 2026
Zai Lab's Q1 2026 revenue fell 6% to $99.6 million, missing expectations, while EPS beat at -$0.05. The company highlighted Zoci intracranial response data and expects three pivotal trials by year-end 2026.
May 10, 2026
The FDA expanded efgartigimod approval to all adult generalized myasthenia gravis serotypes. Phase 3 ADAPT SERON met its primary endpoint and showed no new safety signals.
May 07, 2026
argenx reported $1.3B in Q1 2026 global product net sales (63% YoY growth). The FDA PDUFA target date for seronegative gMG is May 10, 2026. Positive ADAPT OCULUS results support an oMG label expansion. Pipeline milestones include myositis readout in Q3 2026 and MMN readout in Q4 2026.
Apr 29, 2026
Three FcRn inhibitors are approved for generalized myasthenia gravis, with a head-to-head trial of efgartigimod and nipocalimab underway. Emerging therapies including telitacicept, gefurulimab, and CAR-T cell therapy (KYV-101) show promise, while Immunovant's batoclimab failed TED trials.
Mar 17, 2026
Global orphan drug sales are forecast to reach $409 billion by 2032, representing one-fifth of prescription drug sales, with Johnson & Johnson and Argenx leading the market amid regulatory uncertainty.
