FDA Rejects Replimune’s Skin Cancer Drug for the Second Time
FDA again rejects Replimune’s skin cancer drug RP1, saying studies don’t prove it works; shares halted, setback for company.
/ 194 items
#XY Event-Driven Stocks↓
FDA Accepts Telix Pixclara NDA: Brain Cancer Imaging Tool on Track for September 2026 Decision
Telix’s Pixclara brain cancer scan got FDA review accepted. It helps detect tumors vs treatment effects. Decision due 2026.
Invivyd Drops Major Update: COVID Study on Track + New Measles Super-Antibody Discovered
Invivyd just announced major progress on its COVID-19 prevention study and a potential first-in-class measles antibody (VMS063).
MacroGenics’ LINNET Trial Back on Track After FDA Removes Partial Hold
FDA lifted hold on MacroGenics’ cancer study. New patients can join again; drug helps immune system fight tough ovarian cancers.
Assertio Agrees to $125 Million All-Cash Buyout by Garda Therapeutics
Assertio is being bought by Garda for $18/share + possible bonus if Sprix hits goals; deal closes June 2026, company goes private.
Plus Therapeutics Stock Jumps After FDA Orphan Drug Win for Kids’ Rare Brain Tumors
Plus Therapeutics’ REYOBIQ gets FDA orphan drug status for rare kids’ brain tumors.