VAX-31 Meets Phase 3 Goals, Putting Vaxcyte’s 31-Strain Pneumococcal Shot on a 2028 Filing Path
Vaxcyte shares surged after VAX-31 met adult Phase 3 goals versus Prevnar 20 and Capvaxive. A BLA filing is targeted for the first half of 2028.
/ 48 items
#PFE↓
Lisraya Wins FDA Approval as First Major Treatment Advance in Decades for Dermatomyositis
Newly approved Lisraya could become a blockbuster. J.P. Morgan calls dermatomyositis highly attractive and sees $2B+ U.S. peak sales.
Valneva’s Lyme Disease Vaccine Candidate Clears Key EMA Hurdle
Valneva shares surge after EMA validates its Lyme disease vaccine candidate developed with Pfizer. Phase 3 trial showed over 70% efficacy.
Celcuity’s Revtorpyk Gets FDA Nod, Delivering Strong Results in PIK3CA Wild-Type Breast Cancer
The new treatment, given with fulvestrant with or without palbociclib, nearly quadrupled progression-free survival versus standard therapy.
Sangamo Therapeutics Files for Chapter 11 Bankruptcy, Strikes Asset Deals with Eli Lilly and Astellas
The deals cover key gene therapy platforms and the Fabry disease program in a court-supervised auction.
No Efficacy or Safety Issues: Achieve Life Sciences Gets FDA CRL for Cytisinicline
Achieve Life Sciences received an FDA Complete Response Letter for its cytisinicline NDA due to manufacturing issues at a former facility. No efficacy or safety deficiencies were identified.