Madrigal Pharmaceuticals faces an August 14 PDUFA date for resmetirom — the first-ever drug for MASH/NASH. A 30-year hunt for a fatty liver disease treatment comes down to one FDA decision.
July 22, 2026 · Rare Disease · $MDGLVertex Pharmaceuticals' suzetrigine (VX-548) has an August 30 PDUFA date. If approved, it would be the first new class of acute pain medication in 25 years — and the first non-opioid to match opioid efficacy.
July 21, 2026 · Rare Disease · $VRTXModerna's personalized cancer vaccine (mRNA-4157, combined with Keytruda) showed a 44% reduction in recurrence-free survival in melanoma. Phase 3 is underway. An November 15 PDUFA could make it the first approved mRNA cancer vaccine.
July 20, 2026 · mRNA · $MRNABiotech companies are experts at spinning trial data. Here's how to read past the headline and find the numbers that actually matter — primary endpoint, p-value, confidence intervals, and the fine print.
July 19, 2026 · GuideCRISPR Therapeutics' CTX112 — a next-gen CAR-T for B-cell malignancies — has a September 12 PDUFA date. Enhanced potency and manufacturing could differentiate it from first-gen CAR-T therapies.
July 18, 2026 · Gene Therapy · $CRSPAlnylam's nucapsiran — an RNAi therapeutic targeting angiotensinogen — showed sustained blood pressure reduction with quarterly dosing. Phase 2 data in Q4 2026 could position it as the first RNAi drug for hypertension.
July 17, 2026 · Rare Disease · $ALNYGilead's lenacapavir showed 100% efficacy in HIV PrEP (prevention) in the PURPOSE 2 trial. Twice-yearly dosing could transform HIV prevention. Phase 3 data expected in Q4 2026.
July 16, 2026 · Infectious Disease · $GILD