Rocket Pharmaceuticals is trading 5.8% up now at $3.61 after announcing FDA alignment on September 15, 2026, supporting continued enrollment and dosing in its pivotal RP-A501 Phase 2 Danon disease trial.
- The FDA confirmed a 12-patient pivotal cohort and unchanged 12-month co-primary endpoints.
- Three patients have been treated under the modified protocol, with nine remaining to enroll.
- The company-specific regulatory update is the clearest catalyst behind the pre-market gain.