FDA Grants Platform Technology Tag to Sarepta's Gene Therapy Vector

Key Takeaways FDA grants platform tech designation to SRPT's rAAVrh74 viral vector used in SRP-9003 The tag lets Sarepta reuse clinical and manufacturing data across other rAAVrh74-based therapies. SRP-9003 is in a phase III trial for LGMD2E/R4; data expected later this month.Sarepta Therapeutics (SRPT) announced that the FDA has granted platform-technology designation to its viral vector rAAVrh74, used in the investigational gene therapy SRP-9003. This therapy is being evaluated in a late-stage study for ...