Avidity rises as FDA eases partial clinical hold on lead asset
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- Avidity Biosciences (NASDAQ:RNA) added ~10% in the pre-market Wednesday after announcing that the FDA lifted the partial clinical hold on its lead candidate AOC 1001, allowing the company to enroll new participants for its MARINA open-label extension study.
- Avidity (RNA) expects to use the data from MARINA OLE to determine the pivotal dose and Phase 3 study design for AOC 1001 in adults with neuromuscular disease myotonic dystrophy type 1 (DM1). The company remains committed to disclose the first readout from MARINA OLE at the year-end.
- Easing the partial hold, the FDA has allowed Avidity (RNA) to double the number of enrollees on 4 mg/kg of AOC 1001 and allowed new enrollments to receive AOC 1001 at 2 mg/kg.
- In September, the agency issued a partial clinical hold on new enrollments to study AOC 1001 after a subject in the Avidity’s (RNA) Phase 1/2 MARINA trial developed a rare serious adverse event in the 4 mg/kg cohort.