The FDA has relaxed the partial clinical waiting period Avidity Biosciences Inc RNA AOC 1001, allowing Avidity to double the number of participants in the MARINA Open-Label Extension (MARINA-OLE) study 4 mg/kg AOC 1001 obtained.

The FDA also allows registration of new participants for AOC 1001 at 2 mg/kg.

The FDA has partially clinically suspended enrollment of new participants in the study September last year.

Data from the MARINA-OLE study will be used to finalize the AOC 1001 registration dose and Phase 3 study design in adults with myotonic dystrophy type 1 (DM1), a fatal neuromuscular disease.

Avidity announced top-line AOC 1001 data from the Phase 1/2 MARINA study demonstrating directed improvement across multiple functional assessments, including myotonia. Strength and mobility measures.

In March, Avidity Biosciences decided to complete the Phase 1/2 MARINA study with the 38 participants enrolled at 1 mg/kg, 2 mg/kg and 4 mg/kg of AOC 1001 and not to proceed with 8 mg/kg Dose for myotonic dystrophy type 1 (DM1).

Avidity remains on track to provide a first look at data from the MARINA-OLE study in late 2023.

Price promotion: RNA shares are up 1.60% to $11.13 at last check on Wednesday.