Avidity: FDA Eases Partial Clinical Hold On AOC 1001

(RTTNews) - Avidity Biosciences, Inc. (RNA) announced the FDA has eased the partial clinical hold on AOC 1001, allowing the company to double the number of participants in the MARINA Open-Label Extension study receiving 4 mg/kg of AOC 1001. The FDA is also allowing new participant enrollment for AOC 1001 at 2 mg/kg.

"This positive step forward in our discussions with FDA provides the opportunity to gather additional data on the 2-4 mg/kg dose range of AOC 1001 while, in parallel, finalizing our Phase 3 study design and aligning with health authorities on a global regulatory path for AOC 1001," said Sarah Boyce, CEO, Avidity.

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