FDA eases partial clinical hold on Avidity trial of AOC 1001

18 May 2023
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The US Food and Drug Administration (FDA) has eased the partial clinical hold on AOC 1001, allowing Avidity Biosciences (Nasdaq: RNA), the drug’s developer, to double the number of participants in the MARINA Open-Label Extension (MARINA-OLE) study receiving 4 mg/kg of AOC 1001.

Initial market reaction was positive, send Avidity’s shares up 14% pre-market, but they were down 1.6% at $10.83 in mid-morning trading.

The FDA is also allowing new participant enrollment for AOC 1001 at 2mg/kg. Data from the MARINA-OLE study will be used to finalize the AOC 1001 pivotal dose and Phase III study design for adults with myotonic dystrophy type 1 (DM1), an underrecognized, progressive and often fatal neuromuscular disease with no approved treatment options.

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