Shares of biopharmaceutical company Avidity Biosciences (NASDAQ:RNA) are rising today after the U.S. Food and Drug Administration eased a partial clinical hold on the company’s product candidate AOC1001.
This allows the company to double the number of subjects in an open-label extension study of the drug (at 4mg/kg of AOC1001). Further, the regulatory body has also allowed Avidity to enroll new subjects (at 2 mg/kg).
Importantly, findings from this study will help in finalizing a pivotal dose and Phase 3 study design of the drug for the treatment of myotonic dystrophy type 1 (DM1) in adults. This neuromuscular disease can be fatal and currently has no approved treatments on the market.
The company announced positive topline data from a Phase 1/2 trial of the drug in April and now expects to deliver the first look at data from the open-label extension study at the end of this year.
Overall, the Street has a $37 consensus price target on Avidity alongside a Strong Buy consensus rating.
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