The Miami Entrepreneur

: Avidity’s stock gains after company shares new data about partial clinical hold

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Shares of Avidity Biosciences Inc. RNA gained about 2.0% in premarket trading on Thursday after the company said a partial clinical hold on its experimental treatment for adults with myotonic dystrophy type 1 is still in place. The Food and Drug Administration placed the partial clinical hold on enrolling new patients in the Phase 1/2 clinical trial in September after a serious adverse event was reported. Avidity said this week that it expects to present topline data from the study in late April, and the event was the result of a rare neurological event. “It’s hard to say whether the rarer-than-rare expected incidence of the SAE will make investors feel better or worse — arguments can be made either way,” SVB Securities Joseph Schwartz told investors. “It is promising that AOC 1001 does not cross the blood-brain barrier and the prior safety data suggests that treatment has been generally well-tolerated.” Avidity’s stock is down 8.9% so far this year, while the broader S&P 500 SPX is up 4.9%.

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