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BUZZ-Avidity rises on plans to submit muscle wasting drug application to US FDA

Reuters
Oct 13, 2025
BUZZ-Avidity rises on plans to submit muscle wasting drug application to US FDA

** Shares of drug developer Avidity Biosciences RNA.O rise 2.1% to $50.65

** After a positive meeting with the U.S. FDA, company plans to submit application in the first quarter of 2026 for potential approval of del-zota, an experimental treatment for Duchenne muscular dystrophy

** DMD is a rare genetic disorder that causes progressive muscle weakness and loss, mostly in boys and young men

** Del-zota has received a "breakthrough therapy designation" from the FDA; company is preparing a confirmatory study to support global approval

** A breakthrough therapy tag is meant to speed up development and review of drugs to treat a serious condition or unmet medical need

** Including sessions move, shares up ~71% YTD

(Reporting by Sahil Pandey in Bengaluru)

((Sahil.Pandey@thomsonreuters.com))

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