European Commission Requests Reevaluation Of Opinion On PTC Therapeutics' Duchenne Dystrophy Drug; Pauses Annual Guidance
Portfolio Pulse from Vandana Singh
The European Commission has requested a reevaluation of the negative opinion on PTC Therapeutics' drug Translarna for Duchenne muscular dystrophy, pausing the company's annual revenue guidance. Translarna remains available in Europe, and PTC plans to resubmit its U.S. marketing application in mid-2024.

May 20, 2024 | 4:03 pm
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The European Commission has requested a reevaluation of the negative opinion on PTC Therapeutics' drug Translarna, pausing the company's annual revenue guidance. Translarna remains available in Europe, and PTC plans to resubmit its U.S. marketing application in mid-2024.
The news is positive for PTC Therapeutics as the European Commission's decision to reevaluate the negative opinion allows Translarna to remain on the market in Europe. This could potentially lead to continued revenue from the drug, although the company has paused its annual revenue guidance due to uncertainty. The stock price has already reacted positively, rising 18.3%.
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