CHMP Issues Negative Opinion For Renewal Of Conditional Marketing Authorization For Translarna Following Re-Examination Procedure; Per European Regulations, The European Commission Has 67 Days To Adopt The Opinion
Portfolio Pulse from Benzinga Newsdesk
PTC Therapeutics, Inc. (NASDAQ:PTCT) received a negative opinion from the CHMP regarding the renewal of the conditional marketing authorization for Translarna, a treatment for Duchenne Muscular Dystrophy. The European Commission will decide on the opinion within 67 days. The CEO expressed disappointment, noting the lack of alternative therapies for patients in Europe.
January 25, 2024 | 9:36 pm
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PTC Therapeutics faces a regulatory hurdle in Europe as CHMP issues a negative opinion on Translarna, potentially affecting its market presence.
The negative opinion from CHMP is a significant regulatory setback for PTC Therapeutics and could lead to the withdrawal of Translarna from the European market. This would likely have a negative impact on the company's revenue and growth prospects in Europe, thus potentially leading to a decrease in investor confidence and a short-term decline in stock price.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100