PTC Therapeutics To Withdraw Its Conditionally Approved Rare Muscle Disorder Disorder Drug In Europe
Portfolio Pulse from Vandana Singh
PTC Therapeutics Inc (NASDAQ:PTCT) will withdraw its rare muscle disorder drug, Translarna, in Europe after the CHMP maintained a negative opinion on its authorization. Translarna had conditional approval since 2014 for treating Duchenne muscular dystrophy but failed to secure full marketing authorization. The drug is still investigational in the U.S., with the FDA indicating that recent trial data does not support substantial evidence of effectiveness. Q3 revenues for Translarna were down 10% Y/Y, and PTCT shares dropped 8.85% in after-hours trading.
January 26, 2024 | 2:00 pm
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NEGATIVE IMPACT
PTC Therapeutics' Translarna is set to be withdrawn in Europe, which could negatively impact future revenue prospects in that market. The FDA's skepticism about the drug's effectiveness may also hinder its U.S. approval, affecting investor confidence. The company's Q3 revenue decline and stock price drop post-news suggest a negative short-term impact.
The withdrawal of Translarna in Europe directly affects PTCT's ability to generate revenue from this product in a major market. The negative feedback from the FDA regarding the drug's effectiveness in the U.S. adds to the bearish outlook, as it may delay or prevent U.S. market entry. The immediate stock price reaction and revenue decline indicate the market is already responding negatively to these developments.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100