PTC Therapeutics Provides Regulatory Update on Translarna™
PTC Therapeutics, Inc. (PTCT)
Last ptc therapeutics, inc. earnings: 4/30 04:01 pm
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Source: PR Newswire
WARREN, N.J., Feb. 12, 2026 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that it has withdrawn the New Drug Application (NDA) resubmission for Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (DMD) following U.S. Food and Drug Administration (FDA) feedback on the application review."FDA shared that based on its review to date, the data in the NDA submission are unlikely to meet the Agency's threshold of substantial evidence of effectiveness to support approval of Translarna. We have therefore made the decision to withdraw the NDA submission," said Matthew B. Klein, M.D., Chief Executive Officer of PTC Therapeutics. "We have worked tirelessly for over two decades to develop a safe and effective therapy for boys and young men affected by nonsense mutation DMD in the U.S. and are disappointed that FDA approval cannot be achieved."About Translarna™ (ataluren)Translarna (ataluren), is a protein restoration therapy designed t
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News
- PTC Therapeutics to Report Fourth Quarter and Full Year 2025 Financial Results on Thursday, Feb. 19, 2026 [Yahoo! Finance]Yahoo! Finance
- PTC Therapeutics to Report Fourth Quarter and Full Year 2025 Financial Results on Thursday, Feb. 19, 2026PR Newswire
- PTC Therapeutics (NASDAQ:PTCT) had its "hold" rating reaffirmed by analysts at TD Cowen.MarketBeat
- PTC Therapeutics (NASDAQ:PTCT) was upgraded by analysts at Barclays PLC from an "equal weight" rating to an "overweight" rating.MarketBeat
- PTC Therapeutics Provides Update at J.P. Morgan Annual Healthcare Conference [Yahoo! Finance]Yahoo! Finance
PTCT
Earnings
- 11/4/25 - Beat
PTCT
Sec Filings
- 2/12/26 - Form 8-K
- 2/10/26 - Form SCHEDULE
- 2/9/26 - Form SCHEDULE
- PTCT's page on the SEC website