PTC Therapeutics Provides Regulatory Update on Translarna™ (ataluren) in Europe
PTC Therapeutics, Inc. (PTCT)
Last ptc therapeutics, inc. earnings: 4/30 04:01 pm
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US:NASDAQ Investor Relations:
ir.ptcbio.com
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Source: PR Newswire
WARREN, N.J., March 28, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the European Commission (EC) has adopted the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to not renew the authorization of Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy. While this action effectively removes the drug's conditional marketing authorization in the European Economic Area, the EC indicated that individual countries within the European Union can leverage Articles 117(3) and 5(1) of the EU Directive 2001/83 to allow continued use of Translarna."We are of course disappointed that after this prolonged period of review the European Commission has decided to adopt the CHMP negative opinion on Translarna," said Matthew B. Klein, M.D., Chief Executive Officer, PTC Therapeutics. "The EC's indication that European Union member states have a mechanism to maintain treatment sp
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News
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PTCT
Earnings
- 11/4/25 - Beat
PTCT
Sec Filings
- 12/19/25 - Form 4
- 12/19/25 - Form 144
- 12/18/25 - Form 4
- PTCT's page on the SEC website