CHMP Maintains Negative Opinion on Translarna™ Reexamination
PTC Therapeutics, Inc. (PTCT)
Last ptc therapeutics, inc. earnings: 4/30 04:01 pm
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Source: PR Newswire
- Opinion to be reviewed by European Commission -WARREN, N.J., Oct. 18, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has maintained its negative opinion on the renewal of the conditional marketing authorization of Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne Muscular Dystrophy (nmDMD) following re-examination. The opinion will now be reviewed by the European Commission (EC) which is expected to decide on opinion adoption in approximately 67 days."CHMP again based its decision on the results of the primary analysis subpopulation of Study 041 instead of the totality of evidence for Translarna. That evidence includes data across three placebo-controlled trials and our STRIDE registry that demonstrates consistent short and long-term efficacy as well as safety supportive of continued authorization. In addition, the CHMP opinion is clearly a
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PTCT
Earnings
- 11/7/24 - Beat
PTCT
Sec Filings
- 11/14/24 - Form SC
- 11/8/24 - Form SC
- 11/7/24 - Form 10-Q
- PTCT's page on the SEC website