PTC Provides Update on Translarna™ (ataluren) Application for Label Expansion
PTC Therapeutics, Inc. (PTCT)
Last ptc therapeutics, inc. earnings: 4/30 04:01 pm
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Source: PR Newswire
SOUTH PLAINFIELD, N.J., June 28, 2019 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has completed their review of a proposed indication extension of Translarna™ (ataluren) for the treatment of patients with nonsense mutation Duchenne muscular dystrophy (nmDMD) who are non-ambulatory. While the CHMP adopted a negative opinion of the extension, PTC was informed by EMA representatives that the European Public Assessment Report (EPAR) will be updated to clarify that patients who start Translarna while ambulatory are not required to discontinue treatment after loss of ambulation. Translarna is currently indicated for ambulatory Duchenne patients who are over two years of age; the requested extension would have allowed for the inclusion of non-ambulatory patients in the label. PTC plans to request a re-examination of the procedure within the next two weeks and expect
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PTCT
News
- PTC Therapeutics Provides Update at J.P. Morgan Annual Healthcare Conference [Yahoo! Finance]Yahoo! Finance
- PTC Therapeutics Provides Update at J.P. Morgan Annual Healthcare ConferencePR Newswire
- PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)PR Newswire
- PTC Therapeutics (NASDAQ:PTCT) had its "overweight" rating reaffirmed by analysts at Morgan Stanley.MarketBeat
- PTC Therapeutics (NASDAQ:PTCT) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=PTCT&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street ZMarketBeat
PTCT
Earnings
- 11/4/25 - Beat
PTCT
Sec Filings
- 1/12/26 - Form 4
- 1/12/26 - Form 4
- 1/12/26 - Form 4
- PTCT's page on the SEC website