PTC Therapeutics Announces FDA Acceptance of Translarna™ NDA Resubmission
PTC Therapeutics, Inc. (PTCT)
Last ptc therapeutics, inc. earnings: 4/30 04:01 pm
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Source: PR Newswire
WARREN, N.J., Oct. 30, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application (NDA) for Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD)."The NDA acceptance for review is a significant milestone that brings us one step closer to providing this important treatment to boys and young men living with nonsense mutation Duchenne muscular dystrophy in the United States," said Matthew B. Klein, M.D., Chief Executive Officer, PTC Therapeutics. "The totality of evidence clearly supports the favorable safety profile and short- and long-term benefits of Translarna for individuals with nmDMD. We look forward to working with FDA throughout the review process.""We thank FDA for accepting the Translarna NDA for review," stated Pat Furlong, Founder and CEO, Parent Project Muscular Dystrophy. "Translarna uniquely addresses
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PTCT
News
- PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)PR Newswire
- PTC Therapeutics to Host Conference Call to Discuss Third Quarter 2024 Financial ResultsPR Newswire
- CHMP Maintains Negative Opinion on Translarna™ ReexaminationPR Newswire
- PTC Therapeutics Announces FDA Target Regulatory Action Date for Sepiapterin and Lancet Publication of Phase 3 Trial ResultsPR Newswire
- PTC Therapeutics, Inc. (NASDAQ: PTCT) had its price target raised by analysts at Morgan Stanley from $32.00 to $45.00. They now have an "equal weight" rating on the stock.MarketBeat
PTCT
Earnings
- 8/8/24 - Beat
PTCT
Sec Filings
- 10/18/24 - Form SC
- 10/18/24 - Form 8-K
- 8/8/24 - Form 10-Q
- PTCT's page on the SEC website