PTC Therapeutics Announces FDA Target Regulatory Action Date for Sepiapterin and Lancet Publication of Phase 3 Trial Results
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. 14, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the FDA has set a target regulatory action date of July 29, 2025, for the review of the New Drug Application (NDA) for sepiapterin, consistent with a standard review timeline. The NDA was submitted with an indication for the treatment of pediatric and adult patients with phenylketonuria (PKU), including all age groups and the full spectrum of disease subtypes. In addition, PTC announced that the results of the Phase 3 APHENITY trial were recently published in The Lancet, one of the most prestigious peer-reviewed medical journals."The Lancet publication reflects the promising and transformative nature of the data collected to date on sepiapterin and the therapy's potential to fill the persistent and significant unmet medical need for PKU patients," said Matthew B. Klein, M.D., Chief Executive Officer of PTC Therapeutics.The sepiapterin NDA includes the results from the Phase 3 APHENIT
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News
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- 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