PTC Announces Submission of Sepiapterin MAA for Treatment of PKU to EMA [Yahoo! Finance]
PTC Therapeutics, Inc. (PTCT)
Last ptc therapeutics, inc. earnings: 4/30 04:01 pm
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Source: Yahoo! Finance
SOUTH PLAINFIELD, N.J. March 28, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the submission of the sepiapterin MAA to the European Medicines Agency. The MAA submission is for the treatment of pediatric and adult patients with PKU, including the full spectrum of disease subtypes. "This MAA submission is the first in a series of global submissions for sepiapterin as we move closer to bringing this therapy to children and adults with PKU worldwide," said Matthew B. Klein , M.D., Chief Executive Officer of PTC Therapeutics. "The strength of the sepiapterin data generated in clinical trials substantiate how differentiated sepiapterin is from currently available therapies and support how sepiapterin could address the significant unmet medical need for PKU patients." The sepiapterin MAA includes the results of the phase 3 APHENITY trial in which sepiapterin had a statistically significant and clinically meaningful reduction in blood phenylalanine levels in
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- PTC Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial ResultsPR Newswire
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PTCT
Earnings
- 4/25/24 - Beat
PTCT
Sec Filings
- 4/26/24 - Form DEFA14A
- 4/26/24 - Form DEF
- 4/25/24 - Form 10-Q
- PTCT's page on the SEC website