PTC Therapeutics Announces FDA Acceptance For Filing Of NDA For Sepiapterin For Pediatric And Adult Phenylketonuria Patients
Portfolio Pulse from Benzinga Newsdesk
PTC Therapeutics announced that the FDA has accepted its New Drug Application (NDA) for Sepiapterin, a treatment for both pediatric and adult patients with Phenylketonuria (PKU). This marks a significant step forward in the approval process for this potential new treatment.
October 01, 2024 | 1:03 pm
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PTC Therapeutics' NDA for Sepiapterin has been accepted by the FDA, indicating progress in the regulatory process for this new treatment for Phenylketonuria.
The acceptance of the NDA by the FDA is a positive regulatory milestone for PTC Therapeutics, suggesting potential future revenue from Sepiapterin if approved. This news is likely to boost investor confidence and positively impact the stock price in the short term.
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