PTC Therapeutics Updates On Translarna (Ataluren) Regulatory Activities In Europe And US; Says FDA suggested Request For Follow-Up Meeting To Align On Specific Contents That Could Support Potential NDA Filing
Portfolio Pulse from Benzinga Newsdesk
PTC Therapeutics has submitted a briefing document for the re-examination of the CHMP's negative opinion on Translarna's renewal in Europe. In the US, PTC discussed with the FDA a potential path for resubmitting a New Drug Application for Translarna, with the FDA suggesting a follow-up meeting to align on contents that could support a potential NDA filing.
December 05, 2023 | 9:19 pm
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POSITIVE IMPACT
PTC Therapeutics is actively engaging with regulatory authorities in Europe and the US to advance the approval process for Translarna. The FDA's suggestion for a follow-up meeting indicates a constructive dialogue that could lead to a potential NDA filing.
The news indicates positive regulatory engagement, which is a critical step towards potential approval of Translarna. This could have a favorable impact on PTCT's stock in the short term as it reflects progress in the drug's approval process.
CONFIDENCE 80
IMPORTANCE 90
RELEVANCE 100