FDA Accepts Ascendis Pharma's Supplemental Biologics License Application for TransCon™ hGH for the Treatment of Adults with Growth Hormone Deficiency
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Ascendis Pharma's supplemental Biologics License Application for TransCon hGH, aimed at treating adult growth hormone deficiency, has been accepted by the FDA. The PDUFA goal date is set for July 27, 2025.
December 12, 2024 | 9:15 pm
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Ascendis Pharma's sBLA for TransCon hGH in adult GHD has been accepted by the FDA, with a PDUFA date set for July 27, 2025. This regulatory milestone could positively impact the company's stock as it progresses towards potential approval.
The acceptance of the sBLA by the FDA is a significant regulatory milestone for Ascendis Pharma, indicating progress towards potential approval. This development is likely to be viewed positively by investors, as it represents a step forward in expanding the use of TransCon hGH to adult patients, potentially increasing market opportunities and revenues.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100