Ascendis Pharma Resubmits NDA For TransCon PTH To The US FDA
Portfolio Pulse from Benzinga Newsdesk
Ascendis Pharma A/S has resubmitted its NDA for TransCon PTH to the FDA for treating hypoparathyroidism. The resubmission follows a Type A meeting with the FDA and is based on positive clinical trial results and a new manufacturing control strategy. TransCon PTH has shown significant health improvements in trials and has received a positive CHMP opinion in the EU, with an EC decision expected soon.
November 15, 2023 | 1:11 pm
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POSITIVE IMPACT
Ascendis Pharma's resubmission of the NDA for TransCon PTH could lead to FDA approval, potentially increasing the company's revenue and market share in the hypoparathyroidism treatment market.
The resubmission of the NDA for TransCon PTH is a critical step towards FDA approval. Given the positive clinical trial results and no new safety concerns, the likelihood of approval is high. Approval would allow Ascendis Pharma to commercialize TransCon PTH in the U.S., which is a significant market. The positive opinion from the CHMP in the EU further supports the potential for approval and market success.
CONFIDENCE 80
IMPORTANCE 90
RELEVANCE 100