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Ascendis has seen a big uptake in sales for its human growth hormone therapy. The company said it plans to request a meeting with the FDA regarding hyperthyroidism therapy TransCon PTH.
Ascendis Pharma A/S (ASND) Q1 2023 Earnings Call Transcript.
We are upgrading from a hold to buy rating for ASND following a 35% drop in stock price after FDA deficiency findings in the NDA for TransCon PTH for hyperparathyroidism. We expect potential US FDA approval delays beyond the April 30 PDUFA date but an eventual approval.
COPENHAGEN, Denmark, April 13, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the company will hold a conference call and live webcast on Thursday, April 27, 2023, at 4:30 p.m. Eastern Time (ET) to review its first quarter 2023 financial results and provide a business update.
Ascendis Pharma A/S (ASND) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock suggests that there could be more strength down the road.
The FDA found deficiencies with Ascendis' regulatory filing for TransCon PTH in treating hypoparathyroidism. Ascendis plans to talk with the FDA to learn more about the issues and hopefully address them.
Ascendis has enjoyed a market cap valuation of >$6bn thanks to its TransCon technology platform and single approved asset SKYTROFA. SKYTROFA is approved for growth hormone deficiency as a once-weekly injection. The current standard of care is a daily injection.
The FDA identifies deficiencies in Ascendis' (ASND) regulatory filing for TransCon PTH in hypoparathyroidism. This might lead to an extended review timeline of the company's filing.
The FDA has identified deficiencies in Ascendis' regulatory filing for the hypoparathyroidism candidate TransCon PTH. With little info on the nature of the deficiencies, investors are moving to the sidelines today.
David Kim is the founder and Chief Investment Officer of Ghost Tree Capital. Before founding Ghost Tree Capital in 2013, Kim worked as the portfolio manager at Diamondback Capital (Nov 2006 – Dec 2012).