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Ascendis Blasts Up despite FDA Troubles
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Ascendis Blasts Up despite FDA Troubles

Normally, when the FDA pans a drug created by a biotech stock like Ascendis Pharma (NASDAQ:ASND), it sets off alarms for investors. However, the only alarm heard by them today was the “Buy More Now” alarm. Ascendis launched upward, gaining over 23% at the time of writing, despite the bad news from the FDA.

The drug in question is known as palopegteriparatide, more commonly known as TransCon PTH, and it’s used to address hypoparathyroidism in adults. The FDA, meanwhile, had some problems with TransCon, and expressed these in its “complete response letter.” The one real concern came from issues of manufacture, specifically controlling variability in the delivered dose. That was less a concern about the drug itself and more about the device from which it’s delivered. Since the FDA requested no additional testing or clinical data, the drug itself seems ready to go ahead.

Thus, Ascendis already plans to request a meeting to address the issues raised and should be able to get the drug ready to go in 2024 as originally planned. This accounts for much of the surge today and falls in line with earlier predictions from TD Cowen analyst Yaron Werber. Werber noted that Ascendis would likely lose ground if the FDA required more studies on the drug itself. However, since the drug isn’t really the issue, the end result should—and did—come out positively.

Therefore, it’s little surprise that Ascendis enjoys as much analyst support as it does. Ascendis Pharma stock has a Strong Buy consensus rating thanks to a combination of nine Buys and three Holds. Plus, Ascendis Pharma stock offers investors 61.9% upside potential thanks to its average price target of $139.56.

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