Yahoo Finance Ascendis (ASND) Down on Hypoparathyroidism Drug NDA Deficiencies
Shares of Ascendis Pharma ASND plummeted 32.1% on Apr 3, after management announced that the FDA identified deficiencies in the company’s new drug application (NDA) filing seeking approval for TransCon PTH (palopegteriparatide) in hypoparathyroidism.
Though the FDA did not disclose these deficiencies in their communication to the company, the same prevented the agency from discussing the drug’s labeling and post-marketing requirements/commitments. The FDA also stated that this communication does not reflect their final decision on the NDA filing.
Share price likely fell as Ascendis had initially expected a potential approval by the end of this month and a potential drug launch later this quarter. The FDA’s identification of deficiencies in the NDA has delayed the regulatory approval and the company’s launch plans for the drug.
Ascendis stated that it would work closely with the FDA to address these deficiencies. The FDA’s communication will likely lead to an extension of the previously set target action date of Apr 30, 2023. Management also confirmed that no safety signals had been identified in the ongoing clinical studies or the expanded access program (EAP) evaluating TransCon PTH in hypoparathyroidism patients.
In the year so far, shares of Ascendis have declined 40.4% compared to the industry’s 5.8% fall.
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Hypoparathyroidism is a rare condition in which the body produces abnormally low levels of parathyroid hormone (PTH). Low production of this hormone causes deficiencies of calcium and phosphorus compounds in the blood, resulting in muscular spasms. Currently, the standard-of-care treatment for this condition consists of activated vitamin D (calcitriol) and calcium supplements.
The NDA filing for TransCon PTH was based on data from phase III PaTHway and phase II PaTH Forward studies which showed that treatment with TransCon PTH led to significant reductions in disease-specific physical and cognitive symptoms and significant improvements in their quality of life. Participants treated with the drug also achieved normalization of serum calcium and independence from conventional therapy.
Last December, the FDA also allowed the company to start an EAP for TransCon PTH to treat eligible adults with hypoparathyroidism previously treated with PTH. Through an EAP, the FDA allows using an investigational drug like TransCon PTH in patients for treatment outside of clinical studies when no comparable or satisfactory alternative therapy options are available.
Apart from the NDA filing, Ascendis has already completed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for TransCon PTH in hypoparathyroidism. A final decision on the MAA is expected in fourth-quarter 2023. If the MAA is approved, Ascendis expects to launch this drug early next year.
Currently, Ascendis has only one marketed drug in its portfolio, Skytrofa (lonapegsomatropin) that was approved by the FDA in 2021 for treating growth hormone deficiency in children aged one year and older. A potential approval for TransCon could help the company diversify and expand its top line, which is currently solely dependent on one marketed product for revenues.
Ascendis Pharma A/S Price
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Zacks Rank & Other Stock to Consider
Ascendis currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the overall healthcare sector include Certara CERT, CRISPR Therapeutics CRSP and EQRx EQRX. While Certara sports a Zacks Rank #1 (Strong Buy), CRISPR Therapeutics and EQRx carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Certara’s 2023 earnings per share have increased from 46 cents to $1.24. During the same period, the earnings estimates per share for 2024 have risen from 54 cents to $1.85. Shares of Certara are up 46.7% in the year-to-date period.
Earnings of Certara missed estimates in two of the last four quarters, beating the mark on one occasion while meeting the mark on another. On average, the company’s earnings witnessed a negative surprise of 3.25%. In the last reported quarter, Certara’searnings beat estimates by 14.29%.
In the past 60 days, estimates for CRISPR Therapeutics’ 2023 loss per share have narrowed from $8.21 to $7.35. Shares of CRISPR Therapeutics have risen 11.4% in the year-to-date period.
Earnings of CRISPR Therapeutics beat estimates in two of the last four quarters while missing the mark on the other two occasions, witnessing an earnings surprise of 3.19%, on average. In the last reported quarter, CRISPR Therapeutics’ earnings beat estimates by 39.22%.
In the past 60 days, estimates for EQRx’s 2023 loss per share have narrowed from 66 cents to 58 cents. In the year so far, shares of EQRx have declined 20.3%.
Earnings of EQRx beat estimates in each of the last four quarters, witnessing an earnings surprise of 34.99%, on average. In the last reported quarter, EQRx’s earnings beat estimates by 73.68%.
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