Shares of Ascendis Pharma ASND lost more than 5% on Tuesday after management announced that the FDA extended the review period for its regulatory submission of a hormone replacement therapy by an additional three months. A final decision is now expected by August 14, 2024.
The company’s filing seeks approval of TransCon PTH (palopegteriparatide) to treat adults with hypoparathyroidism, 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 muscle spasms.
The delay is due to additional data submitted by Ascendison to the FDA application during the ongoing review of TransCon PTH. According to the agency, the information presented by the company constitutes a significant modification of the data presented in its previous regulatory filing.
This submission is a new submission that was accepted by the FDA last year in December. Just over a year ago, the agency had issued a complete response letter (CRL) to the company’s initial filing, citing a manufacturing problem and questioning the variability of delivered doses of the treatment due to variability in dose of therapy. The FDA did not raise any concerns about the clinical data in the CRL.
The FDA submission is supported by data from the 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.
Year to date, Ascendis shares are down 0.9% compared to the sector’s 5.7% decline.
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Last year, in November, the European Commission granted marketing authorization for the therapy for chronic hypoparathyroidism, which is marketed under the trade name Yorvipath. The therapy was commercially launched earlier this year in Europe and achieved 1.5 million product sales. The therapy received a similar marketing approval for the drug in the UK last month.
Although not approved, the FDA allowed Ascendis to initiate an expanded access program (EAP) for TransCon PTH to treat eligible adults with hypoparathyroidism previously treated with PTH. Through an EAP, the FDA allows an investigational drug like TransCon PTH to be used in patients for treatment outside of clinical studies when no comparable or satisfactory alternative therapy options are available. This EAP remains open for enrollment of eligible patients.
Ascendis currently has only one marketed drug in its portfolio, Skytrofa (lonapegsomatropin), which was approved by the FDA in 2021 to treat growth hormone deficiency in children one year of age and older. A potential approval for TransCon could help the company diversify and expand its top line, which currently relies solely on one marketed product for revenue.
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Zacks Rank and Key Picks
Ascendis currently carries a Zacks Rank #3 (Hold). Some top-rated stocks in the general healthcare sector include ANI Pharmaceuticals ANIP, Pharmaceutical ligands LGND and Heron Therapeutics HRTX, each currently carrying a Zacks Rank #2 (Buy). you can see the full list of current Zacks #1 Rank (Strong Buy) stocks here.
In the last 60 days, ANI Pharmaceuticals 2024 earnings per share (EPS) estimates have increased from $4.40 to $4.44. During the same period, EPS estimates for 2025 have improved from $5.01 to $5.04. So far this year, ANIP shares have increased by 19.8%.
ANI Pharmaceuticals’ earnings beat estimates in each of the past four quarters. ANI delivered a four-quarter average earnings surprise of 53.90%.
In the last 60 days, Ligand Pharmaceuticals 2024 EPS estimates have increased from $4.42 to $4.56. During the same period, EPS estimates for 2025 have improved from $5.11 to $5.27. Year to date, LGND shares have appreciated 19.4%.
Ligand Pharmaceuticals’ earnings beat estimates in each of the past four quarters. Ligand delivered a four-quarter average earnings surprise of 56.02%.
In the past 60 days, Heron Therapeutics 2024 loss per share estimates have improved from 22 cents to 14 cents. Over the same period, loss estimates for 2025 have been reduced from 9 cents to 2 cents. HRTX shares are up 65.3% year to date.
Heron Therapeutics’ earnings beat estimates in three of the past four quarters and missed the mark once. HRTX delivered a four-quarter average earnings surprise of 30.33%.
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