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Ascendis (ASND) Up on FDA Nod for Hormone Therapy Yorvipath
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Shares of Ascendis Pharma A/S (ASND - Free Report) were up 8.7% on Aug 13 after the company announced that the FDA had approved Yorvipath (palopegteriparatide) for the treatment of adults with hypoparathyroidism.
Yorvipath (developed as TransCon PTH) is a hormone replacement therapy for treating 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 muscular spasms.
Following the FDA nod, Yorvipath became the first and only treatment to be approved for hypoparathyroidism in adults.
The FDA approval was based on the review of data from the phase III PaTHway and phase II PaTH Forward studies.
Shares of Ascendis have rallied 10.9% so far this year against the industry’s decline of 3.9%.
Image Source: Zacks Investment Research
We remind investors that a decision from the FDA was originally expected in May 2024 but the FDA extended the review period for TransCon PTH by an additional three months..
The delay was on account of the additional data submitted by Ascendis on the FDA’s request during the ongoing review of TransCon PTH. Per the regulatory body, the information submitted by ASND constitutes a “major amendment” to the data in its earlier regulatory filing.
Ascendis plans to begin the initial supply of Yorvipath in the first quarter of 2025 in the United States.
In November 2023, the European Commission granted marketing authorization to Yorvipath for treating chronic hypoparathyroidism. The therapy was commercially launched earlier in 2024 in Europe. Yorvipath is also approved for the treatment of adults with chronic hypoparathyroidism in Great Britain.
In the first quarter of 2024, Yorvipath recorded sales worth €1.5 million. The FDA approval for Yorvipath should help drive the company’s top line further.
Zacks Rank & Stocks to Consider
Ascendis currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.18 to $2.74. Earnings per share estimates for 2025 have improved from $2.81 to $4.24. Year to date, shares of ILMN have lost 14%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have surged 35.9%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
In the past 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have narrowed from 14 cents to 13 cents. Loss per share estimates for 2025 have narrowed from $3.44 to $3.21. Year to date, shares of TRDA have risen 4.7%.
TRDA’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 42.18%.
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Ascendis (ASND) Up on FDA Nod for Hormone Therapy Yorvipath
Shares of Ascendis Pharma A/S (ASND - Free Report) were up 8.7% on Aug 13 after the company announced that the FDA had approved Yorvipath (palopegteriparatide) for the treatment of adults with hypoparathyroidism.
Yorvipath (developed as TransCon PTH) is a hormone replacement therapy for treating 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 muscular spasms.
Following the FDA nod, Yorvipath became the first and only treatment to be approved for hypoparathyroidism in adults.
The FDA approval was based on the review of data from the phase III PaTHway and phase II PaTH Forward studies.
Shares of Ascendis have rallied 10.9% so far this year against the industry’s decline of 3.9%.
Image Source: Zacks Investment Research
We remind investors that a decision from the FDA was originally expected in May 2024 but the FDA extended the review period for TransCon PTH by an additional three months..
The delay was on account of the additional data submitted by Ascendis on the FDA’s request during the ongoing review of TransCon PTH. Per the regulatory body, the information submitted by ASND constitutes a “major amendment” to the data in its earlier regulatory filing.
Ascendis plans to begin the initial supply of Yorvipath in the first quarter of 2025 in the United States.
In November 2023, the European Commission granted marketing authorization to Yorvipath for treating chronic hypoparathyroidism. The therapy was commercially launched earlier in 2024 in Europe. Yorvipath is also approved for the treatment of adults with chronic hypoparathyroidism in Great Britain.
In the first quarter of 2024, Yorvipath recorded sales worth €1.5 million. The FDA approval for Yorvipath should help drive the company’s top line further.
Zacks Rank & Stocks to Consider
Ascendis currently carries a Zacks Rank #3 (Hold).
Some top-ranked stocks in the biotech sector are Illumina, Inc. (ILMN - Free Report) , Fulcrum Therapeutics, Inc. (FULC - Free Report) and Entrada Therapeutics, Inc. (TRDA - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.18 to $2.74. Earnings per share estimates for 2025 have improved from $2.81 to $4.24. Year to date, shares of ILMN have lost 14%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have surged 35.9%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
In the past 60 days, estimates for Entrada Therapeutics’ 2024 loss per share have narrowed from 14 cents to 13 cents. Loss per share estimates for 2025 have narrowed from $3.44 to $3.21. Year to date, shares of TRDA have risen 4.7%.
TRDA’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 42.18%.