Ascendis Pharma (ASND) Surges 8.7%: Is This an Indication of Further Gains?
Ascendis Pharma (ASND) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.
Ascendis Pharma: Yorvipath Approved, Launch Delayed, Many Other Updates Coming Up
Ascendis Pharma's shares are modestly higher after the company announced the FDA approval of Yorvipath for the treatment of hypoparathyroidism. The label is broad and clean, without a black box warning for osteosarcoma or a REMS program. The approval is delayed until Q1 2025 due to the need for a new drug supply, with the potential for a fourth quarter launch if the FDA approves the use of the existing supply.
Ascendis' Hypoparathyroidism Drug Scores FDA Approval As First and Only Treatment, Replacing Takeda's Drug Discontinued Due To Supply Issues
Monday, the FDA approved Ascendis Pharma A/S' ASND Yorvipath (palopegteriparatide; developed as TransCon PTH) for hypoparathyroidism in adults.
Ascendis Pharma's stock surges after FDA approval for first and only treatment for rare disease
The stock of Ascendis Pharma A/S jumped 11% early Monday, after the biotech said the U.S. Food and Drug Administration has approved its Yorvipath as the first and only treatment for a rare endocrine disease.
FDA approves Ascendis Pharma's hormone disorder therapy
The U.S. Food & Drug Administration has approved Ascendis Pharma's therapy to treat adult patients with a hormone disorder, bringing an end to its years-long efforts to introduce the treatment to the market, the company said on Monday.
Weaker USD, Revenue Growth, And TransCon Technology Make Ascendis Pharma A Strong Buy Opportunity
ASND's pipeline includes promising candidates for various endocrine disorders and oncology, positioning the company as a leader in innovative medical solutions. FDA-approved Skytrofa for pediatric GHD showcases TransCon technology's efficacy in enhancing patient outcomes. The company's financial outlook is strong, with projected revenue growth and positive EBIT expected by 2025.
