ASND Stock Recent News
ASND LATEST HEADLINES
The FDA approves Ascendis' (ASND) Yorvipath (palopegteriparatide) as the first and only treatment for hypoparathyroidism in adult patients. Shares rise.
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'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.
Monday, the FDA approved Ascendis Pharma A/S' ASND Yorvipath (palopegteriparatide; developed as TransCon PTH) for hypoparathyroidism in adults.
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.
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.
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.
• Data demonstrate significant improvements in well-being and physical functioning compared to placebo in patients treated for 1 year with TransCon CNP at the pivotal 100μg/kg/week dose
COPENHAGEN, Denmark, June 04, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that company executives will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024, at 8:00 a.m. ET in Miami, Florida.
- 40% of efficacy-evaluable patients (2 out of 5) in the initial cohort of patients with anti-PD-1 refractory melanoma treated with TransCon IL-2 β/γ in combination with TransCon TLR7/8 Agonist exhibited confirmed clinical responses with no new safety signals