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Ascendis Pharma A/S (ASND) FDA Approvals

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Ascendis Pharma A/S's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Ascendis Pharma A/S (ASND). Over the past two years, Ascendis Pharma A/S has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SKYTROFA®, TransCon, TransCon, TransCon, TransCon, and YORVIPATH. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

SKYTROFA® FDA Regulatory Events

SKYTROFA® is a drug developed by Ascendis Pharma A/S for the following indication: For the Once-Weekly Treatment of Children and Adolescents with Growth Hormone Deficiency. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

TransCon CNP FDA Regulatory Timeline and Events

TransCon CNP is a drug developed by Ascendis Pharma A/S for the following indication: In Children with Achondroplasia. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

TransCon hGH (Lonapegsomatropin) FDA Regulatory Timeline and Events

TransCon hGH (Lonapegsomatropin) is a drug developed by Ascendis Pharma A/S for the following indication: Pediatric Growth Hormone Deficiency (GHD). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

TransCon IL-2 β/γ FDA Regulatory Events

TransCon IL-2 β/γ is a drug developed by Ascendis Pharma A/S for the following indication: Advanced cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

TransCon PTH FDA Regulatory Timeline and Events

TransCon PTH is a drug developed by Ascendis Pharma A/S for the following indication: Adult Hypoparathyroidism. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

YORVIPATH FDA Regulatory Timeline and Events

YORVIPATH is a drug developed by Ascendis Pharma A/S for the following indication: For Hypoparathyroidism in Adults. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Ascendis Pharma A/S FDA Events - Frequently Asked Questions

Yes, Ascendis Pharma A/S (ASND) has received FDA approval for YORVIPATH. This page tracks recent and historical FDA regulatory events related to Ascendis Pharma A/S's drug portfolio.

In the past two years, Ascendis Pharma A/S (ASND) has reported FDA regulatory activity for the following drugs: TransCon CNP, TransCon PTH, TransCon hGH (Lonapegsomatropin), YORVIPATH, SKYTROFA® and TransCon IL-2 β/γ.

The most recent FDA-related event for Ascendis Pharma A/S occurred on July 28, 2025, involving SKYTROFA®. The update was categorized as "FDA approved," with the company reporting: "Ascendis Pharma announced that the U.S. Food & Drug Administration (FDA) has approved SKYTROFA® (lonapegsomatropin-tcgd; developed as TransCon hGH) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD), a rare disorder resulting from decreased or total loss of growth hormone production."

Current therapies from Ascendis Pharma A/S in review with the FDA target conditions such as:

  • In Children with Achondroplasia - TransCon CNP
  • Adult Hypoparathyroidism - TransCon PTH
  • Pediatric Growth Hormone Deficiency (GHD) - TransCon hGH (Lonapegsomatropin)
  • For Hypoparathyroidism in Adults - YORVIPATH
  • For the Once-Weekly Treatment of Children and Adolescents with Growth Hormone Deficiency - SKYTROFA®
  • Advanced cancer - TransCon IL-2 β/γ

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:ASND) was last updated on 8/2/2025 by MarketBeat.com Staff
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