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Ascendis Pharma A/S (ASND) FDA Events

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FDA Events for Ascendis Pharma A/S (ASND)

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 TransCon, TransCon, TransCon, TransCon, and YORVIPATH. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Ascendis Pharma A/S's Drugs in FDA Review

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 Timeline and 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 and TransCon IL-2 β/γ.

The most recent FDA-related event for Ascendis Pharma A/S occurred on July 7, 2025, involving TransCon PTH. The update was categorized as "Oral presentation," with the company reporting: "Ascendis Pharma A/S announced two oral presentations at ENDO 2025, the annual meeting of the Endocrine Society being held July 12-15, 2025, in San Francisco. Dr. Aliya Khan will present new data from Week 156 of the Company's Phase 3 PaTHway Trial demonstrating the safety and efficacy of long-term treatment with TransCon® PTH (palopegteriparatide) in adults with hypoparathyroidism – including maintenance of serum and urine biochemistries within normal levels and sustained improvement in renal function."

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
  • 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 7/10/2025 by MarketBeat.com Staff
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