Free Trial

Zentalis Pharmaceuticals (ZNTL) FDA Events

Zentalis Pharmaceuticals logo
$1.31 +0.04 (+3.15%)
Closing price 07/9/2025 04:00 PM Eastern
Extended Trading
$1.32 +0.01 (+0.69%)
As of 07:00 AM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.
FDA Events for Zentalis Pharmaceuticals (ZNTL)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Zentalis Pharmaceuticals (ZNTL). Over the past two years, Zentalis Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as azenosertib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

azenosertib - FDA Regulatory Timeline and Events

azenosertib is a drug developed by Zentalis Pharmaceuticals for the following indication: Wee1 inhibitor. 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.

Zentalis Pharmaceuticals FDA Events - Frequently Asked Questions

As of now, Zentalis Pharmaceuticals (ZNTL) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Zentalis Pharmaceuticals (ZNTL) has reported FDA regulatory activity for azenosertib.

The most recent FDA-related event for Zentalis Pharmaceuticals occurred on April 28, 2025, involving azenosertib. The update was categorized as "Dose Update," with the company reporting: "Zentalis® Pharmaceuticals, Inc. announced that the first patient has been dosed in Part 2 of the Phase 2 DENALI clinical trial (NCT05128825) of azenosertib in patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC)."

Currently, Zentalis Pharmaceuticals has one therapy (azenosertib) targeting the following condition: Wee1 inhibitor..

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:ZNTL) was last updated on 7/10/2025 by MarketBeat.com Staff
From Our Partners