Free Trial

Mural Oncology (MURA) FDA Events

Mural Oncology logo
$2.55 -0.01 (-0.23%)
As of 10:33 AM Eastern
This is a fair market value price provided by Polygon.io. Learn more.
FDA Events for Mural Oncology (MURA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Mural Oncology (MURA). Over the past two years, Mural Oncology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ARTISTRY-7 and nemvaleukin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Mural Oncology's Drugs in FDA Review

ARTISTRY-7 - FDA Regulatory Timeline and Events

ARTISTRY-7 is a drug developed by Mural Oncology for the following indication: pre-treated patients with platinum-resistant ovarian cancer (PROC). 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.

nemvaleukin - FDA Regulatory Timeline and Events

nemvaleukin is a drug developed by Mural Oncology for the following indication: For Solid Tumors. 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.

Mural Oncology FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Mural Oncology (MURA) has reported FDA regulatory activity for the following drugs: ARTISTRY-7 and nemvaleukin.

The most recent FDA-related event for Mural Oncology occurred on April 15, 2025, involving ARTISTRY-7. The update was categorized as "Provided Update," with the company reporting: "Mural Oncology plc announced that following review of data from its phase 2 ARTISTRY-6 trial in melanoma and previously announced results from the phase 3 ARTISTRY-7 trial in platinum-resistant ovarian cancer, the company is discontinuing all clinical development of nemvaleukin alfa and plans to immediately commence the exploration of strategic alternatives focused on maximizing shareholder value. Mural has engaged Lucid Capital Markets, LLC to act as its financial advisor in connection with the exploration of strategic alternatives."

Current therapies from Mural Oncology in review with the FDA target conditions such as:

  • pre-treated patients with platinum-resistant ovarian cancer (PROC) - ARTISTRY-7
  • For Solid Tumors - nemvaleukin

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