Free Trial

Sutro Biopharma (STRO) FDA Events

Sutro Biopharma logo
$0.79 +0.01 (+0.75%)
As of 01:14 PM Eastern
This is a fair market value price provided by Polygon.io. Learn more.
FDA Events for Sutro Biopharma (STRO)

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

luvelta - FDA Regulatory Timeline and Events

luvelta is a drug developed by Sutro Biopharma for the following indication: Treatment of endometrial 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.

Sutro Biopharma FDA Events - Frequently Asked Questions

As of now, Sutro Biopharma (STRO) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Sutro Biopharma (STRO) has reported FDA regulatory activity for luvelta.

The most recent FDA-related event for Sutro Biopharma occurred on March 15, 2025, involving luvelta. The update was categorized as "Data," with the company reporting: "Sutro Biopharma, Inc announced expanded data in a late-breaking oral presentation from the dose-optimization portion of the REFRαME-O1 trial with luveltamab tazevibulin (luvelta) in patients with platinum resistant ovarian cancer (PROC) at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer®."

Currently, Sutro Biopharma has one therapy (luvelta) targeting the following condition: Treatment of endometrial cancer.

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