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Mersana Therapeutics (MRSN) FDA Events

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FDA Events for Mersana Therapeutics (MRSN)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Mersana Therapeutics (MRSN). Over the past two years, Mersana Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as XMT-1660. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

XMT-1660 - FDA Regulatory Timeline and Events

XMT-1660 is a drug developed by Mersana Therapeutics for the following indication: High unmet need tumors such as breast, endometrial and ovarian. 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.

Mersana Therapeutics FDA Events - Frequently Asked Questions

As of now, Mersana Therapeutics (MRSN) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Mersana Therapeutics (MRSN) has reported FDA regulatory activity for XMT-1660.

The most recent FDA-related event for Mersana Therapeutics occurred on June 2, 2025, involving XMT-1660. The update was categorized as "Additional data," with the company reporting: "Mersana Therapeutics, announced additional interim Phase 1 clinical data for emiltatug ledadotin (Emi-Le; XMT-1660), the company's B7-H4-directed Dolasynthen ADC."

Currently, Mersana Therapeutics has one therapy (XMT-1660) targeting the following condition: High unmet need tumors such as breast, endometrial and ovarian.

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:MRSN) was last updated on 7/10/2025 by MarketBeat.com Staff
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