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Seres Therapeutics (MCRB) FDA Events

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FDA Events for Seres Therapeutics (MCRB)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Seres Therapeutics (MCRB). Over the past two years, Seres Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SER-155. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

SER-155 - FDA Regulatory Timeline and Events

SER-155 is a drug developed by Seres Therapeutics for the following indication: Prevention of Antibiotic-Resistant Bacterial Infections and Graft-versus-Host Disease (GvHD). 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.

Seres Therapeutics FDA Events - Frequently Asked Questions

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

In the past two years, Seres Therapeutics (MCRB) has reported FDA regulatory activity for SER-155.

The most recent FDA-related event for Seres Therapeutics occurred on May 27, 2025, involving SER-155. The update was categorized as "Data Presentation," with the company reporting: "Seres Therapeutics, Inc. announced the Company will be presenting new exploratory biomarker data from its SER-155 Phase 1b study in a poster session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 –June 3 in Chicago."

Currently, Seres Therapeutics has one therapy (SER-155) targeting the following condition: Prevention of Antibiotic-Resistant Bacterial Infections and Graft-versus-Host Disease (GvHD).

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