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Monte Rosa Therapeutics (GLUE) FDA Events

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FDA Events for Monte Rosa Therapeutics (GLUE)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Monte Rosa Therapeutics (GLUE). Over the past two years, Monte Rosa Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as MRT-2359, MRT-51443, MRT-6160, MRT-8102, and MRT-9643. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Monte Rosa Therapeutics' Drugs in FDA Review

MRT-2359 - FDA Regulatory Timeline and Events

MRT-2359 is a drug developed by Monte Rosa Therapeutics for the following indication: MYC-driven 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.

MRT-51443 - FDA Regulatory Timeline and Events

MRT-51443 is a drug developed by Monte Rosa Therapeutics for the following indication: HR-positive/HER2-negative breast 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.

MRT-6160 - FDA Regulatory Timeline and Events

MRT-6160 is a drug developed by Monte Rosa Therapeutics for the following indication: To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC). 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.

MRT-8102 - FDA Regulatory Timeline and Events

MRT-8102 is a drug developed by Monte Rosa Therapeutics for the following indication: For the treatment of inflammatory diseases. 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.

MRT-9643 - FDA Regulatory Timeline and Events

MRT-9643 is a drug developed by Monte Rosa Therapeutics for the following indication: To Treat HR-positive/HER2-negative Breast 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.

Monte Rosa Therapeutics FDA Events - Frequently Asked Questions

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

In the past two years, Monte Rosa Therapeutics (GLUE) has reported FDA regulatory activity for the following drugs: MRT-6160, MRT-2359, MRT-8102, MRT-51443 and MRT-9643.

The most recent FDA-related event for Monte Rosa Therapeutics occurred on June 10, 2025, involving MRT-8102. The update was categorized as "Results," with the company reporting: "Monte Rosa Therapeutics, Inc. announced that MRT-8102 Phase 1 clinical results, including data on safety, pharmacokinetics, NEK7 protein degradation, and key downstream pharmacodynamic markers, expected in H1 2026"

Current therapies from Monte Rosa Therapeutics in review with the FDA target conditions such as:

  • To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC). - MRT-6160
  • MYC-driven solid tumors - MRT-2359
  • For the treatment of inflammatory diseases - MRT-8102
  • HR-positive/HER2-negative breast cancer - MRT-51443
  • To Treat HR-positive/HER2-negative Breast Cancer - MRT-9643

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