Free Trial

Corbus Pharmaceuticals (CRBP) FDA Events

Corbus Pharmaceuticals logo
$8.37 +0.83 (+11.01%)
Closing price 07/9/2025 04:00 PM Eastern
Extended Trading
$8.21 -0.16 (-1.86%)
As of 05:44 AM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.
FDA Events for Corbus Pharmaceuticals (CRBP)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Corbus Pharmaceuticals (CRBP). Over the past two years, Corbus Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CRB-601, CRB-701, and CRB-913. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Corbus Pharmaceuticals' Drugs in FDA Review

CRB-601 - FDA Regulatory Timeline and Events

CRB-601 is a drug developed by Corbus Pharmaceuticals for the following indication: Designed to block the activation of latent TGFβ in the tumor microenvironment. 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.

CRB-701 - FDA Regulatory Timeline and Events

CRB-701 is a drug developed by Corbus Pharmaceuticals for the following indication: Targets the expression of Nectin-4 on cancer cells. 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.

CRB-913 - FDA Regulatory Timeline and Events

CRB-913 is a drug developed by Corbus Pharmaceuticals for the following indication: For Obesity. 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.

Corbus Pharmaceuticals FDA Events - Frequently Asked Questions

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

In the past two years, Corbus Pharmaceuticals (CRBP) has reported FDA regulatory activity for the following drugs: CRB-701, CRB-913 and CRB-601.

The most recent FDA-related event for Corbus Pharmaceuticals occurred on June 30, 2025, involving CRB-913. The update was categorized as "Dose Update," with the company reporting: "Corbus Pharmaceuticals Holdings Inc. announced the initiation of the multiple ascending dose (MAD) portion of its Phase 1 trial for CRB-913, a highly peripherally restricted CB1 inverse agonist for the treatment of obesity."

Current therapies from Corbus Pharmaceuticals in review with the FDA target conditions such as:

  • Targets the expression of Nectin-4 on cancer cells - CRB-701
  • For Obesity - CRB-913
  • Designed to block the activation of latent TGFβ in the tumor microenvironment - CRB-601

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