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Oric Pharmaceuticals (ORIC) FDA Events

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FDA Events for Oric Pharmaceuticals (ORIC)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Oric Pharmaceuticals (ORIC). Over the past two years, Oric Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ORIC-114 and ORIC-944. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Oric Pharmaceuticals' Drugs in FDA Review

ORIC-114 - FDA Regulatory Timeline and Events

ORIC-114 is a drug developed by Oric Pharmaceuticals for the following indication: Advanced Solid Tumors with EGFR or HER2 Exon 20 Alterations or HER2 Amplifications. 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.

ORIC-944 - FDA Regulatory Timeline and Events

ORIC-944 is a drug developed by Oric Pharmaceuticals for the following indication: In patients with mCRPC. 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.

Oric 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, Oric Pharmaceuticals (ORIC) has reported FDA regulatory activity for the following drugs: ORIC-944 and ORIC-114.

The most recent FDA-related event for Oric Pharmaceuticals occurred on May 28, 2025, involving ORIC-944. The update was categorized as "Efficacy and Safety Data," with the company reporting: "ORIC Pharmaceuticals, Inc announced potentially best-in-class preliminary efficacy and safety data from the ongoing Phase 1b trial of once daily ORIC-944 in combination with androgen receptor (AR) inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC)."

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

  • In patients with mCRPC - ORIC-944
  • Advanced Solid Tumors with EGFR or HER2 Exon 20 Alterations or HER2 Amplifications - ORIC-114

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