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Recursion Pharmaceuticals (RXRX) FDA Events

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FDA Events for Recursion Pharmaceuticals (RXRX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Recursion Pharmaceuticals (RXRX). Over the past two years, Recursion Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as REC-1245, REC-3565, REC-4881, REC-617, and REC-994. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Recursion Pharmaceuticals' Drugs in FDA Review

REC-1245 - FDA Regulatory Timeline and Events

REC-1245 is a drug developed by Recursion Pharmaceuticals for the following indication: For the treatment of biomarker-enriched solid tumors and lymphoma. 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.

REC-3565 - FDA Regulatory Timeline and Events

REC-3565 is a drug developed by Recursion Pharmaceuticals for the following indication: For Small-Cell Lung 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.

REC-4881 - FDA Regulatory Timeline and Events

REC-4881 is a drug developed by Recursion Pharmaceuticals for the following indication: Familial Adenomatous Polyposis (FAP). 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.

REC-617 - FDA Regulatory Timeline and Events

REC-617 is a drug developed by Recursion Pharmaceuticals for the following indication: CDK7 inhibitor, in advanced 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.

REC-994 - FDA Regulatory Timeline and Events

REC-994 is a drug developed by Recursion Pharmaceuticals for the following indication: Cerebral Cavernous Malformation (CCM). 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.

Recursion 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, Recursion Pharmaceuticals (RXRX) has reported FDA regulatory activity for the following drugs: REC-4881, REC-3565, REC-994, REC-1245 and REC-617.

The most recent FDA-related event for Recursion Pharmaceuticals occurred on May 4, 2025, involving REC-4881. The update was categorized as "Efficacy and Safety results," with the company reporting: "Recursion announced preliminary safety and efficacy results from its ongoing Phase 1b/2 TUPELO trial of REC-4881, an investigational, allosteric MEK1/2 inhibitor in development for Familial Adenomatous Polyposis (FAP)."

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

  • Familial Adenomatous Polyposis (FAP) - REC-4881
  • For Small-Cell Lung Cancer - REC-3565
  • Cerebral Cavernous Malformation (CCM) - REC-994
  • For the treatment of biomarker-enriched solid tumors and lymphoma. - REC-1245
  • CDK7 inhibitor, in advanced solid tumors. - REC-617

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:RXRX) was last updated on 7/11/2025 by MarketBeat.com Staff
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