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Phio Pharmaceuticals (PHIO) FDA Events

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FDA Events for Phio Pharmaceuticals (PHIO)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Phio Pharmaceuticals (PHIO). Over the past two years, Phio Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as PH-762. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

PH-762 (INTASYL) - FDA Regulatory Timeline and Events

PH-762 (INTASYL) is a drug developed by Phio Pharmaceuticals for the following indication: Murine colorectal 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.

Phio Pharmaceuticals FDA Events - Frequently Asked Questions

As of now, Phio Pharmaceuticals (PHIO) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Phio Pharmaceuticals (PHIO) has reported FDA regulatory activity for PH-762 (INTASYL).

The most recent FDA-related event for Phio Pharmaceuticals occurred on June 25, 2025, involving PH-762 (INTASYL). The update was categorized as "Dose escalation," with the company reporting: "Phio Pharmaceuticals Corp. announced that the Safety Monitoring Committee (SMC) recommended dose escalation in its Phase 1b clinical trial designed to evaluate the safety and tolerability of intratumoral (IT) PH-762 in the treatment of Stages 1, 2, and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma."

Currently, Phio Pharmaceuticals has one therapy (PH-762 (INTASYL)) targeting the following condition: Murine colorectal cancer.

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:PHIO) was last updated on 7/9/2025 by MarketBeat.com Staff
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