Free Trial

Phio Pharmaceuticals (PHIO) FDA Approvals

Phio Pharmaceuticals logo
$0.95 +0.02 (+1.62%)
Closing price 03:59 PM Eastern
Extended Trading
$0.93 -0.02 (-1.96%)
As of 04:27 PM 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 Massive. Learn more.

Upcoming FDA Events for Phio Pharmaceuticals

Phio Pharmaceuticals (PHIO) has upcoming FDA regulatory milestones for PH-762 (INTASYL). The table below outlines estimated target dates and event types for these pending regulatory actions.

DrugTarget DateAnnouncement
PH-762 (INTASYL)Q1 2027Initiation
Phio Pharmaceuticals Corp announced the Planned Phase 2b Clinical Trial Initiation in First Quarter 2027 (October 13, 2026)

Phio Pharmaceuticals' Drugs in the FDA Approval Process

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 and PH-894. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

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.

PH-894 FDA Regulatory Events

PH-894 is a drug developed by Phio Pharmaceuticals for the following indication: Antitumor cytotoxic agent. 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

In the past two years, Phio Pharmaceuticals (PHIO) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Phio Pharmaceuticals (PHIO) has reported FDA regulatory activity for the following drugs: PH-762 (INTASYL) and PH-894.

The most recent FDA-related event for Phio Pharmaceuticals occurred on October 13, 2026, involving PH-762 (INTASYL). The update was categorized as "Provided Update," with the company reporting: "Phio Pharmaceuticals Corp. announced the successful release of its first commercial-scale cGMP batch of PH-762 drug substance (active pharmaceutical ingredient), representing a critical operational and strategic milestone as the Company advances PH-762 to the next stage of clinical development."

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

  • Murine colorectal cancer - PH-762 (INTASYL)
  • Antitumor cytotoxic agent - PH-894
  • 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

FDA progress for NASDAQ:PHIO last updated on 10/13/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
From Our Partners