Phio Pharmaceuticals' Drug 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. 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.
- Drug:
- PH-762 (INTASYL)
- Announced Date:
- June 25, 2025
- Indication:
- Murine colorectal cancer
Announcement
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.
AI Summary
Phio Pharmaceuticals recently announced that its Safety Monitoring Committee (SMC) has recommended a dose escalation in its Phase 1b clinical trial. The trial is testing the safety and tolerability of intratumoral PH-762 for treating various skin cancers, including Stages 1, 2, and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma.
In the fourth cohort, five patients were enrolled—four with cSCC and one with Merkel cell carcinoma. The injections were well-tolerated, with no dose-limiting toxicities, serious adverse events, or clinically significant treatment-related reactions observed. This positive outcome has encouraged the dose increase for the anticipated fifth cohort, suggesting that a higher dose may also maintain a favorable safety profile. Researchers are hopeful that PH-762 will continue to be a promising non-surgical treatment for these difficult-to-treat skin cancers.
Read Announcement- Drug:
- PH-762 (INTASYL)
- Announced Date:
- June 24, 2025
- Indication:
- Murine colorectal cancer
Announcement
Phio Pharmaceuticals Corp. announced today that Mr. Robert Bitterman, CEO and Chairman of the Board, Phio Pharmaceuticals will present an update on the company's proprietary INTASYL siRNA technology and progress on the on-going clinical trial with lead compound PH-762 for treatment of skin cancers.
AI Summary
Phio Pharmaceuticals Corp., a clinical-stage siRNA biopharmaceutical company, announced that its CEO and Chairman, Mr. Robert Bitterman, will soon update stakeholders on their proprietary INTASYL® gene silencing technology. During the presentation, Mr. Bitterman will review the progress of the on-going Phase 1b clinical trial of PH-762, the company’s lead compound for treating skin cancers. PH-762 is designed to target and silence specific genes involved in cancer progression, and recent early trial results have shown promise in terms of safety and efficacy. The update, which includes a live Q&A session, is scheduled for Monday, June 30, 2025, at 10:00 am EST. This presentation is part of Phio's ongoing efforts to develop innovative, non-surgical treatment options for various forms of skin cancer, highlighting the company’s commitment to advancing cancer therapies through its INTASYL technology.
Read Announcement- Drug:
- PH-762 (INTASYL)
- Announced Date:
- May 19, 2025
- Indication:
- Murine colorectal cancer
Announcement
Phio Pharmaceuticals Corp announced that Mr. Robert Bitterman, CEO and Chairman of the Board, Phio Pharmaceuticals will present an update on the company's proprietary INTASYL siRNA technology and progress on the on-going clinical trial with lead compound PH-762 for treatment of skin cancers.
AI Summary
Phio Pharmaceuticals Corp’s CEO and Chairman, Robert Bitterman, will present an update on the company’s proprietary INTASYL siRNA technology. During his presentation on May 22, 2025, Mr. Bitterman will share progress on the ongoing Phase 1b clinical trial of PH-762, the company’s lead compound for treating skin cancers. The trial focuses on cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma, aiming to provide a non-surgical treatment option. The presentation will outline how INTASYL technology works by silencing specific genes to enhance the body’s immune response against cancer cells. This update is expected to highlight the innovation behind Phio’s approach and offer valuable insights for investors and stakeholders on the company’s progress toward a cancer-free future with advanced gene-silencing therapeutics.
Read Announcement- Drug:
- PH-762 (INTASYL)
- Announced Date:
- May 7, 2025
- Indication:
- Murine colorectal cancer
Announcement
Phio Pharmaceuticals Corp. announced today that a complete pathologic response (100% tumor clearance) has been reported for 2 of 3 patients with cutaneous squamous cell carcinoma (cSCC) treated in the third dose cohort.
AI Summary
Phio Pharmaceuticals Corp. announced promising results from the third dose cohort of its Phase 1b trial for skin cancers. In this group, two of three patients with cutaneous squamous cell carcinoma achieved a complete pathologic response, meaning they experienced 100% tumor clearance. This result highlights the potential of PH-762 as a non-surgical treatment option for cSCC.
The trial uses Phio’s INTASYL® gene silencing technology and is designed to test the safety and tolerability of the treatment. So far, the therapy has been well tolerated with few adverse effects, which adds to optimism about its future use in the skin cancer market. Phio plans to continue enrolling patients as the trial progresses, aiming to further explore the benefits and optimal dosing of PH-762.
Read Announcement- Drug:
- PH-762 (INTASYL)
- Announced Date:
- April 9, 2025
- Indication:
- Murine colorectal cancer
Announcement
Phio announced today that the Safety Monitoring Committee (SMC) recommended dose escalation in Phio's Phase 1b clinical trial (NCT 06014086) for Phio's lead product candidate, PH-762.
AI Summary
Phio Pharmaceuticals announced that the Safety Monitoring Committee (SMC) recommended dose escalation in its ongoing Phase 1b clinical trial (NCT 06014086) for its lead product candidate, PH-762. The decision comes after observations from the third cohort, where patients with cutaneous squamous cell carcinoma were treated without any serious adverse events or dose-limiting toxicities. This favorable safety profile supports the plan to increase the dose concentration in future cohorts. The Phase 1b trial is a multi-center, dose-escalating study aimed at assessing the safety and tolerability of intratumoral PH-762 administration in skin cancer patients, including those with melanoma and Merkel cell carcinoma. This step forward suggests that PH-762 may continue to demonstrate both safety and potential effectiveness, reinforcing its promise as a possible non-surgical treatment option for various types of skin cancers.
Read Announcement- Drug:
- PH-762 (INTASYL)
- Announced Date:
- March 5, 2025
- Indication:
- Murine colorectal cancer
Announcement
Phio Pharmaceuticals Corp. announced that it has fulfilled the required enrollment for safety in its third dose cohort in its Phase 1b dose escalating clinical study for their lead compound PH-762.
AI Summary
Phio Pharmaceuticals has reached a key milestone in its Phase 1b dose-escalation study for PH-762, its lead compound for treating skin cancers. The company announced that it has successfully enrolled the required number of patients in the third dose cohort needed to assess safety. Utilizing its INTASYL siRNA gene silencing technology, PH-762 is designed to enhance immune cells so they can better attack cancer cells, potentially offering a non-surgical treatment option for conditions such as cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma.
Following this important enrollment achievement, Phio plans to begin screening for the fourth dose cohort in early April. This progress is a vital step in determining the optimal dose and ensuring patient safety as the study advances, bringing the therapy closer to future clinical development and potential treatment options for skin cancer patients.
Read Announcement- Drug:
- PH-762 (INTASYL)
- Announced Date:
- January 13, 2025
- Indication:
- Murine colorectal cancer
Announcement
Phio Pharmaceuticals Corp announced pathologic responses for patients enrolled in the 2nd cohort, which includes 2 patients with a complete response or 100% tumor clearance.
AI Summary
Phio Pharmaceuticals Corp reported promising new results from its Phase 1b clinical trial. In the 2nd cohort of the study, two patients with cutaneous squamous cell carcinoma achieved a complete pathologic response, meaning they experienced 100% tumor clearance. These results show a significant improvement as complete response is a strong indicator of the therapy’s potential effectiveness in fighting cancer.
The study also noted that one patient experienced a partial response with a 90% reduction in tumor size, while another patient had stable disease. Importantly, the treatment was well tolerated with no dose-limiting toxicities or significant treatment-related adverse events reported. These encouraging outcomes support further evaluation of higher dose concentrations as the trial continues to assess the safety and potential benefits of PH-762 in treating skin cancers.
Read Announcement- Drug:
- PH-762 (INTASYL)
- Announced Date:
- December 19, 2024
- Indication:
- Murine colorectal cancer
Announcement
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 PH-762 in the treatment of Stages 1, 2, and 4 cutaneous squamous cell carcinoma, Stage 4 melanoma and Stage 4 Merkel cell carcinoma.
AI Summary
Phio Pharmaceuticals recently announced promising results from its Phase 1b clinical trial evaluating PH-762. The trial, which treats patients with Stages 1, 2, and 4 cutaneous squamous cell carcinoma—as well as Stage 4 melanoma and Stage 4 Merkel cell carcinoma—has shown an encouraging safety profile. In the second cohort, patients diagnosed with cutaneous squamous cell carcinoma received intratumoral injections that were well tolerated, with no dose-limiting toxicities or serious adverse events reported.
Based on these strong safety outcomes and early signs of efficacy, the Safety Monitoring Committee (SMC) recommended escalating the dose to further assess PH-762’s potential benefits. This dose increase is a key step in the ongoing clinical investigation as researchers continue to monitor its safety and effectiveness in enhancing the body’s immune response against skin cancers.
Read Announcement- Drug:
- PH-762 (INTASYL)
- Announced Date:
- November 19, 2024
- Indication:
- Murine colorectal cancer
Announcement
Phio Pharmaceuticals Corp. announced it has completed the enrollment of its second patient cohort in its PH-762 Phase 1b dose-escalating clinical trial, and added a sixth clinical site in San Diego, CA.
AI Summary
Phio Pharmaceuticals Corp. announced that it has finished enrolling its second patient cohort in the PH-762 Phase 1b dose-escalation trial. The study is testing a new treatment for skin cancers such as squamous cell carcinoma, melanoma, and Merkel cell carcinoma. In this group, one patient achieved complete tumor clearance and another reached 90% tumor reduction. Along with this milestone, Phio expanded its clinical trial network by adding a sixth site in San Diego, California. The new site at Paradigm Clinical Research Centers joins five other locations across the United States, reinforcing the company’s commitment to advancing its innovative therapy. Phio’s efforts with PH-762 use its INTASYL gene silencing technology to help the immune system attack cancer more effectively, highlighting promising steps toward improved cancer treatment.Read Announcement
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
FDA Event Stage Terminology & Abbreviation Guide
- 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 7/29/2025 by MarketBeat.com Staff
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