Phio Pharmaceuticals Announces PH-762 FDA Submission, Plans Phase 2b Study

What Happened
Phio Pharmaceuticals (PHIO) filed a Form 8‑K on September 14, 2026 (Item 8.01) and issued a press release reporting a development milestone for its oncology candidate PH‑762. The company says it has submitted materials to the U.S. Food and Drug Administration to support the next phase of clinical development in cutaneous cell carcinoma and is planning a Phase 2b neoadjuvant study. The press release is attached as Exhibit 99.1 to the filing.

Key Details

• Filing date: September 14, 2026 (Form 8‑K, Item 8.01).
• Program: PH‑762 for cutaneous cell carcinoma.
• Action: Submission of materials to the FDA to support next‑phase clinical development.
• Planned study: Phase 2b neoadjuvant trial (company announced plan; timing and study details to follow).

Why It Matters
This filing documents a clinical development milestone for PH‑762 and indicates Phio is moving toward a larger Phase 2b study. For investors, FDA submissions and progression to later‑stage trials are key operational events that can affect timelines, future data readouts, and the program’s valuation. Watch for subsequent updates on FDA feedback, trial start dates, protocol details, and clinical results.