INO-3107 Gets FDA Green Light: What Inovio's Rare Disease Therapy Means for Investors

Inovio Pharmaceuticals has cleared a major regulatory hurdle as the FDA greenlit its Biologics License Application for INO-3107, marking a critical milestone in treating recurrent respiratory papillomatosis (RRP). The agency set an October 30, 2026 target date for a complete review decision and signaled it won’t require an advisory committee meeting—a positive sign that typically accelerates timelines.

However, there’s a caveat: while INO-3107 is advancing under accelerated approval, the FDA flagged in its acceptance letter that additional justification may be needed to maintain this fast-track status. Inovio management plans to engage the agency promptly to clarify requirements and believes the therapy addresses a genuine medical need.

The Clinical Picture: Strong Data Supporting 3107’s Case

Recurrent respiratory papillomatosis is a brutal condition where benign tumors grow repeatedly in the airway, caused primarily by HPV-6 and HPV-11 strains. Patients face frequent surgeries to clear obstructions—a cycle that damages vocal cords and severely impacts quality of life. Current treatment essentially amounts to repeated procedures, offering no cure.

INO-3107 works differently. The therapy primes the immune system to recognize and attack HPV-infected cells, potentially stopping papilloma growth before it starts. Clinical results are compelling: in a Phase 1/2 study of adults who’d undergone at least two surgeries the previous year, 72% saw their surgical needs cut by half to completely eliminated during year one. Even more striking, 86% of patients maintained these benefits into year two without additional doses—and notably, half required no surgery at all.

The therapy demonstrated strong safety profiles too, with mostly mild side effects limited to injection-site soreness and fatigue.

Financial Runway and Stock Market Reality

As of end-September 2025, Inovio held $50.8 million in cash and equivalents, enough to sustain operations through Q2 2026. That timeline creates pressure to maintain momentum toward approval and potential commercialization.

The market, however, remained skeptical. Following the FDA announcement, Inovio’s stock took a hit in pre-market trading, dropping nearly 20% to $1.85 as investors digested the agency’s hint about additional information requirements. Over the past year, the stock has ranged between $1.30 and $2.98, reflecting typical volatility around regulatory events.

What’s Next for 3107

Inovio carries Orphan Drug and Breakthrough Therapy designations for INO-3107, both intended to accelerate development for serious, unmet conditions. The Phase 1/2 data have been published in Nature Communications and The Laryngoscope, adding scientific credibility.

With the BLA now officially under review, the company’s immediate focus is addressing FDA concerns and positioning INO-3107 for potential approval within the 10-month review window. Success here could open a door to treating thousands of RRP patients who currently have no alternatives beyond repeated surgery.