INO-3107 Clears FDA Milestone: What Inovio's Clinical Victory Means for RRP Patients

Inovio Pharmaceuticals (INO) just scored a major regulatory win. The FDA has accepted the company’s Biologics License Application for INO-3107, a potential game-changer for patients battling recurrent respiratory papillomatosis (RRP). The agency set an October 30, 2026 PDUFA date and signaled it won’t require an advisory committee meeting—though it flagged that additional evidence may be needed to fully support accelerated approval status.

The Clinical Data That Got FDA’s Attention

Here’s why the market should care: INO-3107’s Phase 1/2 trial delivered compelling results. Among RRP patients who’d undergone at least two surgeries in the prior year, 72% saw their surgery frequency drop by 50-100% in year one post-treatment. Even more impressive, 86% of evaluable patients maintained those gains into year two without repeat dosing, with half requiring zero surgeries.

These aren’t vanity numbers. RRP, caused primarily by HPV-6 and HPV-11, forces patients into a cycle of repeated surgical procedures to clear benign papillomas blocking their airways. Each surgery risks permanent vocal cord damage and devastating quality-of-life impacts. A therapy that slashes surgical burden could be transformative.

How INO-3107 Actually Works

The drug’s mechanism is straightforward: it primes the immune system to mount an antigen-specific T-cell attack against HPV-infected cells, potentially halting or slowing papilloma regrowth. Clinical testing showed it’s well-tolerated, with mostly mild adverse events like injection-site soreness and fatigue.

INO-3107 already carries both Orphan Drug and Breakthrough Therapy designations, reflecting the unmet need in this rare disease space. The company plans to engage the FDA on next steps, though the agency’s caveat about additional information suggests some regulatory groundwork remains.

The Financial Reality Check

Here’s the catch: Inovio ended Q3 2025 with $50.8 million in cash and equivalents—enough runway to fund operations into Q2 2026. That timeline cuts close to the PDUFA decision, creating potential pressure points down the road.

Market reaction was mixed. While the FDA acceptance is objectively positive, investors zeroed in on the regulatory uncertainty around accelerated approval. INO stock dropped 19.21% in pre-market trading to $1.85, reflecting concern that the approval pathway could be bumpier than hoped. The stock has ranged between $1.30 and $2.98 over the past year.

What’s Next for INO and RRP Patients?

INO-3107 represents one of few pharmaceutical approaches to RRP, a condition that’s devastated patient populations for decades. With clinical efficacy demonstrated and FDA engagement underway, the next 12 months will determine whether this therapy reaches patients and reshapes RRP treatment paradigms.