Balanced View on INOVIO’s INO-3107: Strong Long-Term Data Offset by Regulatory and Timing Uncertainty Driving Hold Rating

Analyst Ram Selvaraju of H.C. Wainwright reiterated a Hold rating on Inovio Pharmaceuticals, retaining the price target of $3.00.

Ram Selvaraju has given his Hold rating due to a combination of factors related to both regulatory trajectory and clinical promise. While he views the FDA’s acceptance of the BLA for INO-3107 in recurrent respiratory papillomatosis as an important milestone, he also notes that the agency assigned only a standard review and declined, for now, to recognize the program as suitable for accelerated approval. This introduces timing and regulatory uncertainty, as INOVIO must now pursue additional discussions with the FDA to argue for accelerated status. At the same time, he acknowledges that INO-3107 benefits from Orphan Drug and Breakthrough Therapy designations and is differentiated by its potential to reduce or eliminate the need for repeated surgeries during the treatment period.

Selvaraju also takes into account the strength of the long-term clinical data, which show sustained and even improving reductions in surgery frequency over multiple years, alongside a clean safety profile. The growing proportion of patients achieving either substantial reductions in surgeries or complete freedom from surgery supports the therapeutic relevance of INO-3107. However, with the PDUFA date set for late 2026 and lingering questions around the regulatory pathway, he appears to view the risk‑reward balance as fairly even at current valuation levels. This mix of encouraging efficacy and safety data on one side, and regulatory and timing risks on the other, underpins his decision to maintain a Neutral (Hold) stance and keep the price target unchanged.

Selvaraju covers the Healthcare sector, focusing on stocks such as Vanda, Genmab, and Anavex Life Sciences. According to TipRanks, Selvaraju has an average return of 25.1% and a 56.71% success rate on recommended stocks.