IO Biotech’s Hold Rating Amid Financial and Regulatory Uncertainty
Morgan Stanley analyst Michael Ulz maintains a Hold rating on IO Biotech with a $0.39 price target due to financial and regulatory uncertainties. The company awaits an FDA meeting in December for its Phase 3 trial design of Cylembio, a drug with promising but not statistically significant Phase 2 results. IO Biotech's cash reserves are limited, supporting operations only until Q1 2026. Ulz suggests a wait-and-see approach for clarity on financial and regulatory paths. Ulz is a 3-star analyst with a 2.6% average return and 43.71% success rate.
Analyst Michael Ulz of Morgan Stanley reiterated a Hold rating on IO Biotech, retaining the price target of $0.39.
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Michael Ulz has given his Hold rating due to a combination of factors surrounding IO Biotech’s current financial and clinical situation. The company is in a phase of uncertainty as it awaits a crucial meeting with the FDA in December to discuss the design of a Phase 3 trial for its drug, Cylembio. Although past clinical data for Cylembio in melanoma showed promising trends in progression-free survival, it narrowly missed achieving statistical significance, which has led to a cautious stance from the FDA regarding a potential Biologics License Application (BLA) submission.
Additionally, while Phase 2 data presented at the European Society for Medical Oncology Congress indicated broad potential for Cylembio in other cancers, such as SCCHN and NSCLC, the company’s limited cash reserves, which are expected to support operations only through the first quarter of 2026, add to the near-term uncertainty. Given these factors, Ulz maintains a Hold rating, suggesting a wait-and-see approach until there is greater clarity on the company’s financial position and regulatory path forward.
According to TipRanks, Ulz is a 3-star analyst with an average return of 2.6% and a 43.71% success rate. Ulz covers the Healthcare sector, focusing on stocks such as Ionis Pharmaceuticals, Kyverna Therapeutics, Inc., and Alnylam Pharma.
