IO Biotech's Promising Phase 3 Results and FDA Engagement Bolster Buy Rating

IO Biotech's promising Phase 3 trial results and strategic FDA engagement have bolstered a Buy rating from H.C. Wainwright analyst Emily Bodnar. The combination of IO102-IO103 with pembrolizumab demonstrated a significant median progression-free survival benefit of over 8 months with a comparable safety profile. Bodnar maintains a $14.00 price target and views these positive clinical outcomes and regulatory plans as key drivers of IO Biotech's stock.

Title: IO Biotech's Phase 3 Trial Results: A Mixed Bag of Results and Regulatory Engagement

IO Biotech, Inc. (IOBT) shares experienced a significant drop of 34.25 percent to $1.19 on Monday, August 10, 2025, after the company announced the topline results from its pivotal Phase 3 trial of the cancer vaccine Cylembio in combination with Merck's KEYTRUDA for advanced melanoma. While the treatment showed an improvement in progression-free survival over KEYTRUDA alone, it narrowly missed statistical significance for the primary endpoint [1].

The stock, which opened at $1.88 and traded between $1.18 and $2.04, saw a surge in volume to 70.37 million shares, far above the average of 0.32 million on the Nasdaq [1]. IO Biotech's 52-week range is $0.66 to $2.48 [1].

The Phase 3 trial (IOB-013/KN-D18; NCT05155254) evaluated Cylembio in combination with pembrolizumab versus pembrolizumab alone as a first-line treatment for unresectable or metastatic (advanced) melanoma. The trial was designed to assess the efficacy and safety of Cylembio in this setting [2][3].

Despite the mixed results, the company is planning to discuss the data package with the U.S. FDA this fall. CEO Mai-Britt Zocca stated that the trial missed the primary endpoint "by a hair" [4]. This strategic engagement with the FDA could potentially lead to further regulatory discussions and potential approvals.

Analyst Emily Bodnar from H.C. Wainwright has maintained a Buy rating for IO Biotech, citing the significant median progression-free survival benefit of over 8 months with a comparable safety profile. She maintains a $14.00 price target and views these positive clinical outcomes and regulatory plans as key drivers of IO Biotech's stock [1].

Investors are advised to closely monitor the upcoming conference call and webcast scheduled for Monday, August 11, 2025, at 8:30 AM ET, where the company will discuss the topline results from the Phase 3 trial [2][3].

References:
1. [1] https://www.rttnews.com/3564626/io-biotech-stock-plunges-34-after-announcement-of-phase-3-trial-results-for-cancer-vaccine.aspx
2. [2] https://investors.iobiotech.com/news-events/news/news-details/2025/IO-Biotech-to-Announce-Topline-Results-of-Pivotal-Phase-3-Trial-of-Cylembio-in-Combination-with-KEYTRUDA-pembrolizumab-as-a-First-Line-Treatment-for-Patients-with-Advanced-Melanoma/default.aspx
3. [3] https://www.marketscreener.com/news/io-biotech-to-announce-topline-results-of-pivotal-phase-3-trial-of-cylembio-in-combination-with-key-ce7c5ed2d881f621
4. [4] https://www.bioworld.com/articles/722996-skin-tight-io-biotech-melanoma-phase-iii-misses-by-a-hair?v=preview