What Happened?

On July 18, 2025, Oscotec announced the submission of its IND application for OCT-598, a potential treatment for advanced solid tumors, to both the Korean MFDS and the US FDA. Following FDA approval on June 2nd, the application to the MFDS accelerates the development process.

Why is Clinical Trial Initiation Important?

Advanced solid tumors represent a large market with high unmet medical needs. Successful development of OCT-598 is expected to increase Oscotec’s sales and the possibility of technology transfer. This presents an opportunity to address concerns about increasing R&D costs and declining royalty income.

What’s Next?

  • Positive Scenario: Success in Phase 1 trials increases the likelihood of technology transfer. Positive clinical results could boost investor confidence and drive stock prices higher.
  • Negative Scenario: The high failure rate of drug development, the competitive landscape, and macroeconomic factors could negatively impact Oscotec. Rising interest rates, in particular, could increase the burden on R&D investment.

Investor Action Plan

OCT-598’s entry into Phase 1 clinical trials is a positive sign for Oscotec’s long-term growth potential. However, investment decisions should be made cautiously. Focus on a long-term investment strategy rather than short-term stock fluctuations. Continuous monitoring of clinical trial results, competitor drug development, and market conditions is crucial.