Chase Knickerbocker's questions to Celcuity (CELC) leadership • Q2 2025
Question
Chase Knickerbocker from Craig-Hallum asked for commentary on the competitive landscape in the PIK3CA mutant population and for an update on the company's confidence in its Chemistry, Manufacturing, and Controls (CMC) package for the upcoming NDA submission.
Answer
CEO Brian Sullivan addressed competition by noting that recently approved drugs like inavolisib target a different, first-line patient population, and positioned Gadafelicitinib as potentially superior due to its efficacy regardless of PIK3CA status and its favorable safety profile. On the CMC package, Sullivan expressed high confidence, stating that all required studies are complete, the data is robust, and the company has engaged with the FDA to ensure alignment, leaving no open questions.