Celcuity (CELC) Q2 FY26 earnings call

Celcuity reported Q2 FY26 results highlighted by the FDA approval of REVTORPYK and a rapid NCCN Category 1 recommendation for HR+/HER2- advanced breast cancer. Positive Phase III VIKTORIA-1 data for the PIK3CA mutant cohort further strengthens the drug's profile, with an sNDA submission planned for Q3 FY26. The company is preparing for REVTORPYK shipments in late Q3 FY26, targeting a significant market opportunity, while also expanding its first-line VIKTORIA-2 study and advancing a prostate cancer program.