Successful Enrollment in Phase III Trial
Celcuity announced that the PIK3CA wild-type cohort in their VIKTORIA-1 Phase III clinical trial is 100% enrolled, marking an important milestone for the company.
Strong Financial Position
Celcuity ended the quarter with approximately $264.1 million in cash, cash equivalents, and short-term investments, an increase of $83.5 million from the previous year.
Robust Research and Development Progress
Research and development expenses increased significantly, indicating active progress in clinical trials and enhanced operations.
Encouraging Safety Profile
Gedatolisib's treatment-related discontinuation rate in the Phase Ib arm was low at 4%, showing a promising safety profile compared to other treatments.
Positive Market Feedback
Feedback from oncologists and market access stakeholders was encouraging, particularly regarding gedatolisib’s IV administration route.
Potential Revenue Growth
Estimated peak revenue potential for gedatolisib in the second line and delayed indication could exceed $2 billion if approved.