Celcuity Q2 net loss $78.9M; FDA approves REVTORPYK, positive PIK3CA MT data

Celcuity Inc.

FDA approved REVTORPYK (gedatolisib) for HR+/HER2- PIK3CA WT advanced breast cancer on July 14, 2026; launch expected late Q3 2026.
Phase 3 VIKTORIA-1 PIK3CA MT: gedatolisib triplet cut progression/death risk 50% vs alpelisib (HR=0.50, p<0.0001); median PFS 11.1 vs 5.6 months.
Q2 2026 net loss $78.9M ($1.44/share) vs $45.3M ($1.04) prior year; adjusted net loss $58.7M ($1.07) vs $40.5M ($0.93).
Completed $575M convertible notes offering, net proceeds $557.2M; used $137M to prepay term loan debt.
sNDA for PIK3CA MT cohort planned Q3 2026; VIKTORIA-2 expanded to first-line endocrine-sensitive patients.

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