Quarterly ResultAug 13, 2026, 04:23 PM
Celcuity Gets FDA Approval for REVTORPYK; Q2 Net Loss $78.9M
AI Summary
Celcuity Inc. announced significant clinical and regulatory milestones, including FDA approval for REVTORPYK™ (gedatolisib) and positive Phase 3 results for its PIK3CA mutant cohort, with an sNDA planned for Q3 2026. The company reported a Q2 2026 net loss of $78.9 million, an increase from the prior year, primarily due to higher SG&A expenses for commercial launch preparations. Celcuity also completed a $575.0 million convertible note offering, boosting its cash reserves to $754.0 million, expected to fund operations into 2029.
Key Highlights
- FDA approved REVTORPYK for HR+/HER2- PIK3CA Wild-Type breast cancer on July 14, 2026.
- Phase 3 VIKTORIA-1 PIK3CA mutant cohort achieved primary endpoint, sNDA planned Q3 2026.
- Q2 2026 net loss was $78.9 million, compared to $45.3 million in Q2 2025.
- Q2 2026 SG&A expenses rose to $35.0 million from $7.6 million YoY.
- Completed $575.0 million convertible note offering, with $557.2 million net proceeds.
- Cash, cash equivalents, and short-term investments totaled $754.0 million at Q2 end.
- NCCN® recommended REVTORPYK as a preferred Category 1 option.
Price Impact
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