Quarterly ResultAug 13, 2026, 04:08 PM
Celcuity's REVTORPYK Receives FDA Approval; Q2 Net Loss $(78.9)M
AI Summary
Celcuity Inc. announced the U.S. FDA approval of REVTORPYK (gedatolisib) on July 14, 2026, for HR+/HER2- PIK3CA Wild-Type breast cancer, with commercial launch expected in late Q3 2026. The drug also received a preferred Category 1 recommendation in NCCN Guidelines and positive Phase 3 trial 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, or $(1.44) per share, reflecting increased SG&A expenses for commercialization. Celcuity also completed a $575.0 million convertible note offering, boosting cash reserves to $754.0 million, expected to fund operations into 2029.
Key Highlights
- U.S. FDA approved REVTORPYK (gedatolisib) on July 14, 2026, for HR+/HER2- PIK3CA Wild-Type breast cancer.
- REVTORPYK received NCCN® Clinical Practice Guidelines preferred Category 1 recommendation for second-line therapy.
- Phase 3 VIKTORIA-1 trial (PIK3CA mutant cohort) achieved primary endpoint; sNDA planned for Q3 2026.
- Completed $575.0 million convertible note offering, with net proceeds of $557.2 million.
- Q2 2026 net loss was $(78.9) million, or $(1.44) per share, compared to $(45.3) million in Q2 2025.
- Q2 2026 SG&A expenses increased to $35.0 million from $7.6 million, driven by commercial launch prep.
- Cash, cash equivalents, and short-term investments totaled $754.0 million, expected to fund operations into 2029.
- VIKTORIA-2 trial expanded to evaluate gedatolisib as first-line treatment for endocrine-sensitive breast cancer.
Price Impact
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