REVTORPYK launch remains on track: Celcuity expects commercial shipments of its FDA-approved gedatolisib therapy for certain advanced breast cancer patients to begin in late Q3 2026. The treatment has a $30,000 per-cycle wholesale acquisition cost, and the company estimates a U.S. addressable market exceeding $6 billion annually. Clinical expansion continues: Celcuity plans a supplemental filing for the PIK3CA-mutant VIKTORIA-1 cohort after results showed roughly 11 months of median progression-free survival and fewer treatment discontinuations than alpelisib.
The company is also expanding first-line breast cancer studies and advancing a prostate cancer trial. Higher losses reflect launch preparations: Q2 net loss widened to $78.9 million as selling, general and administrative expenses increased substantially for commercial hiring and pre-launch activities. Celcuity ended June with $754 million in cash and investments, expected to fund operations into at least 2029. 3 Stocks You'll Wish You Bought Before 2026 Celcuity (NASDAQ:CELC) said it remains on track to begin commercial shipments of REVTORPYK, its gedatolisib therapy for certain patients with advanced breast cancer, late in the third quarter of 2026 following its recent FDA approval.
The FDA approved REVTORPYK in July in combination with fulvestrant, with or without palbociclib, for patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation who progressed on or after at least one line of endocrine therapy in the metastatic setting. Shortly afterward, the National Comprehensive Cancer Network recommended both the triplet and doublet regimens as preferred Category 1 options for second-line or subsequent treatment in tumors without a PIK3CA mutation, Chief Executive Officer and Co-founder Brian Sullivan said during the company's second-quarter call. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Sullivan said Celcuity plans to submit a supplemental new drug application in the third quarter seeking to include data from the PIK3CA-mutant cohort of its Phase III VIKTORIA-1 trial. The company also expects to submit VIKTORIA-1 data from both the wild-type and mutant cohorts to global regulators after the U.S. filing.
At the ASCO annual meeting in June, Celcuity presented results from the PIK3CA-mutant cohort. In the primary analysis, the gedatolisib triplet produced median progression-free survival of 11.1 months, compared with 5.6 months for alpelisib plus fulvestrant, with a hazard ratio of 0.50. The gedatolisib doublet showed median progression-free survival of 11.3 months, compared with 5.6 months for alpelisib plus fulvestrant, with a hazard ratio of 0.51. → Nebius' Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand Celcuity updated its adverse-event discontinuation analysis using the methodology used for the wild-type cohort in the REVTORPYK label.
The company said 5.2% of patients receiving the gedatolisib triplet and 3.8% receiving the doublet discontinued gedatolisib because of an adverse event in the mutant cohort, compared with 19% who discontinued alpelisib due to an adverse event. The company is also expanding its VIKTORIA-2 first-line breast cancer program. A second study will evaluate gedatolisib with palbociclib and letrozole in treatment-naive, endocrine-sensitive HR-positive, HER2-negative advanced breast cancer.
The ongoing first study is evaluating gedatolisib, palbociclib and fulvestrant in treatment-naive endocrine-resistant disease. → On Holding's Price Stumble May Be an Opening for a Company Built to Run Sullivan cited an earlier Phase Ib trial of gedatolisib, palbociclib and letrozole in 41 endocrine-sensitive patients, in which median progression-free survival was 48.6 months and the objective response rate was 79%. He said Celcuity is also continuing work on a subcutaneous formulation intended to demonstrate clinical equivalence with the current intravenous formulation. Celcuity said its commercial infrastructure is in place, including 88 oncology sales specialists.
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