Celcuity Wins FDA Clearance for REVTORPYK
Gedatolisib was approved July 14 for HR+/HER2- PIK3CA wild-type advanced breast cancer, with shipments expected late in the third quarter of 2026.
Celcuity Inc. (CELC), a biotechnology company developing targeted therapies for solid tumors, said the U.S. Food and Drug Administration approved REVTORPYK (gedatolisib) on July 14, 2026, for hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation after progression on at least one line of endocrine therapy.
The company said it is on track to begin shipping the drug late in the third quarter of 2026. The National Comprehensive Cancer Network recommended REVTORPYK in combination with fulvestrant, with or without palbociclib, as a preferred Category 1 second-line option. Commercial infrastructure was complete, and launch activities started immediately after approval. An Expanded Access Program opened last week, and gedatolisib has begun to be distributed to participating physicians.
Chief Executive Brian Sullivan said the company is well positioned to address unmet need in HR+/HER2-, PIK3CA wild-type disease that has progressed after endocrine therapy.
Detailed results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial, presented at the 2026 ASCO Annual Meeting, showed the gedatolisib triplet reduced the risk of disease progression or death by 50% versus alpelisib plus fulvestrant (HR=0.50; 95% CI 0.37–0.68; p<0.0001). Median progression-free survival was 11.1 months with the triplet versus 5.6 months with alpelisib plus fulvestrant. The gedatolisib doublet reduced that risk by 49% (HR=0.51), with median PFS of 11.3 months. Objective response rates were 49% for the triplet and 36% for the doublet. Discontinuations due to adverse events were 5.2% for the triplet and 3.8% for the doublet, versus 19.1% for alpelisib. Celcuity intends to file a supplemental New Drug Application in the third quarter of 2026 and to submit VIKTORIA-1 data to other regulators afterward.
The Phase 3 VIKTORIA-2 trial was expanded in the second quarter to add Study 2, evaluating gedatolisib with palbociclib and letrozole in treatment-naive endocrine-sensitive HR+/HER2- advanced breast cancer. Study 1 continues in endocrine-resistant patients. Sullivan said the expansion positions gedatolisib regimens to potentially be available for nearly all patients in the first- and second-line setting, irrespective of endocrine sensitivity or PIK3CA status.
In metastatic castration-resistant prostate cancer, the Phase 1b study of gedatolisib with darolutamide completed evaluation of a 240 mg dose, with no adverse events leading to discontinuation and no dose-limiting toxicity criteria met. A 300 mg dose is under evaluation. The company expects to select recommended Phase 2 dose levels after the Phase 1/1b portion is complete and to provide updated mCRPC data in the fourth quarter of 2026. A subcutaneous gedatolisib formulation is in development.
Net loss for the second quarter ended June 30, 2026, was $78.9 million, or $1.44 a share, compared with a net loss of $45.3 million, or $1.04 a share, a year earlier. Non-GAAP adjusted net loss was $58.7 million, or $1.07 a share.
Total operating expenses were $66.1 million. Selling, general and administrative expenses were $35.0 million, up $27.4 million from $7.6 million a year earlier. The $23.4 million increase related to commercial headcount and other launch-related activities, including hiring for the anticipated REVTORPYK launch and pre-commercial costs. Research and development expenses were $31.1 million, down $5.3 million from $36.4 million, primarily because of lower VIKTORIA-1 clinical trial costs and license milestone costs.
Net cash used in operating activities was $55.4 million. The company completed a $575.0 million convertible note offering in June, with net proceeds of $557.2 million, and used $137.0 million of the proceeds to prepay term loan debt. Convertible notes on the balance sheet were $753.2 million at June 30, 2026, versus $195.3 million at December 31, 2025; the note payable was zero. An $11.5 million loss on debt extinguishment appeared in the quarter. Interest expense was $5.4 million.
Cash, cash equivalents and short-term investments were $754.0 million at the end of the second quarter. That balance will finance operations at least into 2029.