Celcuity Inc. Reports Release of Second Quarter 2026 Financial Results and Provides Corporate Update

August 13, 2026 - 22:15

Celcuity Inc. has released its financial results for the second quarter of 2026, highlighted by the recent U.S. Food and Drug Administration approval of its lead candidate, REVTORPYK (gedatolisib). The therapy was cleared on July 14, 2026, for adult patients with HR-positive, HER2-negative, PIK3CA wild-type locally advanced or metastatic breast cancer. The company confirmed it remains on schedule to launch the product commercially in the late third quarter of 2026.

Adding to the momentum, the National Comprehensive Cancer Network has updated its clinical practice guidelines to recommend REVTORPYK in combination with fulvestrant, with or without palbociclib, as a preferred Category 1 option for second-line treatment in advanced HR-positive, HER2-negative breast cancer. This designation places the regimen among the top choices for physicians managing this patient population.

In the pipeline, the Phase 3 PIK3CA mutant cohort of the VIKTORIA-1 trial successfully achieved its primary endpoint. The company did not disclose specific efficacy data in the announcement but noted that full results will be presented at an upcoming medical conference. Management emphasized that this positive readout expands the potential addressable patient population beyond the initial wild-type approval.

Financially, the company reported its cash position and operating expenses for the quarter, reflecting increased investment in manufacturing scale-up and pre-commercialization activities. Celcuity leadership stated that the company is well capitalized to support the upcoming launch and ongoing clinical development programs. The full financial statement is available on the company's investor relations page.