Celcuity Inc. Announces FDA Approval of REVTORPYK

What Happened

• On July 14, 2026 (reported on Form 8-K filed July 15, 2026), Celcuity Inc. announced the U.S. Food and Drug Administration approved REVTORPYK™ (gedatolisib) for treatment of patients with hormone receptor positive (HR+), HER2‑negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected, following progression on or after at least one line of endocrine therapy in the metastatic setting.
• The company held a live webcast and conference call on July 14, 2026 (4:30 p.m. CT) to discuss the approval and furnished a press release and investor presentation as exhibits to the 8-K.

Key Details

• Approval announced: July 14, 2026; Form 8-K filed July 15, 2026.
• Indication: HR+/HER2‑ metastatic breast cancer patients without a detected PIK3CA mutation after progression on ≥1 endocrine therapy.
• Commercial timing: Celcuity anticipates launching REVTORPYK in late Q3 2026.
• Regulatory next step: Celcuity plans to submit a supplemental NDA (sNDA) in Q3 2026 to seek approval for HR+/HER2‑ patients with PIK3CA mutations, based on results from the mutant cohort of the Phase 3 VIKTORIA‑1 trial.

Why It Matters

• FDA approval allows Celcuity to begin commercializing REVTORPYK for a defined metastatic breast cancer population, with a planned launch in late Q3 2026—an important commercial milestone for the company.
• The planned sNDA for the PIK3CA‑mutated cohort could expand the drug’s label and address an additional patient subgroup if approved, based on Phase 3 VIKTORIA‑1 data.
• Investors should note the timing (late Q3 launch) and the near‑term regulatory action (sNDA submission in Q3 2026) as key catalysts for upcoming company activity and potential revenue generation.