Celcuity Inc. Announces FDA Approval of REVTORPYK for HR+/HER2- Breast Cancer

What Happened

• On July 14, 2026 Celcuity Inc. (CELC) announced that the U.S. Food and Drug Administration approved REVTORPYK™ (gedatolisib) for the treatment of patients with hormone receptor–positive (HR+), HER2‑negative (HER2‑) locally advanced or metastatic breast cancer without a PIK3CA mutation detected, after progression on or after at least one line of endocrine therapy in the metastatic setting.
• The company issued a press release (Exhibit 99.1) and provided an investor presentation (Exhibit 99.2), and hosted a live webcast and conference call on July 14, 2026 at 4:30 p.m. CT to discuss the approval.

Key Details

• Approval announced: July 14, 2026 (reported in Form 8-K filed July 15, 2026).
• Indication: HR+/HER2‑, locally advanced or metastatic breast cancer WITHOUT a PIK3CA mutation detected, after ≥1 line of endocrine therapy in the metastatic setting.
• Commercial timing: Company anticipates commercial launch of REVTORPYK in late Q3 2026.
• Regulatory follow-up: Celcuity plans to submit an sNDA in Q3 2026 for REVTORPYK to treat HR+/HER2‑ patients WITH PIK3CA mutations, based on results from the mutant cohort of the Phase 3 VIKTORIA‑1 trial (referenced in slide 18 of Exhibit 99.2).

Why It Matters

• FDA approval creates an immediate commercial pathway for REVTORPYK with a planned launch in late Q3 2026, which could meaningfully affect Celcuity’s near‑term revenue opportunity.
• The planned sNDA for the PIK3CA‑mutant population aims to expand the drug’s labeled patient population if approved, using Phase 3 VIKTORIA‑1 data.
• For investors, the filing signals a shift from development to commercialization and upcoming corporate communications (press release, investor presentation, webcast) that will provide more details on launch plans and potential market opportunity.