Celcuity Inc. Announces U.S. Commercial Launch of REVTORPYK

What Happened

Celcuity Inc. announced on September 30, 2026 (via an 8-K and press release) that REVTORPYK™ (gedatolisib) is now commercially available in the United States. The approval covers eligible patients with hormone receptor‑positive (HR+), HER2‑negative (HER2‑) locally advanced or metastatic breast cancer (ABC) who do not have a PIK3CA mutation detected and who have progressed on or after at least one line of endocrine therapy in the metastatic setting. The press release is furnished as Exhibit 99.1 to the 8-K.

Key Details

• Filing date: September 30, 2026 (Form 8-K; Regulation FD disclosure and Other Events).
• Product: REVTORPYK™ (gedatolisib) — now commercially available in the U.S.
• Indication: HR+/HER2- locally advanced or metastatic breast cancer without a detected PIK3CA mutation after progression on ≥1 line of endocrine therapy in the metastatic setting.
• Press release attached as Exhibit 99.1 to the 8-K.

Why It Matters

This filing notifies investors that Celcuity has moved REVTORPYK from development/approval into commercial availability in the U.S., creating the potential for product sales to appear in future revenue reporting. Investors should watch upcoming quarterly filings and company updates for information on product launch progress, uptake, pricing, reimbursement, and any reported commercial revenue or launch-related expenses.