Celcuity Inc. filed a Form 8-K on August 26, 2026, disclosing that it submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for REVTORPYK (gedatolisib) for the treatment of certain patients with advanced or metastatic breast cancer.

Key Highlights

  • sNDA Submitted: Celcuity submitted a supplemental New Drug Application to the FDA for REVTORPYK (gedatolisib) on August 26, 2026.
  • Target Indication: The application covers patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation.
  • Prior Treatment Requirement: The indicated patient population is defined as those following progression on or after treatment with at least one line of endocrine therapy.
  • Brand Name: The drug is identified in the filing under the trade name REVTORPYK.
  • Signed by CEO: The filing was signed by Brian F. Sullivan, Chief Executive Officer of Celcuity Inc.

Celcuity Submits sNDA for Gedatolisib in PIK3CA-Mutated Advanced Breast Cancer

According to the filing, Celcuity Inc. (NASDAQ:CELC) issued a press release on August 26, 2026, announcing the submission of its supplemental New Drug Application to the FDA for REVTORPYK, the brand name for gedatolisib. The application targets patients with hormone receptor-positive ("HR+"), human epidermal growth factor receptor 2-negative ("HER2-"), locally advanced or metastatic breast cancer ("ABC") who carry a PIK3CA mutation and have progressed on or after at least one line of endocrine therapy.

The disclosure was made under both Item 7.01 (Regulation FD Disclosure) and Item 8.01 (Other Events) of the Form 8-K. The filing notes that the information furnished under Item 7.01, including the accompanying press release filed as Exhibit 99.1, "shall not be deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934" and is not subject to the liabilities of that section. The press release dated August 26, 2026, is attached as Exhibit 99.1 to the report.

Celcuity is incorporated in Delaware and maintains its principal executive offices at 2800 Campus Drive, Suite 140, Minneapolis, Minnesota 55441, according to the filing. The company's common stock, with a par value of $0.001 per share, is listed on The Nasdaq Stock Market LLC under the trading symbol CELC. The filing was signed by Chief Executive Officer Brian F. Sullivan on August 26, 2026.

What Was Disclosed

Celcuity disclosed the submission of an sNDA to the FDA for REVTORPYK (gedatolisib) to treat HR+/HER2- locally advanced or metastatic breast cancer with a PIK3CA mutation in patients who have received prior endocrine therapy.