Celcuity says Revtorpyk boosts progression-free survival in breast cancer

Celcuity Inc. (CELC) announced the FDA accepted its sNDA for REVTORPYK (gedatolisib) to treat HR+/HER2-negative, PIK3CA-mutated advanced breast cancer. A decision is expected by June 25, 2027. The drug targets the PI3K/AKT/mTOR pathway and is supported by Phase 3 trial data. CELC stock rose 5.17% to $70.24.

Celcuity Inc. (CELC) announced the FDA accepted its application to expand the use of REVTORPYK for treating specific breast cancer patients. The FDA set a review goal date of June 25, 2027, based on Phase 3 trial data. The drug is already approved for a similar indication without PIK3CA mutations. Celcuity is developing REVTORPYK for other cancer treatments.

Celcuity Inc. (CELC) announced the FDA accepted its supplemental New Drug Application (sNDA) for REVTORPYK, aiming to treat a specific type of breast cancer. The FDA set a goal date of June 25, 2027, for review. This follows the drug's expected approval in July 2026 for patients without a detected PIK3CA mutation.

Celcuity (CELC) reported strong Q3 2026 results, with Revtopik, its drug for advanced breast cancer, showing high adoption. 78% of top accounts ordered it, and 91% of U.S. commercial and Medicare lives have coverage. The company estimates a $9B annual market. Clinical data showed significant efficacy, and Celcuity plans to submit data to global regulators.

Celcuity (CELC) reported Q3 earnings, highlighting sufficient production capacity and regulatory updates. The company submitted a supplemental new drug application to the FDA and expects to provide further data to global regulators. Operating expenses rose to $77.3M, driven by commercial spending. Celcuity ended the quarter with $642.7M in cash and expects it to fund operations through 2029.

Celcuity reported no revenue in Q3 2026, with a net loss of $73.34M and EPS of ($1.33). Expenses rose due to commercialization efforts. REVTORPYK launched commercially, and the company submitted an sNDA for its use in advanced breast cancer. New data was presented at ESMO Congress, and a prostate cancer study showed promising results.