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Celcuity reports $73.3m Q3 loss as REVTORPYK shipments begin after FDA approval

🇺🇸 Celcuity Inc. (CELC) · Thu 05 Nov 2026

The company has no product revenue yet, as gedatolisib shipments began only on 30 September, while payer coverage is reported at 91% of US commercial and Medicare lives.

Celcuity Inc. reported third-quarter 2026 results on 5 November, posting a net loss of $73.3 million. The company recorded no product revenue for the period because shipments of REVTORPYK (gedatolisib) began only on 30 September.

The US Food and Drug Administration approved REVTORPYK on 14 July 2026. The indication covers HR+/HER2- advanced breast cancer without a PIK3CA mutation, in patients who have already received endocrine therapy.

Celcuity says 91% of US commercial and Medicare lives are now covered for the product. The summary on file does not specify the terms of that coverage, such as prior authorisation or step-therapy requirements.

During the quarter, the company also submitted a supplemental new drug application (sNDA) to the FDA for the PIK3CA-mutant cohort. An sNDA is the route used in the US to seek approval of a new indication or population for an already-approved medicine. At the ESMO congress, Celcuity presented updated data from the VIKTORIA-1 trial and data in prostate cancer.

What it means for your team

  • Market-access teams should note the reported 91% coverage figure, but check the actual payer criteria, since the available information does not detail them.
  • Regulatory teams can track the sNDA for the PIK3CA-mutant cohort, which could extend the label beyond the current wild-type indication; no FDA decision date is given in the information available.
  • With commercial shipments only just started, post-launch safety and real-world data collection for gedatolisib are at an early stage.

Company's press release (SEC filing): Celcuity Inc. ↗

Article written by VigiEye from the official source (Celcuity Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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