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Celcuity Shares Tumble on Trial Results
4 Jun
Summary
- Celcuity shares fell 25% after trial data release.
- Gedatolisib showed longer progression-free survival than placebo.
- FDA decision on PIK3CA mutation treatment expected July 17.
Celcuity's stock plummeted 25%, marking its largest single-day decline, after its experimental breast cancer drug, gedatolisib, showed mixed results in a recent trial. The drug, used in combination with Pfizer's Ibrance and AstraZeneca's Faslodex, extended progression-free survival (PFS) to 11.1 months for patients with PIK3CA mutations, compared to 5.6 months with Faslodex and Novartis' Piqray.
Analysts noted that this PFS was lower than observed in earlier, smaller trials, potentially disappointing investors. CEO Brian Sullivan attributed the difference to a more heavily pre-treated patient population in the latest study. Celcuity expects higher peak revenues for gedatolisib than AstraZeneca's Truqap, aiming for it to become the standard of care.
The U.S. Food and Drug Administration is slated to decide on the therapy's use in advanced breast cancer patients without a PIK3CA mutation by July 17. Celcuity also plans to seek expanded approval for patients irrespective of PIK3CA status.
