Celcuity Shares Climb on Positive Breast-Cancer Drug Trial Results

By Adriano Marchese


Celcuity shares rose in premarket trading Monday after the company reported encouraging results from its Phase 3 trial for its proposed breast-cancer treatment.

Shares rose 14.6% in ahead of the morning bell to $144.

The clinical-stage biotechnology company said late Friday that it received positive top-line results from its Viktoria-1 clinical trial for gedatolisib, used with standard hormone-blocking treatments, in people with a common type of advanced breast-cancer mutation called PIK3CA.

The drug showed a statistically significant and clinically meaningful improvement in progression-free survival, as well as for its secondary endpoint.

Celcuity said it plans to send the study results to the Food and Drug Administration for an expanded approval of the drug.

After that, the company will also share the data with regulators in other countries, it said.


Write to Adriano Marchese at adriano.marchese@wsj.com


(END) Dow Jones Newswires

May 04, 2026 07:45 ET (11:45 GMT)

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