Celcuity shares fall as second quarter loss exceeds estimates

Published 14/08/2025, 21:20
Celcuity shares fall as second quarter loss exceeds estimates

Investing.com -- Celcuity Inc. (NASDAQ:CELC), a clinical-stage biotechnology company, reported a wider-than-expected loss for the second quarter of 2025, sending its shares down 2.2% as investors reacted to the earnings miss.

The company posted a second quarter loss of $1.04 per share, missing analyst estimates of a $0.88 per share loss by $0.16. The earnings disappointment overshadowed the company’s recent clinical progress with its lead drug candidate, gedatolisib, for HR+/HER2- advanced breast cancer.

"We have had an eventful past few months at Celcuity . Last month, we announced positive topline data from the PIK3CA wild-type cohort of the pivotal Phase 3 VIKTORIA-1 clinical trial, which showed unprecedented reduction in risk of disease progression or death and incremental improvement in progression free survival in patients with HR+/HER2- advanced breast cancer," said Brian Sullivan, CEO and co-founder of Celcuity.

Despite the earnings miss, the company remains focused on its regulatory pathway, with plans to submit a New Drug Application for gedatolisib later this year based on data from the PIK3CA wild-type cohort. Celcuity also expects to report topline data from the PIK3CA mutant cohort in the fourth quarter of 2025.

The company recently completed a financing round to support its clinical development programs, which include potential treatments for both breast and prostate cancer. Management believes these programs could yield multiple potential blockbuster indications.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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