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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.
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