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Stock impact report

Celcuity Q4 Earnings Call Highlights [Yahoo! Finance]

Celcuity Inc. (CELC) 
Last celcuity inc. earnings: 3/12 04:00 pm Check Earnings Report
US:NASDAQ Investor Relations: celcuity.com/home/investors
Company Research Source: Yahoo! Finance
Celcuity (NASDAQ:CELC) executives used the company's fourth-quarter and full-year 2025 earnings call to highlight progress toward a potential 2026 U.S. launch of gedatolisib, review data from its lead breast cancer program, and outline its commercial and regulatory preparations. Management also reported higher operating expenses and a larger net loss in 2025 as the company expanded headcount and ramped launch-related activities. Gedatolisib NDA accepted with priority review Chief Executive Officer and co-founder Brian Sullivan said the company is preparing for what it expects could be a “transformative year” as it moves toward a potential approval and commercialization of gedatolisib. Sullivan said the FDA has accepted Celcuity's new drug application (NDA) and granted priority review, with a Prescription Drug User Fee Act (PDUFA) goal date of July 17, 2026 . He added that the submission was made under the FDA's Real-Time Oncology Review Program , which he described as being used Show less Read more
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