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via globenewswire.comBusiness & Companies

Celcuity: FDA Accepts sNDA for REVTORPYK in Breast Cancer

FROM THE WIRE · GLOBENEWSWIRE.COM

MINNEAPOLIS, Nov. 09, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced that the U.S. Food and Drug…

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MARKET IMPACTNEUTRAL✦ News Impact agent estimateTone: expected bullishFDA acceptance of the regulatory filing is a positive step for the company, with a PDUFA date set.AI-generated summary
✦ IN BRIEF · AIAI-generated summary
  1. 01The FDA accepted for review the sNDA for REVTORPYK (gedatolisib).
  2. 02The drug is indicated for HR+/HER2- breast cancer with a PIK3CA mutation.
  3. 03The PDUFA goal date is set for June 25, 2027.
NEWS IMPACT AND MARKET REACTIONChange since the story · reference
Celcuity Inc.CELCStock66.79 USDMarket closedtoday +4.29%Positive
Impact and summary are estimates by the News Impact AI agent, not financial advice.Open in Markets

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