BRIEF-FDA Accepts NDA For Roche's Giredestrant In ER-Positive Early-Stage Breast Cancer

June 2 (Reuters) - Roche Holding AG ROPC.S:

  • FDA ACCEPTS NEW DRUG APPLICATION FOR ROCHE’S GIREDESTRANT IN ER-POSITIVE EARLY-STAGE BREAST CANCER, THE FIRST AND ONLY ORAL SERD WITH POSITIVE PHASE III RESULTS IN THE CURATIVE SETTING

  • ROCHE HOLDING AG - FDA SETS PDUFA DATE FOR GIREDRESTRANT DECISION AS NOV 30, 2026

  • ROCHE HOLDING AG - PHASE III DATA SHOW GIREDRESTRANT REDUCES RISK OF DISEASE RECURRENCE OR DEATH BY 30%

  • ROCHE HOLDING AG - 92.4% OF GIREDRESTRANT PATIENTS ALIVE AND DISEASE-FREE AT 3 YEARS VERSUS 89.6% FOR SOC

Source text: ID:nGNE2cp2kZ

Further company coverage: ROPC.S


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