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Day One Biopharma Announces 3-Yr Results From OJEMDA Pivotal Phase 2 FIREFLY-1 Trial In Oral Presentation At 2025 SNO Annual Meeting

Author: Benzinga Newsdesk | November 24, 2025 08:03am

Updated data expands clinically meaningful results available from FIREFLY-1 pivotal trial 

77% of patients who entered the treatment-free observation period following OJEMDA treatment remained off therapy for at least 12 months

The median time to next treatment (TTNT) following initiation of OJEMDA exceeded 3.5 years
  

BRISBANE, Calif., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (NASDAQ:DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced three-year results from the OJEMDA pivotal Phase 2 FIREFLY-1 trial in an oral presentation at the 30th Annual Meeting & Education Day of the Society for Neuro-Oncology . 

New data from the ongoing FIREFLY-1 trial (Arm 1), with an updated median study duration of 40.6 months (data cutoff June 6, 2025), are described below. Primary trial results, including trial eligibility, patient demographics, efficacy and safety have been previously reported (Kilburn, et al. Nature Medicine 2024).

Posted In: DAWN

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