Day One Biopharma (DAWN) Announces Positive 3-Year Follow-up Results from Pivotal Phase 2 FIREFLY-1 Trial of OJEMDA (Tovorafenib)

Day One Biopharmaceuticals Inc. (NASDAQ:DAWN) is one of the stocks that will double in 2026. On November 24, JonesTrading analyst Soumit Roy maintained a bullish stance on the company, with a Buy rating.

On the same day, Day One Biopharmaceuticals also announced 3-year follow-up results from the pivotal Phase 2 FIREFLY-1 trial of OJEMDA (tovorafenib). This updated data, derived from the ongoing FIREFLY-1 trial (Arm 1) with a median study duration of 40.6 months (data cutoff June 6 this year), expands on the previously reported clinically meaningful results.

Day One Biopharma (DAWN) Announces Positive 3-Year Follow-up Results from Pivotal Phase 2 FIREFLY-1 Trial of OJEMDA (Tovorafenib)

Tovorafenib is a Type II RAF kinase inhibitor approved by the US FDA for treating pediatric patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma/pLGG harboring a BRAF fusion or rearrangement. The approval was granted under accelerated approval based on the response rate and duration of response.

No new safety signals were identified in this updated three-year analysis. Grade 3 or higher adverse events most commonly reported included decreased growth velocity, anemia, increased blood creatine phosphokinase, maculopapular rash, and increased alanine aminotransferase.

Day One Biopharmaceuticals Inc. (NASDAQ:DAWN) is a commercial-stage company that advances class medicines for childhood and adult diseases with equal intensity in the US.

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Disclosure: None. This article is originally published at Insider Monkey.