October 30, 2023

Day One announced that the U.S., Food and Drug Administration (FDA) accepted Day One’s New Drug Application (NDA) for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG). The NDA is based on results from FIREFLY-1, the open-label, pivotal Phase 2 trial evaluating tovorafenib as a once-weekly monotherapy in patients aged 6 months to 25 years with relapsed or progressive pLGG.

FDA acceptance of the NDA means that the FDA will now review the application for potential approval of tovorafenib for sale and marketing in the U.S.

Additionally, with Day One’s NDA, the FDA has granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.

Tovorafenib is an investigational medicine. The safety and efficacy of tovorafenib has not been established. There is no guarantee that tovorafenib will receive health authority approval or become commercially available in any country for the uses being investigated.

For more details, the complete press release is available here.

On behalf of everyone at Day One, we thank the patients for their participation in the FIREFLY-1 study and their families, without whom this advancement toward a potential new targeted therapy for pLGG would not be possible.

We also thank the pediatric cancer non-profit and patient advocacy community for your partnership and support as we move forward in developing potential new therapies for children with cancer.

September 11, 2023

Day One announced the submission of the rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG). We anticipate the FDA will determine the acceptability of the rolling NDA submission by mid-November 2023.

For more details, the complete press release is available here.

June 4, 2023

Day One announced new data from the registrational Phase 2 FIREFLY-1 clinical trial.  These data were shared in an oral presentation delivered by Dr. Lindsey Kilburn at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

In addition, Day One announced that it has initiated a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG).

You can read the full press release here.

April 26, 2023

Day One announced our accepted abstracts for the 2023 American Society of Clinical Oncology (ASCO) meeting in June.

For more information, please see our press release here.

January 8, 2023

Day One announced top-line results from our ongoing pivotal Phase 2 FIREFLY-1 trial of tovorafenib (DAY101) in patients with recurrent or progressive pediatric low-grade glioma, or pLGG.

For more details, the complete press release is available here.

June 12, 2022

Day One announced positive initial data from the first subset of participants in our ongoing pivotal Phase 2 FIREFLY-1 trial of tovorafenib (DAY101) in patients with relapsed pediatric low-grade glioma, or pLGG. Please see our press release and corporate presentation for more details.

For more details, the complete press release is available here.