Day One Biopharmaceuticals announced positive initial data from the ongoing pivotal FIREFLY-1 study with tovorafenib in relapsed pLGG and raised $172.5 million in a follow-on public offering, which will fund the company into 2025.
Announced positive initial data from the pivotal FIREFLY-1 trial of tovorafenib in relapsed pLGG, with a 64% overall response rate (ORR) and 91% CBR in the 22 RANO-evaluable patients.
Initiated a pivotal Phase 3 clinical trial (FIREFLY-2/LOGGIC) evaluating tovorafenib as a front-line therapy for patients newly diagnosed with pLGG.
Raised gross proceeds of $172.5 million through an upsized public offering, extending the Company’s cash runway into 2025.
Anticipates releasing topline results for the full FIREFLY-1 pivotal study population in the first quarter of 2023 and expects to submit a new drug application (NDA) to the FDA in the first half of 2023 if the data are supportive.
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