![]() (Note: Day One Biopharmaceuticals, Inc., priced its IPO on May 26, 2021, in sync with its recently upsized terms – 10 million shares at $16, the top of its $14-to-$16 range – to raise $160 million. We also plan to study DAY101 alone or in combination with additional agents that target other key signaling nodes in the MAPK pathway in patient populations where various genetic alterations are believed to play an important role in driving disease. Food and Drug Administration, or FDA, for the treatment of pLGG, based on initial results from a Phase 1 trial which showed evidence of rapid anti-tumor activity, a greater than 50% monotherapy response rate and durable responses in pLGG patients. DAY101 has been granted Breakthrough Therapy designation by the U.S. We dosed the first patient in this trial in the second quarter of 2021 and we expect to report initial data from this trial in the first half of 2022. We have initiated a pivotal Phase 2 (FIREFLY-1) trial of DAY101 for pediatric patients with relapsed or progressive low-grade glioma, or pLGG, the most common brain tumor diagnosed in children, for which there are no approved therapies and no standard of care. DAY101 has demonstrated encouraging anti-tumor activity in pediatric and adult populations with specific genetic alterations that result in the over-activation of the RAS/mitogen-activated protein kinase, or MAPK, pathway leading to uncontrolled cell growth. DAY101 has been studied in over 250 patients and has been shown to be well-tolerated as a monotherapy. Our lead product candidate, DAY101, is an oral, brain-penetrant, highly-selective type II pan-rapidly accelerated fibrosarcoma, or pan-RAF, kinase inhibitor. Initially, we focus our clinical development efforts on pediatric patients living with cancer, a vulnerable population that has been underserved in the recent revolution in targeted therapeutics and immuno-oncology. ![]() We are a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for patients of all ages with genetically defined cancers. We aim to re-envision cancer drug development and redefine what’s possible for all people living with cancer-regardless of age-starting from Day One. ![]() Our name was inspired by the “The Day One Talk” that physicians have with patients and their families about an initial cancer diagnosis and treatment plan. Price Action: DAWN shares are up 85.65% at $12.29 during the premarket session on the last check Monday.Day One was founded to address a critical unmet need: children with cancer are being left behind in a cancer drug development revolution. The Phase 3 trial will enroll approximately 400 patients. If the data are supportive, the company expects to submit an FDA marketing application in 1H 2023.īased on these initial FIREFLY-1 data, Day One plans to expand the development of tovorafenib as front-line therapy for patients newly diagnosed with pLGG. Initial safety data, based on the first 25 patients, indicated monotherapy tovorafenib to be generally well-tolerated.ĭay One will release topline results for the entire FIREFLY-1 pivotal study population in Q1 of 2023. All patients who responded remain on therapy (n=14), and no patients have discontinued treatment due to adverse events. The median-time-to-response was 2.8 months. The data included 14 partial responses and six patients with stable disease.Īll patients with stable disease (n=6) were noted to have tumor shrinkage, ranging between 19% and 43% Initial data demonstrated an overall response rate (ORR) of 64% and a clinical benefit rate (CBR) of 91%. ![]() Day One Biopharmaceuticals (NASDAQ: DAWN) shares are surging on initial data from the first 22 evaluable patients in the Phase 2 FIREFLY-1 trial for tovorafenib (DAY101) in relapsed or progressive pediatric low-grade glioma (pLGG), the most common brain tumor diagnosed in children. ![]()
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