Day One Biopharmaceuticals on Monday revised its corporate deck, which included an update on FIREFLY-2’s primary endpoint, which had changed from response assessment in neuro-oncology-high grade glioma to response assessment in neuro-Oncology criteria for low-grade gliomas, Oppenheimer analyst Matthew Biegler tells investors in a research note. The change was done to align with Novartis’ (NVS) recently-approved dabra plus tram combination, which used RANO-LGG criteria, says the firm. Opco believes this admission creates two potential issues: the FDA might ask the company to change the endpoint in FIREFLY-1, potentially delaying accelerated approval, and tovorafenib’s efficacy may now look a lot more like the dabra-tram combination, contends the analyst. Opco doesn’t view either problem as deal-breakers for tovorafenib’s ultimate approval, but says they could delay timelines and/or effect the drug’s competitive posturing. It reiterates a Perform rating on Day One shares.
Published first on TheFly
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