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Day One not changing endpoint for FIREFLY-1 trial, says JonesResearch
The Fly

Day One not changing endpoint for FIREFLY-1 trial, says JonesResearch

JonesResearch notes the firm is getting a few investor questions around the recent change in the endpoint evaluation of FIREFLY-2 trial in first-line pediatric low grade glioma based on Day One Biopharmaceuticals’ updated corporate deck, which indicates that the response rate will be evaluated by RANO-LGG versus the prior evaluation method of RANO-HGG. After having spoke with Day One’s management, the analyst noted that they said that they will not change the endpoint evaluation for the upcoming data in Q2 and it will continue to be RANO-HGG. This means the ORR of 64% from the January update can be compared to the upcoming data readout, according to the analyst, who also notes that Day One is meeting with the FDA in Q2 for the pre-NDA meeting and there is a possibility that the FDA could ask for response rates based on RANO-LGG in addition. JonesResearch has a Buy rating and $40 price target on Day One shares, which are down 91c, or nearly 6%, to $15.51 in Friday afternoon trading.

Published first on TheFly

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