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Posted On: 04/14/2017 2:20:25 PM
Post# of 2218
$LLY $INCY 11:08 am Incyte & Eli Lilly (LLY) receive complete response letter from the FDA for the baricitinib New Drug Application; LLY reaffirms FY17, mid-term guidance, Incyte evaluating impact (INCY) :
The letter indicates that the FDA is unable to approve the application in its current form. Specifically, the FDA indicated that additional clinical data are needed to determine the most appropriate doses. The FDA also stated that additional data are necessary to further characterize safety concerns across treatment arms. The companies disagree with the Agency's conclusions. The timing of a resubmission will be based on further discussions with the FDA.
Lilly is reaffirming both its financial guidance for 2017 and its mid-term guidance for the remainder of this decade. Incyte is evaluating the impact of the complete response on its previously-issued milestone and R&D expense guidance for 2017; any update will be provided on its Q1 2017 earnings call.
The letter indicates that the FDA is unable to approve the application in its current form. Specifically, the FDA indicated that additional clinical data are needed to determine the most appropriate doses. The FDA also stated that additional data are necessary to further characterize safety concerns across treatment arms. The companies disagree with the Agency's conclusions. The timing of a resubmission will be based on further discussions with the FDA.
Lilly is reaffirming both its financial guidance for 2017 and its mid-term guidance for the remainder of this decade. Incyte is evaluating the impact of the complete response on its previously-issued milestone and R&D expense guidance for 2017; any update will be provided on its Q1 2017 earnings call.
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