Why Incyte (INCY) Shares Are Trading Lower Today - Incyte (NASDAQ:INCY)

Incyte Corporation INCY will discontinue the Phase 3 LIMBER-304 trial following the results of a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC), indicating that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population.
LIMBER-304 trial assessed parsaclisib plus ruxolitinib (Jakafi) versus placebo plus ruxolitinib in adult patients with myelofibrosis who have an inadequate response to ruxolitinib monotherapy.
The recommendation to stop the study was not due to safety.
Related: Incyte's Oral JAK Inhibitor Shows Durable Efficacy, Safety At One Year In Skin Disorder.
While further data review is conducted, Incyte will inform investigators of the results and work with them to appropriately conclude the study.
Data from this study will be submitted for presentation at an upcoming scientific meeting.
The primary endpoint of LIMBER-304 was the proportion of patients achieving a targeted reduction in spleen volume.
William Blair writes that the trial discontinuation represents the first setback in Incyte’s Jakafi lifecycle extension program (LIMBER), with an to generate fixed-dose combinations of Jakafi with drugs with additional mechanisms of action to extend patent expiration beyond year-end 2028
The analyst said it highlighted reservations about the parsaclisib combination multiple times in the past based on the initial data from the Phase 2 study in which spleen responses were at the lower end of those reported across multiple other trials investigating Jakafi combinations in inadequate responders to Jakafi monotherapy.
The analyst also writes that while investor expectations in the parsaclisib program have been very low, the failure underpins some investor concerns on the level of R&D expenses given recent productivity.
Price Action: INCY shares are down 2.94% at $75.28 on the last check Monday.

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Incyte Discontinues LIMBER-304 On Doubts Regarding Meeting Primary Goal, Analyst Says It Underpins Some Investor Concerns