Incyte Corporation (NASDAQ:INCY) is withdrawing the New Drug Application for parsaclisib in relapsed/refractory follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL).
- Parsaclisib is the Company's next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ).
- The decision impacts only the FL, MZL, and MCL indications in the U.S. and does not affect other ongoing clinical trials in the U.S. or other countries.
- Related: Gilead Withdraws Use Of Zydelig In Two Forms Of Blood Cancer In US.
- The decision to withdraw the NDA follows discussions with the FDA regarding confirmatory studies to support accelerated approval.
- Incyte said that it could not complete the required studies within a time period to support the investment.
- The withdrawal is a business decision and not related to any changes in either the efficacy or safety of parsaclisib.
- Additionally, Incyte has opted out of its ex-U.S. development of MCLA-145, restoring full global rights to Merus NV (NASDAQ:MRUS)
- MCLA-145 is a CD137/PD-L1 bispecific antibody co-developed under a global collaboration and license agreement between Incyte and Merus.
- Price Action: INCY stock closed at $74.15, while MRUS shares closed at $26.31 on Tuesday.
