By Stephen Nakrosis

 

Biopharmaceutical company Incyte Corp. on Tuesday said it was withdrawing its new drug application for parsaclisib to treat certain lymphoma patients following discussions with the Food and Drug Administration.

The company said it would withdraw its NDA for parsaclisib "for the treatment of patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma."

According to the company, the decision to withdraw the application came after talks with the FDA regarding confirmatory studies to support an accelerated approval. The company said it determined the studies couldn't be completed within a time period that would support the investment.

"The withdrawal of the NDA is a business decision and is not related to any changes in either the efficacy or safety of parsaclisib," Incyte said.

The company also said its 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."

The company also said it decided to opt out of the continued development of MCLA-145, a CD137/PD-L1 bispecific antibody which was being co-developed under a global collaboration and license agreement with Merus.

Incyte said it will "continue to collaborate with Merus and leverage their platform to develop a pipeline of novel agents."

 

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

 

(END) Dow Jones Newswires

January 25, 2022 17:28 ET (22:28 GMT)

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