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Incyte Halts Development of Cholestatic Pruritus Drug and Pauses Urticaria Trial

• Incyte has ceased the development of MRGPRX4 (INCB000547) for cholestatic pruritus (CP) after Phase 2 data did not support further advancement. • Enrollment in the Phase 2 trial of MRGPRX2 (INCB000262) for chronic spontaneous urticaria (CSU) has been paused due to preclinical toxicology findings. • The company is collaborating with the FDA to determine the next steps following these decisions, impacting its development pipeline.

Incyte has announced the discontinuation of its MRGPRX4 (INCB000547) program for cholestatic pruritus (CP) and a pause in the Phase 2 trial of MRGPRX2 (INCB000262) for chronic spontaneous urticaria (CSU). The decision, revealed on Tuesday afternoon, led to a significant decline in Incyte's stock value.
The biopharmaceutical firm stated that data from the Phase 2 study of MRGPRX4 in treating cholestatic pruritus, a liver disorder characterized by intense itching, did not warrant further development. Incyte has shared the data with the Food and Drug Administration (FDA) and is working with the agency to determine the subsequent course of action.

Pause in Urticaria Trial

Simultaneously, Incyte has paused enrollment in the ongoing Phase 2 trial of MRGPRX2 for chronic spontaneous urticaria, commonly known as chronic hives. This decision was prompted by "the observation of certain in vivo preclinical toxicology findings." In vivo toxicology assesses the toxic effects of a drug on a living organism, typically an animal, before human trials proceed.

Impact and Next Steps

The company's stock experienced a downturn following the announcement. Incyte is collaborating with the FDA to evaluate the data from both programs and determine future steps. These changes reflect the inherent risks and challenges in pharmaceutical research and development.
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Reference News

[1]
Incyte Stock Slumps After Firm Scraps Drug, Pauses Enrollment in Other Study
investopedia.com · Nov 19, 2024

Incyte led S&P 500 decliners after halting development of a drug for cholestatic pruritus and pausing enrollment in a Ph...

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