Incyte has announced the suspension of enrollment in its Phase II study of the investigational MRGPRX2 inhibitor INCB000262 for chronic spontaneous urticaria following the emergence of concerning preclinical toxicology findings. The company is collaborating with the FDA to assess the implications of these findings and determine the future direction of the program.
The specific nature of the toxicology signals has not been disclosed. However, Incyte has completed enrollment in the proof-of-concept studies for INCB000262, and the data from these studies will be used to inform future development decisions and guide the potential development of backup molecules.
Discontinuation of INCB000547
In addition to the setback with INCB000262, Incyte also announced that Phase II data for its MRGPRX4 antagonist INCB000547 in cholestatic pruritus did not warrant further development. This decision further compounds concerns about the company's pipeline and the value of its acquisition of Escient Pharmaceuticals.
Financial Impact and Analyst Reactions
The news led to a significant drop in Incyte's stock price, with shares falling approximately 9% in after-hours trading. Analysts have expressed disappointment with these developments, particularly given that INCB000262 was a key asset acquired through the $750 million acquisition of Escient Pharmaceuticals in April 2024. William Blair analyst Matt Phipps noted that the setback was "clearly disappointing," as INCB000262 was projected to contribute significant sales in the coming decade, with a potential launch in 2029.
BMO Capital Markets’ Evan Seigerman described the update as "another pipeline misstep," raising concerns that the toxicology findings for INCB000262 could introduce "significant new uncertainty" in ongoing studies for chronic inducible urticaria and atopic dermatitis. The discontinuation of INCB000547 was seen as removing a potential upside catalyst and raising questions about the Escient deal's merits.
Implications for Incyte's Future
These setbacks raise concerns about Incyte's ability to offset potential revenue declines as patent protections for its JAK inhibitor ruxolitinib (Jakafi) expire in 2028. Seigerman concluded that the news "concretizes our lack of confidence that Incyte’s pipeline can overcome Jakafi concerns."
