On Monday, Incyte Corporation INCY announced that it will pause enrollment in the ongoing Phase 2 study of MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU).
The decision was made following the observation of certain in vivo preclinical toxicology findings.
These data have been shared with the FDA, and Incyte will work closely with the FDA to determine the next steps.
Also Read: Incyte’s Jakafi Demand Is Strong, Analyst Upgrades Stock
Enrollment in the other INCB000262 proof-of-concept studies is complete. Data from all clinical studies will help inform its future development and guide the potential development of backup molecules.
In addition, data from the Phase 2 study evaluating MRGPRX4 (INCB000547) in cholestatic pruritus (CP) does not support further development.
The company added the investigational drugs via the Escient Pharmaceuticals deal for $750 million.
William Blair says the ‘update is clearly disappointing’ as the proof-of-concept data across all three indications was anticipated in the first quarter of 2025.
The analyst has not included estimates for the molecule in the model yet. However, William Blair previously projected it could launch in 2029 and bring substantial sales for Incyte in the 2030s, as it’s being tested for major market opportunities with the potential to become a blockbuster.
“Although ‘547 was not the focus of the Escient acquisition, it is clearly negative to also see the discontinuation of the other clinical-stage program associated with the acquisition,” the analyst adds.
William Blair writes that before more information is released about the toxicology findings and next steps for the ‘262 program, investors are likely to focus on other key pipeline updates expected in 2025.
These include Phase 3 results for povorcitinib in hidradenitis suppurativa, due in early 2025, and initial data on mutant-specific inhibitors (mCALR and JAK2V617F) for myeloproliferative neoplasms later in the year. These developments could significantly impact Incyte’s long-term outlook.
Price Action: INCY stock fell 11.35% at $68.28 during premarket session at the last check on Tuesday.
Read Next:
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
date | ticker | name | Price Target | Upside/Downside | Recommendation | Firm |
---|
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.