FDA Approves ICOTYDE, Securing $50M Milestone and $121 Price Target
FDA approved ICOTYDE, the first oral IL-23 receptor antagonist for moderate-to-severe plaque psoriasis in patients 12 and older after four Phase 3 trials with 2,500 participants. Protagonist will receive a $50 million milestone, 6%–10% royalties and up to $580 million in future payments; Jefferies set a $121 price target.
1. FDA Approval of ICOTYDE
The FDA approved ICOTYDE for moderate-to-severe plaque psoriasis in patients aged 12 and older, based on four Phase 3 trials involving 2,500 participants that met primary endpoints and showed a favorable safety profile.
2. Financial Terms and Royalties
Protagonist will receive a $50 million milestone payment upon approval, earn royalties of 6%–10% on net sales, and remains eligible for up to $580 million in future milestone payments tied to clinical and commercial milestones.
3. Analyst Price Target Revision
Jefferies raised its Protagonist price target to $121, suggesting about 23.75% upside from current levels, driven by expectations for ICOTYDE’s launch, sustained royalty streams and milestone revenue contributions.