FDA approves Icotyde (icotrokinra) oral IL-23 for plaque psoriasis; Guggenheim upgrade highlights growth [developing]
Key Questions
What is Icotyde and what is it approved for?
Icotyde (icotrokinra) is an oral IL-23 inhibitor approved by the FDA in mid-March for plaque psoriasis. It is a once-daily pill that provides sustained skin clearance.
What were the Phase 3 efficacy results for Icotyde?
In 52-week Phase 3 studies, Icotyde achieved PASI 100 rates of 49% in adults and 48% in adolescents, improving to around 60% in some data. This demonstrates durability with sustained skin clearance.
How does Icotyde compare to other psoriasis treatments?
Icotyde edges out competitors like Tremfya, Skyrizi, and Stelara in efficacy. It offers a convenient oral option with high-margin potential.
What is Guggenheim's view on Johnson & Johnson and Icotyde?
Guggenheim upgraded Johnson & Johnson to a $240 (later $244) Top Pick, citing Icotyde's $8B peak sales potential and high-margin growth. They highlight resilient execution and mispriced upside.
What is the projected peak sales for Icotyde?
Analysts project peak sales between $4.4B and $10B for Icotyde. Guggenheim emphasizes its high-margin potential driving J&J growth.
Has AbbVie commented on Icotyde as a rival?
AbbVie has flagged Icotyde as a rival, particularly in the context of their immunology sales like Skyrizi and Rinvoq. Investor focus remains on competitive dynamics.
What should be monitored for Icotyde post-approval?
Key watches include launch success, pricing, uptake, and comparisons to JNJ-4804 and AbbVie products. Durability data supports long-term potential.
What recent data supports Icotyde's durability?
One-year results from Phase 3 studies show PASI 100 rates improving from 41% to 49% over 52 weeks. This confirms lasting skin clearance in plaque psoriasis patients.
Mid-Mar approval; Ph3 52-wk PASI100 49%/48% adults/adolesc ~60%; edges Tremfya/Skyrizi/Stelara; Guggenheim $240 Top Pick on $8B peak high-margin potential; AbbVie flags rival; $4.4-10B peak. Watches: launch/pricing/uptake/JNJ-4804/AbbVie comps.