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LLY Wins CHMP Nod for Olumiant's Expanded Use in Alopecia Areata
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Key Takeaways
Eli Lilly received a positive CHMP opinion to expand Olumiant use in adolescents with severe AA.
Phase III data showed 42% patients with severe AA achieved at least 80% scalp hair coverage at 36 weeks.
Olumiant recorded sales worth $1.01B in 2025; U.S. adolescent decision expected in H2 2026.
Eli Lilly (LLY - Free Report) and Incyte (INCY - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending the approval of the expanded use of Olumiant (baricitinib) in adolescents (aged 12 to less than18) with severe alopecia areata (AA).
A final decision from the European Commission is expected in the next one to two months.
LLY’s Price Performance
Year to date, shares of Lilly have lost 2.1% against the industry’s increase of 5.2%.
Image Source: Zacks Investment Research
The positive CHMP opinion was based on data from the phase III BRAVE-AA-PEDS study, which evaluated the safety and efficacy of once-daily, oral Olumiant versus placebo in the given patient population. Data from the same showed that 42% of the patients with severe AA reached 80% or more scalp hair coverage at 36 weeks following treatment with Olumiant. Additionally, many patients achieved successful eyebrow and eyelash regrowth.
The study is the first of its kind, specifically designed to investigate children and adolescents with severe AA.
Per the company, the positive CHMP opinion supports the potential expansion of Olumiant as a new treatment option for adolescents living with alopecia areata, a chronic autoimmune condition that can significantly affect patients’ quality of life.
More on LLY/INCY's JAK Inhibitor, Olumiant
Olumiant is a once-daily oral JAK inhibitor discovered by Incyte and licensed to LLY. The drug is approved for several types of autoimmune diseases, including adult patients with severe AA.
Lilly is also seeking approval for Olumiant to treat severe AA in adolescents in the United States. A decision on the same is expected in the second half of 2026.
Incyte earns royalty revenues from Lilly on Olumiant sales.
Lilly and Incyte’s Olumiant generated sales worth $1.01 billion in 2025. Successful label expansion for expanded use in additional indications should drive sales in 2026 and beyond.
LLY's Zacks Rank & Stocks to Consider
Eli Lilly currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, Castle Biosciences’ 2026 loss per share estimates have narrowed from $1.06 to 96 cents, while the same for 2027 have narrowed from 76 cents to 61 cents. CSTL’s shares have plunged 24% year to date.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.08 to $8.22, while the same for 2027 have increased from $9.25 to $9.90. ANIP’s shares have fallen 6.4% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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LLY Wins CHMP Nod for Olumiant's Expanded Use in Alopecia Areata
Key Takeaways
Eli Lilly (LLY - Free Report) and Incyte (INCY - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending the approval of the expanded use of Olumiant (baricitinib) in adolescents (aged 12 to less than18) with severe alopecia areata (AA).
A final decision from the European Commission is expected in the next one to two months.
LLY’s Price Performance
Year to date, shares of Lilly have lost 2.1% against the industry’s increase of 5.2%.
Image Source: Zacks Investment Research
The positive CHMP opinion was based on data from the phase III BRAVE-AA-PEDS study, which evaluated the safety and efficacy of once-daily, oral Olumiant versus placebo in the given patient population. Data from the same showed that 42% of the patients with severe AA reached 80% or more scalp hair coverage at 36 weeks following treatment with Olumiant. Additionally, many patients achieved successful eyebrow and eyelash regrowth.
The study is the first of its kind, specifically designed to investigate children and adolescents with severe AA.
Per the company, the positive CHMP opinion supports the potential expansion of Olumiant as a new treatment option for adolescents living with alopecia areata, a chronic autoimmune condition that can significantly affect patients’ quality of life.
More on LLY/INCY's JAK Inhibitor, Olumiant
Olumiant is a once-daily oral JAK inhibitor discovered by Incyte and licensed to LLY. The drug is approved for several types of autoimmune diseases, including adult patients with severe AA.
Lilly is also seeking approval for Olumiant to treat severe AA in adolescents in the United States. A decision on the same is expected in the second half of 2026.
Incyte earns royalty revenues from Lilly on Olumiant sales.
Lilly and Incyte’s Olumiant generated sales worth $1.01 billion in 2025. Successful label expansion for expanded use in additional indications should drive sales in 2026 and beyond.
LLY's Zacks Rank & Stocks to Consider
Eli Lilly currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Castle Biosciences (CSTL - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . While Castle Biosciences currently sports a Zacks Rank #1 (Strong Buy), ANI Pharmaceuticals holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, Castle Biosciences’ 2026 loss per share estimates have narrowed from $1.06 to 96 cents, while the same for 2027 have narrowed from 76 cents to 61 cents. CSTL’s shares have plunged 24% year to date.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.08 to $8.22, while the same for 2027 have increased from $9.25 to $9.90. ANIP’s shares have fallen 6.4% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.