Eli Lilly and Company LLY announced the FDA approval of Olumiant (baricitinib), a once-daily oral therapy, for the treatment of pediatric patients 12 years of age and older with severe alopecia areata (AA).
The FDA decision expands Olumiant’s U.S. label to include adolescents with severe hair loss. The drug is already approved in several geographies for adults with moderately to severely active rheumatoid arthritis and adults with severe AA. In April 2026, the European Commission approved Olumiant for adolescents aged 12 to under 18 with severe AA, expanding the therapy’s patient coverage in the EU as well. Olumiant is also approved in the United States to treat hospitalized adults with COVID-19.
Shares of Eli Lilly have gained 10.1% year to date compared with the industry’s 13.2% growth.
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Clinical Data Supporting the Label Expansion of LLY’s Olumiant
The FDA approval was supported by 36-week results from the ongoing phase III BRAVE-AA-PEDS study, which was specifically designed to evaluate adolescents aged 12 to under 18 with severe AA. Eligible patients had a Severity of Alopecia Tool (SALT) score of at least 50, reflecting at least 50% scalp hair loss and had experienced a current severe episode for at least six months and no more than eight years. The first cohort enrolled 257 adolescents weighing at least 30 kilograms who were randomized equally to receive once-daily Olumiant 4 mg, Olumiant 2 mg or placebo. A second cohort of 166 adolescents was randomized between the two Olumiant doses to further expand safety data.
The study met its primary endpoint, with 42% of patients receiving Olumiant 4 mg and 27% receiving the 2-mg dose achieving a SALT score of 20 or less at week 36, corresponding to at least 80% scalp hair coverage compared with 5% for placebo, demonstrating substantially greater scalp hair regrowth with both Olumiant doses.
Olumiant therapy also showed higher rates of more extensive scalp hair regrowth. At week 36, 37% of patients treated with Olumiant 4 mg achieved a SALT score of 10 or less, representing at least 90% scalp hair coverage compared with 21% for Olumiant 2 mg and 2% for placebo. Olumiant 4 mg also improved eyebrow and eyelash coverage among patients who had substantial eyebrow and eyelash hair loss at baseline. The overall safety profile observed in adolescents was consistent with the established safety profile of Olumiant in adults with severe AA.
Per Eli Lilly, more than 33,000 patients have been prescribed Olumiant in the United States since 2017. Olumiant is a once-daily oral JAK inhibitor discovered by Incyte INCY and licensed to Lilly. In 2009, Lilly and Incyte entered into an exclusive worldwide license and collaboration agreement to develop and commercialize Olumiant and certain follow-on compounds for inflammatory and autoimmune diseases. Olumiant is available through specialty pharmacies nationwide.
AA is a chronic immune-mediated disease that causes unpredictable hair loss and can range from small patches to extensive or complete loss of scalp hair. The condition affects as many as 2% of people at some point in their lives, with nearly 40% of cases occurring before age 20. Early-onset disease can be more severe and may result in extensive hair loss during adolescence, a period when physical appearance can have a significant social and emotional impact.
Eli Lilly and Company Price and Consensus
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Zacks Rank and Stocks to Consider
Eli Lilly currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Precigen PGEN and AC Immune ACIU, carrying a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 24 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 73 cents. PGEN shares have gained 85.4% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents per share. ACIU shares have lost 19.8% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
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