Eli Lilly LLY and partner Incyte INCY announced that a late-stage study evaluating oral baricitinib in adolescent patients (aged 12-18) with severe alopecia areata (AA) showed clinically meaningful improvements in hair regrowth on the scalp, eyebrows and eyelashes at Week 36.

The phase III BRAVE-AA-PEDS study enrolled 257 patients who were randomized to receive either a dose of baricitinib (4 mg or 2 mg) or placebo. 

AA is an immune system disorder that leads to patchy hair loss on the scalp, face, and occasionally other parts of the body, with the potential to worsen over time. Around 40% of individuals with AA experience their first onset by the age of 20.

Baricitinib, a once-daily, oral JAK inhibitor, is already approved under the brand name Olumiant to treat adult patients with severe AA.

LLY/INCY’s Phase III Alopecia Study Data in Detail

Lilly reported that 60% of patients receiving Olumiant 4 mg and 36.9% receiving Olumiant 2 mg experienced at least a 50% improvement in their condition, as measured by SALT score (a popular metric for hair loss) compared to 5.7% on placebo. Additionally, 42.4% of patients receiving the 4 mg dose and 27.4% receiving the 2 mg dose achieved at least 80% scalp hair coverage compared to 4.5% on placebo, while 36.5% on 4 mg and 21.4% on 2 mg reached 90% or more scalp hair coverage compared to 2.3% on placebo.     

Regarding eyebrow regrowth, 50% of those on 4 mg and 24.1% on 2 mg showed significant improvement, whereas none on placebo did. For eyelash regrowth, 42.9% of patients on 4 mg and 25.5% on 2 mg saw improvement compared to 14% on placebo.

In the past three months, shares of LLY have gained 9.2% compared with the industry’s 5.2% growth.

Image Source: Zacks Investment Research

Lilly stated that at 36 weeks, adolescents achieved results similar to those seen in adults after 52 weeks of treatment with the drug, indicating that hair regrowth may occur more quickly in adolescents. In the BRAVE-AA1 and BRAVE-AA2 studies, 40.9% of adults receiving Olumiant 4 mg and 21.2% receiving 2 mg achieved at least 80% scalp hair coverage by Week 52.

Per Lilly, early onset AA can be more severe, resulting in extensive hair loss that often does not respond to commonly prescribed first-line treatments like topicals or corticosteroids, representing a huge unmet medical need. The encouraging results from the phase III BRAVE-AA-PEDS study demonstrate Olumiant’s potential to address such needs.

The drug was generally safe and overall well-tolerated in the late-stage AA study of adolescent patients. The results were recently presented at the American Academy of Dermatology Annual Meeting. Additional data readout from the BRAVE-AA-PEDS study is expected later this year.

Approved Indications of LLY/INCY’s Olumiant

The initial FDA approval to treat severe AA, made Olumiant the first systemic treatment approved in the United States for severe disease.

Olumiant is also approved in more than 75 countries, including the United States, for treating adults with moderate to severe rheumatoid arthritis. It is also authorized in more than 40 countries for patients as young as two years old with moderate-to-severe atopic dermatitis requiring systemic therapy. Additionally, it is approved in the EU and Japan for adults with severe AA and has received authorization in multiple countries for treating hospitalized COVID-19 patients.

Olumiant generated sales of $957.4 million in 2024, up 4% on a year-over-year basis. The drug was originally discovered by Incyte. Later, LLY gained exclusive worldwide development and commercialization rights to the drug from INCY for inflammatory and autoimmune diseases.

Eli Lilly and Company Price and Consensus

Eli Lilly and Company price-consensus-chart | Eli Lilly and Company Quote

LLY’s Zacks Rank and Stocks to Consider

Eli Lilly currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the sector are Gilead Sciences GILD and BioMarin Pharmaceutical BMRN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

In the past 30 days, Gilead Sciences’ earnings estimates for 2025 have improved from $7.60 to $7.87 per share. During the same timeframe, the earnings per share for 2026 have improved from $7.92 to $8.27. In the past three months, shares of Gilead Sciences have gained 27.1%.

GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.

In the past 30 days, estimates for BioMarin Pharmaceutical’s 2025 earnings per share have increased from $4 to $4.24. Estimates for 2026 earnings per share have increased from $5.16 to $5.25 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have gained 9.5%.

BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 32.36%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

BioMarin Pharmaceutical Inc. (BMRN) : Free Stock Analysis Report

Eli Lilly and Company (LLY) : Free Stock Analysis Report

Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report

Incyte Corporation (INCY) : Free Stock Analysis Report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research