Olumiant (baricitinib) was approved by the FDA on September 25, 2026 for severe alopecia areata in pediatric patients 12 years of age and older (previously adults only).
The FDA approved Olumiant (baricitinib) for severe alopecia areata in patients 12 years of age and older on September 25, 2026 (NDA 207924, supplement 9), extending the 2022 adult approval to adolescents. Lilly announced it the same day.
The FDA's approval letter for NDA 207924 supplement 9 is dated September 25, 2026 and provides for the treatment of severe alopecia areata in adults and pediatric patients 12 years of age and older (FDA approval letter). Lilly announced the approval the same day (Lilly release). Per Lilly, the approval rests on 36-week data from the adolescent cohort of the Phase 3 BRAVE-AA-PEDS study (median baseline SALT score 100, complete scalp hair loss): 42% of patients on 4 mg and 27% on 2 mg reached 80% or more scalp hair coverage (SALT 20 or less), compared with 5% on placebo. pdufa.bio did not hold a goal date for this supplement, so no early or late margin is computed.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA approval letter, NDA 207924 supplement 9, September 25, 2026
FDA record of the action: the FDA approved on September 25, 2026, per NDA 207924 SUPPL-9 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 257,900 | $309.3 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Yes. The FDA approved the application for Olumiant (baricitinib) on September 25, 2026, per the FDA's own record. The primary source is linked on this page.
Olumiant (baricitinib) is an Eli Lilly and Company (LLY) program. The FDA decision came on September 25, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), LLY moved +27.5%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.