Shares of Spyre Therapeutics fell 14% in extended trading on Tuesday after the company reported mixed Phase 2 trial results for its experimental rheumatoid arthritis drug SPY072.
The SKYWAY trial evaluated SPY072 in 143 participants across three arms: high dose, low dose, and placebo. The low-dose cohort met its primary endpoint, showing a statistically significant improvement in DAS28-CRP scores at Week 12, with a change from baseline of -1.9 versus -1.3 for placebo. The high-dose arm achieved an ACR20 response rate of 63%, compared with 43% for placebo, while the low-dose arm recorded a 38% ACR50 response versus 19% for placebo.
Despite these positive signals, Spyre indicated the efficacy did not meet internal thresholds required to advance SPY072 as a monotherapy for rheumatoid arthritis. The drug candidate was well-tolerated, with adverse events reported in 27% of SPY072-treated participants versus 36% in the placebo group, and most events classified as mild to moderate.
The company emphasized that the results support the broader potential of its TL1A antibody platform in autoimmune diseases, including combination therapy approaches. Spyre plans to release preliminary data for SPY072 in psoriatic arthritis and axial spondyloarthritis in the fourth quarter of 2026, with preliminary combination therapy data for hidradenitis suppurativa expected in late 2027 or early 2028.
Spyre closed at $107.36 on Tuesday, before dropping to $95.00 in after-hours trading, a decline of $12.36 or 11.51%.
