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Spyre Therapeutics, Inc. (SYRE) filed an 8-K current report with the SEC on June 15, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1). Positive initial 12-week induction topline data from Phase 2 SKYLINE Part A for SPY002 in moderately-to-severely active ulcerative colitis.
Spyre Therapeutics, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Positive initial 12-week induction topline data from Phase 2 SKYLINE Part A for SPY002 in moderately-to-severely active ulcerative colitis
- Disclosure dated June 15, 2026, marking an important clinical-development update for Spyre’s UC pipeline
- Full efficacy and safety results available in Exhibit 99.1; investor focus on response durability and development progression
Item 8.01 · Other Events
- Phase 2 SKYLINE Part A met all key objectives in moderately-to-severely active UC
- Primary endpoint achieved with 10.7-point RHI reduction at Week 12 (p<0.0001)
- Clinical remission reached 33%; endoscopic improvement reached 42%
- Safety profile: 41.7% reported adverse events; 4.2% experienced severe events
- Two serious adverse events, both deemed unrelated to SPY002; no deaths or drug-related serious events
Item EX-99.1 · Exhibit EX-99.1
- SPY002 met its primary endpoint with a 10.7-point RHI reduction at Week 12, statistically significant at p<0.0001
- Clinical remission reached 33% and endoscopic improvement 42% in moderately-to-severely active ulcerative colitis
- Safety appeared manageable: 41.7% experienced adverse events, with zero drug-related serious adverse events or deaths
- Part B enrollment underway with three combination arms, increasing potential efficacy upside but adding execution risk
- SPY003 anti-IL-23 monotherapy data expected in Q3, providing the next major pipeline catalyst
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
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