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Spyre Therapeutics, Inc. (SYRE) filed an 8-K current report with the SEC on April 13, 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 for SPY001 in moderate-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 for SPY001 in moderate-to-severely active ulcerative colitis
- Results from Part A of the Phase 2 SKYLINE trial, a key clinical-development milestone
- Press release and supporting data presentation attached as Exhibits 99.1 and 99.2
- Conference call and webcast scheduled April 13, 2026 at 8:00 a.m. Eastern Time
Item 8.01 · Other Events
- SPY001 met the Phase 2 primary endpoint, reducing RHI score 9.2 points at Week 12 with p<0.0001
- Clinical remission reached 40% and endoscopic improvement 51%, supporting SPY001’s ulcerative-colitis efficacy signal
- Safety appeared favorable in 43 subjects, with 14% reporting adverse events and no drug-related adverse events
- SKYLINE Part A recruitment closed; Part B opened with three monotherapy and three combination cohorts
- Remaining Part A data expected mid-2026 and Q3 2026; all Part B induction data remain targeted for 2027
Item EX-99.1 · Exhibit EX-99.1
- SPY001 met the Phase 2 primary endpoint, reducing RHI by 9.2 points at Week 12 versus baseline (p<0.0001)
- Clinical remission reached 40% and endoscopic improvement 51%, supporting potential competitiveness against existing α4β7 therapy
- Safety appeared favorable: 6 of 43 patients reported adverse events, with no drug-related events or discontinuations
- Part A recruitment closed; Part B now tests SPY001, SPY002, SPY003 monotherapies and three combinations
- Remaining Part A data expected mid-2026 and Q3 2026; Part B induction data targeted for 2027
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