Spyre Therapeutics, Inc.

Spyre Therapeutics Announces Clinical and Preclinical Data Presentations at United European Gastroenterology Week (UEGW) 2026

Spyre Therapeutics will present the first congress data covering all three of its IBD antibodies — SPY001 (anti-α4β7), SPY002 (anti-TL1A), and SPY003 (anti-IL-23) — at United European Gastroenterology Week 2026 in Barcelona. The data come from the SKYLINE Phase 2 platform trial, where the antibodies are being tested as monotherapies and pairwise combinations; new preclinical data show additive efficacy of the combined mechanisms. Steering Committee Chair Silvio Danese says clinical proof-of-concept is now demonstrated across all three antibodies, with combination results expected next year — the key catalyst for raising the therapeutic ceiling in IBD.

•14d ago

Spyre Announces Potential Best-in-Class SPY003 (anti-IL-23) Part A Induction Results from SKYLINE Trial, Completing Proof-of-Concept for All Three Components of its IBD Combinations

Spyre Therapeutics' SPY003 (anti-IL-23) met its primary endpoint in SKYLINE Part A, delivering a statistically significant 10.0-point reduction in Robart's Histopathology Index at Week 12 (p<0.0001) in moderately-to-severely active ulcerative colitis. Clinical remission was 20% and endoscopic improvement 30%, with a -3.5 change in modified Mayo Score across 44 subjects; SPY003 was well tolerated with a safety profile consistent with the IL-23 class and no drug-related serious adverse events. This marks the third positive Part A readout in five months — SPY001 and SPY002 posted RHI reductions of 9.2 and 10.7 points — completing clinical proof-of-concept for every component of Spyre's planned IBD pairwise combinations. Part B of SKYLINE, testing high-dose combination arms SPY120, SPY130 and SPY230, is actively enrolling with topline induction data expected in 2027; SKYWAY (4Q 2026) and SKYLIGHT (late 2027/early 2028) readouts follow over the next 12-18 months.

•1mo ago

Spyre Therapeutics Announces Launch of SPY772 Program and Initiation of Phase 2 SKYLIGHT Trial in Hidradenitis Suppurativa

Spyre Therapeutics launched the SPY772 program, a long-acting coformulation of anti-TL1A and anti-IL-17A/F antibodies, and initiated the Phase 2 SKYLIGHT trial in Hidradenitis Suppurativa. The randomized study will enroll approximately 150 adults to evaluate the efficacy of adding SPY072 to background bimekizumab therapy, with topline HiSCR75 data expected in late 2027 or early 2028. Management believes the dual inhibition strategy has the potential to raise the efficacy ceiling in HS and expand applications across other immunologic diseases.

•2mo ago

Spyre Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update

Spyre Therapeutics reported a second quarter net loss of $36.2 million and ended the period with $1.1 billion in cash, providing a runway expected to extend into the second half of 2029. The company announced positive topline induction data for SPY001 and SPY002 from Part A of the Phase 2 SKYLINE trial, showing statistically significant reductions in the Robart’s Histopathology Index score of 9.2 and 10.7 points, respectively. Enrollment has completed for the Phase 2 SKYWAY basket trial in rheumatic diseases, with management remaining on track for six proof-of-concept Phase 2 readouts in 2026, including data for the RA sub-study expected in September.

•2mo ago

Spyre Announces Potential Best-in-Class SPY002 (anti-TL1A) Part A Induction Results from SKYLINE Trial in Moderate-to-Severe Ulcerative Colitis Patients

Spyre Therapeutics reported positive 12-week induction data from Part A of the Phase 2 SKYLINE trial for SPY002, an anti-TL1A antibody for ulcerative colitis. The drug met its primary endpoint with a statistically significant 10.7-point reduction in Robart’s Histopathology Index (RHI) score (p<0.0001), alongside 33% clinical remission and 42% endoscopic improvement rates. Safety was consistent with the TL1A class, with 41.7% of subjects experiencing treatment-emergent adverse events and no drug-related serious adverse events reported.

•4mo ago

Spyre Therapeutics Announces Completion of Enrollment in SKYWAY Basket Trial Evaluating SPY072 (anti-TL1A) in RA, PsA, and axSpA

Spyre Therapeutics announced the completion of enrollment for all sub-studies in the SKYWAY Phase 2 basket trial of SPY072. The trial evaluates the anti-TL1A antibody in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA). Enrollment was completed in less than nine months, keeping the company on track for its planned six Phase 2 readouts in 2026, with RA data expected in Q3 and PsA/axSpA data in Q4.

•4mo ago

Spyre Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update

Spyre Therapeutics reported positive topline induction data from Part A of the Phase 2 SKYLINE trial for SPY001, achieving the primary endpoint with a 9.2-point reduction in RHI score. The company strengthened its balance sheet with $463 million in gross proceeds from a recent offering, bringing pro forma cash to $1.2 billion with a runway into the second half of 2029. Q1 net loss was $69.0 million, driven by increased R&D expenses of $60.4 million as the company advances its pipeline of six Phase 2 agents.

•5mo ago