On track for 6 proof-of-concept readouts in 2026 across the SKYLINE and SKYWAY Phase 2 trials Part A readouts from SKYLINE platform trial in ulcerative colitis ("UC") expected to begin in the second quarter, with enrollment continuing ahead of schedule Enrollment on track in Phase 2 SKYWAY basket trial evaluating TL1A inhibition in rheumatoid arthritis ("RA"), psoriatic arthritis ("PsA"), and axial spondyloarthritis ("axSpA"), with fourth quarter readouts expected in each sub-study Strengthened the balance ...

WALTHAM, Mass., Feb. 18, 2026 (GLOBE NEWSWIRE) -- Spyre Therapeutics, Inc. (NASDAQ: SYRE), a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases, today announced scientific presentations at the 21st Congress of the European Crohn’s and Colitis Organisation (ECCO), held February 18-21, 2026 in Stockholm, Sweden. “We are excited to share follow-up data out to 20 weeks fro ...

Core Insights - Spyre Therapeutics is set to deliver six proof-of-concept readouts in 2026 from its SKYLINE and SKYWAY trials, focusing on inflammatory bowel disease and rheumatic diseases [2][3] - The company has appointed Kate Tansey Chevlen as Chief Commercial Officer, bringing extensive experience from Amgen to enhance its commercial strategy [2][7][8] Group 1: Trial Updates - The SKYLINE platform trial for ulcerative colitis is progressing faster than anticipated, with SPY001 enrollment completed ahead of schedule and Part A readouts expected to begin in Q2 2026 [1][4] - The SKYWAY basket trial is on track, with enrollment ongoing across rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, with all readouts anticipated in Q4 2026 [1][5] Group 2: Financial Position - As of September 30, 2025, Spyre Therapeutics reported a strong balance sheet with pro forma cash, cash equivalents, and marketable securities totaling $783 million, providing a cash runway into the second half of 2028 [2][9] Group 3: Leadership and Strategy - The appointment of Kate Tansey Chevlen as CCO is expected to significantly contribute to the company's Phase 3 strategy and product uptake, leveraging her nearly two decades of experience in biopharma [3][8] - The company aims to redefine the standard of care for inflammatory bowel disease and rheumatic diseases with its innovative long-acting antibodies and combinations [2][10]

Core Insights - Spyre Therapeutics reported positive interim Phase 1 results for SPY003, a next-generation anti-IL-23 antibody, indicating a well-tolerated profile and an approximately 85-day half-life, supporting quarterly or biannual maintenance dosing [1] - The company initiated the Phase 2 SKYWAY basket study for SPY072, focusing on TL1A inhibition in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis [1] - Spyre is on track for six proof-of-concept readouts in 2026 across the SKYLINE and SKYWAY Phase 2 trials [1] - The company strengthened its balance sheet with $316 million in gross proceeds from a public offering, resulting in $783 million in pro forma cash as of September 30, 2025, with a projected runway into the second half of 2028 [1][13] Company Overview - Spyre Therapeutics is a clinical-stage biotechnology company focused on long-acting antibodies and antibody combinations aimed at redefining the standard of care for inflammatory bowel disease and rheumatic diseases [1][16] - The company’s pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23, with a market potential exceeding $60 billion in annual revenue across its indications [2][3] Development Pipeline - The company is advancing multiple investigational antibodies, including SPY001, SPY002, SPY003, and SPY072, targeting validated mechanisms for the treatment of inflammatory bowel disease and rheumatic diseases [4][10][11] - SPY001 targets α4β7 and is designed for infrequent subcutaneous maintenance dosing, while SPY002 and SPY072 are anti-TL1A monoclonal antibodies also engineered for extended half-lives [5][6][7] - The SKYLINE Phase 2 platform trial includes SPY001, SPY002, and SPY003, with Part A focusing on safety and preliminary efficacy, and Part B planned for randomized assessments [10] Financial Performance - As of September 30, 2025, Spyre reported cash, cash equivalents, and marketable securities totaling $486.2 million, with pro forma cash reflecting $782.7 million after a recent public offering [13] - Research and development expenses for Q3 2025 were $45.2 million, slightly higher than $44.7 million in Q3 2024, driven by increased clinical trial costs [14] - The net loss for Q3 2025 was $11.2 million, a significant improvement from a net loss of $69.0 million in Q3 2024 [15][27]

Core Insights - Spyre Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing long-acting antibodies for inflammatory bowel disease and rheumatic diseases, recently presenting scientific data at the ACR Convergence Congress [1][3] Group 1: Product Development - The company shared follow-up data from a Phase 1 study of SPY072, an anti-TL1A agent, indicating it is well tolerated and supports quarterly or biannual dosing [2] - New preclinical data showed that anti-TL1A antibody treatment is as effective or more effective than etanercept in a rodent model of collagen-induced arthritis, supporting ongoing Phase 2 studies for various rheumatic diseases [2] Group 2: Pipeline and Research - Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23, aiming to redefine treatment standards for IBD and rheumatic diseases [3]