Earnings summaries and quarterly performance for Spyre Therapeutics.
Executive leadership at Spyre Therapeutics.
Board of directors at Spyre Therapeutics.
Research analysts covering Spyre Therapeutics.
Recent press releases and 8-K filings for SYRE.
Spyre Provides Updates on Clinical Trials and Combination Strategy
SYRE
New Projects/Investments
Guidance Update
- Spyre anticipates Part A readouts next year for its ulcerative colitis (UC) trial (SKYLINE), covering alpha-4 TL1A and IL-23 monotherapies. The primary endpoint for this trial is RHI, an objective histologic score.
- The company also expects all three readouts next year for its dose-ranging phase II SKYWAY studies in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, which collectively represent a $30 billion market.
- Spyre is focused on a co-formulation approach for combination therapies, believing it offers lower risk and superior product profiles compared to bispecifics, with strong evidence supporting additive efficacy.
- Spyre plans to advance successful programs from the SKYLINE study into Crohn's disease.
3 days ago
SYRE Provides Updates on Ulcerative Colitis and Arthritis Clinical Trials
SYRE
New Projects/Investments
- SYRE expects all three Part A readouts for its ulcerative colitis (UC) trial (Skyline), evaluating alpha-4 beta-7, TL1A, and IL-23 monotherapies, next year (2026). The primary endpoint for the UC trial is the objective, centrally read RHI (histologic score).
- The Part A component of the UC trial is targeting about 100 patients in total across the three arms.
- For its arthritis program (Skyway), SYRE anticipates all three phase two readouts for rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis next year (2026).
- SYRE is pursuing combination therapies as co-formulations in a single shot, believing they will provide meaningful efficacy improvement by blocking multiple pathways in heterogeneous diseases.
3 days ago
Spyre Provides Updates on Ulcerative Colitis and Arthritis Clinical Programs
SYRE
New Projects/Investments
Guidance Update
- Spyre anticipates readouts for all three Part A monotherapy arms (alpha-4 beta-7, TL1A, and IL-23) of its Ulcerative Colitis (UC) trial (Skyline) next year (2026).
- The UC trial's primary endpoint is RHI (histologic score), an objective, centrally read measure, with historical benchmarks suggesting a 5-7 change from baseline correlates with positive Phase 3 outcomes.
- The company is also expecting all three placebo-controlled, dose-ranging Phase 2 readouts next year (2026) for its Skyway trial, targeting rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis, which collectively represent a $30 billion market.
- Spyre emphasizes the potential for meaningful efficacy improvement from combining mechanisms, opting for a co-formulation approach over bispecifics due to perceived lower risk and superior product profile.
3 days ago
Spyre Therapeutics Outlines Combination Therapy Approach in Autoimmune Diseases
SYRE
New Projects/Investments
- Spyre Therapeutics, a phase II biotechnology company, is developing optimized antibodies for autoimmune diseases, including inflammatory bowel disease (IBD) and rheumatic diseases, aiming to improve efficacy and convenience.
- The company's strategy in IBD involves developing both monotherapies and co-formulated combination products, which are anticipated to offer a significant advancement in treatment by simultaneously blocking multiple disease pathways.
- Spyre targets achieving a 10-point clinical remission delta with its combination therapies, a level historically associated with "mega blockbuster" product sales in IBD, utilizing three orthogonal mechanisms: Alpha-4 beta-7, TL1A, and IL-23.
- Their extended half-life molecules are designed to provide higher therapeutic trough levels with lower peak concentrations, potentially enhancing efficacy and patient convenience without increasing safety risks.
- Spyre's ongoing phase II study for IBD employs a master protocol design to rigorously evaluate the contribution of individual components and their combinations, with results expected in the next year to year and a bit.
Nov 19, 2025, 8:00 AM
Spyre Discusses Phase 2 Combination Therapies for Autoimmune Diseases
SYRE
New Projects/Investments
- Spyre is a Phase 2 biotechnology company focused on advancing optimized antibodies for autoimmune diseases, including inflammatory bowel disease (IBD) and rheumatic diseases.
- In IBD, Spyre is developing co-formulated combination products targeting alpha-4 beta-7, TL1A, and IL-23, aiming to achieve significantly higher efficacy than current monotherapies.
- The company's current Phase 2 study is designed to evaluate both monotherapies and combinations in a mixed population of naive and refractory IBD patients.
- Spyre aims to demonstrate a 10-point delta in clinical remission, a difference considered clinically meaningful based on market research and historical precedents for blockbuster products.
- Their long-half-life molecules are expected to offer improved efficacy and convenience by allowing higher trough levels with lower peak concentrations, potentially leading to long-term remission for patients.
Nov 19, 2025, 8:00 AM
Spyre Therapeutics Outlines IBD and Rheumatic Disease Pipeline Strategy
SYRE
New Projects/Investments
- Spyre Therapeutics is developing long-acting antibodies for inflammatory bowel disease (IBD) targeting alpha-4 beta-7, TL1A, and IL-23, engineered to have more than three times the half-life of first-generation products.
- The company's core strategy in IBD is to use co-formulation combination therapies of these antibodies, aiming for substantially better efficacy and convenience than current monotherapies.
- Spyre has expanded its pipeline into rheumatic diseases (RA, PsA, and axSpA) by utilizing a second TL1A molecule, with phase II studies initiated in Q3.
- Key upcoming milestones include open-label monotherapy data for all three IBD antibodies and phase II data for rheumatic diseases expected next year.
- The company maintains a strong financial position with nearly $800 million on its balance sheet, providing a cash runway into the second half of 2028.
Nov 11, 2025, 1:40 PM
Spyre Therapeutics Discusses Pipeline and Strategy at Stifel 2025 Healthcare Conference
SYRE
New Projects/Investments
- Spyre Therapeutics is developing three long-acting antibodies for autoimmune diseases, specifically inflammatory bowel disease (IBD) and rheumatic diseases, with a strategic focus on combination therapies to enhance efficacy and convenience.
- The company's antibodies, targeting alpha-4 beta-7, TL1A, and IL-23, are engineered to have approximately or more than three times the half-life of first-generation products, enabling less frequent dosing.
- Spyre has nearly $800 million on its balance sheet, providing strategic flexibility and funding operations well into the second half of 2028.
- The company anticipates six phase two data readouts in 2026, including monotherapy data for its IBD assets and its TL1A program in rheumatic diseases (RA, PsA, and axSpA).
Nov 11, 2025, 1:40 PM
Spyre Therapeutics Details Pipeline and Combination Therapy Strategy
SYRE
New Projects/Investments
Guidance Update
Product Launch
- Spyre Therapeutics is developing three long-acting antibodies (alpha-4 beta-7, TL1A, and IL-23) for inflammatory bowel disease (IBD) and a second TL1A for rheumatic diseases. These antibodies are engineered to have more than three times the half-life of first-generation products, aiming for greater convenience and potentially superior efficacy.
- The company's core strategy in IBD focuses on combination therapies of these long-acting antibodies, believing this approach will deliver substantially better efficacy than current monotherapies. They are pursuing a co-formulation approach over bi-specifics due to perceived lower risk and better target engagement.
- Upcoming catalysts include open-label monotherapy data for all three IBD antibodies and data from the TL1A basket study in rheumatic diseases, all expected in 2026. Combination therapy data is anticipated in 2027.
- Spyre holds nearly $800 million on its balance sheet, providing a cash runway into the second half of 2028, which offers significant strategic flexibility for advancing its pipeline.
- The company targets a combined $60 billion commercial market across IBD and rheumatic diseases, with the potential for indication-leading products.
Nov 11, 2025, 1:40 PM
SYRE Discusses Phase 2 Clinical Programs and Upcoming Readouts
SYRE
New Projects/Investments
Product Launch
Guidance Update
- SYRE is conducting two large Phase 2 trials: the Skyline Study in inflammatory bowel disease (IBD) and the Skyway Study in three rheumatic diseases (rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis).
- The Skyline Study is testing three long-acting antibodies (alpha-4 beta-7, TL1A, and IL-23) as monotherapies and in pairwise combinations for IBD, aiming for improved efficacy and convenience with quarterly or twice-annual dosing.
- The Skyway Study is exploring a potentially best-in-class anti-TL1A molecule for rheumatic diseases, targeting quarterly or twice-annual subcutaneous dosing with a cleaner safety profile and efficacy comparable to existing products.
- SYRE expects six readouts next year (2026) from these two studies: three in IBD and three in rheumatic diseases.
- The company recently raised $300 million, bringing its balance sheet to nearly $800 million, providing cash for more than a year beyond all anticipated readouts.
Nov 10, 2025, 3:00 PM
Spyre Therapeutics Reports Q3 2025 Financial Results and Positive Clinical Updates
SYRE
Earnings
New Projects/Investments
- Spyre Therapeutics reported a net loss of $11.2 million for the third quarter of 2025.
- As of September 30, 2025, the company held $486.2 million in cash, cash equivalents, and marketable securities. Following $296.5 million in net proceeds from an October 2025 public offering, the pro forma total reached $782.7 million, extending the expected cash runway into the second half of 2028.
- The company announced positive interim Phase 1 results for SPY003, an anti-IL-23 antibody, which was well-tolerated and demonstrated an ~85-day half-life, supporting potential quarterly or twice-annual maintenance dosing.
- Spyre Therapeutics initiated the Phase 2 SKYWAY basket study of SPY072 for rheumatic diseases and anticipates 6 proof-of-concept readouts in 2026 from its SKYLINE and SKYWAY Phase 2 trials.
Nov 4, 2025, 9:11 PM
Quarterly earnings call transcripts for Spyre Therapeutics.
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