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Spyre Therapeutics, Inc. (NASDAQ: AGLE) is a biotechnology company dedicated to advancing a robust pipeline of antibody therapeutics aimed at transforming the treatment of inflammatory bowel disease (IBD). The company was formed following the acquisition by Aeglea BioTherapeutics in June 2023, shifting the focus from rare metabolic diseases to innovative IBD treatments. Spyre combines advanced antibody engineering, rational therapeutic combinations, and precision immunology to maximize the efficacy, safety, and convenience of its treatments.
With a promising portfolio, Spyre's lead programs—SPY001 and SPY002—focus on targeting α4β7 and TL1A, respectively.
- SPY001: This program involves a highly potent and selective anti-α4β7 monoclonal antibody, engineered with half-life extension technology for high-concentration, convenient dosing. It is expected to enter first-in-human studies in the first half of 2024, with interim data anticipated by the end of 2024.
- SPY002: A highly potent anti-TL1A monoclonal antibody engineered for half-life extension, targeting both TL1A monomers and trimers with exceptional binding affinity. First-in-human studies are expected to commence in the second half of 2024, with interim data anticipated in the first half of 2025.
Additionally, Spyre is developing SPY003, a monoclonal antibody targeting the p19 subunit of IL-23, expected to enter clinical trials in 2025.
The company operates with robust financial health, having successfully raised $210 million through a private placement in June 2023, and is positioned to fund its operations into 2026. Spyre aims to address the significant and growing IBD market, which includes conditions like Crohn's disease and ulcerative colitis, affecting approximately 1.7 million patients in the United States alone.
Aeglea BioTherapeutics (NASDAQ: AGLE) announced significant progress with pegzilarginase, submitting a Biologics License Application (BLA) to the FDA for Arginase 1 Deficiency treatment, seeking Priority Review. At the SIMD Annual Meeting, new data showed 76.7% reduction in mean plasma arginine in treated patients, with 90.5% achieving normal levels. The company's first-quarter 2022 report noted $68.6 million in cash reserves, $1.4 million in development fee revenues, but a net loss of $24.4 million.
Aeglea BioTherapeutics (Nasdaq: AGLE) has submitted a Biologics License Application (BLA) for pegzilarginase to the FDA for treating Arginase 1 Deficiency (ARG1-D). The company seeks FDA Priority Review, aiming to become the first approved therapy for this severe rare disease. Pegzilarginase has shown effectiveness in normalizing arginine levels in clinical trials, with the PEACE Phase 3 study reporting a 76.7% reduction in plasma arginine. The company continues to collaborate with the FDA while also planning a European Marketing Authorization Application submission.
Aeglea BioTherapeutics (Nasdaq: AGLE) presented new data from its PEACE Phase 3 study of pegzilarginase for Arginase 1 Deficiency (ARG1-D) at the SIMD Annual Meeting in Orlando, FL. The study demonstrated a significant 76.7% reduction in plasma arginine, achieving normal levels in 90.5% of treated patients. Additionally, pegzilarginase showed improvements in mobility assessments and was well-tolerated. This data enhances understanding of ARG1-D and supports pegzilarginase's potential as a transformative therapy for affected patients, with regulatory designations reinforcing its significance.
Aeglea BioTherapeutics, Inc. (Nasdaq: AGLE) announced its participation in the 21st Annual Needham Virtual Healthcare Conference, taking place from April 11-14, 2022. Aeglea's president and CEO, Anthony G. Quinn, will present on April 13 at 9:30 a.m. EDT. The company focuses on human enzyme therapeutics for rare metabolic diseases, having recently reported positive data from its PEACE Phase 3 clinical trial for pegzilarginase, designed for Arginase 1 Deficiency. Aeglea also has an active trial for AGLE-177 targeting Homocystinuria. For more details, visit their website.
Aeglea BioTherapeutics (AGLE) announced upcoming presentations at two medical meetings, showcasing data from its PEACE Phase 3 study of pegzilarginase for Arginase 1 Deficiency (ARG1-D). The Society for Inherited Metabolic Disorders Annual Meeting will feature results from the trial, scheduled for April 11, 2022. Additional posters will be presented at the American Academy of Neurology Annual Meeting, focusing on ARG1-D management and the role of arginine. The company recently reported positive topline data from the trial, which received Rare Pediatric Disease and Breakthrough Therapy Designations.
Aeglea BioTherapeutics (Nasdaq: AGLE) announced the withdrawal of its proposed public offering, emphasizing its strong financial position with cash and equivalents of $95 million as of December 31, 2021. This amount is projected to sustain operations into Q1 2023. The company is developing human enzyme therapeutics for rare metabolic diseases, with positive topline data from its Phase 3 trial for pegzilarginase for Arginase 1 Deficiency and ongoing trials for AGLE-177 for Homocystinuria.
Aeglea BioTherapeutics (Nasdaq:AGLE) announced a proposed underwritten public offering of its common stock and pre-funded warrants. The company plans to use proceeds from this offering to support its Biologics License Application for pegzilarginase, ongoing clinical trials, and continued research and development.
JonesTrading and LifeSci Capital are the joint book-running managers for this offering. This public offering is subject to market conditions, and there are no guarantees about its completion or terms.
Aeglea BioTherapeutics (Nasdaq: AGLE) announced a webinar on Arginase 1 Deficiency scheduled for February 3, 2022, at 2:30 PM EST. The event will feature Dr. Barbara Burton, Dr. George Diaz, and Tanja Brandt, who will share insights into the disease and treatment approaches, with a live Q&A session afterward. Aeglea's pegzilarginase has received Rare Pediatric Disease and Breakthrough Therapy designations, following positive results from its Phase 3 PEACE trial. The company continues its research in rare metabolic diseases with ongoing trials for AGLE-177.
Aeglea BioTherapeutics (Nasdaq: AGLE) will participate in two key investor conferences in January 2022. The first is the 40th Annual J.P. Morgan Health Care Conference from January 10-13, with a live presentation by CEO Anthony G. Quinn on January 12 at 10:30 a.m. EST. The second is the H.C. Wainwright Bioconnect Virtual Conference, featuring an on-demand presentation by Quinn on January 10 at 7:00 a.m. EST. Aeglea focuses on developing human enzyme therapeutics for rare metabolic diseases, with lead candidate pegzilarginase in a Phase 3 trial and AGLE-177 in Phase 1/2 for Homocystinuria.
Aeglea BioTherapeutics (NASDAQ: AGLE) announced significant results from its Phase 3 PEACE trial for pegzilarginase, designed for Arginase 1 Deficiency. The study achieved its primary endpoint, showing an 80% reduction in plasma arginine after 24 weeks (p < 0.0001). Notably, 90.5% of patients reached normal arginine levels. There was a positive trend in mobility assessed by GMFM-E. Aeglea plans to submit a Biologics License Application to the FDA in 2022 and pursue marketing authorizations in Europe. Pegzilarginase is a novel therapy aimed at significantly improving patient outcomes in this rare disease.
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