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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 the appointment of Alison Lawton to its Board of Directors. Lawton, who previously served as president and CEO of Kaleido Biosciences, brings over 30 years of biopharma experience. The company is focused on developing human enzyme therapeutics for rare diseases, with its lead candidate, pegzilarginase, in a pivotal Phase 3 trial for Arginase 1 Deficiency. Aeglea aims to become commercial-ready, enhancing its board's capabilities as it advances clinical programs including another therapy for Homocystinuria.
Aeglea BioTherapeutics (NASDAQ: AGLE) received Rare Pediatric Disease Designation from the FDA for ACN00177 aimed at treating Homocystinuria, a severe metabolic disorder. This designation highlights the need for effective therapies as Homocystinuria leads to serious complications such as blood clots and developmental issues. Aeglea has commenced a Phase 1/2 clinical trial for ACN00177, designed to lower elevated homocysteine levels. Approval of a Biologics License Application may qualify Aeglea for a Priority Review Voucher, promoting further drug development.
Aeglea BioTherapeutics (NASDAQ:AGLE) has announced updated details for its Fireside Chat at the Evercore ISI 3rd Annual HealthCONx Conference. The conference is scheduled for December 1-3, 2020, with the Fireside Chat occurring on December 1 at 8:00 a.m. EST. Anthony G. Quinn, M.B. Ch.B., Ph.D., will present. Interested parties can access the live and archived webcast through the Company's website.
Aeglea BioTherapeutics (NASDAQ: AGLE) announced its participation in two investor conferences this December. The fireside chats will feature CEO Anthony G. Quinn, M.B. Ch.B., Ph.D. The first event, Piper Sandler 32nd Annual Virtual Healthcare Conference, runs from November 30 to December 3, with an accessible chat starting on November 23. The second, Evercore ISI 3rd Annual HealthCONx Conference, is scheduled for December 1-3, with Quinn presenting on December 1 at 4:20 p.m. EST. Archived webcasts will be available on the company’s website.
Aeglea BioTherapeutics (NASDAQ: AGLE) reported its Q3 2020 results, highlighting significant enrollment progress in its PEACE trial for Arginase 1 Deficiency, with over 50% enrollment achieved and completion expected by January 2021. The company identified 250 patients, a 25% increase from last year. Aeglea received Orphan Drug Designation for ACN00177 for Homocystinuria. Financially, they raised $25 million through an ATM program, extending their cash runway into 2023, with available funds of $141.5 million. The net loss was reduced to $18 million from $21.6 million year-over-year.
Aeglea BioTherapeutics (NASDAQ: AGLE) announced that the FDA has granted Orphan Drug Designation for ACN00177 to treat Homocystinuria, a serious metabolic disorder. The European Medicines Agency also recommended Orphan Drug Designation for the same treatment. ACN00177 aims to reduce elevated homocysteine levels, which can cause severe complications. The FDA designation offers benefits like market exclusivity and tax credits. Aeglea plans to initiate its Phase 1/2 clinical trial, aiming to provide impactful therapy for patients suffering from this condition.
Aeglea BioTherapeutics (NASDAQ:AGLE) announced significant presentations at two upcoming virtual meetings. At the 49th Child Neurology Society Annual Meeting, the company will showcase their research on the misdiagnosis of Arginase 1 Deficiency (ARG1-D) as Hereditary Spastic Paraplegia, scheduled for October 12-23, 2020. Additionally, Aeglea will present on ACN00177, a novel enzyme therapy for Homocystinuria, at the American Society of Human Genetics Virtual Meeting from October 27-30, 2020. The posters will be available for download on their website.
Aeglea BioTherapeutics (NASDAQ: AGLE) announced its participation in three investor conferences in September 2020. Notably, Aeglea will present at the H.C. Wainwright 22nd Annual Global Investment Conference from September 14-16, 2020, with a scheduled presentation by CEO Anthony G. Quinn at 11:00 a.m. EDT on September 14. Additionally, Aeglea will be part of the Wells Fargo 15th Annual Healthcare Conference on September 9-10, and the Cantor Global Healthcare Conference on September 15-17. The company's lead candidate, pegzilarginase, is in a pivotal Phase 3 trial for Arginase 1 Deficiency.
Aeglea BioTherapeutics (NASDAQ: AGLE), a clinical-stage biotech firm, announced its participation in the World Orphan Drug Congress USA 2020 from August 24-27, 2020. The company will present on two topics: industry partnerships for patient inclusion and next-generation human enzymes for rare diseases. The first presentation will be moderated by Michael C. Hanley on August 24 at 9:10 a.m. EDT, while the second will be led by CEO Anthony G. Quinn on August 25 at 12:50 p.m. EDT. Aeglea’s lead candidate, pegzilarginase, is in a Phase 3 trial for Arginase 1 Deficiency, having received Rare Pediatric Disease and Breakthrough Therapy Designation.
Aeglea BioTherapeutics (NASDAQ:AGLE) announced promising results for pegzilarginase, demonstrating a significant and sustained reduction in plasma arginine over 56 weeks in a Phase 1/2 clinical trial with 85% patient clinical response. They also initiated a Phase 1/2 trial for ACN00177 targeting Homocystinuria. Financially, Aeglea reported a net loss of $21.4 million for Q2 2020, a slight increase from $18.0 million in Q2 2019. The company holds $159.2 million in cash, sufficient to fund operations through 2022.
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