Welcome to our dedicated page for Spyre Therapeutics news (Ticker: agle), a resource for investors and traders seeking the latest updates and insights on Spyre Therapeutics stock.
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) has appointed Dr. Linda Neuman as the new Chief Medical Officer, promoting her from Senior Vice President of Clinical Development. Dr. Neuman's rich background includes significant roles in drug development at various biotech firms, including overseeing programs for hemophilia and gene therapy. The company is advancing its drug pegtarviliase for Classical Homocystinuria, currently in Phase 1/2 trials. Pegzilarginase, another candidate, has received both Rare Pediatric Disease and Breakthrough Therapy Designations and is under review by the European Medicines Agency.
Aeglea BioTherapeutics (AGLE) reported its third-quarter financial results for 2022, highlighting available cash of $75.2 million as of September 30, 2022, ensuring funding through Q4 2023. The company is currently dosing cohort 3 in its Phase 1/2 trial of pegtarviliase for Classical Homocystinuria and plans to announce interim data by year-end. Additionally, its partner Immedica's marketing application for pegzilarginase for Arginase 1 Deficiency is under EMA review. Aeglea experienced a net loss of $18.2 million for the quarter, compared to $20.3 million in 2021.
Aeglea BioTherapeutics (NASDAQ: AGLE) announced a webinar on Classical Homocystinuria scheduled for October 27, 2022, at 10 AM ET. Key opinion leader Dr. Harvey Levy will discuss the unmet medical need and current treatments for this rare metabolic disease. Aeglea will provide an overview of its lead clinical asset, pegtarviliase, which is in Phase 1/2 development. The company has received Rare Pediatric Disease Designation for pegtarviliase and is also progressing with pegzilarginase, which has achieved its primary endpoint in clinical trials.
Aeglea BioTherapeutics (NASDAQ:AGLE) announced that the third cohort of the Phase 1/2 clinical trial of pegtarviliase for Classical Homocystinuria is underway, with patients receiving weekly doses of 1.35 mg/kg. The FDA placed the trial on partial hold for patients under 18 due to insufficient justification to include adolescents. However, the company believes this will not affect enrollment for patients aged 18 and older in the U.S. or those 12 and older in the UK and Australia. Data from cohort 3 is expected in Q4 2022, focusing on safety and tolerability.
Aeglea BioTherapeutics (NASDAQ: AGLE) has announced presentations at the SSIEM Annual Symposium 2022 in Freiburg, Germany, from August 30 to September 2. Key topics include dietary management strategies for Homocystinuria and new data from the PEACE Phase 3 trial regarding pegzilarginase for Arginase 1 Deficiency. Significant presentations are scheduled for August 31 and September 1, showcasing advances in treatments for rare metabolic diseases. Aeglea's product AGLE-177 is also under investigation for Homocystinuria and has received Rare Pediatric Disease Designation.
Aeglea BioTherapeutics (NASDAQ:AGLE) has announced a leadership transition as Dr. Anthony Quinn steps down from CEO to an advisory role. The company is restructuring to focus resources on AGLE-177, a treatment for Homocystinuria, with interim clinical data expected in Q4 2022. The restructuring has led to a 25% workforce reduction and a shift away from pegzilarginase studies. New leadership includes Jim Kastenmayer as interim CEO and Michael Hanley as chief business officer. Aeglea aims to extend its cash runway into Q4 2023 to support AGLE-177 development.
Aeglea BioTherapeutics (NASDAQ: AGLE) has successfully submitted a Marketing Authorization Application (MAA) for pegzilarginase to the European Medicines Agency (EMA) for treating Arginase 1 Deficiency (ARG1-D). This therapy aims to reduce elevated arginine levels in patients, potentially improving their mobility and overall wellbeing. The MAA submission includes data from multiple clinical studies, including the PEACE Phase 3 trial, which demonstrated a significant reduction in plasma arginine levels. Pegzilarginase has received Orphan Drug Designation from the EMA, highlighting its potential in treating this rare disease.
Aeglea BioTherapeutics (NASDAQ:AGLE) reported financial results for Q2 2022, with a net loss of $22.3 million. The company completed dosing of cohort 2 in its Phase 1/2 trial for AGLE-177 and is preparing to announce data in Q4 2022. Aeglea secured $45 million in gross proceeds from a direct offering, extending its cash runway through Q2 2023. The firm is actively engaging the FDA on the pegzilarginase program while postponing certain Cystinuria activities due to resource constraints. Research and development expenses rose to $15.4 million, partially due to IND-enabling activities.
Aeglea BioTherapeutics (NASDAQ: AGLE) announced receiving a Refusal to File (RTF) letter from the FDA regarding its Biologics License Application (BLA) for pegzilarginase, intended for treating Arginase 1 Deficiency (ARG1-D). The FDA requires additional data demonstrating that plasma arginine reduction correlates with clinical benefits. Aeglea plans to meet with the FDA to address these concerns. Despite the setback, the company remains committed to the ARG1-D community, highlighting the urgency of treatment as there are no approved therapies available. Pegzilarginase has shown promise in clinical trials.
Aeglea BioTherapeutics (NASDAQ:AGLE) has announced a registered direct offering with institutional investors, aiming to raise approximately $45 million. This offering includes 10,752,688 shares of common stock priced at $1.60 each and pre-funded warrants for an additional 17,372,397 shares at $1.5999 per warrant. The proceeds will support ongoing efforts related to the Biologics License Application for pegzilarginase, clinical trials for AGLE-177, and research for AGLE-325, ensuring funds through the second quarter of 2023.
FAQ
What is the market cap of Spyre Therapeutics (agle)?
What does Spyre Therapeutics, Inc. specialize in?
What are the key programs of Spyre Therapeutics?
How is Spyre Therapeutics funded?
What diseases does Spyre Therapeutics aim to treat?
When are the clinical studies for SPY001 and SPY002 expected to begin?
What sets Spyre Therapeutics' treatments apart from current IBD treatments?
What is the market opportunity for Spyre Therapeutics' products?
Where can I find more information about Spyre Therapeutics?
