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Spyre Therapeutics, Inc. - AGLE STOCK NEWS

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.

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Aeglea BioTherapeutics (NASDAQ: AGLE) will hold an investor conference call on December 6, 2021, at 8:00 AM ET to discuss topline results from the PEACE Phase 3 clinical trial of pegzilarginase for treating Arginase 1 Deficiency (ARG1-D). The company is focused on developing innovative enzyme therapeutics for rare metabolic diseases. Pegzilarginase has received both Rare Pediatric Disease and Breakthrough Therapy Designations.

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Aeglea BioTherapeutics (Nasdaq: AGLE) announced the appointment of Hunter C. Smith to its board of directors. Smith, currently CFO of Rhythm Pharmaceuticals, brings extensive biotech experience, including corporate strategy and product launches. His addition aims to enhance Aeglea's mission of developing human enzyme therapeutics for rare metabolic diseases. Smith expressed enthusiasm about joining as the company approaches pivotal data from its Arginase 1 Deficiency program trial next month. The company is in a Phase 3 trial for pegzilarginase, which has received designations for Rare Pediatric Disease and Breakthrough Therapy.

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Aeglea BioTherapeutics, Inc. (Nasdaq: AGLE) announced its Q3 2021 financial results, highlighting a net loss of $20.3 million, up from $18.0 million in Q3 2020. The company reported $1.4 million in development fee revenues, a significant increase from no revenue in the same period last year. Cash reserves stand at $114.3 million, sufficient to fund operations into 2023. Key developments include advancing the Phase 3 trial of pegzilarginase for Arginase 1 Deficiency, with topline data expected in December 2021, and ongoing trials for AGLE-177 in Homocystinuria.

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Aeglea BioTherapeutics (Nasdaq: AGLE) announced the presentation of seven abstracts at the 14th International Congress of Inborn Errors of Metabolism (ICIEM) from November 21-23, 2021. The abstracts focus on Arginase 1 Deficiency (ARG1-D) and emphasize the urgent need for enhanced disease awareness, diagnosis, and improved treatments. Key highlights include data setting the stage for the pivotal Phase 3 PEACE study, where topline results are expected in December. Presentations showcase patient characteristics, the impact of high arginine levels, and the deficiencies in current treatments.

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Aeglea BioTherapeutics, a clinical-stage biotechnology company, will participate in various medical and investor conferences in September 2021. Key events include the Wells Fargo Virtual Healthcare Conference on September 9, the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, and the Cantor Virtual Global Healthcare Conference on September 27. Aeglea will present findings on pegzilarginase for Arginase 1 Deficiency at the MDS Virtual Congress (September 17-22) and the CNS Annual Meeting (September 29 - October 2), highlighting gait kinematics and spasticity analysis.

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Aeglea BioTherapeutics (Nasdaq:AGLE) reported its Q2 2021 financial results, showcasing significant progress in its clinical programs and corporate structure. The company initiated dosing in its Phase 1/2 trial of AGLE-177 for Homocystinuria and published data on pegzilarginase for Arginase 1 Deficiency, with results expected in Q4 2021.

Financially, Aeglea recorded $13.7 million in license and development revenues, with a net loss of $6.8 million. Cash reserves stood at $130.4 million, enabling operations through 2023.

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Aeglea BioTherapeutics (NASDAQ:AGLE) announced the appointment of Jim Kastenmayer, Ph.D., J.D., as general counsel. His extensive background in both big pharma and biotech, along with experience in intellectual property, is expected to support the company's clinical programs as it transitions towards commercialization. Kastenmayer previously served as general counsel at Viela Bio, contributing to the FDA approval of Uplizna®. Aeglea is advancing its lead product candidate pegzilarginase in a Phase 3 trial and recently began dosing patients in a Phase 1/2 trial for AGLE-177.

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Aeglea BioTherapeutics (NASDAQ: AGLE) announced the publication of 20-week data from its Phase 1/2 clinical trial of pegzilarginase, aimed at treating Arginase 1 Deficiency (ARG1-D). The study showed that pegzilarginase was well tolerated, with treatment-related adverse events decreasing over time. Remarkably, 93% of patients had plasma arginine levels below the clinical goal of 200 µM, while 79% demonstrated significant improvements in mobility assessments. These results, published in the Journal of Inherited Metabolic Disease, support the ongoing pivotal Phase 3 PEACE trial for pegzilarginase.

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Aeglea BioTherapeutics (AGLE) has appointed Jonathan D. Alspaugh as Chief Financial Officer, bringing over a decade of experience in healthcare advisory. CEO Anthony Quinn highlighted the importance of this appointment, especially as the company approaches significant milestones, including Phase 3 data for pegzilarginase and updates on AGLE-177. Alspaugh's prior roles include managing director at Evercore and involvement in major mergers and acquisitions. Aeglea also granted 290,000 stock options under its 2018 Equity Inducement Plan, including 160,000 to Alspaugh, with an exercise price of $7.03.

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Aeglea BioTherapeutics (AGLE) announced the dosing of the first patient in a Phase 1/2 clinical trial for AGLE-177, a novel therapy targeting Homocystinuria, a rare metabolic disorder. This trial aims to evaluate AGLE-177's safety and effectiveness in lowering plasma homocysteine levels, which are dangerously elevated in affected patients. The trial will enroll 16-20 participants aged 12 and older across the UK and Australia, with results expected later in 2021. Aeglea aims to demonstrate proof of concept to advance toward a Phase 3 trial.

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FAQ

What is the market cap of Spyre Therapeutics (agle)?

The market cap of Spyre Therapeutics (agle) is approximately 48.6M.

What does Spyre Therapeutics, Inc. specialize in?

Spyre Therapeutics specializes in developing advanced antibody therapeutics aimed at transforming the treatment of inflammatory bowel disease (IBD).

What are the key programs of Spyre Therapeutics?

The key programs include SPY001, an anti-α4β7 monoclonal antibody expected to enter clinical studies in 2024, and SPY002, an anti-TL1A monoclonal antibody also projected for clinical trials in 2024.

How is Spyre Therapeutics funded?

Spyre Therapeutics secured $210 million through a private placement in June 2023, providing financial stability to fund operations into 2026.

What diseases does Spyre Therapeutics aim to treat?

Spyre Therapeutics aims to treat inflammatory bowel diseases (IBD) including Crohn's disease and ulcerative colitis.

When are the clinical studies for SPY001 and SPY002 expected to begin?

Clinical studies for SPY001 are expected to begin in the first half of 2024, while SPY002 is projected to enter clinical trials in the second half of 2024.

What sets Spyre Therapeutics' treatments apart from current IBD treatments?

Spyre Therapeutics combines best-in-class antibody engineering, rational therapeutic combinations, and precision immunology, aiming to improve the efficacy, safety, and convenience of IBD treatments.

What is the market opportunity for Spyre Therapeutics' products?

The IBD market, which includes Crohn's disease and ulcerative colitis, is substantial and growing, with an estimated 1.7 million patients in the United States alone.

Where can I find more information about Spyre Therapeutics?

For more information, visit the company's official website at www.spyretx.com and follow their social media profiles on Twitter and LinkedIn.

Spyre Therapeutics, Inc.

Nasdaq:AGLE

AGLE Rankings

AGLE Stock Data

48.63M
1.92M
3.45%
Biotechnology
Healthcare
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United States
Austin