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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.