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Aeglea BioTherapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Program Updates
Jeffrey Goldberg, experienced biotech executive, appointed president and CEO; further strengthened senior management team with appointments of chief medical
About this update from Spyre Therapeutics, Inc.
[{"type":"text","content":"Jeffrey Goldberg, experienced biotech executive, appointed president and CEO; further strengthened senior management team with appointments of chief medical officer and chief product officer\n$57.3 million of cash, cash equivalents, marketable securities, and restricted cash as of December 31, 2022, which is expected to fund operations into the fourth quarter of 2023\nAUSTIN, Texas, March 2, 2023 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced financial results for the fourth quarter and full year 2022, and provided program updates.\n\"Since joining the company, I have been impressed by the programs and the potential impact that they may have on patient lives. In 2023, we are highly focused on execution, specifically the generation of data from our pegtarviliase Phase 1/2 clinical trial in Classical Homocystinuria and, assuming success with those data, preparations to advance into a potential pivotal trial,\" said Jeffrey Goldberg, president and chief executive officer of Aeglea. \"We are also continuing to work with our partner Immedica Pharma AB to support the EMA [European Medicines Agency] review process for the Marketing Authorization Application for pegzilarginase for the treatment of Arginase 1 Deficiency. A decision by the EMA regarding the approval of the pegzilarginase Marketing Authorization Application is expected in late 2023. By delivering on these objectives, I believe we will be in a strong position to bring forward solutions that can positively impact the lives of our patient communities.\"\nProgram and Corporate Updates\nPegtarviliase in Homocystinuria\nReceived Fast Track Designation from the U.S. Food and Drug Administration (FDA). Fast Track Designation is designed to expedite the FDA's review of innovative, new drugs that demonstrate the potential to address unmet medical need.Announced in late November 2022 the completion of dosing of two patients in the third cohort of the Phase 1/2 clinical trial. Patients in the third cohort receive 1.35 mg/kg of pegtarviliase administered subcutaneously once weekly.Pegzilarginase in Arginase 1 Deficiency\nTransitioning patients who participated in the PEACE Phase 3 long-term extension (LTE) and...