Business
Aeglea BioTherapeutics Reports First Quarter 2021 Financial Results and Corporate Highlights
Completed Patient Randomization for Phase 3 PEACE Clinical Trial; Topline Data Expected in Q4 Entered into Ex-U.S. Commercialization Agreement for
About this update from Spyre Therapeutics, Inc.
[{"type":"text","content":"Completed Patient Randomization for Phase 3 PEACE Clinical Trial; Topline Data Expected in Q4\n Entered into Ex-U.S. Commercialization Agreement for Pegzilarginase with Upfront and Milestone Payments Up to $151.5 Million Plus Royalty Percentage in the Mid-Twenties\n Launched THINK ARGININE™, a Disease Education and Diagnostic Testing Initiative for Arginase 1 Deficiency\n\n\nAUSTIN, Texas, May 10, 2021 /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 reported its first quarter 2021 financial results, and provided recent corporate and program highlights.\n\"We've had a strong start to 2021 and I am excited to see the significant momentum we have built for our pegzilarginase program from a clinical perspective as well as strengthening our commercial foundation in preparation for a potential FDA approval and launch. In just the last two months, we completed patient randomization for PEACE, secured a commercialization partner for pegzilarginase in Europe and the Middle East and launched THINK ARGININE, an Arginase 1 Deficiency disease education and diagnostic testing initiative in the United States,\" said Anthony Quinn, M.B Ch.B, Ph.D., president and chief executive officer of Aeglea. \"This substantial progress sets us up well for the rest of 2021. We expect to provide topline data from the PEACE study in the fourth quarter, continue progressing our commercial strategy for pegzilarginase and advance our AGLE-177 clinical program in Homocystinuria. These accomplishments are critical milestones as we move closer to our mission of bringing impactful therapies to patients with rare metabolic disorders who currently have limited treatment options.\" \nRecent Highlights and Updates\nCorporate\nIn March, Aeglea announced it has entered into a license and supply agreement with Immedica Pharma AB granting Immedica exclusive commercialization rights in Europe and several Middle Eastern countries. Aeglea will receive an upfront payment of $21.5 million and is eligible for commercial and regulatory milestones of up to approximately $130 million and mid-twenties percentage royalties on net sales.Pegzilarginase in Arginase 1 Deficiency\nIn April, the Company completed patient scree...