Aeglea BioTherapeutics, Inc. AGLE announced a corporate restructuring plan to focus resources and prioritize the development of its pipeline candidate, AGLE-177 for the treatment of patients living with homocystinuria.
With the current restructuring, the company is looking to increase its focus and capital deployment towards AGLE-177, rather than its lead candidate, pegzilarginase, which is being developed for treating patients with Arginase 1 Deficiency (AGR1-D).
The latest restructuring is likely to reduce the headcount of AGLE by approximately 25% year to date. The restructuring will result in extending the company’s cash runway into the fourth quarter of 2023.
Aeglea’s current chief executive officer and president also decided to step down from his positions and transitioned to an advisory role with immediate effect following the corporate restructuring. The company has appointed Jim Kastenmayer as its interim president and chief executive officer while looking for a permanent replacement.
Shares of Aeglea were down 19.8% following the announcement on Wednesday. The stock, however, recovered thereafter and was up in pre-market trading on Thursday.
Aeglea’s stock has plunged 88.5% this year compared with the industry’s decline of 21.5%.
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We remind investors that, in April 2022, AGLE submitted a biologics license application (“BLA”) to the FDA for use of pegzilarginase in the treatment of ARG1-D in the United States.
However, in June 2022, the company received a Refusal to File (RTF) letter from the FDA related to its BLA for pegzilarginase for the given indication.
The FDA requested additional data to support the effectiveness of pegzilarginase in the RTF. The regulatory body also requested additional information relating to Chemistry Manufacturing and Controls. However, no safety issues were raised in the RTF.
Earlier this month, Aeglea submitted a marketing authorization application to the European Medicines Agency (EMA), seeking approval for pegzilarginase, for treating patients with AGR1-D.
ARGN1-D is a rare progressive disease characterized by high levels of the amino acid arginine in the body, that presents in early childhood.
Zacks Rank & Stocks to Consider
Aeglea currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Achilles Therapeutics plc ACHL, Atara Biotherapeutics, Inc. ATRA and ORIC Pharmaceuticals, Inc. ORIC, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Achilles Therapeutics’ loss per share estimates narrowed 6.4% for 2022 and 9.6% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ACHL delivered an earnings surprise of 12.45%, on average.
Atara Biotherapeutics’ loss per share estimates narrowed 43.2% for 2022 and 31.8% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.
ORIC Pharmaceuticals’ loss per share estimates narrowed 5.3% for 2022 and 15.8% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.
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