We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Aeglea (AGLE) Down on Corporate Restructuring, CEO Steps Down
Read MoreHide Full Article
Aeglea BioTherapeutics, Inc. 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%.
Image Source: Zacks Investment Research
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.
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.
Zacks' 7 Best Strong Buy Stocks (New Research Report)
Valued at $99, click below to receive our just-released report predicting the 7 stocks that will soar highest in the coming month.
Image: Bigstock
Aeglea (AGLE) Down on Corporate Restructuring, CEO Steps Down
Aeglea BioTherapeutics, Inc. 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%.
Image Source: Zacks Investment Research
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 - Free Report) , Atara Biotherapeutics, Inc. (ATRA - Free Report) and ORIC Pharmaceuticals, Inc. (ORIC - Free Report) , 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.