Published on 26 Aug 2022 on Zacks via Yahoo Finance
Shares of Erytech Pharma ERYP fell 19.6% on Aug 25 after management announced that it would no longer pursue the development of Graspa (asparaginase), its most advanced pipeline candidate, in hypersensitive acute lymphoblastic leukemia (ALL).
This decision by ERYP’s management is based on recently received feedback from the FDA last month. After carefully evaluating the feedback, management decided to halt its plans to pursue the development of Graspa in ALL. This decision was made after taking into account the dynamics in the competitive landscape for treating hypersensitive ALL and additional data requested by FDA, which if taken into consideration, will require Erytech Pharma to incur significant cash resources. Based on these points, management decided to focus on preclinical candidates and seek strategic partnerships to expand its pipeline development.
Since last year, the company has been engaged in discussions with the regulatory authority seeking to file a biologic license application (BLA) for Graspa in hypersensitive ALL. At the time, the FDA advised the company to submit additional data alongside the BLA application as well as an agreement on an Initial Pediatric Study Plan (iPSP).