- Erytech Pharma SA (NASDAQ: ERYP) will no longer seek approval for Graspa in hypersensitive acute lymphoblastic leukemia (ALL) following feedback from the FDA.
- The company said, "the changing competitive landscape, combined with new FDA's requests for additional clinical data that would require significant additional resources on our part, led to the difficult decision to stop the development of Graspa in ALL."
- Erytech said it will now focus its resources on preclinical programs while pursuing strategic partnering options.
- A meeting to discuss the submission of a Biologics License Application (BLA) took place in June 2021, after which the company confirmed its intention to submit a BLA, subject to the submission of the additional requested information to the FDA and agreement on an Initial Pediatric Study Plan (iPSP).
- The company recently received feedback from the FDA on its iPSP, submitted in July 2022. After thoroughly evaluating this feedback, the company has determined it is prudent to drop working on Graspa.
- Following the sale of its production facility in Princeton, New Jersey, for $44.5 million in April, the company appointed an advisor to evaluate strategic options to leverage its ERYCAPS platform with complementary assets and/or a broader corporate transaction.
- Multiple options are under review, and the company expects to give further updates on these strategic initiatives in Q4 of 2022.
- Price Action: ERYP shares traded 22.96% lower at $0.95 during pre-market trading on Thursday.
Read at Benzinga