- The stock price of Erytech Pharma SA (NASDAQ: ERYP) increased by over 10% pre-market. This is why it happened.
The stock price of Erytech Pharma SA (NASDAQ: ERYP) – a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells – increased by over 10% pre-market. Investors are responding positively to ERYTECH Pharma announcing its intention to move forward towards the submission of a BLA to the US Food and Drug Administration (FDA) for eryaspase in hypersensitive acute lymphoblastic leukemia (ALL) patients following feedback from the agency in a pre-BLA meeting.
And the purpose for the meeting was to discuss clinical, non-clinical, and quality content and expectations for the company’s potential BLA submission. And based on the discussion and the totality of the available information to the company to date, ERYTECH believes its regulatory package could potentially support approval of eryaspase in hypersensitive ALL patients. With the pending successful completion of the remaining steps, the company anticipates submitting a BLA in the fourth quarter of 2021.
In December 2020, the positive Phase 2 clinical results were presented by the Nordic Society of Pediatric Hematology and Oncology, at the 2020 American Society of Hematology annual meeting. And Eryaspase — in combination with chemotherapy, administered every two weeks — provided a sustained asparaginase enzyme activity level, and was generally well tolerated with few hypersensitivity reactions.
“We are encouraged by the interactive dialogue with the agency, and grateful for the feedback and guidance we received on a potential path to approval. This is an important milestone for ERYTECH as it advances our lead product candidate eryaspase as an alternative treatment for ALL patients with hypersensitivity to PEG-asparaginase, while our Phase 3 trial in second line pancreatic cancer is nearing completion. If all goes well, we could be in a position to make this product candidate available to ALL and pancreatic cancer patients in the course of next year.”
— Gil Beyen, CEO of ERYTECH
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