- The stock price of ERYTECH Pharma (Nasdaq: ERYP) increased by over 10% pre-market. These are some details you should know.
The stock price of ERYTECH Pharma (Nasdaq: ERYP) – a clinical-stage biopharmaceutical company, leader in red blood-cell based cancer therapeutics – increased by over 10% pre-market. This is a continuation of momentum as the company stock price increased 54.99% in the previous trading session, going from a previous close of $4.11 to $6.37.
Investors have been responding positively to the company announcing that the U.S. Food and Drug Administration (FDA) has granted eryaspase Fast Track designation for the treatment of acute lymphocytic leukemia (ALL) patients who have developed hypersensitivity reactions to E. coli-derived pegylated asparaginase (PEG-ASNase).
Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment-limiting hypersensitivity in up to 30% of patients. And the discontinuation of asparaginase therapy in ALL patients has been associated with inferior event-free survival, highlighting the need for additional asparaginase-based treatment options.
Back in December 2020, positive results from a Phase 2 trial evaluating the safety and enzyme activity of eryaspase in primarily pediatric ALL patients who developed hypersensitivity reactions to pegylated asparaginase were presented by the Nordic Society of Pediatric Hematology and Oncology at the 2020 American Society of Hematology annual meeting. And this data demonstrated that eryaspase, in combination with chemotherapy, administered every 2 weeks, provided a sustained asparaginase enzyme activity level, and was generally well tolerated with few hypersensitivity reactions.
ERYTECH recently confirmed its intention to submit a Biologics License Application (BLA) for eryaspase in this indication in the fourth quarter of 2021 pending successful completion of remaining steps. And in April 2020, eryaspase was also granted Fast Track designation for the development of a second-line treatment of patients with metastatic pancreatic cancer. A Phase 3 trial in this indication completed enrollment in January 2021 and final results are expected in the fourth quarter of 2021.
“This is yet another significant milestone and meaningful inflection point in advancing our lead product candidate eryaspase, further supporting our recently announced intention to submit a BLA for eryaspase in hypersensitive ALL patients. We believe that the FDA’s Fast Track designation for eryaspase underscores its potential to address this high unmet medical need.”
— Gil Beyen, CEO of ERYTECH
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.