France's Erytech Closer To Realizing Market Ambitions With Eryaspase US Filing
Positive FDA Feedback For Leukemia Submission
It has taken almost two decades but it looks as though Erytech could get approval for eryaspase in the US in two indications next year – acute lymphoblastic leukemia and pancreatic cancer.
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The French biotech's shares have sunk 30% but Erytech's decision to withdraw its European marketing authorization application for Graspa in the crowded acute lymphoblastic leukemia market, and focus solely on solid tumors, has gone down well with analysts.
The Phase III PROpel study has shown that a combination of AstraZeneca's Lynparza and Johnson & Johnson's Zytiga significantly delayed disease progression as a first-line treatment for men with metastatic castration-resistant prostate cancer.
A mix of equity and debt financing has raised enough to satisfy Santhera's liquidity needs until mid-2022, which will be after the Swiss firm has filed its Duchenne drug vamorolone.