- Alexion Pharmaceuticals (NASDAQ:ALXN) is up 11% premarket on light volume in response to its announcement of successful results from a Phase 3 clinical trial assessing ALXN1210 in patients with paroxysmal nocturnal hemoglobinuria (PNH).
- The data showed ALXN1210 to be non-inferior to Soliris (eculizumab) by virtue of achieving the co-primary endpoints of transfusion avoidance and normalization of lactate dehydrogenase (LDH) levels, a direct marker of complement-mediated hemolysis in PNH.
- ALXN1210 also demonstrated non-inferiority to Soliris on all four key secondary endpoints.
- Detailed results will be submitted for presentation at a future medical conference.
- ALXN1210 is a long-acting C5 inhibitor that is administered six times per year compared to 26 times per year for Soliris.
- The company plans to file marketing applications in the U.S., EU and Japan in H2.
- Management will host a conference call this morning at 8:30 am ET to discuss the results.
- PNH-related tickers: (NASDAQ:APLS)(NASDAQ:RARX)(NASDAQ:AKTX)(NASDAQ:ACHN)(NASDAQ:FBIO)
- Now read: Alexion Pharmaceuticals - Appeal Increases, Not Pulling The Trigger Yet
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