Alexion Pharmaceuticals' (NASDAQ:ALXN) Soliris (eculizumab) is under close scrutiny for meningococcal infection risk in its Phase III for neuromyelitis optica (NMO), experts said. Even a low incidence of meningococcal infection is going to impact its risk profile, they said, though noted other adverse events (AEs) seem acceptable.
Analysts were mixed on Soliris’ outlook, with some saying that the risk profile is not out of the woods yet, and others saying that its AE profile looked sound in Phase II. Some said that the one meningococcal infection in Phase II was a red flag that could affect approval chances, and meningococcal incidences in Phase III will be watched closely.
Analysts project sales of USD 129.4m by 2025; however, they expect a positive readout of Phase III to increase Alexion's share price by as much as 5%, while a negative readout could sink prices by up to 2%. Alexion has a market cap of USD 23.2bn.
Soliris is in a 132-patient Phase III trial (NCT01892345), which started in January 2014 and has a study completion date of May 2018 and top-line data expected YE18, according to Alexion’s April quarterly earnings report.