Mizuho expects news this week from Europe on Amylyx’s Relyvrio

Mizuho notes that the draft agenda for the October meeting of the EMA’s Committee for Medicinal Products for Human Use, or CHMP, was released to the public and that it includes Amylyx’s AMX0035, or Relyvrio as it is known in the U.S. Based on the firm’s read of the draft agenda, beyond the oral explanation taking place on October 10, the firm believes it is also possible the CHMP could use this week’s meeting to again formally review AMX0035 and also then issue its opinion either recommending for, or against, an approval for AMX0035 in Europe by the end of this week. The firm, which is “pleased to see” AMX0035 appearance on the draft agenda as “it provides an element of certainty with respect to the timing of next steps with the approval process in Europe,” keeps a Buy rating and $48 price target on Amylyx shares.