Piper Sandler analyst Christopher Raymond believes Apellis' (APLS) PEGASUS study "falls short by a wide margin" of positioning APL-2 as a serious competitor to to Alexion's (ALXN) Soliris in a broad paroxysmal nocturnal hemoglobinuria population and he is "breathing a sigh of relief" with respect to his bullish thesis on the latter's shares. While the headline from the study points to statistical superiority versus Soliris, he sees little to worry about for Alexion's complement franchise and believes the larger question for Apellis remains if Hb change is an approvable endpoint. The PEGASUS trial missed non-inferiority on change in LDH levels, which was the primary endpoint for Alexion's C5 inhibitors, the analyst noted. Raymond, who views today's event as removing a key overhang for Alexion, keeps an Overweight rating on the shares with a $180 price target.

Apellis Pharmaceuticals announced that the European Medicines Agency has reset the review of the marketing authorization application for intravitreal pegcetacoplan for geographic atrophy to the last phase of the initial assessment. The procedure is expected to be led by the original rapporteurs, and EMA has stated their intent to convene a new expert group meeting. Apellis anticipates an opinion from the Committee for Medicinal Products for Human Use no later than July 2024. The update follows the judgment by the Court of Justice of the European Union on March 14, 2024, which ruled on the organization of EMA's expert groups. The judgment has implications on EMA's policy for handling competing interests of experts. This decision by EMA is strictly procedural in response to the CJEU judgment and is not related to the pegcetacoplan data package. Apellis will continue to work closely with EMA on the review of the pegcetacoplan marketing application.