The FDA did not identify concerns about the clinical efficacy or safety of NASP that would affect its potential for approval.
The pharma company plans to pause or terminate investment in most of Apellis’ legacy research programmes.
The Jaypirca application moves to the EC for a decision, expected within the next one to two months.
Ionis has forecast peak sales of $2bn for Tryngolza as it seeks to harness first-mover advantage.
The collaboration will see the companies gather and analyse data from many patient samples.
Amid the debut of positive Phase I data, the biotech will push its lead asset further down the clinical pipeline in endometriosis and pattern hair loss.
