As signaled when Pfizer acquired Biohaven’s Nurtec and CGRP assets, Biohaven will continue under a modified name, with a focus on epilepsy, obsessive compulsive disorder and spinal muscular atrophy.

Some filling lines and API plants fared poorly in post-pandemic inspections, with shortfalls identified in sterility assurance and impurity control. Zhejiang Tianyu and System Kosmetik got warning letters. Alvotech, Cipla and Aurobindo got Form 483 reports posted on the FDA website.

The US firm’s nanoparticle candidate has disappointed in a late-stage ALS trial but experts say secondary survival data could prove a silver lining given an increasingly flexible US regulatory environment.

Many gene therapies companies have faced R&D and financial problems this year but the longer term potential of the field and low prices might tempt big pharma into deals.