Clene leadership spoke with the Pink Sheet about its push for accelerated approval for its ALS nanoparticle treatment. A new nudge from Congress asking the US FDA to consider survival data in accelerated approval could help.

CEO Raj Mehta told Scrip Seelos anticipates conducting a Phase III study of SLS-005 after the cohort in HEALEY ALS failed overall, but indicated some efficacy in patients not receiving Relyvrio.

Public Company Edition: Follow-on offerings may not be the favored path to funding development programs or product launches after major milestones in the current environment. Amicus secured $430m in a deal with Blackstone, while OPKO’s Modex garnered up to $168m from BARDA.

Apellis’s pegcetacoplan – approved for two other indications – will not go forward in amyotrophic lateral sclerosis after a Phase II failure, two days after Wave Life made a similar call in the neurodegenerative disease.