A November 2022 refuse-to-file letter cited clinical and statistical issues for the stem cell therapy, which failed its Phase III clinical efficacy endpoint. However, BrainStorm has consistently asserted that NurOwn demonstrated benefit in patients with less advanced disease at baseline, and it is encouraged by regulatory flexibility FDA recently has shown for the neurodegenerative disease.

Neuroscience and oncology fuel high hopes for therapeutic R&D progress among 90-plus surveyed biopharma industry leaders.

Recent financings, including the $150m launch of Pathalys and a planned $100m IPO for Mineralys, illustrate the reality of biopharma funding in 2023 – that having near-term clinical trial milestones are key to fundraising this year. Companies with dwindling cash are conserving the funds they have left.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker