AB Science, the Paris-based biopharmaceutical company, released an update Wednesday on its clinical development program for several experimental drugs targeting rare cancers and neurodegenerative diseases. The announcement comes as regulators increasingly scrutinize mid-stage trial data before granting accelerated approval pathways.
The company confirmed ongoing Phase 2 studies for masitinib in amyotrophic lateral sclerosis (ALS) and progressive multiple sclerosis, with Phase 3 trials expected to begin in Q4 2024 pending regulatory feedback. Analysts note this represents a six-month delay from previous projections, which AB Science attributes to protocol adjustments requested by European Medicines Agency reviewers.
“We’re seeing more conservative approaches from regulators after high-profile trial failures in the neurology space,” said a healthcare analyst at a major investment bank who requested anonymity due to client relationships. “Companies like AB Science must demonstrate robust biomarkers before advancing to late-stage trials.”
AB Science’s update made no mention of its COVID-19 program, which had drawn skepticism from researchers last year over small sample sizes in early trials. The company’s stock fell 3% in Paris trading following the announcement, underperforming the broader healthcare index.
Industry observers will watch for the FDA’s upcoming decision on masitinib for severe asthma, with a Prescription Drug User Fee Act (PDUFA) date set for August 15. Approval could validate the company’s kinase inhibitor platform, while rejection may force pipeline reprioritization.