Despite market headwinds, the endovascular treatment of acute ischemic stroke remains a growing and highly under-penetrated market opportunity valued at more than $1 billion worldwide. Although advances in neurothrombectomy devices, access catheters, imaging, and neuroprotective therapies have the potential to help expand the treatable population, positive Level I clinical evidence is needed to drive adoption and market growth.

Pink Sheet reporters and editors consider the fallout from Brainstorm Cell Therapeutics Inc.’s negative US FDA advisory committee decision on its ALS drug, the impact of a government shutdown on the agency, and a study showing only a limited possibility for significant savings in the first round of Medicare price negotiations.

Foreign tablets, active pharmaceutical ingredient residues and failed line clearance plagued operations at repackers that received FDA warning letters in FY 2023.