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

MacroGenics believes its next-gen anti-CD123 candidate MGD024 has a potentially favorable toxicity profile, as other bispecifics with the same target have floundered. But it lacks the cash to advance on its own.

Top-line results from the firm’s pivotal trial of pivekimab sunirine in a rare cancer indication have been delayed for two more years as the firm shifts focus to a specific subpopulation.

Chaos wrought by the ongoing coronavirus pandemic. A heavy workload and continuing resource constraints at the European Medicines Agency. Nonetheless, a record number of novel drugs and vaccines were cleared for marketing in the EU last year.