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

At nearly $194,000, the wholesale acquisition cost for Tzield came in above analysts’ $100,000-$115,000 estimates, but payer pushback is not expected as the drug faces no competition.

November should see FDA action on what could be the first standardized fecal microbiota transplant product, rare cancer therapies from Y-mAbs and Spectrum, uniQure/CSL’s hemophilia B gene therapy and Provention Bio’s biologic to delay type 1 diabetes.

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.