CytoDyn's Leronlimab Suffers Refuse To File Letter; US FDA Concerned About Dosing, Manufacturing
US FDA declines to review the CCR5 antagonist for use in highly treatment-experienced HIV patients. Safety data from an ongoing study should be sufficient to address the agency’s concerns about the higher 700mg dose, CytoDyn management says, but FDA also has questions about the production of the self-injectable syringes.
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Troubled leronlimab is placed on partial clinical hold in HIV, full clinical hold in COVID-19. While searching for a new CEO, CytoDyn tries to reassure investors about its business plan going forward.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
CytoDyn’s COVID-19 candidate leronlimab joins BrainStorm’s ALS therapy in being taken to task as FDA has become more willing to publicly counter investigational drug data announcements it considers to be misleading.