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CytoDyn, Inc.

http://www.cytodyn.com

Latest From CytoDyn, Inc.

US FDA Rebukes Another Sponsor For Touting Investigational Product Based On Subgroup Efficacy

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.

Clinical Trials Coronavirus COVID-19

HIV Market To Meet Patent Cliff In 2026-27 But Novel Products Coming

Market Snapshot: Gilead’s Biktarvy and ViiV’s two-drug regimens are expected to dominate the HIV market over the next few years as market exclusivity losses loom, but drugs with new mechanisms of action, and longer-acting products, might influence market dynamics.   

Market Snapshot Infectious Diseases

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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Keeping Track: Good News For Deciphera, BMS And Clovis; Bad News For bluebird/BMS, Blueprint And Tonix

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

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Company Information

  • Industry
  • Pharmaceuticals
  • Biotechnology
    • Large Molecule
      • Antibodies
  • Other Names / Subsidiaries
    • Advanced Genetic Technologies INC.
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