Fierce Biotech February 29, 2024
Annalee Armstrong

After two years, CytoDyn’s HIV program is finally free of the FDA clinical hold.

In a short update Thursday, CEO Jacob Lalezari, M.D., heralded the lifting of the hold as a “new chapter” for lead asset leronlimab, which has been tested in multiple indications without success so far. The company is now cleared to advance a trial in HIV.

Leronlimab was placed on clinical hold in March 2022, with a partial pause on the HIV program and full hold in COVID-19. At the time, CytoDyn did not provide many details on the reasons behind the hold.

In a November 2023 letter to shareholders, Board Chair Tanya Durkee Urbach said the year “proved to be a very difficult” one for the...

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