CytoDyn shares slammed as BLA filing for leronlimab in HIV hits a wall
In a press release issued in early June announcing a BLA acknowledgment letter from the FDA, CytoDyn CEO Nader Pourhassan said he is hopeful about getting a PDUFA date for its lead drug, leronlimab, on July 10.
Instead, they received a refuse-to-file letter today.
The company said the agency is just looking for “certain information needed to complete a substantive review.” No clinical trials are necessary; all that’s needed is additional analysis and a meeting with the FDA.
The spurn of regulators marked one of the surest episodes in a submission campaign shrouded in uncertainty. Back in late April, CytoDyn had told shareholders that it’s submitted a complete BLA for leronlimab as a combination therapy with an antiretroviral regimen for HIV patients who are highly treatment-experienced. It then added on May 7 that it needed to send in clinical datasets within days before the FDA would consider the filing; the press release about the acknowledgment letter didn’t come out until June 8.
The chaotic communication was cited prominently in a short report by Citron Research, calling for the SEC to “immediately halt this stock promotion scheme.”
Pourhassan hit back by calling the report fraudulent and touting the $87.5 million in milestones he negotiated in a licensing deal with Vyera Pharma, the latest reincarnation of Martin Shkreli-founded Turing Pharma.
Vyera holds rights to market and distribute leronlimab in the US for HIV — if it gets approved. RTF letters can take months, if not years, to resolve, even for experienced drugmakers. CytoDyn has never brought a new compound to market.
A CCR5 antagonist, leronlimab supposedly works by inhibiting viral entry and protecting healthy T cells from viral infection.
Aside from HIV, CytoDyn has the drug for NASH and CCR5+ metastatic triple negative breast cancer. More recently, Covid-19 was spotlighted as a disease potentially addressed by the antibody.
CytoDyn tasked Bruce Patterson, the chief of its diagnostic partner IncellDx, with explaining how:
“Leronlimab has both the potential to enhance the cellular immune response by suppressing Treg cells that, in turn, inhibit the anti-viral T-cell responses and the potential to repolarize macrophage activity,” Patterson said in January, when CytoDyn began an evaluation. “Lung (alveolar) macrophages in coronavirus infections have been implicated as a contributing factor to significant morbidity and mortality of the infectious disease. Leronlimab could potentially synergize with other retroviral therapies that currently being used for the potential treatment of 2019-nCoV.”
Phase II data from a trial involving mild to moderate patients are expected later this month, as are results from a safety review for a Phase III study in the severe/critical population.
July is shaping up to be an important month, Pourhassan promised, and the RTF is nothing to worry about.
“We are 100% committed and confident we can provide the necessary information to the FDA as soon as possible,” he said in a statement. “No additional trials will be required and all the information the FDA has requested is obtainable.”
Investors are less confident. Shares $CYDY fell 21.99% to $3.69.