CytoDyn Shares Drop as FDA Seeks More HIV-Treatment Data

Shares of CytoDyn dropped after the biotech said the FDA sought more data, but didn't require new trials, for its leronlimab treatment for HIV.
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Shares of CytoDyn  (CYDY) - Get Report dropped after the late-stage biotech said the Food and Drug Administration requested more information regarding a license application for its leronlimab treatment for HIV.

The Vancouver, Wash., company on May 11 said it submitted all remaining parts of its Biologics License Application. The FDA said, however, that CytoDyn's application "does not contain certain information."

"We are 100% committed and confident we can provide the necessary information to the FDA as soon as possible," Chief Executive Nader Pourhassan said in a statement. 

The company won't have to perform any additional trials, and all the information the FDA is seeking is "obtainable," Pourhassan said.

The FDA application targeted using leronlimab as a combination therapy with Haart - physician-prescribed custom combinations of medications - for "highly treatment experienced HIV patients."  

Last week the company published preliminary results from a study of leronlimab's effectiveness as an HIV PrEP agent in macaques.

CytoDyn said that it was looking to build on those preclinical results. 

"We are confident July will be a very important month for our shareholders," Pourhassan said ahead of the company's conference call Monday.

"I understand many of our shareholders are very eager to see these results soon and I welcome the opportunity to answer any questions from our shareholders." 

The company is holding a conference call with investors at 4 p.m. U.S. Eastern.

At last check the stock was trading down 16% at $3.96. It has traded on Monday down as much as 40%. It traded at 26 cents a share in December and $10 in June.