FDA Declines Approval for Hemispherx's Ampligen

On Tuesday, the maker of a treatment for genital warts, Hemispherx Biopharma Inc., shared that its experimental drug Ampligen, intended as a treatment for chronic fatigue symptom, has been rejected by the US Food and Drug Administration.

As per the company, the FDA believed that the two studies undertaken by the company were not enough to prove the effectiveness of the drug and the agency wants more research and further studies. At least one more study has been demanded by the FDA.

Also, the FDA listed some manufacturing issued that the company needs to look into and resolve. To discuss the maters, Hemispherx is now seeking an expedited meeting with the FDA.

According to an official statement released by the company, it was shared that the firm "is pleased to have received specific advice on the remaining issues and is looking forward to making a thorough but expedited response its top priority".

Post the rejection, shares of Hemispherx dropped 59 cents, or a whopping 49%, to trade at a new low of 61 cents on Wednesday in pre-market trading.

 

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