NEW YORK (TheStreet) -- Shares of Ampio Pharmaceuticals (AMPE) - Get Report shares are up 12.27% to $3.57 in afternoon trading on Tuesday after the company received Special Protocol Assessment from the U.S.Food and Drug Administration.
A Special Protocol Assesment is a written agreement between the FDA and Ampio that defines the clinical trial endpoints required for approval of the company's treatment candidate and significantly reduces the risk of the company's treatment candidate being rejected by the FDA.
The company also announced that it has commenced its second phase III study of its osteoarthritis pain and inflammation treatment candidate Ampion.
"We greatly appreciate the effort by the FDA in reviewing the extensive data and protocols we submitted before granting the SPA," stated CMO Vaughan Clift, MD. "The Ampion™ drug and control saline were manufactured in our state-of-the-art, cGMP facility in Colorado. Our sites have been carefully chosen and the site personnel and monitors have been thoroughly trained on the protocol and administration of the WOMAC 3.1 pain index. The pre-trial preparation has been extensive."
TheStreet Ratings team rates AMPIO PHARMACEUTICALS INC as a Sell with a ratings score of D. TheStreet Ratings Team has this to say about their recommendation:
"We rate AMPIO PHARMACEUTICALS INC (AMPE) a SELL. This is driven by multiple weaknesses, which we believe should have a greater impact than any strengths, and could make it more difficult for investors to achieve positive results compared to most of the stocks we cover. The company's weaknesses can be seen in multiple areas, such as its disappointing return on equity and generally disappointing historical performance in the stock itself. "