NEW YORK (TheStreet) -- AcelRx Pharmaceuticals(ACRX) - Get Report shares are down 34.67% to $5.71 in early market trading on Monday after the company announced that the FDA is demanding another clinical trial for its pain pill Zalviso.
As a result of the request the company announced that it will not resubmit the drug's regulatory application this quarter. Zalviso was initially rejected by the FDA last July.
The company said that it received correspondence from the FDA last week stating that in addition to the bench testing and two Human Factors studies it had already performed, the regulatory agency was requesting that it also conduct clinical trials to assess the overall risk of dispensation failures.
The company said that it plans to meet with the FDA to "discuss and clarify the agency's belief that an additional clinical study is needed," in a statement today.
TheStreet Ratings team rates ACELRX PHARMACEUTICALS INC as a Sell with a ratings score of D. TheStreet Ratings Team has this to say about their recommendation:
"We rate ACELRX PHARMACEUTICALS INC (ACRX) a SELL. This is driven by a few notable 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. Among the areas we feel are negative, one of the most important has been a generally disappointing historical performance in the stock itself."
Highlights from the analysis by TheStreet Ratings Team goes as follows:
- You can view the full analysis from the report here: ACRX Ratings Report