Why Antares Pharma Inc Plummeted Today
Shares of Antares Pharma (NASDAQ: ATRS) are down 38% at 2:36 p.m. EDT after the company said -- in not so many words -- that it expects the Food and Drug Administration to reject the marketing application for its testosterone replacement therapy Xyosted.
Technically, Antares only said that it received a letter from the Food and Drug Administration that said there are "deficiencies that preclude the continuation of the discussion of labeling and postmarketing requirements/commitments at this time."
But investors who understand the regulatory process know that a rejection is coming. As the FDA wraps up its review of a marketing application and believes it'll approve a drug, the agency starts talking to the company about the drug's label as well as any requirements that the agency may request the company agree to complete after the drug is approved. If the deficiency is so substantial that the FDA doesn't want to talk about labeling and postmarketing requirements, it's clearly going to turn down the marketing application.
Source: Fool.com
