ADMA Biologics tanks 21% as Raymond James downgrades stock

Shares of ADMA Biologics Inc. tanked 21% Monday, after the company said it had received a complete response letter from the Food and Drug Administration regarding an application for a treatment for primary humoral immunodeficiency disease. Raymond James downgraded the stock to market perform from strong buy on the news, although it said it still expects the treatment to be approved, as the letter stemmed from issues at a third-party manufacturer, and not the clinical efficacy and safety data for the drug, named RI-002. "Although these manufacturing issues are largely addressable, the uncertainty surrounding the timing of the resubmission and review remain the key issue, and therefore we are withdrawing RI-002 revenue estimates from our model until we obtain further clarity as to when and what type of a resubmission is possible," analysts wrote in a note. With a cash position of $24.6 million and lowered monthly burn rate of $1.2 million, Raymond James is expecting the company to have sufficient cash to get through 2017 and resubmit the application. Shares are down 23% in the year so far, while the S&P 500 has gained about 6%.

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