Dallas, Texas 02/21/2014 (FINANCIALSTRENDS) – The $173 million market capped drug manufacturing firm DURECT Corporation (NASDAQ:DRRX) provided significant updates on its target drug POSIDUR. The update came on the back of the company receiving a complete response letter from FDA on 12th February.
DURECT Corporation (NASDAQ:DRRX) Chief Executive Officer and CEO Jim Brown addressed a press conference to break the news in which he is quoted to have said that, “FDA is not ready to approve the NDA in its present form, they stated that the NDA does not contain sufficient information to demonstrate that POSIDUR is safe when used in the manner described in the proposed label. The FDA has indicated that additional clinical safety studies need to be conducted. We are evaluating the issues described in the Complete Response Letter and plan to have further discussions around them”.
Since the announcement was made on 13th February, the stock has lost 20.6 percent of its market valuation. Looking at the positives which are coming out of the “complete response letter”, DURECT Corporation (NASDAQ:DRRX) has explained that the FDA note is quite on the efficacy of the drug data under the lens. The drug maker has also pointed out that the regulator has not made any mention on the safety concerns related to the drugs cardiovascular treatment. It also highlights that the CMC section, followed by the non clinical pharma section too does not get commented upon by the FDA.
It is appropriate to note here that the development stage drug maker has accumulated a net loss of $22 million from operations over past 12 months, even as it has generated close to $14.3 million in sales from royalties for its patents.
In a latest development related to the FDA letter, law firm Bronstein, Gewirtz & Grossman, LLC have come forward to investigate the sudden drop in the share price of the drug firm on behalf of its clients.