File image of the Nasdaq Composite stock market index seen inside their studios at Times Square in New York
File image of the Nasdaq Composite stock market index seen inside their studios at Times Square in New York REUTERS

The top pre-market NASDAQ stock market gainers are: Endo Pharmaceuticals, Biosante Pharmaceuticals, Ariad Phamaceuticals. The top pre-market NASDAQ stock market losers are: Onyx Pharmaceuticals, Diamond Foods, Nuance Communications, ASML Holding, Cisco Systems.

Gainers

Shares of Endo Phamaceuticals Holdings, Inc. (NASDAQ:ENDP) rose 9.53 percent, or $3.24, to $37.25 after it announced that the U.S. Food and Drug Administration (FDA) has approved a new formulation of Opana ER designed to be crush-resistant.

FDA's approval of this new formulation of Opana ER is an important milestone for both the Long Acting Opioid category as well as Endo's branded pharmaceutical portfolio, said Ivan Gergel , executive vice president, R&D and chief scientific officer, Endo Pharmaceuticals.

Biosante Phamaceuticals, Inc. (NASDAQ:BPAX) shares advanced 4.08 percent, or 10 cents, to $2.55.

Shares of Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) edged up 3.10 percent, or 36 cents, to $11.99 after it reported positive trial results in a mid-stage cancer study. The company said preliminary clinical data from the pivotal PACE trial -- a fully enrolled and ongoing Phase 2 study of its investigational pan-BCR-ABL inhibitor, ponatinib, in patients with chronic myeloid leukemia (CML) showed that 47 percent of chronic-phase CML patients in the trial achieved a major cytogenetic response to date.

Losers

Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) plunged 8.93 percent, or $3.63, to $37 after U.S. Food and Drug Administration (FDA) rejected its request for an expedited six-month review of the multiple myeloma drug carfilozimib. However, the agency has granted Standard Review designation to the New Drug Application (NDA) for carfilzomib for the potential treatment of patients with relapsed and refractory multiple myeloma.

Diamond Foods, Inc. (NASDAQ:DMND) shares fell 4.04 percent, or $1.64, to $38.92.

Nuance Communications, Inc. (NASDAQ:NUAN) dropped 1.78 percent, or 44 cents, to $24.30.

Shares of ASML Holding N.V. (NASDAQ:ASML) fell 1.63 percent, or 68 cents, to $40.92.

Shares of Cisco Systems, Inc. (NASDAQ:CSCO) declined 0.9 percent, or 17 cents, to $18.71.