Merck & Co., Inc. (NYSE:MRK) said the U.S. Food and Drug Administration has granted a Breakthrough Therapy Designation to its Keytruda drug to treat non-small cell lung cancer. The designation is specifically for treatment of patients with Epidermal Growth Factor Receptor mutation-negative, and Anaplastic Lymphoma Kinase rearrangement-negative non-small cell lung cancerwhose disease has progressed on or following platinum-based chemotherapy.The designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Keytruda is currently indicated in the U.S. for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Merck & Co., Inc. (NYSE:MRK) is trading in the upper half of the 52-week range between $44.62 and $61.33.Compugen Ltd. (USA) (NASDAQ:CGEN) has disclosed successful experimental data for CGEN-15027 that demonstrated that the treatment has a strong potential to serve as a target for monoclonal antibody cancer therapy. CGEN-15027 is a Compugen-discovered immune checkpoint target candidate and is potentially distinct from previously-disclosed Compugen checkpoint target candidates, it said."Six of our eleven computer-predicted novel immune checkpoint candidates have demonstrated initial successful biological validation supporting their involvement in tumor immunology. To our knowledge, this hit rate is unprecedented," said Dr. Anat Cohen-Dayag, Compugen president and CEO. Compugen Ltd. (USA) (NASDAQ:CGEN) shares are trading close to the bottom of a 52-week range of $7.20 - $14.32.Pain Therapeutics, Inc. (NASDAQ:PTIE) shares slumped Monday to a record low, after the biopharmaceutical comapny was informed pharmaceutical giant Pfizer (PFE) has decided to discontinue its agreement to develop and commercialize REMOXY (oxycodone) Extended-Release Capsules CII, an investigational extended-release oral formulation of oxycodone. Pain Therapeutics, Inc. (NASDAQ:PTIE) shares were down 61% at $1.63 recently, after sinking to the new record low at $1.61. Shares of DURECT (DRRX) also slumped to their lowest level in two and a half years as Pain Therapeutics had the rights to develop and commercialize this product candidate under a license from DURECT. DURECT was down 38% at $0.85 after dropping earlier to $0.78, its lowest since May 2012.Both stocks had initially been halted on the news in Monday's pre-market session. Pfizer said it will return all rights, including responsibility for regulatory activities, to Pain Therapeutics. The actual termination will become effective in six months. The move comes after Pfizer concluded an internal review of the top-line results of five recently completed clinical studies required to address a Complete Response Letter received in June 2011 from the U.S. Food and Drug Administration. Pfizer said it will continue ongoing activities under the agreement for the next six months until the scheduled termination date.
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