Financial Results, Data Presentations, and Breakthrough Therapy Designation - Analyst Notes on Insys, Seattle Genetics, Cubist, Celldex and Clovis

NEW YORK, May 22, 2014 /PRNewswire/ --

Today, Analysts Review released its analysts' notes regarding Insys Therapeutics, Inc. (NASDAQ: INSY), Seattle Genetics Inc. (NASDAQ: SGEN), Cubist Pharmaceuticals Inc. (NASDAQ: CBST), Celldex Therapeutics Inc. (NASDAQ: CLDX) and Clovis Oncology, Inc. (NASDAQ: CLVS). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/2784-100free.

Insys Therapeutics, Inc. Analyst Notes

On May 13, 2014, Insys Therapeutics, Inc. (Insys) reported its Q1 2014 financial results. Total net revenue increased 274.8% YoY to $41.6 million. Net income stood at $7.7 million, or $0.21 per diluted share, compared to $143,000, or $0.01 per diluted share, in Q1 2013. According to the Company, the revenue growth was driven by robust increase from Subsys (fentanyl sublingual spray) revenues, which registered 319.6% YoY increase to $40.7 million. For Q2 2014, the Company expects Subsys net revenue to exceed $52 million. The full analyst notes on Insys are available to download free of charge at:

http://www.analystsreview.com/2784-INSY-22May2014.pdf

Seattle Genetics Inc. Analyst Notes

On May 14, 2014, Seattle Genetics Inc. (Seattle Genetics) announced that data from multiple proprietary and collaborator antibody drug-conjugate (ADC) programs will be presented at the American Society of Clinical Oncology (ASCO) 2014 Annual Meeting to be held from May 30, 2014 to June 3, 2014 in Chicago, Illinois. The Company stated that on May 30, 2014, a phase 1 study evaluating ABT-414 and a phase 1 study of DMOT4039A will be presented. Seattle Genetics added that on May 31, 2014, preliminary results of a phase II randomized study (ROMULUS), phase I study of DNIB0600A, phase I study of DSTP3086S, a phase 2 trial of prostate-specific membrane antigen antibody-drug conjugate targeting STEAP-1, and a phase 2 trial of prostate-specific membrane antigen antibody-drug conjugate (PSMA ADC) will be presented. The Company concluded that on June 1, 2014, Interim analysis of a phase 1, open-label, dose-escalation study of SGN-CD19A will be presented. The full analyst notes on Seattle Genetics are available to download free of charge at:

http://www.analystsreview.com/2784-SGEN-22May2014.pdf

Cubist Pharmaceuticals Inc. Analyst Notes

On May 9, 2014, Cubist Pharmaceuticals Inc. (Cubist) announced results from positive Phase 3 clinical trials of its antibiotic candidate of ceftolozane/tazobactam in development to treat serious infections including complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (clAI). Cubist stated that the new data include additional details on eftolozane/tazobactam's clinical cure or microbiological eradication rates, which met and exceeded pre-specified FDA and European Medicines Agency (EMA) non-inferiority margins. "We are delighted by the growing body of evidence indicating that ceftolozane/tazobactam may prove to be an important treatment option to address three of the most difficult to treat Gram-negative pathogens- specifically Pseudomonas aeruginosa and ESBL-producing E. coli and Klebsiella pneumoniae, -in cUTI and cIAI," said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist. The full analyst notes on Cubist are available to download free of charge at:

http://www.analystsreview.com/2784-CBST-22May2014.pdf

Celldex Therapeutics Inc. Analyst Notes

On May 14, 2014, Celldex Therapeutics Inc. (Celldex) announced that it will present data from its Phase 1 study of varlilumab, a fully human monoclonal antibody targeting CD27 at the American Society of Clinical Oncology (ASCO) Annual Meeting 2014 in Chicago. The Company stated that data from the hematologic malignancy dose-escalation arm will be presented by Stephen M. Ansell, MD, Ph.D. Professor of Medicine, Mayo, Clinic in a poster entitled "Phase 1 Evaluation of an Agonist Anti-CD27 Human Antibody (CDX-1127) in Patients with Advanced Hermatologic Malignancies" on June 2, 2014 from 1:15 p.m. to 4:15 p.m. CDT. Celldex noted that data from solid tumor expansion cohorts in metastatic melanoma and renal cell carcinoma will be presented by Jeffrey R. Infante, MD, Director, Drug Development Program, Sarah Cannon Research Institute, in a poster entitled "Immunologic Activity of an Activating Anti-CD27 Antibody (CDX-1127) in Patients with Solid Tumors" on June 2, 2014 from 1:15 p.m. to 4:15 p.m. CDT. The full analyst notes on Celldex are available to download free of charge at:

http://www.analystsreview.com/2784-CLDX-22May2014.pdf

Clovis Oncology, Inc. Analyst Notes

On May 19, 2014, Clovis Oncology, Inc (Clovis) announced that the FDA granted Breakthrough Therapy designation for the Company's investigational agent CO-1686 as monotherapy for second-line EGFR mutant NSCLC treatment in patients with T790M mutation. The Company stated that the designation was granted based on safety results from an ongoing Phase 1/2 study of CO-1686, the Company's targeted covalent inhibitor of mutant forms of epidermal growth factor receptor (EGFR) for non-small cell lung cancer treatment in patients with initial activating EGFR mutations and dominant resistance mutation T790M. "We very much appreciate this designation by FDA, which recognizes the meaningful benefit CO-1686 may provide patients with T790M positive NSCLC," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "This designation is well timed for us as well, as the increased interaction with FDA that it provides will come as we are initiating our registration studies and preparing to submit our initial New Drug Application (NDA) by mid-2015." The full analyst notes on Clovis are available to download free of charge at:

http://www.analystsreview.com/2784-CLVS-22May2014.pdf

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