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Pharma Stocks in the News: AstraZeneca plc (ADR) (NYSE:AZN), Theravance Biopharma Inc (NASDAQ:TBPH), Array Biopharma Inc (NASDAQ:ARRY)

Pharma Stocks in the News: AstraZeneca plc (ADR) (NYSE:AZN), Theravance Biopharma Inc (NASDAQ:TBPH), Array Biopharma Inc (NASDAQ:ARRY)
Written by
Chris Sandburg
Published on
November 4, 2014
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AstraZeneca plc (ADR) (NYSE:AZN), Pharmacyclics (PCYC) and Janssen Research & Development said Tuesday they have entered into a clinical trial collaboration to evaluate the efficacy and safety of AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Imbruvica, an oral Bruton's tyrosine kinase inhibitor, co-developed and co-commercialized by Pharmacyclics and Janssen Biotech. The study will assess the drug combination as a treatment for patients with hematologic cancers including Diffuse Large B-Cell Lymphoma and Follicular Lymphoma, which are investigational uses for both compounds.The Phase I trial is expected to establish a recommended dose regimen for MEDI4736 and Imbruvica and the Phase II part of the study will assess the safety and efficacy of the combination. Under the terms of the agreement, the trial will be conducted by Pharmacyclics. Financial terms were not disclosed. AstraZeneca plc (ADR) (NYSE:AZN) and PCYC shares both gained more than 1% Tuesday morning.Theravance Biopharma Inc (NASDAQ:TBPH), through its U.S. operating subsidiary, Theravance Biopharma US, Inc., Tuesday announced what the company called positive results from the first three cohorts of Study 0110, a Phase 1 proof-of-concept study of TD-6450, a next-generation investigational NS5A inhibitor in development to treat patients with hepatitis C virus infection. All doses of TD-6450 were generally well tolerated after three doses and for the 28-day observation period. There were no serious adverse events and no patient discontinuations. There was no pattern of clinical adverse events or laboratory abnormalities related to treatment.Among several finding Theravance Biopharma Inc (NASDAQ:TBPH) will discuss in a 5 p.m. ET conference call Tuesday, the 120 and 240 mg dose groups, three days of once-daily oral treatment resulted in levels of serum HCV RNA below the limit of detection (LOD) in 43% (3/7) and 57% (4/7) of patients treated with TD-6450, respectively. Three of the seven LOD patients went on to show no measurable virus at Day 14, and two of these patients still had no measurable virus at Day 28. At a two-month time point in a long-term follow-up study, the viral load in these two patients was measurable, but both remained more than three logs below their baseline.Array Biopharma Inc (NASDAQ:ARRY) shares are up more than 3% in early trading after the company posted better-than-expected fiscal Q1 results and said it may make commercial revenue within the next two years. The net loss in the three months ending June 30th was $27.6 million, or $0.21 per share, compared to a net loss of $15.7 million, or $0.13 per share, for the same period in fiscal 2014, beating forecasts for a net loss of $0.22, according to Capital IQ. Array ended the quarter with $111 million in cash, cash equivalents and marketable securities.Revenue for fiscal Q1 dropped to $6.1 million, compared to $14.2 million for the same period in fiscal 2014, but topped the $5.58 million analysts had been expecting. Array Biopharma Inc (NASDAQ:ARRY) said the lower revenue is due to the full recognition in prior periods of up-front license fees. Array said its MEK inhibitors, binimetinib and selumetinib, are currently advancing in six Phase 3 trials, and its partners expect the first regulatory filing next year with top line results from the other trials available in 2016.

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