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April 8, 2014
16:10 EDTRHHBY, PRTAProthena says first human dosed in Phase 1 study of PRX002
Prothena (PRTA) announced the successful start of a Phase 1 clinical trial of its therapeutic monoclonal antibody candidate, PRX002, for the treatment of Parkinson's disease. Prothena has earned a $15M milestone payment from Roche (RHHBY) related to the initiation of this study. The initial Phase 1 clinical trial of PRX002 is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy subjects. It is designed to assess PRX002 for safety, tolerability, pharmacokinetics and immunogenicity. As previously announced in December 2013, Prothena entered into a worldwide collaboration with Roche to develop and commercialize antibodies that target α-synuclein, including PRX002. Including the current milestone payment, Prothena has now achieved a total of $45M through its worldwide PRX002 collaboration with Roche.
News For PRTA;RHHBY From The Last 14 Days
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October 9, 2015
08:21 EDTRHHBYRoche to acquire Adheron Therapeutics
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October 8, 2015
11:57 EDTRHHBYRoche says ocrelizumab cuts disability progression in studies of two forms of MS
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October 6, 2015
13:32 EDTRHHBYBiotechs plummet with TPP seen as industry negative
Biotechs are falling intraday after reports that the Trans-Pacific Partnership, or TPP, has language that the exclusivity period for bioligics, or drugs derived from a biological sources, would be eight years, less than the twelve years it is currently in the United States. WHAT'S NOTABLE: In the U.S., biologics are protected from competition by follow-on products for twelve years from the time they are first granted marketing approval by the U.S. Food and Drug Administration, a protection that is distinct from patent protection. Recent reports on the TPP suggest that the protection will last five years with an additional safety monitoring period of up to three years before a biosimilar can be registered, which would effectively be an eight year exclusivity period. ANALYST REACTION: Piper Jaffray analyst Joshua Schimmer, however, said the development is a "step forward," especially since it does not overrule the 12 years' exclusivity for the drugs in the U.S. While the sector asked for twelve years' exclusivity to match the U.S., eight years is a "reasonable compromise," the analyst argued. His top picks were Alexion (ALXN), Celgene (CELG), and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC), and Ignyta (RXDX) in the small-cap sector. Further, Schimmer stated that more names look "increasingly compelling" amid the selloff. NOTABLE DECLINERS: Alexion is lower by 2.53%, Celgene is down 4.32%, Amgen is declining 1.91%, Biogen (BIIB) is down 3.4%, and Gilead Sciences (GILD) is falling 2.22%. STOCKS TO WATCH: Other publicly traded companies in the pharmaceutical space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
05:22 EDTRHHBYExelixis reports phase 3 pivotal trial of cobimetinib met secondary endpoint
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October 4, 2015
14:39 EDTRHHBYPTC presents Phase 2 data on RG7800 for spinal muscular atrophy
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September 30, 2015
17:48 EDTRHHBYPacific Biosciences launches new sequencing platform
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September 28, 2015
10:43 EDTRHHBYRoche to hold an analyst briefing with a conference call hookup
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07:52 EDTRHHBYIIR Holdings to hold a conference
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05:15 EDTRHHBYGenentech announces Phase III study of ocrelizumab met primary endpoint
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September 27, 2015
17:02 EDTRHHBYNewLink Genetics reports early Phase 1a data on GDC-0919
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16:42 EDTRHHBYRoche present Phase 2 results on atezolizumab for urothelial cancer
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16:40 EDTRHHBYRoche reports results from two Phase 2 studies on atezolizumab
Genentech, a member of the Roche Group, announced results from two Phase 2 studies that evaluated the investigational cancer immunotherapy atezolizumab -- or anti-PDL1; MPDL3280A -- in people with advanced non-small cell lung cancer. In the randomized Phase 2 study POPLAR, atezolizumab met its primary endpoint and showed a statistically significant survival benefit compared to chemotherapy in people with recurrent NSCLC whose tumors expressed medium and high levels of PD-L1, which corresponded with people living 7.7 months longer than people who received docetaxel chemotherapy. A separate, single-arm Phase 2 study, BIRCH, met its primary endpoint and showed that atezolizumab shrank tumors in up to 27% of people whose disease had progressed on prior medicines and also expressed the highest levels of PD-L1. Median survival had not yet been reached. In both studies of atezolizumab, adverse events were consistent with those observed in previous studies. "We plan to submit these results to global health authorities to bring this potential new option to people as soon as possible," said Chief Medical Officer Sandra Horning.

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