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News Breaks
November 28, 2012
08:30 EDTRHHBY, CRISCuris licenses worldwide development, commercialization rights for IAP Inhibitor
Curis (CRIS) announced that it has licensed from Genentech, a member of the Roche Group, (RHHBY), exclusive, worldwide rights for the development and commercialization of GDC-0917, a small molecule that is designed to promote cancer cell death by antagonizing inhibitor of apoptosis proteins. Genentech has recently completed a Phase I clinical trial of GDC-0917, in which 42 people received daily oral doses of GDC-0917 for two weeks, followed by a one week rest period. This 21-day cycle is repeated until disease progression or study discontinuation for any other reason. The primary endpoints of the study include evaluating the safety and tolerability and the pharmacokinetics of GDC-0917 in people with solid tumors or lymphoma and determining the maximum-tolerated-dose and a potential recommended dose for further clinical studies. Secondary endpoints include a preliminary assessment of anti-tumor activity of GDC-0917 and evaluating pharmacodynamic markers. Genentech plans to present full study results at a medical conference in mid-2013, Curis said.
News For CRIS;RHHBY From The Last 14 Days
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January 29, 2015
12:00 EDTRHHBYLeerink biotech analysts hold an analyst/industry conference call
Biotech Analyst Schwartz discusses Biogen Idec BIIB037 and whether 2015 will be the year when Amyloid Beta is finally validated as a disease-modifying target in Alzheimer's Disease on an Analyst/Industry conference call to be held on February 3 at 2 pm.
05:47 EDTRHHBYRoche, Qualcomm collaborate on remote patient monitoring
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January 28, 2015
08:07 EDTRHHBYRoche unit receives orphan status for alectinib
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05:49 EDTRHHBYRoche sees 2015 sales growth in low- to mid-single digit
Roche expects sales to grow low- to mid-single digit, at constant exchange rates for 2015. Core earnings per share are targeted to grow ahead of sales at constant exchange rates. Roche expects to further increase its dividend in Swiss francs.
05:48 EDTRHHBYRoche reports 2014 core EPS CHF14.29 vs. CHF14.27 last year
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January 27, 2015
14:00 EDTRHHBYRoche to hold a meeting with a conference call hookup
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January 26, 2015
05:15 EDTRHHBYRoche receives FDA clearance for next generation cobas MRSA/SA test
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January 23, 2015
08:17 EDTRHHBYRoche management to meet with JPMorgan
Meeting to be held in New York on January 29 hosted by JPMorgan.
January 22, 2015
08:20 EDTCRISCuris price target raised to $5 from $3 at Oppenheimer
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January 21, 2015
09:02 EDTRHHBYRoche's Ventana seeks FDA premarket approval for ALK IHC lung cancer assay
Roche Group member Ventana Medical Systems announced its FDA submission for premarket approval of the Ventana ALK CDx Assay. The companion diagnostic immunohistochemistry test is designed to identify ALK1-positive lung cancer patients that may benefit from treatment with targeted therapy that inhibits the ALK gene. This submission was the fourth and final module and application required by the FDA's PMA process.
07:34 EDTCRISCuris to host conference call
Conference call to discuss the Curis-Aurigene transaction will be held on January 21 at 8 am. Webcast Link
06:07 EDTCRISCuris and Aurigene Discovery announce exclusive collaboration agreement
Curis and Aurigene Discovery Technologies announced that they have entered into an exclusive collaboration agreement focused on immuno-oncology and selected precision oncology targets. The collaboration provides for inclusion of multiple programs, with Curis having the option to exclusively license compounds once a development candidate is nominated within each respective program. The partnership draws from each company's respective areas of expertise, with Aurigene having the responsibility for conducting all discovery and preclinical activities, including IND-enabling studies and providing Phase 1 clinical trial supply, and Curis having responsibility for all clinical development, regulatory and commercialization efforts worldwide, excluding India and Russia, for each program for which it exercises an option to obtain a license. The first two programs under the collaboration are an orally-available small molecule antagonist of programmed death ligand-1 in the immuno-oncology field and an orally-available small molecule inhibitor of Interleukin-1 receptor-associated kinase 4 in the precision oncology field. Curis expects to exercise its option to obtain exclusive licenses to both programs and file IND applications for a development candidate from each in 2015. The agreement provides that the parties will collaborate exclusively in immuno-oncology for an initial period of approximately two years, with the option for Curis to extend the broad immuno-oncology exclusivity.In addition Curis has agreed to make payments to Aurigene as follows: For the first two programs: up to $52.5 million per program, including $42.5 million per program for approval and commercial milestones, plus specified approval milestone payments for additional indications, if any; For the third and fourth programs: up to $50 million per program, including $42.5 million per program for approval and commercial milestones, plus specified approval milestone payments for additional indications, if any; and for any program thereafter: up to $140.5 million per program, including $87.5 million per program in approval and commercial milestones, plus specified approval milestone payments for additional indications, if any. Curis has agreed to pay Aurigene royalties on any net sales ranging from high single digits to 10% in territories where it successfully commercializes products and will also share in amounts that it receives from sublicensees depending upon the stage of development of the respective molecule.
January 16, 2015
16:36 EDTRHHBYMarket finishes week lower on continued oil, global growth worries
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06:21 EDTRHHBYRoche acquires Trophos for EUR120M plus contingent payments
Roche has agreed to acquire Trophos, a privately held biotechnology company based in Marseille, France. Trophos’s proprietary screening platform generated olesoxime, TRO19622, which is being developed for SMA – a rare and debilitating genetic neuromuscular disease that is most commonly diagnosed in children. Results from a pivotal phase II clinical trial with olesoxime in SMA showed a beneficial effect on the maintenance of neuromuscular function in individuals with Type II and non-ambulatory Type III SMA, as well as a reduction in medical complications associated with the disease. These data were first presented in April 2014 at the annual meeting of the American Academy of Neurology. Under the terms of the agreement, Trophos’s shareholders will receive an upfront cash payment of EUR 120M, plus additional contingent payments of up to EUR 350M based on achievement of certain predetermined milestones.

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