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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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November 23, 2014
13:23 EDTRHHBYTetraphase said to explore sale, Bloomberg reports
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November 19, 2014
08:03 EDTRHHBYPTC to receive $10M milestone payment from Roche as SMA program advances
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07:52 EDTRHHBYInforma Business Information to hold a conference
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November 18, 2014
14:59 EDTRHHBYRanbaxy sues FDA for rescinding approval of Nexium, Valcyte copies, Reuters says
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11:22 EDTRHHBYTeva patent victory over Warner Chilcott, Roche affirmed
The U.S. Court of Appeals for the Federal Circuit ruled that a district court was correct to grant summary judgment to Teva (TEVA) in a patent dispute with Warner Chilcott and Roche (RHHBY) over patents related to osteoporosis drug risedronate.
November 17, 2014
05:30 EDTRHHBYInovio, Roche terminate collaboration for INO-5150
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November 14, 2014
14:53 EDTRHHBYCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies 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). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
13:27 EDTRHHBYRoche reports FDA nod for Avastin in platinum-resistant recurrent ovarian cancer
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November 12, 2014
11:17 EDTRHHBYLeerink major pharma & biotech analysts hold analyst/industry conference call
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07:22 EDTRHHBYAssociation of Molecular Pathology is holding annual meeting
2014 Annual Meeting of AMP is being held in National Harbor, Maryland on November 12-15.
November 11, 2014
15:43 EDTRHHBYLeerink major pharma & biotech analysts hold analyst/industry conference call
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November 10, 2014
16:07 EDTRHHBYUBS to hold a conference
UBS European Conference is being held in London, England on November 11-12.
07:18 EDTCRISCuris provides pipeline update for CUDC-907, CUDC-427, Debio 0932
A total of 41 patients with relapsed/refractory lymphomas or multiple myeloma have been enrolled thus far, with 10 patients continuing to receive treatment in the dose escalation and expansion phases of the single agent, first-in-human Phase 1 clinical study of CUDC-907. The safety profile of CUDC-907 has been consistent with prior reports of diarrhea and thrombocytopenia as the most frequent adverse events, with diarrhea and hyperglycemia identified as dose limiting toxicities. Curis has completed enrollment in all consecutive, escalating dose cohorts at 100, 200 or 300 mg per day in the single-agent Phase 1 study of CUDC-427 in patients with advanced and/or refractory solid tumors or lymphoma. The primary objective of this monotherapy study under the amended protocol is to determine the safety and recommended Phase 2 dose for CUDC-427 when administered orally once daily for two weeks, followed by a one week rest period in 21-day cycles until disease progression or study discontinuation. Curis collaborator Debiopharm has decided that the Phase 1 dose escalation data from the Phase 1/2 HALO study of Debio 0932 in combination with 3 different standard-of-care chemotherapy regimens in an unselected population of patients with advanced or metastatic non-small cell lung cancer were inconclusive, and has opted not to advance Debio 0932 into the Phase 2 portion of the study. No new Debio 0932-related side effects were identified and safety observations were generally consistent with the expected side effects of Debio 0932 and/or the respective chemotherapeutic regimens administered in the study. Curis expects to receive formal notice of termination of the license agreement from Debiopharm shortly and the partners are expected to enter into a transition agreement in the fourth quarter of 2014 regarding the orderly return of the program and all rights to Curis.
07:17 EDTCRISCuris reports Q3 EPS (6c), consensus (4c)
Reports Q3 revenue $1.78M, consensus $4.13M

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