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News Breaks
September 3, 2013
08:40 EDTOMEDOncoMed reports Q2 EPS ($8.83), may not compare to consensus (2c)
Reports Q2 revenue $2.9M, may not compare to consensus $8.31M. The decrease in revenue vs. $7.5M in 2Q12 was mainly a result of timing of a $5M milestone payment that was achieved in the 2Q12, offset by $400K in collaboration revenue recognized in the 2Q13 related to the amortization of a payment from Bayer received in August 2012.
News For OMED From The Last 14 Days
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January 29, 2015
08:40 EDTOMEDOncoMed tarextumab granted ODD by FDA
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January 28, 2015
09:06 EDTOMEDOncoMed receives orphan status for tarextumab as pancreatic cancer treatment
The FDA granted OncoMed orphan status for tarextumab, as a treatment for pancreatic cancer. Note that earlier the FDA also granted the drug orphan status as a treatment for small cell lung cancer. Reference Link
08:11 EDTOMEDOncoMed receives orphan status for tarextumab
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January 16, 2015
14:33 EDTOMEDOncoMed presents final Phase 1b data for Tarextumab
OncoMed Pharmaceuticals presented final safety, efficacy and biomarker data from the company's Phase 1b "ALPINE" clinical trial of tarextumab in 40 patients with frontline metastatic pancreatic cancer. Tarextumab was generally well tolerated when administered with gemcitabine and Abraxane, with manageable, on-target drug-related toxicities. The Phase 2 dose of tarextumab was determined to be 15 mg/kg every two weeks in combination with the standard-of-care. Among patients evaluable for response using RECIST criteria, 38% achieved partial responses, with an additional 35% achieving stable disease for an overall clinical benefit rate of 73%. Median progression-free survival and overall survival values for the three drug combination of tarextumab-gemcitabine-Abraxane were 5.6 months and 11.6 months, respectively, for all patients treated with the three-drug combination. The data presented included biomarker analyses that showed that among patients whose tumor samples had elevated levels of Notch3 gene expression, trends toward higher response rates and longer survival were noted, as compared to patients with low Notch3 expression. Median PFS and OS for patients with high Notch 3 expression were 6.6 months and 14.6 months, respectively. Given the small sample size and potential imbalances in patient characteristics, these encouraging preliminary efficacy and predictive biomarker observations are being assessed in the ongoing randomized, placebo-controlled, Phase 2 ALPINE trial
January 15, 2015
08:36 EDTOMEDOncoMed enrolls first biomarker-selected patient in Notch1 antibody Phase trial
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