OncoMed 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.
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FDA removes partial clinical hold on OncoMed ipafricept OncoMed Pharmaceuticals announced that the FDA removed the partial clinical hold on the company's ipafricept phase 1 clinical trials. Enrollment and dosing of new patients is expected to resume within the next few weeks as the study sites' institutional review boards receive and approve the revised trial protocols. Ipafricept is being studied in combination with standard-of-care in three Phase 1b studies. OncoMed submitted a substantial clinical safety and efficacy data package for ipafricept along with revised study protocols to the FDA's Division of Oncology Products 1, which resulted in the removal of the partial clinical hold. The amendments for the phase 1b combination trials include modified dosing regimens, risk mitigation measures, such as increased monitoring and bone protection strategies, and modified enrollment criteria.