PARD off only 20% as we approach the close.
8:33AM Poniard Pharma suspends efforts to obtain regulatory approval for picoplatin in SCLC; has engaged Leerink Swann to conduct a review of strategic alternatives (PARD) 1.56 : Co announced a clinical and regulatory update on its lead product candidate, picoplatin. Following a detailed analysis of primary and updated data from the Phase 3 SPEAR study of picoplatin in small cell lung cancer (SCLC) and an evaluation of the ongoing New Drug Application (NDA) process with the U.S. Food and Drug Administration (FDA), the Company has decided to suspend its efforts to obtain regulatory approval for picoplatin in SCLC at this time. The Company will focus its resources on developing pivotal clinical strategies for picoplatin in small cell lung cancer, as well as colorectal, prostate, and ovarian cancers. Pursuant to this decision, the Company announced that it has engaged Leerink Swann LLC to conduct a comprehensive review of strategic alternatives aimed at enabling the execution of these strategies and optimizing shareholder value. These alternatives could include capital raising alternatives, merger, sale or partnership. In connection with this action, Poniard announced a restructuring of its workforce, eliminating those positions focused on pursuing an NDA filing for SCLC, along with certain supporting functions. This reduction in personnel will decrease the number of employees by approximately 45 percent, to a total of 12, effective April 30, 2010. Poniard will continue to provide clinical and regulatory support activities for its current studies. Poniard expects the reduction in force to result in an approximately $2.2 million decrease in operating expenses in 2010, net of a charge in the second quarter of approximately $0.5 million related to the workforce reduction. Co expects that efficacy and safety data from the SPEAR study will be presented at the American Society of Clinical Oncology 2010 Annual Meeting taking place June 4-8, 2010 in Chicago. |
