NeurogesX down after response to EMEA
NeurogesX (NASDAQ:NGSX) fell $0.25 (10%) to $2.33 on Wednesday after announcing it submitted a response to EMEA's Day 120 questions on an MAA for NGX-4010 to treat peripheral neuropathic pain. The company did not disclose the questions but did say the agency had asked for "clarifying information." The response included data from two Phase III trials that were not available at the time of submission: one to treat pain associated with HIV-distal sensory polyneuropathy (HIV-DSP) and one to treat neuropathic pain associated with post-herpetic neuralgia (PHN). In the PHN trial, NGX-4010 met the primary endpoint of a significant reduction in baseline pain compared with a control patch. In the HIV-DSP trial, NGX-4010 missed the primary and secondary endpoints due to a higher-than-expected response in the control group (See BioCentury Extra, Wednesday, Feb. 27, 2008). ...