NeurogesX ($NGSX) finds itself on the ropes this morning, with its badly battered shares taking yet another beating after an FDA panel unanimously shot down an attempt to get an approval to use its pain patch for HIV-related neuropathy.
Earlier in the week, regulators issued an internal assessment that NeurogesX never laid out a clear set of data supporting the efficacy of the patch, and that's exactly the Achilles heel that the panel zeroed in on. The experts also decided that the risk/benefit profile was acceptable to HIV patients. Though no surprise, the panel vote triggered another selloff of shares, with the stock plunging 31% to a rock-bottom 55 cents a share.
The final decision has yet to be made, but the chances of an FDA approval at this stage are negligible. Nevertheless, the company is confident in the product.
"We will continue to work closely with the FDA to address the Advisory Committee's comments as the Agency finalizes its review of our sNDA," said NeurogesX CEO Ronald Martell. "We remain confident that Qutenza(R) has the potential to address significant, unmet medical needs and to improve the quality of life for patients with HIV-PN. We would like to thank the FDA and the Advisory Committee members for their careful and thoughtful deliberation on this matter."
- here's the press release
- get the report from Bloomberg