NeuroDerm ($NDRM) has received written confirmation from the FDA that it can file for approval of its Parkinson's disease treatment on the strength of data from one clinical trial, freeing it of the need to run a second, 360-person study. But with the FDA also demanding additional GMP documents from NeuroDerm's device supplier, investors were unsure whether the update was good or bad news.
Rehovot, Israel-based NeuroDerm made the slimmed-down clinical trial program the focal point of its release to outline the feedback it has received from the FDA. NeuroDerm had previously expected to have to run a pair of late-phase trials of ND0612L, its drug-device combination that continuously administers levodopa. However, the company is now reporting that the FDA will review a regulatory filing that features data from just one study, the design of which is unchanged from the original plan. The dropping of the planned 360-person study, the largest on the roster, will save NeuroDerm cash.
Investors initially welcomed the news, sending shares in the company up by more than 10% in early trading on Nasdaq. The surge was short lived, though. Further down the statement about the new slimline clinical trial program, NeuroDerm revealed the FDA wants to see more documents from a device supplier before signing off on the importation of the products into the U.S.. NeuroDerm is free to use any devices already in the country. But with question marks hanging over the date that supply will resume, it is holding off on enrolling patients at U.S. trial sites for now.
NeuroDerm has downplayed the significance of the FDA's requests. "They are certainly not major," NeuroDerm CEO Oded Lieberman told investors on a conference call to discuss the company's third-quarter results. "Based on our interaction with this manufacturer, we're quite convinced they will be resolved soon." The current expectation is that the supplier will provide the requested documents in the first quarter of 2016, clearing NeuroDerm to start enrolling patients at U.S. sites before the end of the first half of the year.
Concerns about the impact of FDA's request on NeuroDerm's timelines led to shares plummeting from their early peak. The stock bottomed out down 13% on its presurge price, before recovering slightly to close down 7%.
- read the release
- and the call transcript