NeuroDerm (NDRM) Will Require Additional Time to Activate BeyoND Clinical Sites in Certain Countries
- Futures rise ahead of Trump's inauguration
- General Electric (GE) Reports In-Line Q4 EPS
- Procter & Gamble (PG) Tops Q2 EPS by 2c
- Bristol-Myers Squibb (BMY) Says It Won't Pursue Accelerated U.S. Regulatory Pathway for Opdivo Plus Yervoy in Lung Cancer
- Dollar recoups losses, caution sets in ahead of Trump inauguration
Get inside Wall Street with StreetInsider Premium. Claim your 2-week free trial here.
NeuroDerm Ltd. (Nasdaq: NDRM) announced that the Company requires additional time to activate clinical sites in certain countries that are participating in its long-term safety trial (trial 012, the "BeyoND" trial) of ND0612, the Company’s continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) liquid formulation. As previously disclosed, upon the completion of the BeyoND trial, as well as the other parallel trials outlined in the Company’s clinical development plan, NeuroDerm intends to submit marketing applications in the U.S. and the EU for ND0612.
Based on the additional time needed for the BeyoND trial, the Company currently expects to submit such marketing applications in the first half of 2018 rather than in the end of 2017, as previously expected. The timeline for product approval could be shortened if the Company applies for, and is granted, an accelerated approval process.
The BeyoND trial is expected to enroll approximately 100 patients. Institutional Review Board (IRB) approval and patient enrollment rates for this trial are proceeding as anticipated in currently active sites.
“We are committed to making our ND0612 product candidates available to Parkinson’s disease patients in need of new therapeutic options. Toward that end, we are expanding the number of countries that will participate in this study as well as the number of U.S. participating sites in order to ensure that we are able to enroll all 100 patients as quickly as possible,” said Oded Lieberman, PhD, CEO of NeuroDerm. “We feel confident that the addition of these sites will allow us to meet the trial’s enrollment target on a timeline that will support submission of regulatory applications in the U.S. and EU in the first half of 2018.”
The Company’s cash guidance remains unchanged, and NeuroDerm believes that it has sufficient cash to advance its product pipeline as planned and reach its clinical and regulatory milestones through mid-2018.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Delphi Automotive (DLPH) Names Glen De Vos as CTO
- Atmos Energy (ATO) Appoints Christopher Forsythe to CFO
- Straight Path Communications (STRP) Releases Statement in Response to Kerrisdale Capital's Report
Create E-mail Alert Related CategoriesCorporate News, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!