|NewLink Genetics Corp (NASDAQ:NLNK) Slump 28% On disappointing trial news for its algenpantucel-L|
|By Marilyn Mullen|
|Tuesday, 12 May 2015 13:47|
Shares of NewLink Genetics Corp. (NASDAQ:NLNK) slumped 28% to $37.53 after the company confirmed continuation of Phase 3 Immunotherapy for Pancreatic RESectable cancer Study named "IMPRESS".
This is meant for patients having surgically resected pancreatic cancer.
Nicholas N. Vahanian, M.D., President and Chief Medical Officer of NewLink Genetics, opined that the firm is keen of bringing the study to the end point as algenpantucel-L has potential to be first and only FDA approved drug for resected pancreatic cancer.
IMPRESS is multi-center clinical trial that assesses efficacy and safety of algenpantucel-L that is being done in over 70 leading cancer centers.
IMPRESS is the largest trial having 700 patients enrolled with resected pancreatic cancer.
This drug has got fast-track status along with orphan drug designation from U.S. Food and Drug Administration (FDA).
NewLink Genetics and FDA reached agreement in January 2010 for the trial design, as well as statistical analyses plan for IMPRESS to be used in support of a Biologic License Application.
Charles Link, Jr., M.D., Chairman and Chief Executive Officer, opined that the fast-track status and SPA gives the firm the confidence in the regulatory strategy.
He added that it is preparing for commercial activities related to potentially positive outcome of the trial. Furthermore, he stated that there was progress in oncology therapeutics but only incremental improvements in survival rates for pancreatic cancer.
The firm had made decision of retaining benefit of SPA as well as not change statistical analysis plan defined in the original protocol.
The firm opines that the trial remains powered to determine efficacy of about 444 events. It expects on giving further guidance on expectations for the IMPRESS trial as well as other clinical studies besides update on financial guidance on its second quarter financial results call in August.