Share prices of
NewLink Genetics Corporation
) fell 16.2% after the independent review committee recommended
continuation of its phase III pancreatic cancer study (IMPRESS)
of HyperAcute Pancreas following the first interim data analyses.
The investors had expected the committee to terminate the trial
early on the back of high efficacy levels. The first interim
analysis evaluated 222 patients.
NewLink Genetics expected the study to continue, bearing in
mind the high statistical threshold assigned to the first interim
analysis under the special protocol assessment. There were
no safety issues and other concerns raised by the independent
data monitoring committee.
The second interim analysis evaluating 333 patients will be
initiated and if required, a final analysis will be conducted on
We remind investors that HyperAcute Pancreas, NewLink
Genetics' lead candidate, is being studied in a phase III study,
IMPRESS (Immunotherapy for Pancreatic Resectable cancer Survival
Study). The study under a Special Protocol Assessment completed
enrolment of 722 patients with surgically resected pancreatic
cancer in the third quarter of 2013.
HyperAcute Pancreas is also being tested in another phase III
study, PILLAR (Pancreatic Immunotherapy with algenpantucel-L for
Locally Advanced non-Resectable), evaluating patients with
locally advanced pancreatic cancer. This study is currently
enrolling patients. The two phase III studies, IMPRESS and
PILLAR, were started on the basis of encouraging phase II data
which demonstrated improvement in both disease-free and overall
The U.S. Food and Drug Administration granted this candidate
fast track and orphan drug designation for the adjuvant treatment
of surgically-resected pancreatic cancer. The European Commission
granted orphan medicinal product designation to this candidate as
NewLink Genetics carries a Zacks Rank #3 (Hold). Investors
looking for better-ranked stocks in the biopharma sector may
consider companies like
Gilead Sciences Inc.
). Gilead Sciences carries a Zacks Rank #2 (Buy) while Shire and
Alkermes carry a Zacks Rank #1 (Strong Buy).
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