NewLink Genetics' Shares Sink - Analyst Blog


Share prices of NewLink Genetics Corporation ( NLNK ) 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 444 patients.

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 survival.

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 well.

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. ( GILD ), Shire ( SHPG ) and Alkermes ( ALKS ). Gilead Sciences carries a Zacks Rank #2 (Buy) while Shire and Alkermes carry a Zacks Rank #1 (Strong Buy).

ALKERMES INC (ALKS): Free Stock Analysis Report

GILEAD SCIENCES (GILD): Free Stock Analysis Report

NEWLINK GENETIC (NLNK): Free Stock Analysis Report

SHIRE PLC-ADR (SHPG): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.

This article appears in: Investing , Business , Stocks

Referenced Stocks: ALKS , GILD , NLNK , SHPG

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