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NLNK > SEC Filings for NLNK > Form 8-K on 14-Nov-2012All Recent SEC Filings

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Form 8-K for NEWLINK GENETICS CORP


14-Nov-2012

Other Events


Item 8.01. Other Events.

On November 14, 2012, NewLink Genetics (NASDAQ:NLNK) announced that the European Commission (EC) has designated HyperAcute-Pancreas® Immunotherapy (algenpantucel-L) as an orphan medicinal product under Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products. NewLink filed the application for orphan designation in June 2012. A positive opinion was adopted by the Committee for Orphan Medicinal Products (COMP) and was formally accepted by the EC. Finalization of the Public Summary is projected for November, 2012. Algenpantucel-L is an "off-the-shelf" product candidate currently being studied in IMPRESS (Immunotherapy Pancreas Resected Survival Study), an open-label, randomized, controlled, multi-center, Phase 3 clinical trial of approximately 700 Stage I and Stage II surgically-resected pancreatic cancer patients, which is being performed under a Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA).

The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.


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