In after-hours trade on Monday shares of NewLink Genetics (NLNK) tumbled by 35% after the company announced that it had failed a phase 3 trial in patients with pancreatic cancer. The phase 3 trial, known as the IMPRESS phase 3 study, recruited a total of 722 patients with resected pancreatic cancer. The phase 3 trial failed to meet the primary endpoint, and NewLink’s vaccine known as algenpantucel-L did not improve clinical outcome compared to control. 

The primary endpoint of the phase 3 trial was overall survival, a measure of how long a patient lives on a treatment compared to placebo. The trial failed because patients in the control arm of the study lived a median of 30.4 months, compared to the patients receiving NewLink’s vaccine who lived for a median of 27.3 months. 

While a major setback, the company does have other clinical trials underway so it may be able to recover.. In addition. the company has another program that uses immunotherapy known  as the IDO inhibitor platform, which is entirely separate from the current platform results posted today. 

While a good pipeline is still in place, it is not yet wise to dip in and buy any shares as the next few days the stock will make new lows. It would be prudent to wait awhile until it settles and bounces before deciding to take a position. Investors should be aware that because of this failed phase 3 trial, the risk is a lot greater than what it was before. 

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