Vital Therapies (NSDQ:VTL) saw share price drop 91.3% this week after the company announced that the leading clinical trial of its ELAD cell-based therapy for treating liver failure failed to meet its primary and secondary endpoints and that it was “ceasing any further development” of the product.
The San Diego-based company’s ELAD cell-based therapy was intended for the treatment of acute liver failure, using a cartridge system designed to produce cells that mimic those of a patient’s liver.
Results from the trial indicated that while there was a numerical improvement for survival in the ELAD-treated patients between three months and one year, it did not meet the primary endpoint of significant improvement in overall survival through at least 91 days as assessed by the Kaplan Meier statistical method.
The trial’s secondary endpoint of proportion of survivors at study day 91 also showed no statistically significant difference between groups.
Vital Therapies said that it “does not believe the ELAD system can be approved in the United States or European Union, if ever, without additional clinical trials that would require substantial capital and time to complete,” according to an SEC filing. The company said that it will cease all further development, and “explore strategic options.”
Shares in the company plummeted in response to the nose, closing on September 11 at $6.30 and opening the next day at 55¢, a drop of approximately 91.3%.
“Although we did not achieve the outcome we were hoping for, we would like to thank those who made this trial possible, including our investigators and their staffs, the patients who were enrolled and their families, and all Vital Therapies employees,” CEO Russell Cox said in an SEC filing.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
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