GPC Biotech withdrew satraplatin from the Fast Track approval process in the US after the FDA said that it would require overall survival data from a trial that would take approximately six months to complete. Shares in the company subsequently fell almost 25%, and the German biotech recently announced staff cuts in an effort to reduce costs.
The complaint alleges that the company failed to tell investors that the FDA had previously expressed disapproval regarding the company’s choice of methodology and a primary endpoint in the satraplatin studies, yet the GPC Biotech continued to evaluate satraplatin using the disputed endpoint.
The class action lawsuit, brought by investors represented by law firm Schiffrin Barroway Topaz & Kessler, says that shareholders were “shocked” when the FDA decided to delay a decision on approval until additional data was gained, as the company had assured investors of the drug’s positive trial results.
According to the suit, the plaintiff seeks to recover damages on behalf of class members.