Tokai Pharmaceuticals Inc. (NASDAQ: TKAI) was not prepared for the determination that an independent data monitoring committee (DMC) has made concerning its prostate cancer drug candidate ARMOR3-SV. All along Tokai hoped that it had in its pipeline a product that could dramatically improve its financial standing. But those hopes appeared to be dashed after the DMC commented that ARMOR3-SV will likely fail to meet its primary endpoint in a Phase 3 trial.
Shares of Tokai have crashed in the aftermath of the DMC verdict on ARMOR3-SV.
But it may not be all over for Tokai Pharmaceuticals Inc. (NASDAQ: TKAI) with its candidate ARMOR3-SV. The immediate reaction from the company was that it will discontinue the clinical trial of the candidate. However, the management hinted that detailed analysis of the data could pave way for a future path for the candidate.
Tokai was developing ARMOR3-SV as a treatment for a certain form of prostate cancer. The Phase 3 clinical trial about which the DMC has raised the red was aimed at finding out if the drug can improve progression-free survival in prostate cancer patients who received it.
But after looking at the early data of the clinical study, the independent committee concluded that it didn’t see ARMOR3-SV succeeding in meeting the primary goal of the trial. The management called the development a disappointment, but it appears the situation could still be salvaged.
For instance, Tokai’s CEO, Jodie Morrison, said they will analyze the data for clue of potential paths in the development of the candidate. In the meantime, Tokai will notify regulators of its decision to discontinue clinical testing of ARMOR3-SV.
Prolonged time to market – Tokai Pharmaceuticals Inc. (NASDAQ: TKAI)
Though there could be a way out for Tokai Pharmaceuticals Inc. (NASDAQ: TKAI) regarding its candidate ARMOR3-SV, the disappointing verdict of the DMC implies that the time to market for the drug could be prolonged.
Tokai had cash balance of about $43.9 million at the end of the last month. The company logged EPS loss of $0.51 in 1Q2016, which was slightly better EPS loss of $0.59 in the same quarter last year.