Drug Development

Tokai retreats from the clinic after lead drug implodes in PhIII

Over the last few days Boston-based Tokai Pharmaceuticals $TKAI has been blasted by the late-stage failure of its lead drug galeterone and forced to jettison more than half of its staff. Yesterday, the company filed an 8-K with the SEC noting that it will also now discontinue enrollment in a separate study for castration-resistant prostate cancer while slamming the brakes on yet another planned study as well.

The steady cascade of bleak news from Tokai has crushed its share price, leaving the company with $48 million in cash and a market cap at $27 million. Its shares dropped 12.5% this morning on the latest setbacks.

At the end of July the data monitoring committee concluded that galeterone wasn’t going to make much of a difference in the progression-free survival of patients with castration-resistant prostate cancer. The biotech immediately hit the brakes on the ARMOR3-SV study, effectively shredding Tokai’s business plan.

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Sr. Manager, Regulatory Affairs, CMC
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