PTC: European Regulators Yank Approval For Muscle Disease Drug

European regulators voted against fully approving a Duchenne muscular dystrophy treatment from PTC Therapeutics (PTCT), and PTC stock crashed Friday.

In morning trades on today's stock market, PTC shares collapsed 27.8% to 27.

The Committee for Medicine Products for Human Use for the European Medicines Agency issued a negative opinion of the PTC drug, Translarna, for patients with the muscle-weakening disease.

The advisors also voted against renewing the conditional approval for Translarna. Conditional approval allows a medicine to be fast-tracked for approval while still under testing. But the drugmaker must continue testing the drug to prove its benefit. The European advisors says PTC's evidence didn't pass muster.

"We are surprised and extremely disappointed by the CHMP decision, given the well-established and favorable safety and (effectiveness) profile of Translarna," Chief Executive Matthew Klein said in a written statement.

https://www.investors.com/news/technology/ptc-stock-crashes-after-european-regulators-reject-its-muscular-dystrophy-drug/