Vertex slumps as FDA delays hepatitis C trial

26 July 2013

US drug maker Vertex Pharmaceuticals (Nasdaq: VRTX) saw its shares drop 11% to $78 a share, in after-hours trading on Thursday (July 25), when the company said it has received notice from the US Food and Drug Administration that a partial clinical hold has been placed on the firm’s ongoing Phase II US study of the nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135.

The partial clinical hold prevents evaluation of a 200mg dose of VX-135 in the US study following observation of reversible elevated liver enzymes in patients receiving 400mg of VX-135 in combination with ribavirin in a Phase II study in Europe. Evaluation of a 100mg dose of VX-135 in combination with ribavirin as part of the 12-week Phase II study in the USA is continuing as planned.

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