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Arrowhead Tumbles As FDA Puts A Clinical Hold On Novel HBV Therapy Trial

 
• By Alexandra Shimmings

Shares in US biotech Arrowhead Pharmaceuticals took a tumble after the FDA put a clinical hold on one of its small interfering RNAs (siRNAs) Phase II programs in hepatitis B because of concerns over a delivery vehicle that is also used in two of its other Phase II candidates.

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• Source: Shutterstock

Arrowhead Pharmaceuticals Inc.’ share priced dropped by more than 26% to $4.5 on early trading on NASDAQ on Nov. 11 following news that the US FDA has placed on clinical hold Heparc-2004, a Phase IIb study of ARC-520, its investigational therapeutic vaccine for the treatment of chronic hepatitis B virus (HBV) infection.

Though still to be confirmed in writing, the company said it had been told verbally by the agency that the hold had been prompted by deaths at the highest doses in an ongoing non-human primate toxicology

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