FDA seals Chemocentryx’s fate

Chemocentryx finally got the green light today for Tavneos in ANCA-associated vasculitis after a Pdufa delay, and the thumbs up follows previous precedent in that Pdufa date extensions rarely result in knockbacks. While the news sent Chemocentry’x shares soaring 64% the reaction is still not enough to put the company to levels seen before the mixed adcom in May, when shares lost three quarters of their value. The FDA’s concerns over liver toxicity seem to have been abated with the use of frequent liver function tests, and Tavneos's label comes without a black box warning. Tavneos, a complement C5a inhibitor, has been pegged as a pipeline in a product, but has suffered mid-stage setbacks in hidradenitis suppurativa and glomerulonephritis, thus leaving vasculitis as its main source of revenue.