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.
| Chemocentry'x pipeline | |||
|---|---|---|---|
| Product | Mechanism of action | Indication/status | 2026e sales ($m) |
| Tavneos (avacopan) | Complement factor C5a inhibitor | Vasculitis (approved in US and Japan, EU decision by end of 2021) | 610 |
| Hidradenitis suppurativa (Aurora Ph2 failed), plan for Ph3 in severe patients | 57 | ||
| Glomerulonephritis (Accolade Ph2 failed), discussing path forward with FDA | 41 | ||
| Lupus nephritis study planned to start H1 2022 | - | ||
| CCX140 | CCR2 inhibitor | Diabetic kidney disease (Ph2), development in focal segmental glomerulosclerosis discontinued | - |
| CCX507 | CCR9 inhibitor | Ulcerative colitis (Ph1) | - |
| CCX559 | PD-L1 inhibitor | Solid tumours (Ph1), oral | - |
| CCX587 | CCR6 inhibitor | Th17-mediated inflammation (psoriasis; preclinical) | - |
| Source: company releases & Evaluate Pharma. https://www.evaluate.com/vantage/articles/news/snippets/fda-seals-chemocentryxs-fate | |||
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