Less than two weeks after Japan’s MHLW became the first regulatory agency to clear avacopan for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, the FDA has followed suit. It cleared the oral, small-molecule C5aR antagonist for use as an adjunct therapy for adults with the two main forms of the rare autoimmune renal disease, granulomatosis with polyangiitis and microscopic polyangiitis, in combination with standard therapy.
The FDA’s Arthritis Advisory Committee panelists groped through cloudy data while complaining about the design of the phase III trial for Chemocentryx Inc.’s avacopan, and after going overtime ended up without consensus. Briefing documents ahead of the meeting darkened what had been a fairly bright picture for the complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, but Wall Street held out hope. Wainwright analyst Edward White opined in a May 5 report that the adcom’s outcome “could still be positive,” and a May 4 dispatch from Canaccord Genuity’s Michelle Gilson said the briefing docs “miss[ed] the big picture.”
Stock-price weakness that has beset Chemocentryx Inc. since early March – likely based on jitters ahead of the FDA advisory panel for avacopan slated for May 6 – became an outright tumble when Wall Street got a gander at briefing documents related to the meeting. Shares of the San Carlos, Calif-based firm (NASDAQ:CCXI) closed at $22.19, down $26.63, or 45%, as company backers sifted paperwork on the complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The compound has been assigned a PDUFA date of July 7.
Inflarx NV has submitted a special protocol assessment (SPA) to the FDA for the phase III trial with vilobelimab against the skin disorder hidradenitis suppurativa (HS), pleasing investors with clarity regarding the path forward for the drug, which is in the works for antineutrophil cytoplasmic antibody-associated vasculitis (AAV) as well – and faces competition on both fronts.
With avacopan’s PDUFA date in anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA vasculitis) set for next summer, Chemocentryx Inc. rolled out long-awaited, COVID-19-delayed top-line findings from the company’s phase II, 390-patient Aurora study testing the compound for hidradenitis suppurativa (HS).
Positive phase III data from the Advocate trial by Chemocentryx Inc. and Vifor Fresenius Medical Care Renal Pharma caused Chemocentryx’s stock (NASDAQ:CCXI) to dramatically rise 281% on Tuesday, clearing the way to an NDA filing for the star small-molecule attraction, avacopan, an oral, selective complement 5a receptor inhibitor.