ChemoCentryx, Inc., CCXI announced that the FDA has acceptedits new drug application (NDA) seeking approval for its investigational candidate, avacopan, for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-associated vasculitis), a rare autoimmune disease. The FDA has set an action date of Jul 7, 2021. ANCA-associated vasculitisis a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. Avacopan is anorally-administered selective complement 5a receptor inhibitor.
Shares of the company have increased 32.9% year to date against the industry’s decline of 6.4%.
The NDA was based on data from the phase III ADVOCATE study. The ADVOCATE study compared the efficacy of avacopan in combination with Roche’s RHHBY Rituxan (rituximab) or cyclophosphamide (followed by azathioprine/mycophenolate) or prednisone plus either rituximab or cyclophosphamide (followed by azathioprine/mycophenolate).
Data from the study showed that patients treated with avacopan achieved both primary endpoints of clinical remission at weeks 26 and 52. Clinical remission was statistically superior in the avacopan arm compared to SOC at 52 weeks.
The FDA in its NDA acceptance letter also mentioned that it may hold an advisory committee meeting to discuss the application per the guidelines for new molecular entities. However, the FDA has not yet determined whether the meeting will be held.
Moreover, ChemoCentryx is developing avacopan for treating other rare diseases, including C3 glomerulopathy and hidradenitis suppurativa.The FDA has granted avacopan orphan drug designation for ANCA-associated vasculitis and C3G.
Zacks Rank &Stocks to Consider
ChemoCentryx currently carries a Zacks Rank #3 (Hold).
Some other top-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. EBS and Bio Techne Corp TECH both carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have increased from $4.23 to $6.58 for 2020 and from $5.55 to $7.62 for 2021 over the past 60 days. Shares of the company have increased 88.3% year to date.
Bio Techne’s earnings estimates have increased from $5.33 to $5.48 for 2020 and from $6.41 to $6.50 for 2021 over the past 60 days. Shares of the company have increased 11.7% year to date.
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