ChemoCentryx ( CCXI Quick Quote CCXI - Free Report) announced that it has filed an amendment to its new drug application (“NDA”) with the FDA for its novel oral drug avacopan for the treatment of anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis.
We remind investors that this amendment comes two months after the FDA Arthritis Advisory Committee’s (“Committee”) outcome on avacopan. The Committee was split 9-9 on the first question whether the efficacy data supports the drug approval, 10-8 on the second question whether the safety profile of avacopan is adequate to support approval and 10-8 on the final question whether the benefit-risk profile is adequate to support the drug’s approval at the proposed dose of 30 mg twice daily.
Per FDA, the amended NDA constitutes a major amendment to the earlier NDA, thereby extending the PDUFA goal date to Oct 7, 2021.
The NDA is primarily based on data from phase III ADVOCATE study. The participants (n=331) were randomized to receive avacopan plus either Rituxan or cyclophosphamide (followed by azathioprine/mycophenolate) or study-supplied oral prednisone plus either rituximab or cyclophosphamide (followed by azathioprine/mycophenolate). If needed, the participants in both treatment groups can also receive non-protocol glucocorticoids.
In the year so far, ChemoCentryx has plunged 77.3% compared with the
industry’s decline of 8.5%. Image Source: Zacks Investment Research
ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, causing inflammation and destruction of small blood vessels, and thereby organ damage and failure, with the kidney as the major target. This may be fatal if not treated.
Current therapies for ANCA-associated vasculitis consist of immuno-suppressants (cyclophosphamide or rituximab) combined with daily-administered glucocorticoids (steroids) for prolonged periods of time, which can cause significant illness including death. The successful development and commercialization of the drug will boost the company’s prospects.
Avacopan is also being developed to treat patients with C3 glomerulopathy (C3G) and hidradenitis suppurativa (HS). Moreover, the drug has been granted orphan drug designation by the FDA for ANCA-associated vasculitis and C3G.
The EMA has already validated the marketing authorization application for avacopan in the treatment of ANCA-associated vasculitis in November 2020. Furthermore, the European Commission has granted orphan medicinal product designation for avacopan to treat two forms of ANCA-associated vasculitis and C3G.
While ChemoCentryx owns and retains the commercial rights to the drug in the United States, Switzerland-based Vifor Pharma holds exclusive rights to commercialize avacopan outside the country.
Zacks Rank & Stocks to Consider
ChemoCentryx currently carries a Zacks Rank #3 (Hold). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .
Some better ranked stocks in the medical sector include
Catalent ( CTLT Quick Quote CTLT - Free Report) , BioNTech ( BNTX Quick Quote BNTX - Free Report) and Bayer ( BAYRY Quick Quote BAYRY - Free Report) . While both Catalent and BioNTech carries a Zacks Rank #1, Bayer currently carries a Zacks Rank #2 (Buy).
Catalent’s earnings estimates for 2021 have increased from $2.85 to $2.94 in the past 60 days while that of 2022 has risen from $3.31 to $3.49 per share over the same period. The stock has risen 8.8% in the year so far.
BioNTech’s earnings estimates for 2021 have increased from $18.39 to $30.58 per share in the past 60 days while that of 2022 has risen from $7.55 to $24.90 over the same period. The stock has surged 161.9% this year so far.
Bayer’s earnings estimates for 2021 have increased from $1.74 to $1.81 per share in the past 60 days while that of 2022 has risen from $1.89 to $2.00 over the same period. The stock has risen 1.2% in the year so far.
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