ChemoCentryx, Inc. (CCXI) falls to 5.87% in the premarket. However, the last trading session concluded at $19.6 with an incline of 5.43%.
Approval in Japan of TAVNEOS for the Treatment of ANCA-Associated Vasculitis
On 27th September 2021, CCXI announced that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has given Kissei Pharmaceutical Co., Ltd. permission to market TAVNEOSTM. Vifor Pharma has been given an exclusive license to commercialize TAVNEOSTM in Japan as part of ChemoCentryx’s Kidney Health Alliance with Vifor Pharma. The MHLW has declared ANCA-associated vasculitis to be an incurable illness. Intractable illnesses are uncommon diseases for which there is no effective cure, but which require long-term care. Japan encourages research into incurable diseases and provides financial assistance to people suffering from them.
CCXI announced Second Quarter 2021 Financial Results
CCXI reported second-quarter 2021 results on 9th August 2021. In the second quarter of 2021, revenue was $1.8 million, down from $49.4 million in the same quarter of 2020. The revenue drop from 2020 to 2021 was mostly due to the acceleration of revenue recognition in 2020. This coincided with the decision to stop developing CCX140 for Focal Segmental Glomerulosclerosis.
Moreover, research and development costs were $20.9 million, up from $18.8 million in the same quarter of 2020. The increase from 2020 to 2021 was mainly due to the production of commercial drug supply. The second quarter of 2021 saw $19.7 million in general and administrative costs, up from $10.3 million in the same quarter of 2020. Increased employee-related expenditures, especially those linked to the CCIX’s commercialization planning activities, and higher professional fees accounted for the majority of the rise from 2020 to 2021. Lastly, CCXI lost $39.2 million in the second quarter of 2021, compared to $20.3 million in the same period of 2020.
Amendment to NDA Submission and Extension of the PDUFA Review Period
On 6th August 2021, CCXI announced an amendment to NDA submission. CCXI filed a modification to its New Drug Application (NDA) for avacopan. This is meant for the treatment of Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated vasculitis. The NDA is based on the results of the avacopan Phase III ADVOCATE study for the treatment of ANCA-associated vasculitis.
The European Medicines Agency (EMA) certified the Marketing Authorization Application (MAA) for avacopan in the treatment of ANCA-associated vasculitis. While the Japanese Pharmaceuticals and Medical Device Agency accepted the Japanese New Drug Application for evaluation in February 2021.
