AVIR 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-12

• Chronic HCV infection remains an ongoing public health crisis. If left untreated, HCV can progress to cirrhosis, end-stage liver disease and liver cancer, and it remains one of the leading causes of liver cancer in the US, Europe and Japan. According to the World Health Organization (cited July 28, …

• Presently, there are no short-course (i.e., eight week) nucleotide inhibitor-based, pan-genotypic HCV treatment regimens. Clinical and nonclinical results from studies we conducted prior to our Phase 3 program have shown that the BEM/RZR regimen has high antiviral potency and has been well tolerated…

• The global HCV Phase 3 program we are conducting consists of two randomized, open label studies: C-BEYOND which has clinical trial sites in the United States (“US”) and Canada, and C-FORWARD which has clinical trial sites in countries outside of North America. In these Phase 3 trials, we are compari…

• In July 2026, we announced positive topline results from C-BEYOND with BEM/RZR demonstrating statistical non-inferiority compared to SOF/VEL in the modified intent-to-treat (mITT) population thereby achieving the trial’s primary endpoint.

• In the mITT analysis (n=905, cirrhotic and non-cirrhotic), BEM/RZR achieved a 93.9% sustained virologic response (SVR) rate vs. 94.8% for SOF/VEL at Week 24 from the start of treatment, encompassing SVR at 12 weeks post-treatment (the generally accepted definition of cure for HCV) in both arms. Thes…

相对上期删除的文字 · 来源:10-Q · 2026-05-12

• Presently, there are no short-course (i.e., eight week) nucleotide inhibitor-based, pan-genotypic HCV treatment regimens. Clinical and nonclinical results from studies conducted to date, including a global Phase 2 clinical trial which enrolled 275 HCV infected patients, have shown that the regimen o…

• The global HCV Phase 3 program we are conducting consists of two randomized, open label studies: C-BEYOND which has clinical trial sites in the United States (“US”) and Canada, and C-FORWARD which has clinical trial sites in countries outside of North America. In these Phase 3 trials we are comparin…

• C-BEYOND is fully enrolled with over 880 patients, and we expect to report topline results mid-2026. We anticipate completing enrollment of an additional 880 patients in C-FORWARD in mid-2026 and reporting topline C-FORWARD results at year-end 2026. Pending successful results from these Phase 3 clin…

• We are executing a focused chemistry, manufacturing and controls (“CMC”) strategy to provide fixed dose combination (“FDC”) tablets for the completion of the Phase 3 program, to fulfill NDA requirements and to prepare us for potential launch with sufficient commercial supply for projected initial sa…

• Given the large number of patients currently infected with HCV, which is reported by the US Center for Disease Control and Prevention to be as many as four million persons in the US, and the incidence of newly reported chronic infections continuing to outpace rates of treatment, we expect that a sub…

相对上期新增的文字 · 来源:10-Q · 2026-08-12

• the timing of, and the costs involved in, obtaining marketing approvals for our current and future product candidates in regions where we choose to commercialize any products including for example, our anticipated submission to the FDA of an NDA for marketing approval of our HCV product candidate th…

• In the future, we may enter into strategic collaborations or other transactions. While we remain open to consideration of a broad range of strategic alternatives, including strategic partnerships, acquisition, merger, or other business combination, sale of assets or other strategic transactions, we …

• There is no assurance we will conclude any specific transaction or outcome. If we do identify suitable collaboration candidates or strategic partners, we may not be able to complete such collaborations or other strategic transactions timely or on favorable terms, or at all. Any collaborations or oth…

• strategic transactions may also divert management attention from day-to-day responsibilities, lead to a loss of key personnel, increase our expenses and reduce our cash and investments available for operations and other uses. We cannot predict the number, timing or size of future collaborations or s…

• time-consuming and may require significant personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.

相对上期删除的文字 · 来源:10-Q · 2026-05-12

• the timing of, and the costs involved in, obtaining marketing approvals for our current and future product candidates in regions where we choose to commercialize any products;

• In the future, we may enter into strategic collaborations or other transactions. While we remain open to consideration of a broad range of strategic alternatives, including strategic partnerships, acquisition, merger, or other business combination, sale of assets or other strategic transactions, we …

• existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may be subject to enforcement action, and we may not achieve or sustain profitability.

• practitioner or supplier of services reimbursable by Medicare or a state healthcare program, unless an exception applies;

• sanctions, including exclusions from government funded healthcare programs and imprisonment, which could affect our ability to operate our business. Further, defending against any such actions can be costly, time-consuming and may require significant personnel resources. Therefore, even if we are su…

相对上期删除的文字 · 来源:10-Q · 2026-05-12

• On March 10, 2026, Janet Hammond, MD, PhD, our Chief Development Officer, adopted a trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) (the “Hammond 10b5-1 Plan”). Between September 1, 2026 and September 1, 2027, the Hammond 10b5-1 Plan provides for the potenti…

• On March 11, 2026, John Vavricka, our Chief Commercial Officer, adopted a trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) (the “Vavricka 10b5-1 Plan”). Between September 1, 2026 and September 1, 2027, the Vavricka 10b5-1 Plan provides for the potential exerc…

• On March 12, 2026, Arantxa Horga, MD, our Chief Medical Officer, adopted a trading arrangement that is intended to satisfy the affirmative defense of Rule 10b5-1(c) (the “Horga 10b5-1 Plan”). Between September 1, 2026 and September 1, 2027, the Horga 10b5-1 Plan provides for the potential exercise o…