Atea Pharmaceuticals (NASDAQ:AVIR) is targeting a mid-2027 U.S. application for its hepatitis C treatment, pending results from a second late-stage trial, and has secured a credit facility of up to $200 million to support its development and commercial plans.
On its third-quarter 2026 earnings call, the company said it expects top-line results from the global C-FORWARD trial in early 2027. Those results, together with positive data from the North American C-BEYOND trial, are expected to support a new drug application for bemnifosbuvir and ruzasvir. Atea is preparing for a potential U.S. launch in 2028.
Hepatitis C trial met its primary endpoint
Chief Medical Officer Arantxa Horga said C-BEYOND met its primary endpoint, demonstrating that Atea’s regimen was statistically non-inferior to sofosbuvir/velpatasvir, marketed as EPCLUSA. The trial enrolled patients with chronic hepatitis C at approximately 120 sites in the U.S. and Canada.
In the trial’s modified intent-to-treat population, 94% of patients receiving bemnifosbuvir/ruzasvir achieved a sustained viral response at week 24, compared with 95% receiving the comparator. The analysis included patients who received at least one dose, including those who discontinued early, were not compliant or were lost to follow-up.
Patients without cirrhosis received Atea’s regimen for eight weeks or the comparator for 12 weeks. Both treatments were given for 12 weeks to patients with compensated cirrhosis. Response rates were 94% and 95%, respectively, among non-cirrhotic patients, while both arms achieved 95% among patients with compensated cirrhosis. Horga cautioned that the subgroups were not powered for statistical analysis.
Overall adverse events were comparable between the treatment arms, Horga said. There were no serious adverse events attributed to the study drugs and no early discontinuations related to them. Three patients receiving the comparator died during the treatment-emergent safety observation period, while none receiving Atea’s regimen died; none of the deaths were related to the study drug.
C-FORWARD enrolled patients in 17 countries and is intended to assess the regimen across a broader range of hepatitis C genotypes, management said.
Commercial preparations and financing
Chief Commercial Officer John Vavricka said Atea sees potential for more than $700 million in peak annual U.S. net sales for the regimen, with pricing expected to be in line with existing branded treatments. The forecast is a company estimate and depends on a successful launch.
Vavricka said Atea has not yet entered discussions with payers because the product is not approved. The company is assessing commercial, Medicare and Medicaid coverage and formulary restrictions as it develops its strategy. He also said a focused specialty sales force of 75 to 100 people could reach most of the market.
Atea reported $191.2 million in cash and investments at Sept. 30. Chief Financial Officer Andrea Corcoran said the company received $65 million at closing on Nov. 6 under its Hercules Capital credit facility. It may access up to another $135 million, subject to specified milestones and other conditions.
Corcoran said the initial funding, together with existing resources, is expected to support planned operations into mid-2028. She said the full $200 million facility would be more than sufficient to carry the company through a commercial launch and alleviate the need for equity financing. The company said the facility could extend its runway through profitability, assuming a successful launch and spending consistent with its operating plans.
Research and development and general and administrative expenses declined in the first nine months of 2026 from the comparable prior-year period, Corcoran said. The company did not provide dollar amounts for those expenses on the call.
Hepatitis E program advances
Atea has completed the single ascending dose portion of a phase 1 trial of AT-587, its experimental treatment for chronic hepatitis E, and is progressing through multiple ascending dose cohorts. Chief Development Officer Janet Hammond said both portions are being conducted in healthy volunteers, with results expected in early 2027.
The company plans to start a proof-of-concept study in infected patients in the first half of 2027 and expects preliminary results toward year-end. Hammond said there are no FDA-approved treatments for hepatitis E; current care can include reducing immunosuppression or using ribavirin off-label.
About Atea Pharmaceuticals (NASDAQ:AVIR)
Atea Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on discovering and developing oral antiviral therapies for serious infectious diseases. The company’s research platform is based on nucleotide and nucleoside prodrug technologies designed to target viral replication.
Atea’s lead product candidate is bemnifosbuvir, formerly known as AT-527, an orally administered antiviral that has been evaluated for the treatment of COVID-19. The company has also investigated bemnifosbuvir and related antiviral approaches for other viral infections, including hepatitis C.
