Welcome to our dedicated page for Atea Pharmaceuticals news (Ticker: AVIR), a resource for investors and traders seeking the latest updates and insights on Atea Pharmaceuticals stock.
Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) is a clinical-stage biopharmaceutical company focused on oral antiviral therapeutics for serious viral diseases, and its news flow reflects this development-driven profile. Company announcements frequently center on progress in its hepatitis C virus (HCV) program, where Atea is advancing a fixed-dose combination regimen of bemnifosbuvir, a nucleotide analog HCV NS5B polymerase inhibitor, and ruzasvir, an NS5A inhibitor.
News items include updates on the global Phase 3 HCV program, such as enrollment milestones in the C-BEYOND and C-FORWARD trials, expectations for topline results, and details of trial design, endpoints and patient populations. Atea also reports new clinical and nonclinical data, including Phase 2 efficacy results, resistance analyses, pharmacokinetic findings and multiscale modeling that explore the regimen’s antiviral activity, barrier to resistance, relative bioavailability and dosing flexibility.
Investors and observers can also find press releases about Atea’s participation in major medical and investor conferences, including presentations at The Liver Meeting of the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver Congress, as well as appearances at healthcare investment conferences. These communications often highlight new data sets, key opinion leader events and discussions of the HCV commercial landscape.
In addition, Atea’s news coverage includes pipeline expansion updates, notably the development of nucleotide analog candidates AT-587 and AT-2490 for hepatitis E virus (HEV), along with background on the unmet medical need in HEV and the company’s preclinical findings. Financial results releases and business updates, furnished in connection with quarterly reports, provide further context on research and development spending, cash resources and strategic priorities. For those tracking AVIR, this news page offers a centralized view of clinical progress, scientific presentations, pipeline evolution and corporate developments.
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Atea Pharmaceuticals (Nasdaq: AVIR) has received Fast Track designation from the FDA for its oral antiviral drug candidate, bemnifosbuvir, intended for treating COVID-19. This designation aims to expedite the drug's development due to significant unmet medical needs in vulnerable patient populations, including high-risk outpatients aged 18 and older regardless of vaccination status. Currently undergoing the Phase 3 SUNRISE-3 trial, bemnifosbuvir is being assessed in over 1,500 participants across approximately 300 sites globally. The trial will evaluate the drug's effectiveness against severe COVID-19 outcomes. Fast Track status will enable more frequent communications with the FDA and a potential rolling review for the New Drug Application.
Atea Pharmaceuticals presented significant findings from the MORNINGSKY Phase 3 trial of bemnifosbuvir for treating mild to moderate COVID-19. The study revealed a 71% reduction in hospitalization risk for patients treated with bemnifosbuvir compared to placebo. Notably, patients over 40 years showed an 82% reduction in hospitalization risk. Despite not meeting its primary endpoint of symptom alleviation, bemnifosbuvir demonstrated lower rates of hospitalization and treatment discontinuations due to adverse events compared to placebo. The investigational drug is now part of a global Phase 3 trial, SUNRISE-3. Atea also shared data on AT-752, an antiviral for dengue, which was well tolerated in early studies. These developments could enhance Atea's position in the antiviral market.
Atea Pharmaceuticals (Nasdaq: AVIR) announced promising Phase 1 data on bemnifosbuvir, its oral antiviral candidate for COVID-19 and hepatitis C (HCV), at the ICAR 2023 conference. Key findings reveal a favorable absorption and metabolism profile for bemnifosbuvir, demonstrating low risk for drug-drug interactions, effective inhibition against all SARS-CoV-2 variants, and potential synergistic effects when combined with ruzasvir against HCV. These results underscore bemnifosbuvir's high barrier to resistance and safety for vulnerable patients. The drug is currently undergoing a Phase 3 trial (SUNRISE-3) for COVID-19 and is in Phase 2 development for HCV treatment.
Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) announced six upcoming presentations at the 36th International Conference on Antiviral Research (ICAR) from March 13-17, 2023, in Lyon, France. Key presentations include:
- The synergistic effects of Bemnifosbuvir and Ruzasvir in treating HCV.
- Low risk of drug-drug interactions for Bemnifosbuvir.
- Pharmacokinetics of [14C]-Bemnifosbuvir.
- Bemnifosbuvir as a potent inhibitor of SARS-CoV-2 variants.
- AT-752 targeting Dengue virus replication.
- Cellular enzymes in the activation pathway of Bemnifosbuvir.
Atea focuses on developing oral therapies for serious viral infections and aims to expand its antiviral pipeline.
Atea Pharmaceuticals (Nasdaq: AVIR) reported its fourth-quarter and full-year 2022 financial results, showing a net loss of $34.4 million and a decline in cash and equivalents to $646.7 million. The company continues enrollment in its Phase 3 SUNRISE-3 trial for bemnifosbuvir, targeting COVID-19 treatment in high-risk patients, with an interim analysis expected in the second half of 2023. Atea has also deprioritized its dengue program to focus on COVID-19 and HCV, with a Phase 2 trial of bemnifosbuvir and ruzasvir for hepatitis C anticipated to start in Q2 2023. The overall research and development expenses decreased significantly due to the cessation of its collaboration with Roche.