Atea Pharmaceuticals, Inc. Stock Price, News & Analysis

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 36^th 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.