Atea Pharmaceuticals, Inc. Stock Price, News & Analysis

Atea Pharmaceuticals (Nasdaq: AVIR) announced that its global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir for COVID-19 treatment did not meet its primary endpoint. The trial, involving 2,221 high-risk patients with mild to moderate COVID-19, failed to show a statistically significant reduction in all-cause hospitalization or death through Day 29 compared to placebo. Despite the disappointing outcome, bemnifosbuvir was generally safe and well-tolerated.

The company attributed the trial's failure to the evolving nature of COVID-19 variants and the trend towards milder disease, resulting in fewer hospitalizations and deaths. Notably, severe respiratory disease caused by COVID was not observed in SUNRISE-3, unlike in previous studies. Atea will not pursue a regulatory pathway for bemnifosbuvir in COVID-19 treatment but remains focused on developing a combination of bemnifosbuvir and ruzasvir for hepatitis C treatment.

Atea Pharmaceuticals (Nasdaq: AVIR) has published new data in PLOS Biology, detailing the metabolic activation pathway of bemnifosbuvir, their oral antiviral drug candidate. The study elucidates how bemnifosbuvir converts into its active form, AT-9010, which selectively inhibits viral enzymes, leading to potent antiviral activity against COVID-19, HCV, and potentially other RNA viruses.

Key findings include:

• Bemnifosbuvir's activation pathway to AT-9010 halts HCV RNA synthesis through chain termination
• It targets SARS-CoV-2 RNA synthesis at two distinct sites
• The drug shows minimal cellular toxicity compared to other antiviral purine nucleotide analogues

Bemnifosbuvir is currently in Phase 3 trials for COVID-19 and Phase 2 trials for HCV in combination with ruzasvir.

Atea Pharmaceuticals (NASDAQ: AVIR) reported Q2 2024 financial results and provided a business update. Key highlights include:

• Full enrollment achieved in global Phase 2 HCV study; SVR12 results expected Q4 2024
• COVID-19 Phase 3 SUNRISE-3 trial results expected H2 2024
• Cash position of $502.2 million as of June 30, 2024
• Q2 2024 R&D expenses increased to $34.7 million from $22.1 million in Q2 2023
• Net loss of $40.5 million for Q2 2024 compared to $28.2 million in Q2 2023

The company completed enrollment in both the HCV Phase 2 study and COVID-19 Phase 3 SUNRISE-3 study. Positive HCV data presented at EASL showed 97% SVR12 rate in lead-in cohort. Atea selected a fixed-dose combination tablet for HCV Phase 3 program.

Atea Pharmaceuticals (Nasdaq: AVIR), a clinical-stage biopharmaceutical company focused on developing oral antiviral therapeutics for serious viral diseases, has announced its upcoming second quarter 2024 financial results conference call. The event is scheduled for Wednesday, August 7, 2024, at 4:30 p.m. ET.

Participants can join the live audio webcast through the Investor Relations section of Atea's website. For those joining via telephone, pre-registration is required. The company will provide a business update along with the financial results for the quarter ended June 30, 2024. An archive of the webcast will be available on Atea's website for at least 90 days following the event.

Atea Pharmaceuticals announced positive initial results from their Phase 2 study combining bemnifosbuvir and ruzasvir for treating hepatitis C virus (HCV). The lead-in cohort of 60 patients showed a 97% sustained virologic response rate at 12 weeks post-treatment (SVR12) following an 8-week regimen. This combination therapy displayed high antiviral potency, short treatment duration, low risk of drug interaction, and a high barrier to resistance.

Additionally, a 100% SVR12 rate was observed in patients with the difficult-to-treat genotype 3. The study reported no severe drug-related adverse events or treatment discontinuations. Atea aims to enroll up to 220 more subjects, including those with compensated cirrhosis. These promising results were shared at the EASL Congress in Milan, Italy, from June 5-8, 2024, highlighting the potential best-in-class profile of the drug combination.

Atea Pharmaceuticals (Nasdaq: AVIR), a clinical-stage biopharmaceutical firm focused on developing oral antiviral treatments for severe viral diseases, announced that CEO and Founder Jean-Pierre Sommadossi, PhD, will present a business update at the Jefferies Healthcare Conference. The presentation is scheduled for June 5, 2024, at 10:30 a.m. ET in New York. Both a live and archived webcast of the presentation will be accessible on Atea's website.

Atea Pharmaceuticals will present new data on the combination of bemnifosbuvir and ruzasvir for treating hepatitis C virus (HCV) at the EASL Congress 2024. The presentations will showcase antiviral efficacy, including SVR12 data from the ongoing Phase 2 HCV trial's lead-in cohort. Preclinical data highlight bemnifosbuvir's high resistance barrier and pharmacokinetics, and ruzasvir's low risk of drug-drug interactions. The full dataset will be available on the EASL Congress website on June 5, 2024. HCV remains a significant health issue in the U.S., with over 2 million chronic cases and annual diagnoses outpacing cure rates.

Atea Pharmaceuticals reported Q1 2024 financial results, highlighting key developments in their COVID-19 and HCV treatment trials. The company completed enrollment in the global Phase 3 SUNRISE-3 trial for bemnifosbuvir in high-risk COVID-19 patients, with results expected in H2 2024. Additionally, they are progressing in their Phase 2 trial for HCV treatment with bemnifosbuvir and ruzasvir, also expecting results in H2 2024. Financially, Atea reported a net loss of $63.2 million, up from $35.5 million YoY, primarily due to increased R&D expenses. Cash and equivalents stood at $541.5 million, down from $578.1 million at the end of 2023.

Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) will host a conference call on May 14, 2024, to report financial results for the first quarter ended March 31, 2024, and provide a business update. Participants can access the live webcast on the company's Investor Relations website. Telephone registration is required for participation.