Anuncio • Nov 13

Atea Pharmaceuticals, Inc. Announces Research Findings, Including Evidence of A Unique Dual Mechanism of Action for Bemnifosbuvir Against Hepatitis C Virus and the Expansion of the Company's Antiviral Pipeline with A New Hepatitis E Virus Program

Atea Pharmaceuticals, Inc. announced new research findings, including evidence of a unique dual mechanism of action for bemnifosbuvir against hepatitis C virus (HCV) and the expansion of the Company's antiviral pipeline with a new hepatitis E virus (HEV) program, and provided a business update. The Company’s combination regimen of bemnifosbuvir, a nucleotide analog HCV NS5B polymerase inhibitor, and ruzasvir, an NS5A inhibitor, for the treatment of HCV is currently being evaluated in a global Phase 3 development program. This program is comprised of two Phase 3 clinical trials with C-BEYOND being conducted in the US and Canada and C-FORWARD being conducted outside North America. Patient enrollment is on track in both trials. The Company currently anticipates that C-BEYOND will be fully enrolled by the end of 2025 with topline results available mid-2026. Additionally, the Company expects patient enrollment in C-FORWARD to be completed mid-2026 with topline results available around the end of 2026.During the past week, presentations made at The Liver Meeting 2025, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) reported new data 1) supporting the antiviral potency of the bemnifosbuvir and ruzasvir regimen, 2) highlighting the regimen’s high barrier to resistance, and 3) demonstrating the high relative bioavailability of the bemnifosbuvir and ruzasvir fixed dose combination (FDC) commercial formulation. These data also support dosing of the FDC with or without food or with famotidine, an H2 blocker which can substantially diminish the effectiveness of HCV oral antivirals. The FDC commercial formulation is being used in the ongoing Phase 3 program. The Liver Meeting took place November 7-11 in Washington, DC. The Company also announced the expansion of its antiviral pipeline with a new HEV program, which includes two proprietary lead candidates with potent nanomolar antiviral activity against HEV in vitro. New Data Show Unique Dual Mechanism of Action (MoA) for Bemnifosbuvir Against HCVBemnifosbuvir, a nucleotide analog HCV NS5B polymerase inhibitor, has an established MoA of inhibition of HCV RNA leading to chain termination, blocking viral production and replication inside the host cell. However, new modeling of HCV viral kinetics from a Phase 1 monotherapy trial suggests that bemnifosbuvir may also inhibit the assembly/secretion of new HCV virions into the bloodstream, significantly reducing extracellular HCV RNA. This additional MoA of bemnifosbuvir is a mechanism previously only associated with NS5A inhibitors, such as ruzasvir and velpatasvir. New in vitroresults confirm the dual MoA of bemnifosbuvir. These new results, demonstrating the dual MoA of bemnifosbuvir, highlight the unique and differentiated profile of bemnifosbuvir and further explain the potency of the combination regimen of bemnifosbuvir and ruzasvir for the treatment of HCV. Highlights from the three presentations included: A resistance analysis from a Phase 2 study of the combination of bemnifosbuvir and ruzasvir demonstrated that SVR12 rates were not impacted by resistance associated substitutions (RASs). These data support the regimen’s high barrier to resistance in patients infected with HCV. Viral kinetics and pharmacokinetic analyses indicated that most of the viral failures were due to treatment non-adherence. Results from a Phase 1 study in healthy participants demonstrated the high relative bioavailability of the bemnifosbuvir and ruzasvir FDC commercial formulation. These results also support dosing of the FDC with or without food or with famotidine, an H2 blocker which can substantially diminish the effectiveness of HCV oral antivirals. Multiscale modeling predicted that the combination regimen of bemnifosbuvir and ruzasvir inhibits both intracellular replication of HCV, as well as viral assembly and secretion of new HCV virions into the bloodstream in patients with chronic HCV infection, with a modeled time to cure of approximately 7 to 8 weeks. Because the regimen suppresses the virus at multiple critical stages, the data support the potential of the combination regimen as a simplified, short-duration therapy for chronic HCV. New Development Program for HEVThe Company is advancing two novel, proprietary development candidates, AT-587 and AT-2490, which have exhibited potent nanomolar antiviral activity in vitro against HEV genotypes GT-1 and GT-3. Investigational new drug (IND) enabling studies of AT-587 and AT-2490 are ongoing to select the clinical candidate for a Phase 1 program, which is anticipated to begin in mid-2026.Chronic HEV GT-3 and GT-4 infections occur most frequently in immunocompromised individuals with the potential of rapid progression to cirrhosis, particularly in at-risk populations including solid organ transplant recipients and patients with hematological malignancies, a history of haematopoietic stem cell transplant (HSCT) and pre-existing liver disease. There are currently no approved antiviral therapies for this unmet medical need. Current interventions include a reduction of immunosuppressives and treatment with ribavirin, an antiviral associated with safety concerns and limited efficacy for HEV. Each of these options pose substantial challenges for immunocompromised patient populations infected with HEV.Phase 3 C-BEYOND and C-FORWARD Trials in Adults with Chronic HCVThe Company’s HCV global Phase 3 development program includes two open-label Phase 3 trials, C-BEYOND being conducted in the US and Canada, and C-FORWARD being conducted outside of North America. Each Phase 3 trial is enrolling approximately 880 treatment-naïve patients, including those with or without compensated cirrhosis. The trials compare the bemnifosbuvir and ruzasvir FDC commercial formulation to the FDC regimen of sofosbuvir and velpatasvir. The regimen of bemnifosbuvir and ruzasvir is administered orally once-daily for eight weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir is administered orally once-daily for 12 weeks to all patients, with or without compensated cirrhosis. The primary endpoint for each trial is HCV RNA Physician Perspectives – Key Market Research Finding A survey of healthcare providers who treat HCV patients revealed they are seeking a new treatment option offering high efficacy, a short treatment duration and a low risk of drug-drug interactions to address the needs of the current HCV patient population as up to 80% of patients take multiple medications to manage comorbidities and coinfections. The healthcare providers surveyed are among the 153 top prescribers of direct acting antivirals (DAA) in the US, including 86 gastroenterologist/hepatologists, 34 infectious disease specialists and 33 internal medicine specialists. IQVIA conducted the survey as part of independent quantitative market research commissioned by the Company.

Anuncio • Jan 09

Atea Pharmaceuticals, Inc. Announces Positive Initial Data from Phase 2 Study for Hepatitis C Virus (HCV) and Significant Enrollment for Phase 3 SUNRISE-3 Trial for COVID-19

Atea Pharmaceuticals, Inc. announced the achievement of two significant clinical milestones from its Hepatitis C Virus (HCV) and COVID-19 programs. The Company reported positive initial data from the first 52 patients in the lead-in cohort of its Phase 2 combination 8-week study of bemnifosbuvir and ruzasvir (RZR) for the treatment of HCV. Additionally, Atea has enrolled more than 650 patients in the monotherapy arm of its Phase 3 SUNRISE-3 trial for the treatment of COVID-19, and enrollment continues with the current wave. This enrollment milestone allows for the first interim analysis of the study by the DSMB, which is expected this March. The Phase 2 open label study of bemnifosbuvir and RZR enrolled a lead-in cohort of 60 direct acting antiviral naïve, non-cirrhotic patients across all genotypes. Patients were administered 550 mg of bemnifosbuvir in combination with 180 mg of RZR once-daily for 8 weeks. Preliminary data are being presented as available, with SVR4 data currently available from 52 of the 60 lead-in patients. Including SVR4 as a decision endpoint, is a study design that is intended to substantially shorten the anticipated timeline for the completion of the Phase 2 trial. Clinical trials of other direct acting antiviral therapy combinations have demonstrated that the SVR4 result is highly correlated with SVR12.The initial results for the first 52 patients who reached this timepoint demonstrated a SVR4 rate of 98%, including one patient with poor adherence who did not achieve SVR4. Additionally, very rapid kinetics were observed in all 60 patients across genotypes with viral load near or below the lower limit of quantification (LLOQ) at 4 weeks of treatment, which is supportive of an 8-week treatment regimen for the combination of bemnifosbuvir and RZR. All 60 patients achieved viral load below the LLOQ at the end of the treatment. The combination was generally safe and well tolerated. There were no drug related serious adverse events, no treatment discontinuations and adverse events were mostly mild.The Phase 2 study aims to assess the safety and efficacy of 8 weeks of treatment with the combination of bemnifosbuvir and RZR in treatment-naïve HCV-infected patients, either without cirrhosis and or with compensated cirrhosis. The primary endpoint of the study is SVR12.Approximately 280 treatment-naïve HCV-infected patients, including the lead-in cohort, are expected to be enrolled in the Phase 2 study. The second part of the trial is anticipated to enroll 220 patients across all genotypes. An expanded geographic footprint to include approximately 50 clinical sites in approximately 15 countries is currently being activated. Full enrollment of the study is expected to be completed by mid-2024 with topline results in the third quarter of 2024. Phase 3 SUNRISE-3 Trial Enrollment Update: SUNRISE-3 is a global, multicenter, randomized, double-blind, placebo-controlled, registrational Phase 3 trial evaluating bemnifosbuvir or placebo administered concurrently with locally available standard of care (SOC). The study has a large global footprint targeting approximately 300 clinical trial sites in the U.S., Europe, Japan and rest of the world. Patients are randomized 1:1 to receive either bemnifosbuvir 550 mg twice-daily (BID) or placebo BID for five days. SUNRISE-3 is the only Phase 3 program in high-risk COVID-19 patients with hospitalization as a primary endpoint.This trial is comprised of two study populations based on the type of SOC received: 1) bemnifosbuvir as monotherapy (primary analysis), and 2) the “combination antiviral population,” assessing combination therapy if the SOC includes other compatible antiviral drugs against COVID-19 (secondary analysis).The SUNRISE-3 patient population includes those aged =70 years (regardless of other risk factors), individuals aged =55 years with one or more risk factors, those aged =50 years with two or more risk factors, and individuals aged =18 years with specific risk factors, including immunocompromised conditions, all irrespective of COVID-19 vaccination status.The primary endpoint of the trial is all-cause hospitalization or death through Day 29 post-treatment in the monotherapy arm in 2,200 patients. The trial includes two interim analyses by the DSMB to assess safety and futility, to be conducted after approximately 650 and 1,350 evaluable patients, respectively, after completion of Day 29 post treatment in the monotherapy arm. Bemnifosbuvir, a nucleotide polymerase inhibitor, has been shown to be approximately 10-fold more active than sofosbuvir (SOF) in vitro against a panel of laboratory strains and clinical isolates of HCV genotypes 1–5. In vitro studies demonstrated bemnifosbuvir remained fully active against SOF resistance-associated strains (S282T), with up to 58-fold more potency than SOF. The pharmacokinetic (PK) profile of bemnifosbuvir supports once-daily dosing for the treatment of HCV and bemnifosbuvir has been well-tolerated at doses up to 550 mg for durations up to 8-12 weeks in healthy and HCV-infected subjects.RZR, an oral NS5A inhibitor, has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and prior clinical studies. RZR has been administered to over 1,200 HCV-infected patients at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. RZR’s PK profile supports once-daily dosing. Bemnifosbuvir targets the SARS-CoV-2 RNA polymerase (nsp12), a highly conserved gene which is responsible for both replication and transcription of SARS-CoV-2. Bemnifosbuvir has a unique mechanism of action, with dual targets consisting of chain termination (RdRp) and nucleotityltransferase (NiRAN) inhibition, which has the potential to create a high barrier to resistance. In vitro data confirmed that bemnifosbuvir is active with similar efficacy against all variants of concern and variants of interest that have been tested, including Omicron subvariants BA.4, BA.5, XBB and EG.5.1.

Rendimiento total para el accionista	7.5%
Rendimiento futuro de los dividendos	n/a
Crecimiento de los dividendos	n/a
Próxima fecha de pago de dividendos	n/a
Fecha ex dividendo	n/a
Dividendo por acción	n/a
Ratio de pago	n/a

Segmento	Rentabilidad por dividendo
Empresa (AVIR)	n/a
Suelo de mercado 25% (US)	1.4%
Techo de mercado 25% (US)	4.3%
Media de la industria (Pharmaceuticals)	2.1%
Analista de previsiones (AVIR) (hasta 3 años)	n/a

Datos	Última actualización (huso horario UTC)
Análisis de la empresa	2026/05/21 01:47
Precio de las acciones al final del día	2026/05/21 00:00
Beneficios	2026/03/31
Ingresos anuales	2025/12/31

Paquete	Datos	Marco temporal	Ejemplo Fuente EE.UU. ^*
Finanzas de la empresa	10 años	Cuenta de resultados Estado de tesorería Balance	Formulario SEC 10-K Formulario SEC 10-Q
Estimaciones del consenso de analistas	+3 años	Previsiones financieras Objetivos de precios de los analistas	Informes de análisis Blue Matrix
Precios de mercado	30 años	Precios de las acciones Dividendos, escisiones y acciones	Datos de mercado ICE Formulario S-1 de la SEC
Propiedad	10 años	Accionistas principales Información privilegiada	Formulario SEC 4 Formulario SEC 13D
Gestión	10 años	Equipo directivo Consejo de Administración	Formulario SEC 10-K Formulario SEC DEF 14A
Principales avances	10 años	Anuncios de empresas	Formulario SEC 8-K

Analista	Institución
Eric Joseph	J.P. Morgan
Matthew Harrison	Morgan Stanley
Maxwell Skor	Morgan Stanley

Atea Pharmaceuticals Dividendos y recompras

Dividendo controles de criterios 0/6

Información clave

Últimas actualizaciones de dividendos y recompras

Atea Pharmaceuticals, Inc. (NasdaqGS:AVIR) announces an Equity Buyback for $25 million worth of its shares.

Recent updates

Hepatitis C Trial And Pricing Risks Will Dominate Outlook Yet Longer Term Potential Remains

We Think Atea Pharmaceuticals (NASDAQ:AVIR) Needs To Drive Business Growth Carefully

Atea Pharmaceuticals, Inc., Annual General Meeting, Jun 18, 2026

Hepatitis Antiviral Pipeline Will Create Long Term Upside Potential

New major risk - Revenue and earnings growth

Hepatitis C And E Antiviral Pipeline Will Reshape Long Term Outlook

Atea Pharmaceuticals, Inc. Presents Preclinical Results Supporting First-In-Class Potential of At-587 for Treatment of Hepatitis E Virus At Croi 2026

Founder exercised options and sold US$450k worth of stock

Price target decreased by 15% to US$6.00

Atea Pharmaceuticals, Inc. Announces Research Findings, Including Evidence of A Unique Dual Mechanism of Action for Bemnifosbuvir Against Hepatitis C Virus and the Expansion of the Company's Antiviral Pipeline with A New Hepatitis E Virus Program

Atea Pharmaceuticals, Inc. Presents New Data Supporting the Fixed-Dose Combination of Bemnifosbuvir and Ruzasvir as A Potential Best-In-Class Regimen for Treatment of Hepatitis C Virus Infection At the Liver Meeting®? 2025

Atea Pharmaceuticals, Inc. to Report Q3, 2025 Results on Nov 12, 2025

New major risk - Revenue and earnings growth

New major risk - Revenue and earnings growth

Atea Pharmaceuticals, Inc. Announces Continued Advancement of Global Phase 3 HCV Program with Dosing of First Patient in C-FORWARD Outside North America

New major risk - Revenue and earnings growth

Atea Pharmaceuticals, Inc. Announces Full Results from Phase 2 Study of Regimen of Bemnifosbuvir and Ruzasvir for Treatment of Hepatitis C Virus (Hcv) Presented At Easl Congress 2025

Atea Pharmaceuticals, Inc. to Report Q1, 2025 Results on May 12, 2025

Atea Pharmaceuticals, Inc., Annual General Meeting, Jun 20, 2025

Atea Pharmaceuticals, Inc. (NasdaqGS:AVIR) announces an Equity Buyback for $25 million worth of its shares.

Atea Pharmaceuticals, Inc. Announces Board Changes

Price target decreased by 8.0% to US$6.50

Atea Pharmaceuticals, Inc. Announces Dosing of First Patient in C-BEYOND, Phase 3 Study Evaluating Regimen of Bemnifosbuvir and Ruzasvir for Treatment of Hepatitis C Virus

The Radoff-JEC Group Nominates Candidates for Election to the Atea Pharmaceuticals Board of Directors

Atea Pharmaceuticals, Inc. Announces Presentation of Bemnifosbuvir Preclinical Data at the 38th International Conference on Antiviral Research (ICAR) 2025

No longer forecast to breakeven

Atea Pharmaceuticals, Inc. Appoints Arthur S. Kirsch to Board of Directors

Lead Independent Director recently bought US$81k worth of stock

Lead Independent Director recently sold US$1.0m worth of stock

Lead Independent Director notifies of intention to sell stock

Atea Pharmaceuticals Announces Positive Results from Phase 2 Study of Bemnifosbuvir and Ruzasvir Regimen for Treatment of Hepatitis C Virus

Founder notifies of intention to sell stock

Atea Pharmaceuticals Provides Update on Global Phase 3 Rise-3 Trial Evaluating Bemnifosbuvir for Treatment of COVID-19

Independent Director recently sold US$61k worth of stock

Price target increased by 18% to US$5.50

Atea Pharmaceuticals Presents Positive Initial Phase 2 Data for Bemnifosbuvir and Ruzasvir Combination for Treatment of Hepatitis C Virus at EASL Congress 2024

Atea Pharmaceuticals Presents New Data Showcasing Potential Best-in-Class Combination Profile of Bemnifosbuvir and Ruzasvir for Treatment of Hepatitis C Virus at EASL Congress 2024

Atea Pharmaceuticals, Inc., Annual General Meeting, Jun 21, 2024

Atea Pharmaceuticals, Inc. Completes Patient Enrollment in Global Phase 3 Sunrise-3 Trial Evaluating Oral Antiviral Bemnifosbuvir for COVID-19 in High-Risk Patients

Founder notifies of intention to sell stock

Atea Pharmaceuticals, Inc. Announces Positive Initial Data from Phase 2 Study for Hepatitis C Virus (HCV) and Significant Enrollment for Phase 3 SUNRISE-3 Trial for COVID-19

Price target decreased by 15% to US$5.33

Atea Pharmaceuticals, Inc. to Present Bemnifosbuvir and Ruzasvir Data for the Treatment of Hepatitis C Virus at AASLD the Liver Meeting 2023

Atea Pharmaceuticals, Inc. to Report Q3, 2023 Results on Nov 08, 2023

Insufficient new directors

Atea Pharmaceuticals, Inc.(NasdaqGS:AVIR) dropped from Russell 2000 Defensive Index

Atea Pharmaceuticals, Inc. Announces First Patient Dosed in Phase 2 Study for Treatment of Hepatitis C with Bemnifosbuvir and Ruzasvir Combination

Concentra Biosciences, LLC cancelled the acquisition of 96.37% stake in Atea Pharmaceuticals, Inc. (NasdaqGS:AVIR).

Concentra Biosciences, LLC submitted a non-binding proposal to acquire 96.37% stake in Atea Pharmaceuticals, Inc. (NasdaqGS:AVIR) for approximately $480 million.

Investor sentiment deteriorates as stock falls 16%

Price target decreased to US$9.00

Atea Pharmaceuticals, Inc. Provides an Update on the Clinical Development Programs for 2023

Atea Pharmaceuticals, Inc. Announces First Patient Dosed in SUNRISE-3 Phase 3 Registrational Trial of Bemnifosbuvir, an Investigational Oral Antiviral for the Treatment of COVID-19

Lead Independent Director notifies of intention to sell stock

Lead Independent Director recently sold US$215k worth of stock

Third quarter 2022 earnings released: US$0.097 loss per share (vs US$0.34 loss in 3Q 2021)

Atea Pharmaceuticals, Inc. Announces U.S. FDA Fast Track Designation Granted to AT-752 for Treatment of Dengue

Atea wins FDA Fast Track status for dengue treatment

Investor sentiment deteriorated over the past week

Atea Pharmaceuticals, Inc. to Advance Global Phase 3 Registrational Study of Bemnifosbuvir in High-Risk Non-Hospitalized Patients with COVID-19

Consensus forecasts updated

First half 2022 earnings released

Atea Pharmaceuticals Q2 2022 Earnings Preview

Atea Pharmaceuticals, Inc.(NasdaqGS:AVIR) dropped from Russell 2000 Growth Index

Investor sentiment deteriorated over the past week

Investor sentiment improved over the past week

Atea Pharmaceuticals, Inc.'s (NASDAQ:AVIR) Shares Not Telling The Full Story

Atea Pharmaceuticals, Inc., Annual General Meeting, Jun 17, 2022

Price target decreased to US$10.50

Investor sentiment improved over the past week

Full year 2021 earnings: EPS and revenues exceed analyst expectations

Price target decreased to US$11.67

Atea Pharmaceuticals, Inc. Announces Executive Changes

Investor sentiment deteriorated over the past week