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Atea Pharmaceuticals, Inc. (NASDAQ: AVIR) is a clinical-stage biopharmaceutical company based in Boston, Massachusetts, dedicated to discovering, developing, and commercializing oral antiviral therapies aimed at treating severe viral diseases. Founded in 2012, Atea focuses on addressing unmet medical needs, particularly in serious viral infections caused by single-stranded RNA viruses.
The company's leading product candidate is AT-527 (bemnifosbuvir), an antiviral agent developed for treating COVID-19, caused by the SARS-CoV-2 virus. Currently, AT-527 is undergoing Phase 3 clinical trials. Additionally, the combination of bemnifosbuvir and ruzasvir, an oral NS5A inhibitor, is being developed for treating Hepatitis C Virus (HCV) and has shown promising results in Phase 2 trials. This combination therapy aims to provide a highly potent pan-genotypic antiviral treatment with a short treatment duration and fewer contraindications, particularly beneficial for HCV patients.
Beyond COVID-19 and HCV, Atea is also advancing other antiviral therapies in its pipeline, including AT-787 for Hepatitis C (under Phase 2 clinical trial), AT-752 for Dengue (under Phase 2 trial), and other candidates like AT-889 and AT-934 for Respiratory Syncytial Virus (currently under clinical trials).
Recent achievements include positive initial data from a Phase 2 study of bemnifosbuvir and ruzasvir for HCV, showing a 97% sustained virologic response rate at 12 weeks post-treatment. Furthermore, Atea has completed enrollment for the Phase 3 SUNRISE-3 trial for treating high-risk COVID-19 patients, with results expected in the second half of 2024.
Financially, Atea reported a solid cash position of $578.1 million as of December 31, 2023, enabling them to continue advancing their clinical programs. Collaborations and strategic partnerships play a crucial role in Atea’s progress, helping to broaden its scope and enhance its therapeutic offerings.
Investors and stakeholders can stay informed about Atea’s developments through their regular updates, financial reports, and participation in industry conferences. For more information, visit their official website at www.ateapharma.com.
Atea Pharmaceuticals (NASDAQ: AVIR) is facing pressure from a Concerned Shareholder Group owning approximately 3% of outstanding shares. The group criticizes the company's performance and governance, particularly focusing on Lead Independent Director Franklin M. Berger's recent sale of 359,606 shares at $2.84 per share, near all-time lows and below net cash value.
The shareholders highlight that the Board previously rejected Tang Capital's bid of $5.75 per share plus rights to 80% of net proceeds from drug programs in May 2023. They believe the company can deliver $4.75 per share in cash to shareholders, representing a 50% premium over current price. The group demands Berger's immediate resignation and calls for appointment of a new, shareholder-oriented Lead Independent Director to oversee the ongoing strategic review process with Evercore.
Atea Pharmaceuticals (AVIR) has announced the engagement of Evercore, a global independent investment bank, to explore strategic opportunities aimed at enhancing shareholder value. The primary focus is on identifying potential strategic partnerships for their Phase 3-ready hepatitis C virus (HCV) treatment program. The company has not established a timeline for completing this review process and has not made any definitive decisions. Atea states it will not provide further updates until either the Board of Directors approves a specific course of action, the review concludes, or disclosure becomes necessary. The company emphasizes that there is no guarantee this process will lead to any specific transaction or outcome.
Atea Pharmaceuticals (NASDAQ: AVIR) announced positive Phase 2 study results for its HCV treatment combining bemnifosbuvir and ruzasvir. The study met its primary endpoints with a 98% sustained virologic response rate at 12 weeks post-treatment in treatment-adherent patients after an eight-week regimen.
The treatment showed 95% efficacy in the overall evaluable population, including non-adherent patients. The regimen was generally safe with no drug-related serious adverse events. Non-cirrhotic patients achieved a 99% success rate, while cirrhotic patients showed 88% efficacy.
The company plans to initiate a Phase 3 program in early 2025, following an FDA meeting. The upcoming phase will feature a fixed-dose combination tablet, reducing daily pill count from four to two tablets.
Atea Pharmaceuticals (Nasdaq: AVIR), a clinical-stage biopharmaceutical company focused on developing oral antiviral therapeutics, has announced its participation in the 7th Annual Evercore HealthCONx Conference. Jean-Pierre Sommadossi, CEO and Founder, along with the management team, will deliver a business update and participate in a fireside chat on December 4, 2024, at 9:35 a.m. ET. The presentation will be accessible via live webcast on the company's website and will remain available for at least 90 days after the event.
Atea Pharmaceuticals (AVIR) presented three posters at AASLD's The Liver Meeting 2024 supporting the combination of bemnifosbuvir and ruzasvir for hepatitis C virus (HCV) treatment. The Phase 2 lead-in cohort showed a 97% SVR12 success rate with an 8-week treatment course. Key findings include: the drug combination effectively blocks viral replication and assembly, bemnifosbuvir demonstrates no clinically relevant effects on cardiac function, and shows a high barrier to resistance. The company plans to report full Phase 2 results in early December and initiate Phase 3 development in early 2025.
Atea Pharmaceuticals (AVIR) reported Q3 2024 financial results and provided updates on its HCV program. The company expects topline SVR12 results from its global Phase 2 Hepatitis C study (N=275) in December 2024. Earlier data showed 97% SVR12 rate in efficacy evaluable patients. The company ended Q3 with $482.8 million in cash and equivalents. Research and development expenses were $26.2 million, down from $28.2 million year-over-year. The company reported a net loss of $31.2 million for Q3 2024. Notably, Atea announced it will not pursue COVID-19 treatment development after its Phase 3 SUNRISE-3 trial failed to meet its primary endpoint.
Atea Pharmaceuticals (Nasdaq: AVIR) announced it will host a conference call and audio webcast on Thursday, November 7, 2024, at 4:30 p.m. ET to discuss third quarter 2024 financial results and provide a business update. The event will be accessible via telephone registration and webcast through the company's investor relations website. An archive of the webcast will be available for at least 90 days following the event.
Atea Pharmaceuticals (NASDAQ: AVIR) announced three upcoming poster presentations at AASLD's The Liver Meeting 2024 in San Diego, showcasing new data on the combination of bemnifosbuvir and ruzasvir for Hepatitis C Virus (HCV) treatment. The combination, currently in Phase 2 development, pairs a nucleotide analog polymerase inhibitor with an NS5A inhibitor.
The presentations, scheduled for November 15, will cover multiscale modeling of Phase 2 study results, cardiac repolarization effects, and resistance barrier studies. The company aims to address unmet needs in HCV treatment, particularly for patients with substance abuse disorders and comorbidities, and plans to advance to Phase 3 development following Phase 2 results later this year.
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.
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