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Atea Pharmaceuticals Announces Positive Results from Phase 2 Study of Bemnifosbuvir and Ruzasvir Regimen for Treatment of Hepatitis C Virus (HCV)
GlobeNewswire News Room· 2024-12-04 12:00
Core Insights - Atea Pharmaceuticals announced that its Phase 2 study for the treatment of hepatitis C virus (HCV) achieved a primary endpoint with a 98% sustained virologic response at 12 weeks post-treatment after an eight-week regimen [1][2] - The regimen, consisting of bemnifosbuvir and ruzasvir, was found to be generally safe and well-tolerated, with no serious adverse events reported [2][3] - Atea plans to initiate a global Phase 3 program in early 2025, following discussions with regulatory bodies [1][3] Efficacy and Safety - The per-protocol treatment adherent patient population achieved a 98% SVR12 rate (208 out of 213 patients) after eight weeks of treatment [2] - The overall efficacy evaluable population, which included 17% non-adherent patients, achieved a 95% SVR12 rate (242 out of 256 patients) [2] - Among treatment adherent patients who were non-cirrhotic and infected with genotypes 1-4, 99% achieved SVR12 [3] Treatment Population and Duration - The Phase 2 study enrolled 275 treatment-naïve patients, both with and without compensated cirrhosis [5] - Treatment adherent patients with cirrhosis achieved an 88% SVR12 rate [3] - For patients with cirrhosis, the treatment duration in the Phase 3 program will be extended to 12 weeks to maximize efficacy [3] Market Context - The HCV market remains underserved, with annual diagnoses in the U.S. outpacing treatment rates [3] - Less than 10% of the HCV patient population in the U.S. is estimated to have cirrhosis, indicating a significant opportunity for effective treatment options [3][9] Drug Profiles - Bemnifosbuvir has shown to be approximately 10-fold more active than sofosbuvir against various HCV genotypes and has a favorable pharmacokinetic profile supporting once-daily dosing [7] - Ruzasvir has demonstrated potent antiviral activity and a favorable safety profile in clinical studies, also supporting once-daily dosing [8] Future Plans - Atea is preparing for the Phase 3 program, which is expected to utilize a fixed-dose combination tablet to enhance patient convenience [4] - Full data from the Phase 2 study are anticipated to be presented at a scientific meeting in the first half of 2025 [2]
Atea Pharmaceuticals Presents Multiple New Datasets Supporting the Combination of Bemnifosbuvir and Ruzasvir for the Treatment of Hepatitis C Virus at AASLD's The Liver Meeting 2024
GlobeNewswire News Room· 2024-11-15 16:00
BOSTON, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today presented three poster presentations supporting the combination of bemnifosbuvir and ruzasvir as a potential treatment for hepatitis C virus (HCV). The combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, is in Phase ...
Atea Pharmaceuticals(AVIR) - 2024 Q3 - Earnings Call Transcript
2024-11-09 18:14
Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) Q3 2024 Results Conference Call November 7, 2024 4:30 PM ET Company Participants Jonae Barnes - SVP of Investor Relations and Corporate Communications Dr. Jean-Pierre Sommadossi - Founder, Chairman and Chief Executive Officer Dr. Janet Hammond - Chief Development Officer John Vavricka - Chief Commercial Officer Dr. Arantxa Horga - Chief Medical Officer Andrea Corcoran - Chief Financial Officer and Executive Vice President of Legal Conference Call Participants Isabell ...
Atea Pharmaceuticals(AVIR) - 2024 Q3 - Quarterly Report
2024-11-07 21:41
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-39661 Atea Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in its Charter) Delaw ...
Atea Pharmaceuticals(AVIR) - 2024 Q3 - Quarterly Results
2024-11-07 21:27
Financial Performance - Atea Pharmaceuticals reported cash, cash equivalents, and marketable securities of $482.8 million as of September 30, 2024, down from $502.2 million at June 30, 2024[12]. - Research and development expenses decreased by $2.0 million to $26.2 million for Q3 2024, primarily due to lower external spending related to the COVID-19 Phase 3 trial[13]. - General and administrative expenses decreased by $1.6 million to $11.0 million for Q3 2024, mainly due to lower professional fees[14]. - The company reported a net loss of $31.2 million for Q3 2024, compared to a net loss of $33.1 million for Q3 2023[16]. Clinical Development - Atea expects to report topline Phase 2 SVR12 results from its HCV combination study in early December 2024, with 275 treatment-naïve patients enrolled[3]. - The Phase 2 study showed a 97% SVR12 rate in non-cirrhotic patients from the lead-in cohort, with a 100% SVR12 rate in genotype 3 patients[4]. - Atea is planning an End of Phase 2 meeting with the FDA in Q1 2025 to support the initiation of the Phase 3 program[5]. - Atea is developing a fixed-dose combination tablet to reduce the daily pill count from four to two, enhancing patient convenience[6]. - The company will present new data at The Liver Meeting 2024 and the American College of Pharmacometrics meeting, showcasing the effectiveness of bemnifosbuvir and ruzasvir[7][8]. - Atea is anticipating the topline results from its Phase 2 trial of the combination of bemnifosbuvir and ruzasvir for HCV treatment[21]. - The company plans to meet with the FDA regarding the potential initiation of the HCV Phase 3 program[21]. Market Outlook - The global HCV commercial market is projected to exceed $3 billion, with the U.S. accounting for approximately half of this market[2]. Forward-Looking Statements - Atea's forward-looking statements are based on current expectations and various assumptions, which are inherently uncertain[21]. - Actual results may differ materially from the forward-looking statements due to dependence on the success of Atea's advanced product candidates[21]. - Important factors affecting actual results are discussed under the "Risk Factors" section in Atea's Quarterly Report on Form 10-Q for the quarter ended June 30, 2024[21].
Atea Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Update
GlobeNewswire News Room· 2024-11-07 21:05
Topline SVR12 Results from Global Phase 2 Hepatitis C Virus (HCV) Study (N=275) Expected Q4’24 New Data Supportive of HCV Combination to be Presented at the American Association for the Study of Liver Diseases’ (AASLD’s) The Liver Meeting 2024 Pharmacokinetic Data for Bemnifosbuvir to be Presented at American College of Pharmacometrics Meeting Conference Call at 4:30 pm ET Today BOSTON, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmac ...
Atea Pharmaceuticals to Present New Data Supporting the Combination of Bemnifosbuvir and Ruzasvir for the Treatment of Hepatitis C Virus at AASLD's The Liver Meeting 2024
GlobeNewswire News Room· 2024-10-30 11:00
BOSTON, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) ("Atea"), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced three upcoming poster presentations supporting the combination of bemnifosbuvir and ruzasvir as a potential treatment for Hepatitis C Virus (HCV). The combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, is ...
New Strong Buy Stocks for October 16th
ZACKS· 2024-10-16 14:01
Here are five stocks added to the Zacks Rank #1 (Strong Buy) List today:Clipper Realty Inc. (CLPR) : This real estate company has seen the Zacks Consensus Estimate for its current year earnings increasing 43.6% over the last 60 days.REE Automotive Ltd. (REE) : This automotive technology company has seen the Zacks Consensus Estimate for its current year earnings increasing 46.3% over the last 60 days.Harmony Gold Mining Company Limited (HMY) : This gold-mining company has seen the Zacks Consensus Estimate fo ...
Atea Pharmaceuticals (AVIR) Loses -8.01% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner
ZACKS· 2024-10-04 14:37
Atea Pharmaceuticals, Inc. (AVIR) has been on a downward spiral lately with significant selling pressure. After declining 8% over the past four weeks, the stock looks well positioned for a trend reversal as it is now in oversold territory and there is strong agreement among Wall Street analysts that the company will report better earnings than they predicted earlier.Guide to Identifying Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whet ...
Are Medical Stocks Lagging Atea Pharmaceuticals (AVIR) This Year?
ZACKS· 2024-08-28 14:46
For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Has Atea Pharmaceuticals, Inc. (AVIR) been one of those stocks this year? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Atea Pharmaceuticals, Inc. is a member of our Medical group, which includes 1017 different companies and currently sits at #5 in the Zacks Sector Rank. The Zacks ...