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Atea Pharmaceuticals, Inc. (AVIR)

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Previous Close63.04
Open62.17
Bid0.00 x 1800
Ask0.00 x 1200
Day's Range57.37 - 62.51
52 Week Range24.15 - 94.17
Volume874,053
Avg. Volume344,416
Market Cap4.955B
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1y Target Est49.00
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    • GlobeNewswire

      Atea Pharmaceuticals Presents Favorable Phase 1 Results for AT-527 at 28th Annual Conference on Retroviruses and Opportunistic Infections

      High Lung Levels of Active Triphosphate Predicted with Oral AT-527 for COVID-19 Patients Data Supportive of AT-527 550 mg BID Dosing Regimen BOSTON, March 06, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today presented results from the Phase 1 study of AT-527 in healthy volunteers at the 28th Annual Conference on Retroviruses and Opportunistic Infections (CROI) in a Science Spotlight presentation. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea’s purine nucleotide prodrug platform and is in Phase 2 clinical development for the treatment of COVID-19. AT-527 targets SARS-CoV-2 ribonucleic acid (RNA) polymerase (nsp12), a highly conserved gene which is responsible for both viral RNA replication and transcription. Given this preferential conserved target site, it is anticipated that the antiviral activity of AT-527 will continue even in the presence of naturally-evolving variants which are now emerging. “We were delighted to present these encouraging results at CROI. Since the respiratory tract is the initiation site of the SARS-CoV-2 infection, these data demonstrate the potential for AT-527, our oral antiviral, to have meaningful clinical uptake in the lungs. Specifically, the data demonstrating rapid attainment of steady state with a fast build-up of trough levels enables us to predict that there should be exposure of drug in the lung above levels that are needed to inhibit viral replication,” said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals. “In addition, these results show that AT-527 was well tolerated with a favorable safety and pharmacokinetic profile and are supportive of the dosing regimen for the upcoming Phase 3 program.” In the Phase 1 study, 20 healthy volunteers were randomized 1:1 to receive oral AT-527 550 mg twice daily (BID) or matching placebo for 5 days. The purpose of this study was to assess the safety and pharmacokinetics (PK) of AT-527 in healthy volunteers and to predict human lung exposure of intracellular AT-9010, the active triphosphate (TP) metabolite of AT-527. Safety assessments included adverse events (AEs), vital signs, electrocardiograms (ECGs), and standard safety laboratory tests. Intensive PK sampling, performed after the first and last two doses, provided information on plasma exposures of AT-511, the free base of AT-527, a hemisulfate salt, and its metabolites including AT-273, the guanosine nucleoside metabolite, a measurable surrogate for intracellular AT-9010. The study results showed AT-527 was well tolerated with a favorable safety profile. There were no discontinuations, serious AEs, clinically significant changes in vital signs, or ECGs observed. The data also demonstrated that AT-511 was rapidly absorbed, followed by fast and extensive stepwise metabolic activation ultimately to the intracellular TP metabolite AT-9010, reflected by plasma AT-273. AT-527 550 mg BID led to fast attainment of steady-state levels of AT-273 within two days of dosing. Plasma levels of AT-273 were further used to predict lung concentrations of AT-9010 using a scaling factor of 1.2X which was previously determined from in vivo tissue distribution of the triphosphate metabolite in cynomolgus monkeys. Beginning as early as three hours after the first dose, and maintained thereafter throughout the five days of dosing, predicted lung AT-9010 levels were consistently above the EC90 level of 0.5 µM for in vitro inhibition by the drug of SARS-CoV-2 replication. These results indicate the potential of AT-527 for the treatment of COVID-19 and are supportive of the dosing regimen of 550 mg BID. About AT-527 AT-527 is an orally administered, direct-acting developmental antiviral agent derived from Atea’s nucleotide prodrug platform. AT-527 is currently under evaluation as a treatment for patients with COVID-19. In collaboration with Roche, AT-527 is currently being evaluated in a global Phase 2 study for hospitalized patients with moderate COVID-19 and a Phase 2 virology study in patients with mild or moderate COVID-19 in an outpatient setting. A pivotal Phase 3 trial is planned in the outpatient setting. A direct-acting antiviral aims to prevent disease progression by minimizing or eliminating viral replication and thereby reducing the severity of the disease, preventing or shortening hospitalization, and also potentially preventing transmission of the virus to others. This makes it well suited for potential use in both pre- and post-exposure prophylactic settings and complementary to vaccines. About Atea Pharmaceuticals Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing, and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company’s deep understanding of antiviral drug development, nucleoside biology, and medicinal chemistry, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com. Contacts Investors: Jonae BarnesSVP, Investor Relations and Corporate Communications617-818-2985Barnes.jonae@ateapharma.com Will O’ConnorStern Investor Relations 212-362-1200will.oconnor@sternir.com Media: Carol Guaccero301-606-4722contactus@ateapharma.com

    • GlobeNewswire

      Atea Pharmaceuticals Announces Chugai In-License of AT-527 from Roche for the Treatment of COVID-19 in Japan

      Chugai obtains exclusive development and marketing rights for AT-527 in Japan from Roche, who has ex-US rights for the treatment of COVID-19BOSTON, Feb. 19, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today announced that Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) has in-licensed the rights for AT-527 for the treatment of COVID-19 in Japan from Roche (SIX: RO, ROG; OTCQX: RHHBY). Under a strategic collaboration, Roche and Atea are jointly developing AT-527 for the treatment of COVID-19 and Roche has the right to commercialize AT-527 outside of the United States. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea’s purine nucleotide prodrug platform and is in Phase 2 development for the treatment of COVID-19. “This agreement between Roche and Chugai underscores a commitment to global accessibility of AT-527 to fight COVID-19 and accelerates its entry into this important Asian market,” said Jean-Pierre Sommadossi, Ph.D., Founder and Chief Executive Officer of Atea Pharmaceuticals. “We are delighted that Chugai, who is closely aligned with Roche through a strategic alliance, will undertake this important work, as they have commercial and development expertise and are a market leader in Japan.” Atea and Roche announced a strategic collaboration on October 22, 2020. The collaboration aims to accelerate the clinical development and manufacturing of AT-527, to investigate its safety and efficacy, and to provide this potential treatment option to patients around the world as quickly as possible. About AT-527 AT-527 is an orally administered, direct-acting developmental antiviral agent derived from Atea’s nucleotide prodrug platform. AT-527 is currently under evaluation as a treatment for patients with COVID-19. In collaboration with Roche, AT-527 is currently being evaluated in a global Phase 2 study for hospitalized patients with moderate COVID-19 and a Phase 2 virology study in patients with mild or moderate COVID-19 in an outpatient setting. A pivotal Phase 3 trial is planned in the outpatient setting. A direct-acting antiviral aims to prevent disease progression by minimizing or eliminating viral replication and thereby reducing the severity of the disease, preventing or shortening hospitalization, and also potentially preventing transmission of the virus to others. This makes it well suited for potential use in both pre- and post-exposure prophylactic settings and complementary to vaccines. About Atea Pharmaceuticals Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company’s deep understanding of antiviral drug development, nucleoside biology, and medicinal chemistry, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com. Contacts Investors: Jonae BarnesSVP, Investor Relations and Corporate Communications617-818-2985Barnes.jonae@ateapharma.com Will O’ConnorStern Investor Relations 212-362-1200will.oconnor@sternir.com Media:Carol Guaccero301-606-4722contactus@ateapharma.com

    • The Daily Biotech Pulse: Dynavax Poaches GSK Vaccine Exec, KalVista Jumps On Data Readout, Corcept Issues Negative Preannouncement
      Benzinga

      The Daily Biotech Pulse: Dynavax Poaches GSK Vaccine Exec, KalVista Jumps On Data Readout, Corcept Issues Negative Preannouncement

      Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Feb. 9) Abbott Laboratories (NYSE: ABT) AEterna Zentaris Inc. (NASDAQ: AEZS) Alkermes Plc (NASDAQ: ALKS) AngioDynamics, Inc. (NASDAQ: ANGO) Anixa Biosciences Inc (NASDAQ: ANIX) Antares Pharma Inc (NASDAQ: ATRS) Applied Molecular Transport Inc. (NASDAQ: AMTI) Arcus Biosciences Inc (NYSE: RCUS) AtriCure Inc. (NASDAQ: ATRC) aTyr Pharma Inc (NASDAQ: LIFE) Beam Therapeutics Inc (NASDAQ: BEAM) Bioatla Inc (NASDAQ: BCAB) BioLineRx ADR Representing 15 Ord Shs (NASDAQ: BLRX) Bolt Biotherapeutics Inc (NASDAQ: BOLT) (went public Friday) BridgeBio Pharma Inc (NASDAQ: BBIO) C4 Therapeutics Inc (NASDAQ: CCCC) Castle Biosciences Inc (NASDAQ: CSTL) Celldex Therapeutics, Inc. (NASDAQ: CLDX) ChemoCentryx Inc (NASDAQ: CCXI) Chimerix Inc (NASDAQ: CMRX) Collplant Biotechnologies Ltd – ADR (NASDAQ: CLGN) - announced an exclusive development and commercialization agreement for dermal and soft tissue filler products with AbbVie Inc's (NYSE: ABBV) Allergan Corcept Therapeutics Incorporated (NASDAQ: CORT) DarioHealth Corp (NASDAQ: DRIO) DermTech Inc (NASDAQ: DMTK) Dicerna Pharmaceuticals Inc (NASDAQ: DRNA) Edap Tms SA (NASDAQ: EDAP) Enlivex Therapeutics Ltd (NASDAQ: ENLV) Eton Pharmaceuticals Inc (NASDAQ: ETON) (announced sale of neurology portfolio) Evaxion Biotech A/S – ADR (NASDAQ: EVAX) (went public Friday) Evogene Ltd (NASDAQ: EVGN) FibroGen Inc (NASDAQ: FGEN) Frequency Therapeutics Inc (NASDAQ: FREQ) Fulgent Genetics Inc (NASDAQ: FLGT) G1 Therapeutics Inc (NASDAQ: GTHX) Genetron Holdings Ltd – ADR (NASDAQ: GTH) Genprex Inc (NASDAQ: GNPX) (announced formation of clinical advisory board to support its oncology and diabetes programs) Halozyme Therapeutics, Inc. (NASDAQ: HALO) Harvard Bioscience, Inc. (NASDAQ: HBIO) Horizon Therapeutics PLC (NASDAQ: HZNP) Ideaya Biosciences Inc (NASDAQ: IDYA) (announced regulatory nod to commence Phase 1 study of IDE397) Immunocore Holdings PLC – ADR (NASDAQ: IMCR) (went public Friday) ImmunoGen, Inc. (NASDAQ: IMGN) Inari Medical Inc (NASDAQ: NARI) Infinity Pharmaceuticals Inc. (NASDAQ: INFI) Inspire Medical Systems Inc (NYSE: INSP) Intra-Cellular Therapies Inc (NASDAQ: ITCI) iTeos Therapeutics Inc (NASDAQ: ITOS) Jounce Therapeutics Inc (NASDAQ: JNCE) Karuna Therapeutics Inc (NASDAQ: KRTX) Ligand Pharmaceuticals Inc. (NASDAQ: LGND) Lucira Health Inc (NASDAQ: LHDX) (went public Friday) Medpace Holdings Inc (NASDAQ: MEDP) MEI Pharma Inc (NASDAQ: MEIP) Meridian Bioscience, Inc. (NASDAQ: VIVO) MiMedx Group Inc (NASDAQ: MDXG) Misonix Inc (NASDAQ: MSON) Moderna Inc (NASDAQ: MRNA) Morphic Holding Inc (NASDAQ: MORF) Nantkwest Inc (NASDAQ: NK) Neubase Therapeutics Inc (NASDAQ: NBSE) Novan Inc (NASDAQ: NOVN) Novavax, Inc. (NASDAQ: NVAX) (capitalized on momentum ahead of key catalytic events) Ocugen Inc (NASDAQ: OCGN) (priced a registered direct offering at a 45.7% premium) Opiant Pharmaceuticals Inc (NASDAQ: OPNT) (announced initiation of a confirmatory pharmacokinetic study for opioid overdose treatment OPNT003) Organogenesis Holdings Inc (NASDAQ: ORGO) Outlook Therapeutics Inc (NASDAQ: OTLK) (jumped on insider buying) Paratek Pharmaceuticals Inc (NASDAQ: PRTK) (announced expansion of commercial promotion of its antibiotic Nuzyra into community setting) Profound Medical Corp (NASDAQ: PROF) Prothena Corporation PLC (NASDAQ: PRTA) Pulse Biosciences Inc (NASDAQ: PLSE) Purple Biotech ADR (NASDAQ: PPBT) Qiagen NV (NYSE: QGEN) Radius Health Inc (NASDAQ: RDUS) Renalytix AI PLC (NASDAQ: RNLX) Rocket Pharmaceuticals Inc (NASDAQ: RCKT) Salarius Pharmaceuticals Inc (NASDAQ: SLRX) Seelos Therapeutics Inc (NASDAQ: SEEL) Sesen Bio Inc (NASDAQ: SESN) SI-Bone Inc (NASDAQ: SIBN) Silence Therapeutics ADR Representing 3 Ord Shs (NASDAQ: SLN) Summit Therapeutics Inc (NASDAQ: SMMT) Sutro Biopharma Inc (NASDAQ: STRO) Synlogic Inc (NASDAQ: SYBX) T2 Biosystems Inc (NASDAQ: TTOO) Terns Pharmaceuticals Inc (NASDAQ: TERN) (went public Friday) Translate Bio Inc (NASDAQ: TBIO) Trinity Biotech plc (NASDAQ: TRIB) Turning Point Therapeutics Inc (NASDAQ: TPTX) Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) Veracyte Inc (NASDAQ: VCYT) Vericel Corp (NASDAQ: VCEL) Veru Inc (NASDAQ: VERU) (announced positive results for a Phase 2 study of VERU-111 in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome) Xencor Inc (NASDAQ: XNCR) Xeris Pharmaceuticals Inc (NASDAQ: XERS) ZIOPHARM Oncology Inc. (NASDAQ: ZIOP) Down In The Dumps (Biotech Stocks Hitting 52-week Lows Feb. 9) Angion Biomedica Corp (NASDAQ: ANGN) (went public Friday) Stocks In Focus Dynavax Appoints GSK Veteran Dong Yu To Lead Vaccine Program Dynavax Technologies Corporation (NASDAQ: DVAX) announced the appointment of Dong Yu as senior vice president of vaccine research and a member of the executive team. Yu, a former GlaxoSmithKline plc (NYSE: GSK) executive, will be responsible for Dynavax's vaccine programs and technology platforms, building and maintaining a pipeline for long-term company growth. Yu has years of experience at GlaxoSmithKline's vaccine unit. The move comes just after Clover, which was working on a COVID-19 vaccine combined with adjuvants from both Dynavax and GlaxoSmithKline, decided to move ahead with only Dynavax's adjuvant. Dynavax shares were down 0.98% premarket at $11.07. Navidea Gains After FDA Grants Type B Meeting to Discuss Rheumatoid Arthritis Study Navidea Biopharmaceuticals Inc (NYSE: NAVB) said it has submitted its formal Type B meeting request to the FDA and that the FDA has granted the Type B meeting and requested submission of the Briefing Book. The FDA will now review Navidea's formal briefing documents containing results from the NAV3-31 Phase 2b study and the proposed Phase 3 design and protocol. The NAV3-31 study is evaluating the precision and sensitivity of Tilmanocept Uptake Value on Tc 99m planar imaging in rheumatoid arthritis patients. Navidea said it expects formal feedback from the FDA within the next several months and a potential launch of the pivotal Phase 3 study in the second quarter of 2021. The stock was climbing 7.83% to $3.03 in premarket trading Tuesday. Related Link: The Week Ahead In Biotech (Feb. 7-13): Regeneron FDA Decision, Earnings, IPOs and Conference Presentations In The Spotlight Ironwood CEO to Depart Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced that Mark Mallon plans to step down as chief executive officer and a member of the board in order to pursue another leadership opportunity, effective March 12. The company named Thomas McCourt, Ironwood's president, as interim CEO effective upon Mallon's departure. The company also said it plans to initiate a candidate search. The stock was rallying by 12.76% to $12.02 premarket. KalVista's Hereditary Angioedema Drug Aces Midstage Study KalVista Pharmaceuticals Inc (NASDAQ: KALV) announced positive topline data from a Phase 2 clinical trial demonstrating statistically and clinically significant efficacy of KVD900 as an oral on-demand treatment for hereditary angioedema attacks. The shares were jumping 220.69% to $50.06 premarket Tuesday. AzurRx To Work With PPD For Phase 2 COVID-19 Study AzurRx BioPharma Inc (NASDAQ: AZRX) said it has entered into an agreement with contract research organization PPD Inc (NASDAQ: PPD) for its planned Phase 2 clinical trial evaluating a proprietary formulation of micronized niclosamide as a treatment for COVID-19-associated gastrointestinal infections. View more earnings on IBB In premarket trading Tuesday, AzurRx shares were rallying 28.4% to $2.17. Collegium to Join S&P SmallCap 600 Index Standard & Poor's announced that Collegium Pharmaceutical Inc (NASDAQ: COLL) will be added to the S&P SmallCap 600 Index, effective Feb. 12. The stock was up 11.9% to $26.52 in premarket trading Tuesday. Atea Announces Publication Of Positive Preclinical Data For COVID-19 Treatment Atea Pharmaceuticals Inc (NASDAQ: AVIR) announced the publication of new data highlighting the highly potent in vitro antiviral activity of AT-527 against SARS-CoV-2, the virus that causes COVID-19. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea's purine nucleotide prodrug platform. "These new data underscore AT-527's potential to treat COVID-19 and to have an impact on global health," said Jean-Pierre Sommadossi, CEO of Atea. Earnings Corcept Therapeutics announced preliminary fourth-quarter revenue of $85.7 million, lower than $87.9 million in the year-ago quarter, and GAAP EPS of 20 cents. Analysts, on average, estimate revenues of $90.63 million. For the full year 2020, the company expects revenue of $353.9 million, below the consensus estimate of $358.48 million. The company guided 2021 revenue to $375 million to $405 million, surrounding the consensus estimate of $403.17 million. In premarket trading Tuesday, the stock was retreating 8.38% to $28. Offerings Geovax Labs Inc (NASDAQ: GOVX) said it has entered into an underwriting agreement with Maxim Group, under which the underwriter has agreed to purchase 1.44 million shares of common stock of the company, at a price to the public of $6.25 per share. The gross proceeds from the offering are expected to be approximately $9 million. The stock was slipping 8.96% to $6.81 in premarket trading Tuesday. Autolus Therapeutics PLC (NASDAQ: AUTL) said it has commenced an underwritten public offering of up to $100 million in American depository shares, with each ADS representing one ordinary share. All shares to be sold in the proposed offering will be offered by Autolus. In premarket trading, the stock was down 1.16% at $8.53. On The Radar Clinical Readouts Orchard Therapeutics PLC – ADR (NASDAQ: ORTX) is scheduled to present at the 17th Annual WORLDSymposium with updated Phase 1/2 data for ex-vivo autologous stem cell gene therapy for mucopolysaccharidosis type IIIA and Phase 1/2 data for ex vivo hematopoietic stem cell gene therapy for mucopolysaccharidosis type I. Gamida Cell Ltd (NASDAQ: GMDA) will present at the Transplantation and Cellular Therapy meeting with results of the Phase 1 study of omidubicel versus standard myeloblative umbilical cord blood transplantation in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. Magenta Therapeutics Inc (NASDAQ: MGTA) is due to present at the TCT meeting Phase 1 data for MGTA-145, in combination with plerixafor. Earnings: Incyte Corporation (NASDAQ: INCY) (before the market open) Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) (before the market open) SurModics, Inc. (NASDAQ: SRDX) (before the market open) Related Link: Attention Biotech Investors: Mark Your Calendar For February PDUFA Dates See more from BenzingaClick here for options trades from BenzingaThe Week Ahead In Biotech (Feb. 7-13): Regeneron FDA Decision, Earnings, IPOs and Conference Presentations In The SpotlightThe Daily Biotech Pulse: J&J Files For COVID-19 Vaccine Approval, Zimmer Biomet's Spin-Off, IPO Deluge Hits Street© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.