COVID-19 Related Opportunities - OraSure has multiple near-term COVID-19 opportunities, including two oral fluid self-collection devices for molecular testing that have received EUAs and CE-IVD marks[3] - The company is pursuing EUA for a lab-based oral fluid antibody test and developing a rapid antigen self-test[3] - OraSure is expanding manufacturing capacity to meet anticipated demand for COVID-19 tests, aiming to reach 55 million total tests per year by Q1 2021 and 70 million total tests per year by Q3 2021[28] - The company aims to increase total capacity for all molecular collection kits to 75 million units per year by Q2 2021 and 80 million kits per year by Q3 2021[29] - OraSure is also expanding capacity for Sars-Cov-2 Oral Fluid Antibody Tests from 10 million units per year to 20 million tests per year by Q4 2021[29] HIV Self-Testing - 21% of the 38 million people with HIV do not know their status, highlighting the need for accessible testing[32] - OraSure is the international HIV self-test market share leader with oral fluid self-collection and in-home results[33] - The Plan for America continues with $267 million in FY 2020 funding and a meaningful increase proposed for FY 2021 to end the HIV epidemic[35] Other Growth Drivers - Market leading microbiome products and services offer tremendous growth potential[3] - The company has $263.7 million in cash on the balance sheet with no debt, supporting ongoing business development activities[3] - Multiple research reports project mid-teens growth for the microbiome market from 2019-2024[39]

Attractive safety profile demonstrated across all dosing cohorts and routes of administration (IV, SC, and IM); all reported adverse events (AEs) deemed unrelated or classified as mild to moderate and largely related to injection site and infusion reactions with no serious or severe adverse events observedFollowing a single dose, serum concentrations of VYD2311 remained high at six months with an observed half-life of the IM dose route having the longest duration at 76.0 (CI: 68.5 – 90.7) days Comprehensive ...

EARNINGS RELEASE & FINANCIAL SUPPLEMENT Second Quarter 2021 Financial Supplement Second Quarter 2021 Table of Contents | Overview | PAGE | | --- | --- | | Corporate Profile | 3 | | Earnings Release | 5 | | Selected Quarterly Financial Data | 16 | | Financial Information | | | Condensed Consolidated Balance Sheets | 18 | | Condensed Consolidated Statements of Operations | 19 | | Reconciliation of Net (Loss) Income to NAREIT FFO, Core FFO and AFFO | 20 | | Reconciliation of Net (Loss) Income to EBITDA, NAREIT ...

- Study will assess relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA comparator at 12 months - SOUTH SAN FRANCISCO, Calif., May 27, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced the first patient was dosed in the 10,000-participant portion of its ongoing Phase 2b clinical trial evaluating its oral pill COVID-19 vaccine candidate. “Initiating dosing in the 10,000-participant portion of this study is a significant st ...

Moderna (MRNA) announced that it has submitted a regulatory filing with the FDA seeking approval for an updated version of its COVID-19 vaccine Spikevax, designed to target the LP.8.1 variant of the virus.The submission is based on guidance from the FDA issued last week, which advised vaccine-makers to update their COVID-19 shots to target strains that are part of the JN.1 lineage, with a preference for the LP.8.1 variant. Per the latest CDC data, LP.8.1 currently accounts for about 70% of total cases in th ...

WALTHAM, Mass., May 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), today announced that PEMGARDA® (pemivibart), its investigational monoclonal antibody, has been added to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas. NCCN joins the Infectious Disease Society of America (IDSA) that updated its COVID-19 guidelines in August 2024 to recommend the use of PEMGARDA (pemivibart) for pre-exposure prophylaxis (PrEP) in moderately to seve ...

FDA acknowledges that the benefit of repeat doses of COVID-19 vaccine boosters for Americans is uncertain; the updated regulatory framework for COVID-19 vaccines articulated by the Agency generally aligns with recent Invivyd Citizen Petition requestsIn contrast to vaccine boosters, monoclonal antibody (mAb) therapies, including pemivibart, underwent contemporary randomized, placebo-controlled trials to evaluate safety, immunogenicity, and exploratory efficacy in relevant, modern Americans, against relevant, ...

Group 1 - Real estate investment trusts (REITs) have shown increased volatility since the onset of COVID-19, initially experiencing a significant decline alongside other asset classes [1] - Following the initial downturn, the REIT sector has seen a notable recovery [1] Group 2 - Roberts Berzins has over ten years of experience in financial management, focusing on helping top-tier corporates with financial strategies and large-scale financings [1] - Berzins has contributed to institutionalizing the REIT framework in Latvia to enhance liquidity in pan-Baltic capital markets [1] - His policy-level work includes developing national state-owned enterprise (SOE) financing guidelines and frameworks for channeling private capital into affordable housing [1]

Shares of Novavax (NVAX) surged nearly 26% in pre-market trading today after its protein-based COVID-19 vaccine, Nuvaxovid, received the long-awaited approval from the FDA, albeit with a narrower label than initially expected.FDA’s Conditions on NVAX’s COVID-19 JabWhile the agency granted full approval to Nuvaxovid for use in older adults aged 65 and above, it restricted the vaccine’s use in individuals aged 12-64 with at least one underlying condition that puts them at high risk for severe outcomes from CO ...

Biotech stock Novavax Inc (NASDAQ:NVAX) is skyrocketing today, up 26% at $8.48 at last glance, after the U.S. Food & Drug Administration (FDA) approved the company's COVID-19 vaccine. The shot, Nuvaxovid, differs from the others in that it is protein-based, not mRNA-based, and is designed for those between the ages of 12 and 64 who have underlying conditions that put them at greater risk due to the illness. Should these gains hold, NVAX will mark its highest single-day percentage gain since last May. Jumpin ...