COVID-19

Akston Biosciences Doses First Subjects in Phase II Clinical Trial of Second-Generation Protein Subunit COVID-19 Vaccine

08/12/2021

Excerpt from the Press Release: BEVERLY, Mass.–(BUSINESS WIRE)–Akston Biosciences Corporation, a developer of new classes of biologic therapeutics, announced today that the first participants have been dosed in a Phase II open-label trial of AKS-452, its protein subunit COVID-19 vaccine candidate. Fifty-two volunteers will receive either one- or two-dose regimens as part of the Phase II…

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Vaxart stock soars after FDA approves IND application for oral COVID-19 vaccine tablet

08/07/2021

Excerpt from the Press Release: Vaxart (NSDQ:VXRT) announced today that the FDA cleared the investigational new drug (IND) application for its oral COVID-19 vaccine. Upon news of the IND application approval for the S-only protein construct-based vaccine candidate, shares of VXRT were up 16.1% at $8.35 in early-morning trading today. Click the button below to read…

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NIH Advances ACTIV-5/BET-B Trial Evaluating Lenzilumab from a Phase 2 Exploratory Study to a Phase 2/3 Study for the Treatment of COVID-19

08/06/2021

Excerpt from the Press Release: BURLINGAME, Calif.–(BUSINESS WIRE)–Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company developing a first-in-class GM-CSF neutralizing antibody to prevent and treat an immune hyper-response called ‘cytokine storm’ across multiple therapeutic indications, has announced that the NIH has advanced the ACTIV-5/BET-B study to a Phase 2/3 study and modified the primary…

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FDA Clears Vaxart’s IND Application for S-Only Oral Tablet COVID-19 Vaccine Candidate

08/06/2021

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Aug. 2, 2021 /PRNewswire/ — Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines administered by tablet, announced today that the U.S. Food and Drug Administration has cleared Vaxart’s Investigational New Drug application for an S-only oral tablet SARS-CoV-2 vaccine candidate. “This is great news because it allows us to move forward…

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Sorrento Announces Dosing of COVID-19 Patients in Phase 2 Clinical Trial for COVIDROPS, a Highly Potent Neutralizing Antibody Against SARS-CoV-2 Including Delta and Alpha Variants of Concern, in an At-Home Outpatient Setting in United Kingdom

08/06/2021

Excerpt from the Press Release: SAN DIEGO, July 21, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced that COVID-19 patients have been dosed in its Phase 2 efficacy trial. Approximately 350 outpatients with COVID-19 who are asymptomatic or have mild symptoms will be enrolled in this large double-blind, randomized clinical trial evaluating COVIDROPS doses of…

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Echocardiography Can Determine Mortality Risk in COVID-19 Patients

08/03/2021

Excerpt from the Press Release: Echocardiography parameters and ARDS linked to higher mortality risk for hospitalized patients. Transthoracic echocardiography (TTE) plays a role in pinpointing the risk a COVID-19-positive patient has of dying. In a study published July 21 in the European Journal of Clinical Investigation, a team of investigators from Italy determined that left ventricular ejection…

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Meissa Announces Preclinical Data on Intranasal COVID-19 Vaccine Showing Protection from SARS-CoV-2 Challenge after a Single Dose

07/30/2021

Excerpt from the Press Release: REDWOOD CITY, Calif.–(BUSINESS WIRE)–Meissa Vaccines (“Meissa”), a biotechnology company developing vaccines to prevent serious viral respiratory infections, announced today the release of preclinical data in nonhuman primates (NHPs) of the company’s intranasal recombinant live attenuated COVID-19 vaccine (MV-014-212). The data demonstrate that a single adjuvant-free dose of MV-014-212 provided equivalent protection against SARS-CoV-2…

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Selva to Present Preclinical Data at ASV 2021 Demonstrating Prophylactic and Therapeutic Oral Dosing of SLV213 for COVID-19 Protected Lungs from SARS-CoV-2-Induced Damage

07/28/2021

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Selva Therapeutics, Inc. (“Selva”) announced new preclinical data demonstrating SLV213, when given as a prophylactic or a treatment for SARS-CoV-2 infection, protects against SARS-CoV-2-induced diffuse alveolar damage (DAD), which is associated with the early stages of acute respiratory distress syndrome (ARDS). Additional in vitro data show that SLV213 greatly enhances the…

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Ocugen, Inc. Announces Initiation of Rolling Submission to Health Canada for COVAXIN™

07/26/2021

Excerpt from the Press Release: MALVERN, Pa., July 15, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that it had initiated a rolling submission to Health Canada for COVAXIN™, the company’s candidate…

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Qualigen Therapeutics, Inc. Announces Submission of Investigational New Drug (IND) Application for QN-165, for the Treatment of COVID-19

07/26/2021

Excerpt from the Press Release: CARLSBAD, Calif., July 14, 2021 (GLOBE NEWSWIRE) — Qualigen Therapeutics, Inc. (NASDAQ: QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, announced today the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Qualigen’s…

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