News & Updates

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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Seres Therapeutics Announces Topline Results for SER-287 Phase 2b Study in Mild-to-Moderate Ulcerative Colitis

08/06/2021

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced topline results from the Phase 2b ECO-RESET study evaluating SER-287 in patients with mild-to-moderate ulcerative colitis (UC). The study did not meet its primary endpoint of improving clinical remission rates compared to placebo. Both dosing regimens of…

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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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EUREKA THERAPEUTICS ANNOUNCES INITIATION OF PHASE I/II ARYA-3 CLINICAL TRIAL OF GPC3 TARGETING ARTEMIS® T CELL THERAPY IN LIVER CANCER

08/06/2021

Excerpt from the Press Release: Emeryville, California, July 21, 2021 — Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T cell therapies to treat solid tumors, today announced the initiation of a Phase I/II clinical trial of ECT204, a GPC3 targeting ARTEMIS® T-cell therapy for the treatment of hepatocellular carcinoma (HCC), the predominant type of…

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Radicle Science Launches Largest Longitudinal Real World Evidence Study to Determine Effectiveness of CBD Products

08/06/2021

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Radicle Science, a transformative healthtech B-corp validating natural products for the first time, announces the launch of the Radicle ACES (Advancing CBD Education and Science) study. Using a virtual, direct to consumer (D2C) approach, Radicle ACES is the largest and most comprehensive randomized controlled trial (RCT) of its…

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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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Prometheus Biosciences Announces Initiation of Global Phase 2 Clinical Trial of PRA023 in Moderate-to-Severe Ulcerative Colitis (UC)

08/05/2021

Excerpt from the Press Release: SAN DIEGO, July 19, 2021 (GLOBE NEWSWIRE) — Prometheus Biosciences, Inc. (Nasdaq: RXDX), a biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD), today announced the…

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Vertex Initiates Phase 2 Clinical Trial Program for VX-548 for the Treatment of Acute Pain

08/05/2021

Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has begun a Phase 2 proof-of-concept (POC) study in acute pain following bunionectomy surgery with the selectiveNaV1.8 inhibitor VX-548 and that it expects to commence a second Phase 2 study in acute pain following abdominoplasty surgery in the coming weeks. “Based…

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Advaxis Announces Initiation of Phase 1 Clinical Trial of ADXS-504 for the Treatment of Early Prostate Cancer

08/05/2021

Excerpt from the Press Release: MONMOUTH JUNCTION, N.J., July 15, 2021 (GLOBE NEWSWIRE) — Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, today announced the initiation of its Phase 1 clinical study evaluating ADXS-504 in patients with biochemically recurrent prostate cancer. The study, being conducted at…

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Pear Therapeutics Reports Nine-Month Real-World Healthcare Utilization Data for reSET-O®

08/04/2021

Excerpt from the Press Release: BOSTON & SAN FRANCISCO–(BUSINESS WIRE)–Pear Therapeutics, Inc. today announced results from an extended retrospective analysis of real-world data analyzing healthcare resource utilization for reSET-O®, the first and only FDA-authorized Prescription Digital Therapeutic (PDT) for the treatment of opioid use disorder (OUD). Results from a nine-month real-world data analysis show a continued…

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