ClinicalTrials
Excerpt from the Press Release: RADNOR, Pa.–(BUSINESS WIRE)–Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of its lead product candidate ganaxolone, to treat seizures…
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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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Excerpt from the Press Release: PLEASANTON, Calif. & NANJING, China & SHANGHAI–(BUSINESS WIRE)–IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company advancing the development of novel cell therapies for cancer, today announced the clearance from China’s National Medical Products Administration (NMPA) of two Initial New Drug (IND) applications for CT120, the company’s in-house developed fully human CD19/CD22…
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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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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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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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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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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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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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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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