Direct Biologics LLC
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11 articles about Direct Biologics LLC
Direct Biologics Announces Publication of Significant Survival Benefit with ExoFlo™ in its Phase 2 Randomized Controlled Clinical Trial in the Journal CHEST
Direct Biologics Announces Publication of Significant Survival Benefit with ExoFlo ™ in its Phase 2 Randomized Controlled Clinical Trial in the Journal CHEST.
Direct Biologics Receives FDA Clearance to Initiate Phase 1b/2a Clinical Trial of ExoFlo™ in Patients with Medically Refractory Perianal Fistulizing Crohn’s Disease
Direct Biologics, LLC announces U.S. Food and Drug Administration (FDA) clearance of the Company’s investigational new drug (IND) application for a Phase 1b/2a clinical trial to evaluate the safety and efficacy of ExoFlo™ for the treatment of medically refractory perianal fistulizing Crohn’s disease (CD).
Direct Biologics Reports Compelling Data as ExoFlo™ Expanded Access Program in Hospitalized COVID-19 Patients with Moderate-to-Severe ARDS Surpasses 100 Subjects
Direct Biologics Reports Compelling Data as ExoFlo ™ Expanded Access Program in Hospitalized COVID-19 Patients with Moderate-to-Severe ARDS Surpasses 100 Subjects.
Direct Biologics Announces FDA Authorization to Expand Ongoing Phase 3 Clinical Study of ExoFlo™ to All-Cause Moderate-to-Severe ARDS
Direct Biologics, LLC, a late-stage biotechnology company leveraging its regenerative medicine platform using extracellular vesicles (EVs) secreted from bone marrow-derived mesenchymal stem cells to address multiple disease indications, announces that the U.S. Food and Drug Administration (FDA) has authorized the expansion of its pivotal Phase 3 EXTINGUISH ARDS trial to evaluate the safety and efficacy of ExoFlo™.
Direct Biologics Announces First Patient Dosed with ExoFlo™ in a Phase 1 Clinical Trial for Medically Refractory Ulcerative Colitis
Direct Biologics, LLC announces that the first patient has been dosed in its Phase 1 clinical trial evaluating ExoFlo™ for the treatment of patients with medically refractory ulcerative colitis (UC).
Direct Biologics Announces Initiation of Phase 1 Clinical Trial for Medically Refractory Crohn’s Disease
Direct Biologics, LLC announced it has dosed the first patient in its Phase 1 clinical trial evaluating ExoFlo ™ for the treatment of patients with medically refractory Crohn’s disease.
Direct Biologics Reports Compelling Results From Phase 2 Trial With ExoFlo™ in Hospitalized Patients With Respiratory Failure or Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19
Direct Biologics, LLC announced favorable safety, dosing and efficacy results from its Phase 2 clinical trial of ExoFlo™ in hospitalized adult COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS).
Direct Biologics, LLC, a late-stage biotechnology company leveraging its regenerative medicine platform using extracellular vesicles derived from bone marrow mesenchymal stem cells, announces the appointment of Amy Lightner, M.D. as Chief Medical Officer.
FDA Approves Direct Biologics to Proceed with a Landmark Phase 3 Acute Respiratory Distress Syndrome (ARDS) Trial
Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced today that the FDA has approved the company to proceed with its Phase 3 clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19.
RMAT designation means a faster, more streamlined approval process and frequent communication with FDA representatives. The FDA recently granted RMAT Designations to both Direct Bio and AlloVir.
Direct Biologics announces topline results from its first-in-human, multicenter, Phase II double-blind, placebo-controlled, randomized clinical trial, EXIT COVID-19,