Direct Biologics LLC

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

  7/12/2023

  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

  4/26/2023

  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

  4/19/2023

  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

  4/4/2023

  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

  3/28/2023

  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

  3/21/2023

  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

  3/14/2023

  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 Appoints Dr. Amy Lightner as Chief Medical Officer

  2/15/2023

  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

  4/21/2022

  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.

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  AlloVir Snags Coveted RMAT Designation For T Cell Therapy

  4/20/2022

  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 Reveals Successful Outcomes from EXIT COVID-19 Phase II Clinical Trial

  4/6/2022

  Direct Biologics announces topline results from its first-in-human, multicenter, Phase II double-blind, placebo-controlled, randomized clinical trial, EXIT COVID-19,