AUSTIN, Texas--(BUSINESS WIRE)--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 (BM-MSCs) to address multiple disease indications, announces favorable safety data and significant efficacy results from its Phase 2 clinical trial (NCT04493242) of ExoFlo™ in hospitalized adult COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS).
Direct Biologics Announces Initiation of Phase 1 Clinical Trial for 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 Appoints Dr. Amy Lightner as Chief Medical Officer
HOUSTON & AUSTIN, Texas--(BUSINESS WIRE)--Good Works II Acquisition Corp. (Nasdaq: GWII) (“Good Works II”), a publicly traded special purpose acquisition company (“SPAC”), and Direct Biologics, LLC (“Direct Biologics”), a late-stage biotechnology company, today announced the signing of a definitive agreement that, upon the satisfaction of all closing conditions, will result in Direct Biologics becoming a publicly traded company. Upon transaction close, which is expected to occur in the first half of 2023, the combined company will be named Direct Biologics, Inc. and shares of its common stock are expected to trade on the Nasdaq Capital Market.
HOUSTON & AUSTIN, Texas--(BUSINESS WIRE)--Good Works II Acquisition Corp. (Nasdaq: GWII) (“Good Works II”), a publicly traded special purpose acquisition company (“SPAC”), and Direct Biologics, LLC (“Direct Biologics”), a late-stage biotechnology company, today announced the signing of a letter of intent for a potential business combination. The letter of intent is non-binding except with respect to certain specified provisions relating to, among other things, exclusivity, expenses and other customary provisions.
AUSTIN, Texas, April 21, 2022 /PRNewswire/ -- 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. Direct Biologics is the first and only EV company to receive FDA Phase 3 approval for an Investigational New Drug (IND) indication to date.
Enforcement Report - Week of March 16, 2022
AUSTIN, Texas, July 20, 2021 /PRNewswire/ -- Direct Biologics, a market-leading innovator and cGMP manufacturer of regenerative biologic products, announced today that it has received FDA approval to initiate a Phase I/II trial under an Investigational New Drug (IND) protocol for the use of ExoFlo™ in the treatment of Post-Acute COVID-19 Syndrome. This trial is Direct Biologics' second approved IND, and it represents the first IND ever approved by FDA for the use of extracellular vesicles (EVs) to treat Post-Acute COVID-19 syndrome, Chronic Post-COVID-19 syndrome, or any post-viral syndrome.
Direct Biologics, a market-leading innovator and cGMP manufacturer of regenerative biologic products, announced today that the U.S. Food and Drug Administration (FDA) has approved the application for a Phase I/II trial under an Investigational New Drug (IND) protocol for the use of ExoFlo™ in the treatment of mild-to-moderate COVID-19. This is Direct Biologics' third FDA-approved IND clinical trial, and it represents the very first IND approved by the FDA to investigate the use of extracellular vesicles (EVs) to treat mild-to-moderate COVID-19.