mesenchymal stem cell therapy / Citius Pharmaceuticals, Ernexa Therapeutics, Factor Bioscience - LARVOL DELTA

Citius announces Pre-IND submission to FDA under the coronavirus treatment acceleration program for a novel stem cell therapy for Acute Respiratory Distress Syndrome (ARDS) in Covid-19 (PRNewswire) - "Citius Pharmaceuticals, Inc....today announced that it submitted a pre-IND meeting request and supporting briefing documents to the Center for Biologics Evaluation and Research ('CBER') of the FDA....Citius and Novellus plan to develop NC-MSCs for the treatment of ARDS...signed an exclusive option agreement....The Company plans a multi-center randomized placebo-controlled dose-finding study followed by an expansion phase....The proposed trial, a Phase 1b/2 clinical trial, is titled 'A Randomized Placebo-Controlled Dose-Finding Study Followed by a Dose Level Expansion to Assess the Safety and Efficacy of NoveCite MSCs in Subjects with Acute Respiratory Distress Syndrome (ARDS) Due to SARS-CoV-2 Disease (COVID-19),' or 'MARCO'."

IND • Licensing / partnership • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

Citius Pharmaceuticals Issues Shareholder Letter with Corporate Update on Recent Achievements and Anticipated Milestones for 2021 (PRNewswire) - "NoveCite i-MSCs development is progressing with: ongoing data generation from our proof-of-concept sheep acute respiratory distress syndrome (ARDS) model demonstrating impressive interim results (studies to be completed in second quarter); FDA-required GLP animal toxicology studies have been implemented...'We plan to submit an IND to the FDA and initiate our Phase 1 first-in-human clinical trial in COVID-19 ARDS by the end of the second quarter of 2022. Our recent $20 million private round of financing and investors' exercise of warrants...three programs in the clinic, as well as manufacturing development..."

Financing • IND • New P1 trial • Preclinical • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease

Novellus Therapeutics Exclusively Licenses Induced Mesenchymal Stem Cells (iMSCs) to NoveCite for COVID-19 Related Acute Respiratory Distress Syndrome (ARDS) and Other Acute Respiratory Conditions (PRNewswire) - "Novellus Therapeutics...announced today that it has licensed its induced mesenchymal stem cells (iMSCs) on a worldwide basis to NoveCite, Inc....NoveCite will develop and commercialize Novellus's iMSCs to treat acute respiratory conditions with a near term focus on Acute Respiratory Distress Syndrome ('ARDS') associated with COVID-19....Novellus received a $5 million upfront payment, and is eligible to receive up to $51 million in development milestone payments, as well as low double-digit royalties."

Licensing / partnership • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease

Citius Pharmaceuticals Signs an Exclusive Worldwide Licensing Agreement with Novellus Therapeutics for Unique iMSC-Therapy for Acute Inflammatory Respiratory Conditions including COVID-19 Related Acute Respiratory Distress Syndrome (ARDS) (PRNewswire) - "Citius Pharmaceuticals, Inc....announced that it has signed an exclusive agreement with Novellus Therapeutics Limited ('Novellus') to license iPSC-derived mesenchymal stem....NoveCite has a worldwide exclusive license from Novellus, an engineered cellular medicines company, to develop and commercialize NoveCite mesenchymal stem cells ('NC-iMSCs') to treat acute respiratory conditions with a near term focus on Acute Respiratory Distress Syndrome ('ARDS') associated with COVID-19."

Licensing / partnership • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease

Citius Receives FDA Response on Pre-Investigational New Drug (PIND) Application for its Induced Mesenchymal Stem Cells (iMSCs) to Treat Acute Respiratory Distress Syndrome (ARDS) in Patients with COVID-19 (PRNewswire) - "Citius Pharmaceuticals, Inc....announced today that the Company has received a written response from the U.S. Food and Drug Administration (FDA) in regards to its pre-investigational new drug (PIND) application for its induced mesenchymal stem cells (iMSCs)....The FDA acknowledged that the Company could apply for fast track designation....The Company plans to initiate actions on the FDA's recommendations and follow up with the FDA with an Investigational New Drug (IND) application under the Coronavirus Treatment Acceleration Program (CTAP)."

FDA event • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease