BioSpace News Archive

Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, today announced its participation in several industry and investor events.

Parexel, a leading global clinical research organization focused on development and delivery of innovative new therapies to advance patient health, announced the appointment of Stephen Pyke as the company’s Executive Vice President, Clinical Data and Digital Services.

Recce Pharmaceuticals Ltd (ASX:RCE) (FSE:R9Q) (Company), the Company developing new classes of synthetic anti-infectives, is pleased to announce the trial registration for its lead compound, RECCE® 327 (R327), in the Australian New Zealand Clinical Trial Registry (ANZCTR) for a Phase I intravenous (IV) clinical trial under the trial ID ACTRN12621001313820p.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), today announced it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream for the treatment of mild-to-severe plaque psoriasis.

Centessa Pharmaceuticals plc, a clinical-stage company leveraging its innovative asset-centric business model to discover, develop and ultimately deliver impactful medicines to patients, announced that it has entered into a $300 million financing agreement with funds managed by Oberland Capital Management LLC.

Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced the company has been granted a Type C written response only meeting with the U.S. Food and Drug Administration (“FDA”) regarding the resubmission of the M207 (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (“NDA”) following receipt of preliminary top-line results from the pharmacokinetic (“PK”) study.

X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), announced today that it has completed enrollment in the ongoing pivotal Phase 3 clinical trial of its lead candidate, mavorixafor, in the treatment of patients with genetically confirmed WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome, a primary immunodeficiency caused by gain-of-function mutations in the CXCR4 gene.

Coherus BioSciences, Inc. announced that positive results from the pivotal COLUMBUS-AMD clinical trial evaluating and comparing the efficacy and safety between CHS-201 and Lucentis® in the treatment of neovascular age-related macular degeneration were presented October 1st by Dr. Peter K. Kaiser at the 54th Annual Scientific Meeting of the Retina Society.

Genetic Technologies Limited, a global leader in genomics-based tests in health, wellness and serious disease, announces a 12-fold increase in revenue generated during the September 2021 quarter to A$850k1.

Olive Diagnostics, developer of the world’s first optical sensor for passive and seamless uranalysis technology at home, begins a round of funding led by the Maccabi Foundation.