BioSpace News Archive

Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease.

Lineage Cell Therapeutics, Inc. today reported that the Company is expected to be added to the broad-market Russell 3000 ® Index at the conclusion of the 2023 Russell indexes annual reconstitution, effective as of the U.S. market open on June 26, 2023, according to a preliminary list of additions posted to the FTSE Russell website, following the close of the U.S. markets on May 19, 2023.

Gamida Cell Ltd. today announced the appointment of Terry Coelho as Chief Financial Officer effective immediately.

MiNK Therapeutics today announced presentation of clinical data from its allo-iNKTs (agenT-797) in COVID-19 associated Acute Respiratory Distress Syndrome (CARDS) at the American Thoracic Society (ATS) International Conference in Washington D.C.

Clearmind Medicine Inc. today announced the selection of its first U.S. site for the company’s Phase I/IIa clinical trial of its proprietary MEAI-based CMND-100 compound for the treatment of alcohol use disorder (“AUD”).

Creative Medical Technology Holdings, Inc. announced significant advances in the ongoing development of its ImmCelz® platform, the Company’s cell-free system which has previously been validated to supercharge a patient’s own cells to treat a number of immune disorders.

Medigene AG, an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, announced that the Company has been issued a patent by the Japan Patent Office protecting its PD1-41BB switch receptor.

Akebia Therapeutics ® , Inc. (Nasdaq: AKBA) today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Vafseo ® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.

PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) agreed to Company’s SHIELD II Phase 3 trial design evaluating D-PLEX100 for the prevention of abdominal colorectal surgical site infections (SSIs).

EBR Systems, Inc. (ASX: EBR), the medical device company developing wireless cardiac pacing systems, has met its primary safety and efficacy endpoints in its pivotal SOLVE-CRT trial of the WiSE® Cardiac Resynchronization Therapy (CRT) System.