Arthex Biotech SL has received FDA clearance to initiate the phase I/IIa Arthemir study of ATX-01 for the treatment of myotonic dystrophy type 1 (DM1).

Clearmind Medicine Inc. has received approval from Israel’s Ministry of Health to initiate a phase I/IIa trial of CMND-100 oral capsules for alcohol use disorder (AUD). The multinational trial in healthy volunteers and AUD subjects will be conducted in Israel and the U.S.

Kurome Therapeutics Inc. has received FDA clearance of its IND for KME-0584.

Trawsfynydd Therapeutics Inc. has received approval to initiate a first-in-man phase I trial of the novel best-in-class COVID-19 treatment, TRX-01, an inhibitor targeting the SARS-CoV-2 viral main protease (3CL, Mpro).

Aprea Therapeutics Inc. has submitted an IND application to the FDA to initiate clinical trials of APR-1051, an oral next-generation small-molecule inhibitor of WEE1 kinase.

Encoded Therapeutics Inc. is advancing its lead gene therapy candidate, ETX-101, for the treatment of SCN1A+ Dravet syndrome into the clinic.

Acepodia Inc. has obtained FDA clearance of its IND application for ACE-2016, an allogeneic γδ2 T-cell therapy for the treatment of epidermal growth factor receptor (EGFR)-expressing malignancies in patients with solid tumors.

Jaguar Gene Therapy LLC’s IND application for JAG-201, a gene therapy for a genetic form of autism spectrum disorder (ASD) and Phelan-McDermid syndrome (PMS; 22q13.3 deletion syndrome), has been cleared by the FDA.

23andme Holding Co. has received FDA clearance of its IND application for 23ME-01473 (‘1473), a dual mechanism antibody and natural killer (NK) cell activator intended to treat cancer.

Ascidian Therapeutics Inc. has received FDA clearance of its IND application for ACDN-01, an RNA exon editor targeting the genetic cause of Stargardt disease.