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.

Biosion Inc. has gained FDA clearance of its IND application for BSI-082, a novel anti-SIRPα monoclonal antibody (mAb) candidate.

Cytomx Therapeutics Inc. has received clearances from the FDA for IND applications for two conditionally activated Probody therapeutics.