Eikon Therapeutics Inc. has received IND clearance from the FDA to initiate phase I studies with IMP-1734, a highly selective poly(ADP-ribose) polymerase 1 (PARP-1) inhibitor developed in partnership with Impact Therapeutics Inc.

Hoth Therapeutics Inc. has submitted a request for a pre-IND meeting to the FDA to discuss the...

Carrick Therapeutics Ltd. has received FDA clearance of its IND application for CT-7439, a novel cyclin dependent kinase 12/13 (CDK12/13) inhibitor.

Artelo Biosciences Inc. has completed a pre-IND meeting with the FDA regarding the manufacturing, preclinical and clinical development plan for ART-26.12.

Pepgen Inc. has received a no objection letter from Health Canada for its clinical trial application (CTA) to initiate a phase I study of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1). Initial data from the study are expected next year.

The FDA has awarded orphan drug designation to Healx Ltd.’s HLX-1502 for the treatment of neurofibromatosis type 1 (NF1). HLX-1502, discovered through the company’s proprietary artificial intelligence (AI) drug discovery platform, has a first-in-class mechanism and supporting data that indicate the potential for a good safety profile.

Wave Life Sciences Ltd. has submitted its first clinical trial application (CTA) for WVE-006 for α1-antitrypsin deficiency (AATD).

The FDA has awarded orphan drug designation to Krystal Biotech Inc.’s KB-408 for the treatment of α1-antitrypsin deficiency (AATD).

Uniqure NV has received FDA clearance of its IND application for AMT-260, the company’s gene therapy candidate that represents a potential one-time administered approach to treating refractory mesial temporal lobe epilepsy (MTLE).