The U.S. FDA has cleared Centessa Pharmaceuticals plc’s IND to initiate a phase I first-in-human, clinical trial of ORX-750 for the treatment of narcolepsy.

YS Biopharma Co. Ltd. has received clinical trial approval by the Philippine Food and Drug Administration to begin a phase I trial of its YS-HBV-002 immunotherapeutic vaccine, designed to treat chronic hepatitis B virus (HBV) infection. The trial will begin in the Philippines in June.

The FDA has granted orphan drug designation to the active ingredient in Soligenix Inc.’s Marvax, a heat stable subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for the prevention and post-exposure prophylaxis against MARV infection.

BLR Bio LLC announced that the U.S. FDA has granted orphan drug designation to BLR-200, the company’s investigational therapy for the treatment of systemic sclerosis (SSc).

The FDA has granted orphan drug designation to the active ingredient in Soligenix Inc.’s Suvax, a subunit protein vaccine of recombinantly expressed Sudan ebolavirus (SUDV) glycoprotein, for the prevention and post-exposure prophylaxis against SUDV infection. SUDV is a type of ebolavirus for which there is no current treatment or vaccine.

The U.S. FDA has cleared Tr1x Inc.’s IND application for TRX-103 for the prevention of graft-vs.-host disease (GVHD) in patients undergoing HLA-mismatched hematopoietic stem cell transplantation (HSCT).

Cereno Scientific AB has submitted a clinical trial application (CTA) to the EMA seeking approval for a first-in-human, phase I study of CS-014, a novel histone deacetylase (HDAC) inhibitor drug candidate under development as an antithrombotic treatment.

The U.S. FDA has cleared Biocity Biopharma Co. Ltd.’s IND application for a phase I study of BC-2027. This is the company’s second first-in-class antibody-drug conjugate (ADC) to be approved for clinical trials, following BC-3195, which is directed against placental-cadherin (CDH3).