Leukogene Therapeutics has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for M2T-CD33 (LTI-214), its immunotherapy candidate targeting acute myeloid leukaemia (AML).
Superluminal Medicines secured $120m in a Series A funding round to advance the development of its assets into clinical trials.
Augustine Therapeutics has secured €17m ($18.5m) in a Series A funding round's initial close for advancing its lead candidate, AGT100216, into a Phase I/II first-in-human clinical trial next year to treat neurological conditions.
Aardvark Therapeutics has secured $85m in an oversubscribed Series C financing round, with Decheng Capital spearheading the investment, to complete studies of ARD-101.
Merck, referred as MSD outside the US and Canada, has confirmed that Health Canada has approved a new indication for PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high risk adult kidney transplant recipients.
Clinical-stage biotechnology company TORL BioTherapeutics has announced the closure of an oversubscribed $158m Series B-2 financing round.
Solid Biosciences has received the US Food and Drug Administration’s (FDA) rare pediatric disease designation for its gene therapy candidate for Duchenne muscular dystrophy (Duchenne), SGT-003.
The US National Institutes of Health (NIH) unit National Institute on Drug Abuse (NIDA) has granted an award of $9m for researchers to advance drug, SBP-9330, to treat nicotine addiction.
The China National Medical Products Administration (NMPA) has accepted Everest Medicines’ investigational new drug (IND) application for its selective immunoproteasome inhibitor, zetomipzomib.
The US Food and Drug Administration (FDA) has accepted Merck’s (MSD) biologics license application (BLA) of sotatercept to treat pulmonary arterial hypertension [PAH (WHO Group 1)], for priority review.
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