Clinical Trials

Affinia receives FDA fast track designation for AFTX-201

Affinia Therapeutics has received the US Food and Drug Administration (FDA) fast track designation (FTD) for AFTX-201, a genetic medicine under investigation for treating Bcl-2-associated athanogene 3 (BAG3)-associated dilated cardiomyopathy (DCM).

Leukogene Therapeutics gains FDA ODD status for M2T-CD33

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 secures $120m in Series A funding round

Superluminal Medicines secured $120m in a Series A funding round to advance the development of its assets into clinical trials.

Augustine raises €17m to advance lead candidate into trials for neuro conditions

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 secures $85m in Series C funding round

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’s PREVYMIS gets Health Canada’s approval for CMV disease prevention

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.

TORL BioTherapeutics secures $158m for oncology pipeline development

Clinical-stage biotechnology company TORL BioTherapeutics has announced the closure of an oversubscribed $158m Series B-2 financing round.

Solid Biosciences’ SGT-003 receives rare pediatric disease designation

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.

NIH grants $9m for nicotine cessation drug development

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.