FDA nod to first-ever treatment for fatal pediatric Menkes disease

FDA issues CRL for Sentynl’s copper histidinate for treatment of Menkes disease

Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease

Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease

Zydus Lifesciences subsidiary Sentynl acquires BridgeBio’s Nulibry

Nulibry is approved by the U.S. Food and Drug Administration (USFDA) to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening paediatric genetic disorder

Cyprium Therapeutics and Sentynl, a Zydus subsidiary announce positive data for CUTX-101, CuHis

The rolling submission to the U.S. FDA will begin in the fourth quarter of this year