April 27, 2024

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[THE INVESTOR] Bukwang Pharmaceutical said on Oct. 31 US biotech Acer Therapeutics has submitted a New Drug Application with the US Food and Drug Administration for its drug candidate EDSIVO, a treatment for vascular Ehler-Danlos Syndrome.

Bukwang is the fourth-largest shareholder with a 6.5 percent stake in the NASDAQ-listed orphan drug developer. 

Along with the NDA submission, Acer has requested Priority Review, which if granted, could result in a six-month review period. It is a designation given to drugs that offer a significant improvement in treatment or provides therapy when no satisfactory alternatives exist.

Vascular Ehlers-Danlos Syndrome is an inherited connective tissue disorder with no FDA-approved drug. Patients with vEDS suffer from life threatening arterial dissections and ruptures, as well as intestinal and uterine ruptures.

EDSIVO received FDA Orphan Drug Designation for the potential treatment of vEDS in 2015.

It is one of Acer’s two late-stage candidates along with ACER-001, for which the company plans to submit an NDA to the FDA in 2019 to treat urea cycle disorders and Maple Syrup Urine Disease.

By Park Han-na (hnpark@heraldcorp.com)