Aucta Pharmaceuticals is pleased to announce the late January launch of PYQUVI oral suspension 22.75 mg/mL.  PYQUVI, a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older, is bioequivalent to Emflaza® (deflazacort) oral suspension 22.75 mg/mL.

PYQUVI will be available exclusively through a specialty pharmacy, offering an option for patients with DMD who prefer to receive deflazacort via a specialty pharmacy channel.

"Patients living with Duchenne muscular dystrophy and their families often face complex treatment-access considerations, including navigating evolving standards of care and insurance coverage variability that can delay timely therapy. These challenges add to the daily burden of a progressive condition such as Duchenne muscular dystrophy and underscore the importance of clear pathways to appropriate treatment and support," said Dr. Marie Tan, Associate Director of Medical Affairs, Clinical Operations, and Pharmacovigilance at Aucta Pharmaceuticals, Inc. "As part of the PYQUVI launch, Aucta plans to offer a patient support program focused on access and specialty pharmacy coordination for eligible patients."

The launch of PYQUVI marks Aucta Pharmaceuticals' first commercial branded-generic product in the United States. Building on this milestone, Aucta Pharmaceuticals will be introducing ZELVYSIA^TM (sapropterin dihydrochloride) Powder for Oral Solution. ZELVYSIA is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria (PKU). ZELVYSIA is to be used in conjunction with a Phe-restricted diet.

ZELVYSIA is anticipated to launch in March 2026, shortly following the introduction of PYQUVI.

Together, these launches represent a significant step forward in Aucta Pharmaceuticals' branded generic portfolio. It also underscores our commitment to providing treatment options for patients and families affected by rare conditions.

Emflaza® is a registered trademark of PTC Therapeutics, Inc.