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Stealth BioTherapeutics Announces Mito Assist™ Patient Support Program and Specialty Pharmacy Partnership with AnovoRx to Distribute FORZINITY™(elamipretide) injection
Drug Approval
Program underscores Stealth's commitment to patient access and partnership with the Barth syndrome community
NEEDHAM, Mass., Oct. 9, 2025 /PRNewswire/ -- Stealth BioTherapeutics Inc. (the "Company" or "Stealth"), a commercial-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced the launch of its Mito Assist™ Patient Support Program for access to FORZINITY™ (elamipretide) injection. FORZINITY was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on September 19, 2025 as the first treatment for Barth syndrome, to improve muscle strength in adult and pediatric patients weighing at least 30 kilograms (kg).
As part of this initiative, Stealth has selected AnovoRx Specialty Pharmacy ("AnovoRx") as its exclusive commercial distribution partner for FORZINITY in the United States. Through this partnership, AnovoRx will play a key role in helping patients, caregivers, and healthcare providers navigate the insurance coverage and access process.
"We have been deeply committed to the Barth syndrome community for over a decade, and access to FORZINITY for eligible patients remains our highest priority," said
Reenie McCarthy, Chief Executive Officer of Stealth BioTherapeutics. "We are investing significantly in our access infrastructure to make sure every eligible patient who may benefit from FORZINITY can receive it. Partnering with AnovoRx allows us to deliver a high-touch experience for families as they navigate access and coverage."
Mito Assist™ will offer personalized patient support services to help affected individuals and caregivers understand coverage options, manage insurance submissions, and access financial assistance resources. This includes:
Co-pay assistance for eligible commercially insured patients.
Patient assistance programs for uninsured or underinsured individuals.
Support for at-home subcutaneous injection training.
Dedicated case management through AnovoRx to provide ongoing communication with patients, caregivers, and healthcare providers.
Patients currently receiving elamipretide through Stealth's Expanded Access Program who meet the weight requirement of 30kg will be contacted directly by their healthcare providers and AnovoRx case managers to facilitate a seamless transition to commercial therapy once FORZINITY™ becomes available.
Stealth anticipates that commercial product will be available through AnovoRx by December 2025, pending final distribution readiness and payer coverage activation. Patients and healthcare providers can learn more by calling
1-833-458-9099.
About FORZINITY™ (elamipretide) injection
INDICATION
FORZINITY™ is a mitochondrial cardiolipin binder indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg.
This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
CONTRAINDICATIONS
Serious hypersensitivity to elamipretide or any of the ingredients.
WARNINGS AND PRECAUTIONS
FORZINITY is not approved in neonates. FORZINITY contains Benzyl Alcohol and serious adverse reactions including fatal reactions have been reported in low birth weight neonates and preterm neonates who received benzyl alcohol containing drugs intravenously. FORZINITY is not approved for intravenous use.
Hypersensitivity reactions, including serious allergic reactions requiring emergency medical intervention, have been reported in patients receiving FORZINITY. Monitor patients for signs and symptoms of hypersensitivity reactions during treatment.
ADVERSE REACTIONS
Most common adverse reactions are injection site reactions.
To report SUSPECTED ADVERSE REACTIONS, contact Stealth BioTherapeutics Inc. at 1-844-444-6486 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information about FORZINITY, please see the full US Prescribing Information.
About Barth Syndrome
Barth syndrome is an ultra-rare genetic condition characterized by mitochondrial abnormalities leading to exercise intolerance, muscle weakness, debilitating fatigue, heart failure, recurrent infections, and delayed growth. The disease is associated with reduced life expectancy, with 85% of early deaths occurring by age 5. Barth syndrome occurs primarily in males and is estimated to affect one in 1,000,000 males births or around 150 individuals in the United States. There are no EMA-approved therapies for patients with Barth syndrome.
About Stealth BioTherapeutics
Stealth BioTherapeutics' mission is to develop novel therapies to improve the lives of patients living with diseases of mitochondrial dysfunction. Stealth's commercial product, FORZINITY, was granted accelerated approval by the U.S. Food & Drug Administration (FDA) in September 2025 as the first FDA-approved treatment for Barth syndrome, as well as the first FDA-approved mitochondria-targeted therapeutic. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Stealth is studying elamipretide in additional indications, including dry age-related macular degeneration and primary mitochondrial myopathy, and is developing its second-generation clinical-stage candidate, bevemipretide (SBT-272), for ophthalmic and neurological disease indications.
Media Contact
Anna Stallmann
[email protected]
Investor Contact
Precision AQ
Austin Murtagh
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Patient Advocacy
[email protected]
SOURCE Stealth BioTherapeutics Inc.
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