Stealth BioTherapeutics Announces Mito Assist™ Patient Support Program and Specialty Pharmacy Partnership with AnovoRx to Distribute FORZINITY™(elamipretide) injection
Stealth BioTherapeutics Announces Mito Assist™ Patient Support Program and Specialty Pharmacy Partnership with AnovoRx to Distribute FORZINITY™(elamipretide) injection |
| [09-October-2025] |
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:
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 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 WARNINGS AND PRECAUTIONS 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 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 About Stealth BioTherapeutics Media Contact Investor Contact Patient Advocacy
SOURCE Stealth BioTherapeutics Inc. | ||
Company Codes: NASDAQ-NMS:NASDAQ: MITO,NASDAQ-NMS:MITO |
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