Stealth BioTherapeutics Announces Mito Assist™ Patient Support Program and Specialty Pharmacy Partnership with AnovoRx to Distribute FORZINITY™(elamipretide) injection

Rhea-AI Summary

Stealth BioTherapeutics (NASDAQ) launched the Mito Assist™ Patient Support Program and named AnovoRx as exclusive U.S. specialty pharmacy distributor for FORZINITY™ (elamipretide) injection. FORZINITY received FDA accelerated approval on September 19, 2025 as the first treatment for Barth syndrome to improve muscle strength in patients ≥30 kg. Mito Assist provides co-pay assistance, patient assistance for uninsured or underinsured individuals, at-home subcutaneous injection training, and dedicated case management via AnovoRx. Current Expanded Access Program patients meeting the weight requirement will be contacted for transition. Commercial availability through AnovoRx is anticipated by December 2025, pending distribution readiness and payer coverage activation.

Positive

• FDA accelerated approval received on September 19, 2025
• Exclusive U.S. distribution partnership with AnovoRx
• Mito Assist offers co-pay assistance and patient aid
• Anticipated commercial availability by December 2025

Negative

• Treatment limited to patients weighing ≥30 kg
• Commercial launch contingent on payer coverage activation

Insights

Commercial access strategist

FDA accelerated approval and an exclusive specialty pharmacy tie-up set the stage for commercial launch and patient access.

Stealth secured accelerated approval for FORZINITY^™ on September 19, 2025, and chose AnovoRx as the exclusive U.S. distributor. This creates a clear commercial channel and a single point of coordination for fulfillment, which simplifies logistics for clinics and payers.

Dependence on final distribution readiness and payer coverage activation shapes near-term rollout risk; availability is expected by December 2025. Key operational items to watch are AnovoRx onboarding, case manager capacity, and payer formulary decisions within the next 1–3 months.

Patient access and reimbursement expert

Mito Assist™ centers on lowering financial and practical barriers for eligible Barth syndrome patients.

The program bundles co-pay support, patient assistance, at-home injection training, and dedicated case management through AnovoRx. Those measures directly address typical barriers: coverage navigation, out-of-pocket costs, and self-administration support.

Critical dependencies include eligibility criteria (weight ≥30kg), timely outreach to Expanded Access patients, and payer activation ahead of the planned December 2025 availability. Monitor case manager throughput, uptake of co-pay assistance, and the transition process for existing Expanded Access patients over the coming weeks.

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
Ascent Strategic Communications
Anna Stallmann
anna@ascentcomms.com

Investor Contact
Precision AQ
Austin Murtagh
Austin.Murtagh@precisionaq.com

Patient Advocacy
PatientAdvocacy@stealthbt.com

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SOURCE Stealth BioTherapeutics Inc.

FAQ

What did Stealth BioTherapeutics announce on October 9, 2025 about FORZINITY distribution?

Stealth announced a U.S. exclusive distribution partnership with AnovoRx to dispense FORZINITY via the Mito Assist program.

When did FORZINITY receive FDA accelerated approval and for whom?

FORZINITY received FDA accelerated approval on September 19, 2025 to improve muscle strength in Barth syndrome patients weighing at least 30 kg.

What patient support services does Mito Assist provide for FORZINITY?

Mito Assist offers co-pay assistance, patient assistance for uninsured or underinsured people, at-home injection training, and dedicated case management.

When will FORZINITY be commercially available through AnovoRx?

Stealth anticipates commercial availability through AnovoRx by December 2025, pending distribution readiness and payer coverage activation.

How will current Expanded Access Program patients transition to commercial FORZINITY?

Expanded Access patients meeting the 30 kg weight requirement will be contacted by their providers and AnovoRx case managers to facilitate transition.

How can patients or healthcare providers get more information about FORZINITY access?

Patients and providers can call 1-833-458-9099 for information on Mito Assist and FORZINITY access.