Welcome to our dedicated page for Stealth Biotherapeutics news (Ticker: MITO), a resource for investors and traders seeking the latest updates and insights on Stealth Biotherapeutics stock.
Stealth BioTherapeutics Corp (MITO) has been the subject of news coverage centered on its mitochondria-targeted drug pipeline, regulatory milestones, and corporate transactions. Historically described as a clinical-stage biotechnology company, Stealth has focused on developing therapies for diseases involving mitochondrial dysfunction in high-energy organs such as the heart, eye, neuromuscular system, and brain.
News about Stealth has included clinical and regulatory updates for its lead candidate elamipretide, including interactions with the U.S. Food & Drug Administration (FDA) regarding Barth syndrome and other indications. Earlier releases detailed pre-NDA discussions and long-term clinical data in Barth syndrome, while a later announcement from Stealth BioTherapeutics Inc. reported that FORZINITY (elamipretide) injection received accelerated approval from the FDA as the first treatment for Barth syndrome and the first FDA-approved mitochondria-targeted therapeutic.
Coverage has also highlighted the company’s second-generation candidate SBT-272, with Phase 1 safety and tolerability results and preclinical data in amyotrophic lateral sclerosis (ALS) and other neurodegenerative disease models. Stealth has reported Orphan Drug Designation for SBT-272 for the treatment of ALS and presented data at scientific conferences focused on ALS and neurodegenerative disease research.
Corporate and capital markets developments are another recurring theme. In 2022, Stealth issued multiple releases about a preliminary non-binding proposal, a definitive agreement for a going-private transaction, and the subsequent completion of a merger that resulted in the company becoming privately held and its ADSs being delisted from the Nasdaq Global Market. Earlier communications also addressed a Nasdaq non-compliance notice related to listing requirements.
Investors and researchers using this news page can review historical announcements on clinical progress, FDA designations and meetings, ultra-rare disease engagement, and the steps leading to Stealth’s transition from a Nasdaq-listed issuer under the MITO symbol to a privately held biotechnology company.
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.
Stealth BioTherapeutics Corp (Nasdaq: MITO) has completed its merger with Stealth Merger Sub Limited, transitioning to a privately held entity. Shareholders will receive $0.03125 per ordinary share and $0.375 per American Depositary Share (ADS), with a cancellation fee applied for ADSs. Trading of ADSs on NASDAQ was suspended on November 16, 2022, following shareholder approval on November 15, 2022. The company will file for deregistration with the SEC and suspend its reporting obligations under the Securities Exchange Act. Financial and legal advisements were provided by prominent firms.
Stealth BioTherapeutics Corp (MITO) reported encouraging Phase 1 results on the safety and tolerability of its drug candidate, SBT-272, for ALS treatment. The drug demonstrated neuroprotective effects in preclinical models and has been granted Orphan Drug Designation by the FDA, highlighting the urgent need for ALS therapies. The Phase 1 study indicates that SBT-272 could achieve therapeutic levels in the brain, supporting its further clinical development. The findings were discussed at the NEALS conference on November 1, 2022.
Stealth BioTherapeutics (MITO) announced an extraordinary general meeting (EGM) for shareholders on November 15, 2022, in New York City. The EGM will focus on approving a merger agreement dated July 31, 2022, which involves Stealth merging with Stealth Parent Limited. If approved, Stealth will become a privately-held subsidiary and its ADSs will be delisted from Nasdaq. Shareholders as of October 7, 2022, are entitled to vote. The board has recommended a vote in favor of the merger, deeming it fair and in the best interests of shareholders.
Stealth BioTherapeutics Corp (Nasdaq:MITO) announced that Chief Financial Officer Robert Weiskopf has left the company, effective September 30, 2022. Weiskopf joined Stealth in 2019 and has played a pivotal role in building the company's financial infrastructure. CEO Reenie McCarthy expressed gratitude for his contributions. On August 1, 2022, Stealth confirmed an agreement for acquisition by a consortium led by Morningside Venture in an all-cash transaction, signaling a transformative phase for the company.
Stealth BioTherapeutics (NASDAQ: MITO) announced its participation in significant events focused on ultra-rare disease drug development on September 15, 2022. CEO Reenie McCarthy will engage in discussions at the Rare Disease Research: A Prescription event and the Business of RARE Biotech Summit. These presentations will spotlight Stealth's clinical progress with elamipretide for Barth syndrome, showcasing over 40% improvement in cardiac function after 3.5 years. The company is also planning further talks with the FDA to clarify regulatory pathways.
Stealth BioTherapeutics Corp (Nasdaq: MITO) announced a definitive merger agreement to be acquired by a consortium led by Morningside Venture Investments Ltd. for $0.03125 per share. The deal includes a premium of 34.4% over the closing price before the proposal and is expected to close in H2 2022, subject to shareholder approval. The consortium holds approximately 65% of shares. Following the merger, Stealth BioTherapeutics will become a privately-held entity and its shares will cease trading on NASDAQ.
Stealth BioTherapeutics (Nasdaq:MITO) announced it received a non-compliance notice from Nasdaq due to failure to meet minimum bid price and market value requirements. Unless an appeal is requested, trading will be suspended on July 18, 2022. The company plans to appeal and present a compliance plan to the Nasdaq Hearings Panel. Additionally, discussions are ongoing regarding a proposed acquisition by Morningside Venture, while no final decisions have been made. Stealth also aims to regain compliance and may seek an extension depending on the status of the acquisition.
Stealth BioTherapeutics Corp (Nasdaq: MITO) has received a non-binding proposal from Morningside Venture and J. Wood Capital to acquire all outstanding shares not currently owned by Morningside. The proposed acquisition price is $0.026 per share and $0.313 per American Depositary Share (ADS), representing premiums of 11.7% and 20% respectively. The company's Board has formed a Special Committee to evaluate this and other strategic alternatives, emphasizing no decisions have been made yet regarding the proposal.
Stealth BioTherapeutics (MITO) has scheduled a Type B meeting with the FDA's Division of Cardiology and Nephrology to discuss new clinical data concerning elamipretide for treating Barth Syndrome. This meeting follows the FDA's previous refusal to file an NDA for the treatment in October 2021. The company aims to present clinical data from the Phase 2 TAZPOWER study, which could support a future NDA submission. Barth Syndrome is a rare genetic condition with no FDA-approved therapies, affecting 1 in 200,000 to 400,000 individuals worldwide.
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