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 Corp (Nasdaq: MITO) presented promising data on elamipretide and its potential synergistic effects with a phosphorodiamidate morpholino oligomer (PMO) in Duchenne muscular dystrophy (DMD) at the 2022 Muscular Dystrophy Association conference. The 7-week study on mdx mice showed that combining PMO with elamipretide resulted in over double the dystrophin protein levels compared to PMO treatment alone. This suggests that improved mitochondrial function could enhance PMO efficacy, offering hope for better treatment outcomes for DMD patients.
Stealth BioTherapeutics Corp (Nasdaq:MITO), a biotechnology firm focused on therapies for mitochondrial dysfunction, announced CEO Reenie McCarthy will present at three investor conferences in March 2022. These include the Oppenheimer 32nd Annual Healthcare Conference on March 15, the 34th Annual Roth Conference also on March 15, and the Maxim Group 2022 Virtual Growth Conference from March 28 to March 30. Webcasts of the presentations will be available on Stealth's website for 30 days post-event, highlighting the company’s lead candidate, elamipretide, targeting mitochondrial-related diseases.
Stealth BioTherapeutics Corp (Nasdaq:MITO) announced that CEO Reenie McCarthy will present at the Mitochondria-Targeted Drug Development Summit on February 24, 2022, at 9:00 a.m. ET. The presentation will focus on mitochondrial dysfunction in ophthalmic diseases, including dry AMD and diabetic retinopathy, showcasing preclinical data on elamipretide's effects. Clinical data indicate a potential predictive relationship between baseline function and therapeutic response in dry AMD patients. More details are available at mitochondria-targets.com.
Stealth BioTherapeutics Corp (Nasdaq:MITO) announced the completion of treatment for the final patient in its ReCLAIM-2 phase 2 clinical trial targeting extra-foveal geographic atrophy (GA) due to dry age-related macular degeneration (AMD). The trial involved 176 subjects and assessed the efficacy and safety of elamipretide. Following positive results from a prior phase 1 trial, topline results are expected in Q2 2022. GA affects over five million people globally, with no approved treatments currently available.
Stealth BioTherapeutics Corp (Nasdaq:MITO) announced on February 11, 2022, that it is not in compliance with Nasdaq's minimum Market Value of Publicly Held Shares requirement. This notification follows a review of the company's MVPHS for the 30 consecutive business days leading up to February 10, 2022. The notice does not affect the trading of the company's ADSs, which will continue on Nasdaq. Stealth has a 180-day compliance period to regain compliance, requiring a minimum MVPHS of $15 million for ten consecutive days.
Stealth BioTherapeutics Corp (Nasdaq: MITO) announced an oral presentation at the 2022 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference, scheduled for March 13-16, 2022, in Nashville, Tennessee. The presentation will discuss how elamipretide may enhance the therapeutic effects of an exon skipping PMO in a mouse model of X-linked muscular dystrophy. Reenie McCarthy, CEO, expressed optimism about advancing clinical development to improve treatments for Duchenne muscular dystrophy.
Stealth BioTherapeutics Corp (Nasdaq: MITO) announced on January 7, 2022, that it received notifications from Nasdaq regarding non-compliance with minimum bid price and market value requirements. The company's ADSs fell below $1.00 and $50 million respectively for over 30 consecutive business days. Stealth has a compliance period until July 5, 2022, to rectify these issues. If compliance is not achieved, the company may receive a notification for delisting. Despite these concerns, the company's shares will continue trading on Nasdaq under the ticker MITO.
Stealth BioTherapeutics Corp (Nasdaq: MITO) announced that CEO Reenie McCarthy will present at the H.C. Wainwright BioConnect Virtual Conference from January 10-13, 2022. The presentation will be available for on-demand viewing starting January 10 at 7:00 a.m. ET on the company's website. Stealth focuses on therapies for mitochondrial dysfunction, with lead candidate elamipretide targeting conditions like Barth syndrome and age-related diseases. The company is also developing second-generation candidate SBT-272 and new compounds SBT-550 for neurological diseases.
Stealth BioTherapeutics (Nasdaq: MITO) announced a positive update from its pre-IND meeting with the FDA regarding its Duchenne muscular dystrophy (DMD) program. The FDA's Division of Cardiology and Nephrology approved Stealth's proposal to assess myocardial fibrosis as a surrogate endpoint for their upcoming clinical trial. This is critical as heart failure is a leading cause of mortality in DMD. The company aims to submit an IND in the first half of the year and initiate trials later, pending regulatory feedback. New preclinical data shows elamipretide may enhance dystrophin expression.
Stealth BioTherapeutics Corp (NASDAQ: MITO) recently updated investors on its clinical programs for rare diseases involving mitochondrial dysfunction. The early data indicates elamipretide, in combination with a PMO, significantly enhances dystrophin expression in a mouse model of Duchenne muscular dystrophy (DMD). The company is on track to initiate its Phase 3 NuPOWER trial for patients with nuclear DNA mutations causing mitochondrial myopathy. Discussions with DCN regarding the Barth syndrome development program are progressing positively, with expectations for regulatory feedback soon.
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