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 preclinical data for SBT-272 at the Keystone Neurodegeneration Symposium. The data indicates significant enhancement in mitochondrial health and neuronal function, specifically in upper motor neurons linked to amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). A Phase 1 study assessing SBT-272's safety and tolerability in healthy volunteers is currently in progress. The drug showed superior effects over existing treatments like edaravone and AMX0035, marking a potential breakthrough in ALS therapies.
Stealth BioTherapeutics (Nasdaq: MITO) has received orphan drug designation from the European Medicines Agency (EMA) for elamipretide aimed at treating myopathic mitochondrial DNA depletion syndrome (M-MDS). This designation applies to patients with nuclear DNA mutations participating in the ongoing NuPOWER Phase 3 clinical trial across multiple sites in the US and Europe. The ODD status underscores the unmet medical need for effective therapies, providing incentives such as marketing exclusivity in the EU for 10 years.
Stealth BioTherapeutics (Nasdaq: MITO) announced updates from the ReCLAIM-2 study of elamipretide for geographic atrophy due to dry age-related macular degeneration. While the primary endpoints were not met, the study indicated significant improvements in low luminance visual acuity (LLVA) and mitochondrial rich ellipsoid zone (EZ) preservation. The data suggest elamipretide could potentially benefit patients with dry AMD. The therapy was well tolerated, showing a lower rate of new-onset exudations compared to placebo. Future clinical development and strategic partnerships are being considered.
Stealth BioTherapeutics Corp (Nasdaq: MITO) announced that the FDA has granted Orphan Drug Designation for elamipretide, aimed at treating Duchenne muscular dystrophy (DMD). The company has also secured a pre-IND meeting with the FDA's Division of Neurology I to discuss development strategies for elamipretide in combination with approved exon-skipping phosphorodiamidate morpholino oligomers. DMD leads to severe muscle dysfunction and current treatments have limited efficacy. The Orphan Drug Designation facilitates drug development for rare diseases, allowing seven-year exclusivity post-approval.
Stealth BioTherapeutics (Nasdaq: MITO) announced top-line results from its Phase 2 ReCLAIM-2 trial of elamipretide for geographic atrophy (GA) linked to dry age-related macular degeneration. Although the trial did not achieve its primary endpoints for mean change in low luminance visual acuity (LLVA) and GA progression, over 15% of elamipretide-treated patients showed significant improvement in vision at Week 48. Additionally, the treatment exhibited a reduction in ellipsoid zone loss, a biomarker of retinal health, suggesting potential for further development in GA.
Stealth BioTherapeutics Corp (Nasdaq: MITO) announced a definitive agreement with an institutional investor for a registered direct offering of 5,583,028 American Depositary Shares (ADSs) at $0.6269 per ADS, generating approximately $3.5 million. Concurrently, a private placement with Morningside Venture raised $5 million through the sale of 95,712,096 ordinary shares at $0.05224 each, plus warrants. Both transactions are set to close around April 13, 2022. The offering will use a previously filed shelf registration statement with the SEC.
Stealth BioTherapeutics Corp (Nasdaq: MITO) has announced the presentation of new preclinical data on SBT-272 at the Mitochondrial Biochemistry in Health and Disease Symposium. Additionally, the company has begun dosing in its Phase 1 clinical trial for SBT-272, targeting mitochondrial dysfunction in neurodegenerative diseases. The preclinical study showed significant motor function improvements in Huntington's disease models with SBT-272 treatment. The trial aims to evaluate the safety and pharmacokinetics of SBT-272 in healthy subjects, progressing towards potential treatments for ALS and other diseases.
Stealth BioTherapeutics Corp (Nasdaq: MITO) has initiated a Phase 2a clinical trial for its drug elamipretide to treat Friedreich's ataxia, a rare genetic disorder affecting about 4,000 individuals in the U.S. The FDA has granted Orphan Drug Designation to elamipretide, which aims to address significant unmet medical needs associated with the disease, including visual and cardiac dysfunction. The trial will assess safety, visual function, and cardiac function in patients at the Children's Hospital of Philadelphia, directed by Dr. David Lynch.
Stealth BioTherapeutics (Nasdaq: MITO) announced the presentation of new data at the ARVO 2022 Annual Meeting in Denver, Colorado, from May 1-4, 2022. The presentation will focus on the effects of elamipretide and SBT-272 on complement gene expression and cell survival in a model of dry age-related macular degeneration (AMD). Dry AMD is a leading cause of blindness, affecting over 5 million people globally. The presentation is scheduled for May 4, 2022, with Mark Fields, MPH, PhD, from Yale University delivering the findings.
Stealth BioTherapeutics Corp (Nasdaq: MITO) will host a virtual R&D event on March 24, 2022, at 9:00 am ET, focusing on its lead candidate, elamipretide, for treating geographic atrophy (GA) related to dry age-related macular degeneration (AMD). The event will feature notable experts including Lucian Del Priore, David S. Boyer, and Mark Fields. It aims to present elamipretide as a potential therapeutic option for GA, a progressive eye condition affecting over five million globally, with no approved treatments available.
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