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) announced that CEO Reenie McCarthy will present at two upcoming virtual investor conferences in May 2021. The conferences are: Oppenheimer's Rare & Orphan Disease Summit on May 21, 2021, from 9:55 to 10:35 a.m. ET, and UBS Global Healthcare Virtual Conference on May 26, 2021, from 10:00 to 10:45 a.m. ET. Live webcasts of the presentations will be available on Stealth's Investor Relations website, with replays archived for 30 days.
Stealth BioTherapeutics Corp (NASDAQ: MITO) will release its first quarter 2021 financial results on May 18, 2021, before market opening. The company focuses on developing therapies for mitochondrial dysfunction and will hold a conference call at 8:30 AM ET on the same day to discuss the results and provide a business update. Investors can access the call via phone or through a live audio webcast on their investor website.
Stealth BioTherapeutics Corp (Nasdaq: MITO) has presented new data from the Phase 1 ReCLAIM study at the 2021 ARVO Annual Meeting, focusing on elamipretide for patients with geographic atrophy (GA) related to dry age-related macular degeneration (AMD). The study revealed significant correlations between improvements in low-light visual acuity (LLVA) and mitochondrial health assessments. CEO Reenie McCarthy expressed optimism about potential clinical trial enrichment strategies based on these findings. Elamipretide has Fast Track designation from the FDA for the treatment of dry AMD with GA.
Stealth BioTherapeutics Corp (Nasdaq: MITO) announced a poster presentation at the 2021 ARVO Virtual Annual Meeting from May 1-7, 2021. The presentation highlights data supporting elamipretide's mechanism of action and backs the ReCLAIM-2 Phase 2 trial, focused on geographic atrophy in dry age-related macular degeneration. Enrollment for ReCLAIM-2, involving 176 patients, has been completed. Key outcomes will assess low-luminance best-corrected visual acuity over 48 weeks, along with secondary endpoints measuring disease progression.
Stealth BioTherapeutics (Nasdaq: MITO) announced that CEO Reenie McCarthy will deliver a keynote speech at the Mitochondria-Targeted Drug Development Digital Summit on April 28, 2021. The presentation will explore the advancements in mitochondrial medicine addressing rare genetic and common age-related diseases. Stealth will also present an abstract showcasing the significance of longitudinal natural history data in evaluating clinical trial outcomes for ultra-rare conditions. The content will be accessible to conference attendees through the event's website.
Stealth BioTherapeutics Corp (Nasdaq: MITO) reported its financial results for 2020, revealing a cash position of $32.8 million, down from $50.8 million in 2019. The company did not generate any revenue in 2020, compared to $21.1 million in 2019 due to the termination of an agreement with Alexion. R&D expenses decreased to $29.3 million, while G&A expenses fell to $19.4 million. Upcoming milestones include Phase 2 data from geographic atrophy trials expected in Q2 2022 and ongoing discussions with the FDA regarding its Barth syndrome NDA.
Stealth BioTherapeutics Corp (Nasdaq: MITO) will announce its full year 2020 financial results on April 6, 2021, before market opening. A conference call will follow at 8:30 am ET to discuss the results and provide a business update, accessible through dedicated phone lines and a live audio webcast. The company is focused on developing therapies for mitochondrial dysfunction, with key candidates including elamipretide for rare diseases and SBT-272 for neurodegenerative conditions. The firm aims to lead advancements in mitochondrial medicine.
Stealth BioTherapeutics (Nasdaq: MITO) announced the promotion of Marty Redmon, Ph.D., to Chief Research & Development Officer, effective immediately. Marty has over 25 years of experience in pharmaceutical R&D and has significantly contributed to the company's pipeline, notably in developing therapies for mitochondrial dysfunction and preparing for a New Drug Application submission. His leadership has generated promising preclinical data for candidates SBT-272 and SBT-550. This strategic move is expected to enhance the company’s development efforts and scientific excellence.
Stealth BioTherapeutics Corp (Nasdaq: MITO) announced that CEO Reenie McCarthy will present at two virtual investor conferences in March 2021. The first is the H.C. Wainwright Global Life Sciences Conference on March 9 at 7:00 a.m. ET, followed by Oppenheimer's 31st Annual Healthcare Conference on March 17 at 10:40 a.m. ET. Live audio webcasts will be available on Stealth's website, with replays archived for 30 days. Stealth focuses on therapies for diseases related to mitochondrial dysfunction, with significant product candidates including elamipretide and SBT-272.
Stealth BioTherapeutics Corp (Nasdaq: MITO) announced the completion of patient enrollment for the ReCLAIM-2 clinical study. The study evaluates the efficacy of elamipretide in treating dry age-related macular degeneration (AMD) with geographic atrophy. Top-line data are expected in the first half of 2022. The trial enrolled 176 patients, with a primary endpoint focused on low-luminance visual acuity. Successful completion of enrollment also unlocks $10 million in additional funding for the company.