$MITO News

Last published 1y ago

1y agoMITOApproval of Forzinity, Nda #215244 (Type 1 - New Molecular Entity)FDA Approved DrugsApproval Date: 09/19/2025; Drug Name: Forzinity, Nda #215244; Active Ingredients: ELAMIPRETIDE; Company: Stealth Biotherapeutics Inc; Submission Status: Approval; Submission Classification: Type 1 - New Molecular Entity; Application Number: 215244
1y agoMITOFDA Grants Accelerated Approval to First Treatment for Barth SyndromeFDA Press ReleasesToday, the U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Barth syndrome is a rare, serious and life-threatening disease of the mitochondria (the energy-producing parts of cells).“The FDA remains committed to facilitating the development of effective and safe therap ...
2y agoMITOSTEALTH BIOTHERAPEUTICS CORP - Appeal, ReversedUS Patent Trial and Appeal Board
3y agoMITOStealth BioTherapeutics Corp Announces Completion of MergerPR NewswireBOSTON, Nov. 16, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO) (the "Company" or "Stealth BioTherapeutics"), a clinical-stage biotechnology company focused on the discovery, development,
4y agoMITOStealth BioTherapeutics Announces SBT-272 Data Updates and Orphan Drug Designation for the Treatment of Amyotrophic Lateral Sclerosis (ALS)PR NewswireSBT-272 Phase 1 safety and tolerability data support further clinical development SBT-272 was neuroprotective and reduced neuroinflammation in ALS preclinical model
4y agoMITOStealth BioTherapeutics Corp to Hold Extraordinary General Meeting of ShareholdersPR NewswireBOSTON, Oct. 7, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO) ("Stealth" or the "Company"), a clinical-stage biotechnology company focused on the discovery, development and
4y agoMITOStealth BioTherapeutics Announces Departure of Chief Financial OfficerPR NewswireBOSTON, Sept. 30, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, to
4y agoMITOStealth BioTherapeutics to Participate in Upcoming Ultra-Rare Disease EventsPR NewswireBOSTON, Sept. 15, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, to
4y agoMITOStealth BioTherapeutics Corp Enters Definitive Agreement for Going Private TransactionPR NewswireBOSTON, Aug. 1, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, ann
4y agoMITOSTEALTH BIOTHERAPEUTICS ANNOUNCES RECEIPT OF NON-COMPLIANCE NOTICE FROM NASDAQPR NewswireBOSTON, July 11, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, ann
4y agoMITOStealth BioTherapeutics Corp Announces Receipt of Preliminary Non-Binding ProposalPR NewswireBOSTON, June 27, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, an
4y agoMITOStealth BioTherapeutics Granted Pre-NDA Meeting for Elamipretide as a Potential Treatment for Barth SyndromePR NewswireType B meeting scheduled with FDA Division of Cardiology and Nephrology Company plans to discuss new clinical data that may inform a potential NDA submission BOSTON, June 14, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clini
4y agoMITOStealth BioTherapeutics Presents New SBT-272 Data Demonstrating Improvement in Upper Motor Neuron Function in ALS Disease Model at Keystone Neurodegeneration SymposiumPR NewswireSBT-272 improved neuronal health, superior to other approved and investigational agents Phase 1 study to evaluate safety and tolerability of SBT-272 in healthy volunteers is underway BOSTON, June 8, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (
4y agoMITOStealth BioTherapeutics Receives Orphan Drug Designation from the European Medicines Agency for Elamipretide for the Treatment of Myopathic Mitochondrial DNA Depletion SyndromePR NewswireOrphan drug designation applies to patients with primary mitochondrial myopathy due to nuclear DNA mutations (nPMM) in the NuPower Phase 3 clinical trial NuPOWER Phase 3 trial is currently enrolling patients with multiple clinical trial sites initiate
4y agoMITOStealth BioTherapeutics Announces Data from the Phase 2 ReCLAIM-2 Study of Elamipretide in Geographic Atrophy at the Clinical Trials at the Summit Meeting 2022PR NewswireNew analysis demonstrates correlation between ellipsoid zone dysfunction and vision BOSTON, May 23, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and comme
4y agoALNA CPNG MITO RIDE+1Thinking about buying stock in Stealth BioTherapeutics, Allena Pharmaceuticals, Salarius Pharmaceuticals, Coupang, or Lordstown Motors?PR NewswireNEW YORK, May 12, 2022 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for MITO, ALNA, SLRX, CPNG, and RIDE. T
4y agoMITOStealth BioTherapeutics Receives Orphan Drug Designation from FDA for Elamipretide for Treatment of Duchenne Muscular DystrophyPR NewswirePre-IND meeting request granted by FDA's Division of Neurology I BOSTON, May 12, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of nov
4y agoMITOSTEALTH BIOTHERAPEUTICS ANNOUNCES DATA FROM RECLAIM-2 PHASE 2 TRIAL OF ELAMIPRETIDE IN GEOGRAPHIC ATROPHYPR NewswireStudy did not meet primary endpoints of mean change in low luminance visual acuity (LLVA) and geographic atrophy (GA) progression Categorical improvement in LLVA, with >15% of elamipretide-treated patients gaining 2+ lines of vision at Week 48 Elami
4y agoMITOStealth BioTherapeutics Announces $8.5 Million in Equity FinancingsPR NewswireBOSTON, April 11, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO) (the "Company"), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial
4y agoMITOStealth BioTherapeutics Announces New SBT-272 Data and Trial InitiationPR NewswireBOSTON, March 30, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, an
4y agoMITOStealth BioTherapeutics Receives Orphan Drug Designation from FDA for Elamipretide for the Treatment of Friedreich's AtaxiaPR NewswirePhase 2a clinical trial in Friedreich's ataxia has been initiated and is currently recruiting patients BOSTON, March 28, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, d
4y agoMITOStealth BioTherapeutics Announces New Data on Complement Gene Expression and Cell Survival in Dry AMD to be Presented at ARVO (2022)PR NewswireBOSTON, March 24, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, an
4y agoMITOStealth BioTherapeutics to Host Virtual Event on the Potential of Elamipretide in Treatment of Geographic Atrophy in Dry Age-Related Macular DegenerationPR NewswireBOSTON, March 17, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, to
4y agoMITOStealth BioTherapeutics Showcases New Duchenne Muscular Dystrophy Nonclinical Data at the 2022 Muscular Dystrophy Association and Clinical and Scientific ConferencePR NewswireBOSTON, March 16, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, to
4y agoMITOStealth BioTherapeutics to Present at Upcoming March Investor ConferencesPR NewswireBOSTON, March 9, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, tod
4y agoMITOStealth BioTherapeutics to Present at Mitochondria-Targeted Drug Development SummitPR NewswireBOSTON, Feb. 22, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, tod
4y agoMITOLast Patient Completes Treatment in Stealth BioTherapeutics' Phase 2 Geographic Atrophy Clinical TrialPR NewswireBOSTON, Feb. 15, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, ann
4y agoMITOStealth BioTherapeutics Receives Nasdaq Notification Regarding Minimum Market Value Of Publicly Held Shares RequirementPR NewswireBOSTON, Feb. 11, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, tod
4y agoMITOStealth BioTherapeutics Announces Oral Presentation of New Duchenne Muscular Dystrophy Data at the 2022 Muscular Dystrophy Association Clinical and Scientific ConferencePR NewswireBOSTON, Feb. 8, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, toda
4y agoMITOStealth BioTherapetuics Receives Nasdaq Notifications Regarding Minimum Bid And Market Value RequirementsPR NewswireBOSTON, Jan. 7, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, toda
4y agoMITOStealth BioTherapeutics to Present at 2022 H.C. Wainwright BioConnect Virtual ConferencePR NewswireBOSTON, Jan. 4, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, toda
4y agoMITOStealth BioTherapeutics Reports Positive Pre-IND Meeting for Duchenne Muscular DystrophyPR NewswireBOSTON, Dec. 20, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, tod
4y agoMITOStealth BioTherapeutics Provides Update On Clinical Stage Rare Disease ProgramsPR NewswireBOSTON, Dec. 13, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, tod
5y agoMITOStealth BioTherapeutics Reports Third Quarter 2021 Financial Results and Recent Business HighlightsPR NewswireBOSTON, Nov. 11, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, tod
5y agoMITOStealth BioTherapeutics to Report Third Quarter Financial Results on Thursday, November 11PR NewswireBOSTON, Nov. 4, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, toda
5y agoMITOStealth BioTherapeutics Receives Refusal to File Letter from the FDAPR NewswireBOSTON, Oct. 20, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, to
5y agoMITOStealth BioTherapeutics Presents Positive SBT-272 Preclinical Data at 2021 Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) MeetingPR NewswireBOSTON, Oct. 7, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, annou
5y agoAVTX HRZN MITOHorizon Technology Finance Provides Third Quarter 2021 Portfolio UpdatePR NewswireFARMINGTON, Conn., Oct. 6, 2021 /PRNewswire/ -- Horizon Technology Finance Corporation (NASDAQ:HRZN) ("HRZN" or the "Company"), a leading specialty finance company that provides capital in the form of secured loans to venture capital backed companies in
5y agoHRZN MITOStealth BioTherapeutics Completes a $25 Million Debt Financing with Horizon Technology FinancePR NewswireBOSTON, Oct. 4, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, toda
5y agoMITOStealth BioTherapeutics Presents Positive Elamipretide Data in Pediatric Cardiology at International Society for Heart Research North American Section Meeting 2021PR NewswireBOSTON, Sept. 28, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, ann
5y agoMITOStealth BioTherapeutics Presents Positive SBT-272 Preclinical Data at International Parkinson and Movement Disorder Society Virtual Congress 2021PR NewswireBOSTON, Sept. 23, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfuncti
5y agoMITOStealth BioTherapeutics to Showcase Leadership in Retinal Mitochondrial Health with Clinical Updates at Ophthalmic ConferencesPR NewswireBOSTON, Sept. 14, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, an
5y agoMITOStealth BioTherapeutics to Present at Upcoming September Virtual Investor ConferencesPR NewswireBOSTON, Sept. 7, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, tod
5y agoMITOStealth BioTherapeutics Submits Elamipretide New Drug Application to FDA for Treatment of Barth SyndromePR NewswireBOSTON, Aug. 24, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, tod
5y agoMITOStealth BioTherapeutics Strengthens IP Portfolio with Issuance of U.S. Patents Covering Elamipretide for Barth SyndromePR NewswireBOSTON, Aug. 23, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, tod
5y agoMITOStealth BioTherapeutics to Present at H.C. Wainwright Ophthalmology Virtual Healthcare ConferencePR NewswireBOSTON, Aug. 11, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, tod
5y agoMITOStealth BioTherapeutics Reports Second Quarter 2021 Financial Results And Recent Business HighlightsPR NewswireBOSTON, Aug. 5, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, toda
5y agoMITOStealth BioTherapeutics to Report Second Quarter Financial Results on Thursday, August 5PR NewswireBOSTON, July 30, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, toda
5y agoMITOStealth BioTherapeutics Joins the Rare Disease Company CoalitionPR NewswireBOSTON, July 7, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (NASDAQ:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, toda
5y agoAPLS MITOCognito Therapeutics Appoints Gerald Chan as Chairman of the BoardBusiness WireCognito Therapeutics, a Phase 3-ready disease-modifying digital therapeutics company, today announced the appointment of Gerald Chan, ScD. as Chairman of the Board. Cognito is a pioneer in using neuromodulation to engage novel targets of neuronal pathop