• Elamipretide to treat Barth syndrome sees FDA target action delay Contemporary Pediatrics Wed, 30 Apr 2025 16:04:43 GMT
• FDA misses decision deadline on Stealth’s Barth syndrome drug The Pharma Letter Wed, 30 Apr 2025 15:54:33 GMT
• FDA misses approval deadline for biotech’s rare disease drug BioPharma Dive Wed, 30 Apr 2025 02:44:36 GMT
• FDA decision on Stealth's Barth syndrome drug delayed, again FirstWord Pharma Tue, 29 Apr 2025 20:00:20 GMT
• fda misses approval deadline for biotech’s rare disease drug BioPharma Dive Tue, 29 Apr 2025 16:21:09 GMT
• UPDATE: FDA misses PDUFA date for Stealth’s ultra-rare disease candidate, delaying approval decision—again Fierce Biotech Tue, 29 Apr 2025 14:12:16 GMT
• fda misses pdufa date for stealth’s ultra-rare disease candidate, delaying approval decision—again Fierce Biotech Tue, 29 Apr 2025 13:54:36 GMT
• Amid FDA chaos, approval of a rare disease drug gets delayed — again statnews.com Tue, 29 Apr 2025 10:32:06 GMT
• FDA delays decision on Stealth BioTherapeutics' rare genetic disorder drug Arizona Daily Sun Tue, 29 Apr 2025 10:04:00 GMT
• Stealth BioTherapeutics Announces Delay in FDA Action Date for Barth Syndrome Application PR Newswire Tue, 29 Apr 2025 10:00:00 GMT
• fda delays pdufa date for small biotech, raising questions about impact of agency cuts Endpoints News Tue, 29 Apr 2025 10:00:00 GMT
• Stealth BioTherapeutics to Present New Bevemipretide Data at ARVO Annual Meeting Yahoo Finance Thu, 24 Apr 2025 07:00:00 GMT
• optic neuropathy therapeutics market size in 7mm is expected openPR.com Tue, 15 Apr 2025 06:22:46 GMT
• stealth biotherapeutics announces achievement of 50% enrollment target in phase 3 renew study of elamipretide in patients with dry... mx.advfn.com Fri, 11 Apr 2025 17:12:34 GMT
• Dry AMD Therapeutics Market Size in 7MM is expected to grow at openPR.com Fri, 11 Apr 2025 07:00:00 GMT
• fda approves diazoxide choline extended-release tablets for hyperphagia in prader-willi syndrome Contemporary Pediatrics Wed, 26 Mar 2025 07:00:00 GMT
• stealth biotherapeutics reaches 50 percent enrollment target in phase 3 renew study Ophthalmology Times Mon, 17 Mar 2025 13:35:18 GMT
• Stealth BioTherapeutics Announces Achievement of 50% Enrollment Target in Phase 3 ReNEW Study of Elamipretide in Patients with Dry... PR Newswire Thu, 13 Mar 2025 07:00:00 GMT
• fda approves surgifort human milk-based fortifier for term infants after gastroschisis surgery Contemporary Pediatrics Tue, 25 Feb 2025 08:00:00 GMT
• fda accepts new drug application for vatiquinone to treat friedreich's ataxia Contemporary Pediatrics Wed, 19 Feb 2025 08:00:00 GMT
• weekly review: several key fda approvals, new puzzler case, and more Contemporary Pediatrics Mon, 17 Feb 2025 08:00:00 GMT
• fda accepts bla for lerodalcibep for lowering ldl-cholesterol in patients with ascvd Contemporary Pediatrics Mon, 10 Feb 2025 08:00:00 GMT
• fda grants rezpegaldesleukin fast track to treat moderate, severe atopic dermatitis Contemporary Pediatrics Mon, 10 Feb 2025 08:00:00 GMT
• fda grants abo-101 orphan, rare pediatric designations to treat primary hyperoxaluria type 1 Contemporary Pediatrics Wed, 05 Feb 2025 08:00:00 GMT
• Stealth faces another hurdle as FDA delays decision on Barth syndrome drug Pharmaceutical Technology Fri, 24 Jan 2025 08:00:00 GMT
• Stealth BioTherapeutics Announces PDUFA Action Date Extension for Elamipretide to Treat Patients with Barth Syndrome PR Newswire Thu, 23 Jan 2025 08:00:00 GMT
• FDA delays decision on Stealth's 2nd shot at approval for ultrarare disease med Fierce Biotech Thu, 23 Jan 2025 08:00:00 GMT
• FDA decision for Stealth's Barth syndrome drug pushed to April FirstWord Pharma Thu, 23 Jan 2025 08:00:00 GMT
• fda delays decision on stealth’s barth syndrome drug; targetrx raises $50m Endpoints News Thu, 23 Jan 2025 08:00:00 GMT
• fda expands immobilized lipase cartridge clearance down to 1 year Contemporary Pediatrics Thu, 16 Jan 2025 08:00:00 GMT
• stealth biotherapeutics : announces positive results for elamipretide in ophthalmic conditions Marketscreener.com Wed, 25 Dec 2024 16:40:06 GMT
• stealth biotherapeutics announces participation at upcoming ophthalmology conferences The Eastern Progress Online Tue, 10 Dec 2024 17:43:39 GMT
• fda accepts bla resubmission for pz-cel to treat recessive dystrophic epidermolysis bullosa Contemporary Pediatrics Wed, 13 Nov 2024 08:00:00 GMT
• mitochondrial-based therapeutics market investments analysis 2024-2031 InsightAce Analytic Tue, 12 Nov 2024 08:00:00 GMT
• The Practice-Changing Drugs That Will Graduate In 2025 insights.citeline.com Mon, 04 Nov 2024 08:00:00 GMT
• petri dish: takeda splits from wave; lilly backs alzheimer’s biotech The Business Journals Thu, 17 Oct 2024 07:00:00 GMT
• fda advisory committee recommends stealth’s elamipretide for barth syndrome PMLiVE Tue, 15 Oct 2024 07:00:00 GMT
• fda panel supports approval of stealth’s elamipretide The Pharma Letter Mon, 14 Oct 2024 07:00:00 GMT
• stealth’s advisory committee meeting showcases power of patient voice BioCentury Mon, 14 Oct 2024 07:00:00 GMT
• stealth’s elamipretide gains fda advisory committee support for barth syndrome Pharmaceutical Business Review Mon, 14 Oct 2024 07:00:00 GMT
• Stealth Wins Adcomm’s Unexpected Support for Ultra-Rare Disease Drug Candidate BioSpace Fri, 11 Oct 2024 07:00:00 GMT
• Stealth BioTherapeutics Announces Positive Vote from FDA Advisory Committee Meeting Supporting Potential Approval of Elamipretide ... PR Newswire Fri, 11 Oct 2024 07:00:00 GMT
• Stealth BioTherapeutics CEO discusses surprise adcomm support for ultra-rare disease drug Endpoints News Fri, 11 Oct 2024 07:00:00 GMT
• fda adcom votes in favour of stealth’s barth syndrome drug Pharmaceutical Technology Fri, 11 Oct 2024 07:00:00 GMT
• stealth’s elamipretide gets us fda panel nod, but not a glowing endorsement, for barth syndrome Citeline News & Insights Fri, 11 Oct 2024 07:00:00 GMT
• stealth’s elamipretide: is a new preapproval trial feasible? Citeline News & Insights Fri, 11 Oct 2024 07:00:00 GMT
• 'Impossible' FDA adcomm ends in favor of Stealth’s ultra-rare disease med Fierce Biotech Thu, 10 Oct 2024 07:00:00 GMT
• adcom gives nod to stealth’s elamipretide despite uncertainties BioWorld Online Thu, 10 Oct 2024 07:00:00 GMT
• Stealth’s Ultrarare Disease Candidate Might Not Meet Bar for Approval: FDA BioSpace Wed, 09 Oct 2024 07:00:00 GMT
• FDA Reviewers Cast Doubt on Drug Candidate for Barth Syndrome MedPage Today Wed, 09 Oct 2024 07:00:00 GMT
• Traditional randomized trials don’t work for ultra-rare diseases like Barth syndrome statnews.com Wed, 09 Oct 2024 07:00:00 GMT
• fda again raises doubts on stealth’s ultra-rare disease drug ahead of adcomm Endpoints News Tue, 08 Oct 2024 07:00:00 GMT
• stealth’s elamipretide efficacy in barth syndrome not shown, us fda says Citeline Tue, 08 Oct 2024 07:00:00 GMT
• angela chun, med, md, faap, highlights key red herrings in pediatric joint pain Contemporary Pediatrics Mon, 07 Oct 2024 07:00:00 GMT
• Stealth BioTherapeutics to Present at UBS Virtual Ophthalmology Day PR Newswire Fri, 27 Sep 2024 07:00:00 GMT
• fda approves arimoclomol as first drug to treat neimann-pick disease, type c Contemporary Pediatrics Fri, 20 Sep 2024 07:00:00 GMT
• Stealth BioTherapeutics Presents New Bevemipretide (SBT-272) Data at Keystone Symposium Targeting Dry Age-Related Macular Degenera... PR Newswire Wed, 18 Sep 2024 07:00:00 GMT
• stealth biotherapeutics announces participation at upcoming ophthalmology conferences PR Newswire Thu, 12 Sep 2024 07:00:00 GMT
• grant supports early studies of sbt-589 for friedreich’s ataxia BioWorld Online Thu, 12 Sep 2024 07:00:00 GMT
• Stealth BioTherapeutics Awarded Grant from Friedreich's Ataxia Research Alliance to Develop Investigational Mitochondrial Therapeu... PR Newswire Wed, 11 Sep 2024 07:00:00 GMT
• stealth biotherapeutics announces fda advisory committee meeting to review elamipretide for barth syndrome treatment PR Newswire Mon, 09 Sep 2024 07:00:00 GMT
• Nuntius Therapeutics Emerges from Stealth, Announces Taiho Pharmaceutical Partnership Genetic Engineering and Biotechnology News Fri, 16 Aug 2024 07:00:00 GMT
• stealth biotherapeutics announces participation at upcoming ophthalmology conferences Longview News-Journal Thu, 15 Aug 2024 14:54:54 GMT
• fda approves axatilimab-csfr to treat graft-versus-host disease Contemporary Pediatrics Wed, 14 Aug 2024 07:00:00 GMT
• stealth biotherapeutics completes mid-cycle review meeting on elamipretide for the treatment of barth syndrome PR Newswire Mon, 29 Jul 2024 07:00:00 GMT
• fda approves ustekinumab-ttwe as biosimilar for pediatric plaque psoriasis, active psoriatic arthritis Contemporary Pediatrics Tue, 09 Jul 2024 07:00:00 GMT
• stealth biotherapeutics | biotechnology | the pharmaletter The Pharma Letter Fri, 05 Jul 2024 15:35:19 GMT
• stealth biotherapeutics corp to hold extraordinary general meeting of shareholders Quantisnow Fri, 05 Jul 2024 04:43:09 GMT
• stealth biotherapeutics announces receipt of non-compliance notice from nasdaq Quantisnow Fri, 05 Jul 2024 04:29:45 GMT
• video: phase 3 dry amd trial focuses on protecting photoreceptors Healio Wed, 03 Jul 2024 07:00:00 GMT
• mirdametinib nda submitted to treat children, adults with nf1-pn Contemporary Pediatrics Tue, 02 Jul 2024 07:00:00 GMT
• reclaim-2 shows potential of elamipretide for geographic atrophy in dry amd MD Magazine Mon, 01 Jul 2024 07:00:00 GMT
• stealth biotherapetuics receives nasdaq notifications regarding minimum bid and market value requirements Quantisnow Sun, 30 Jun 2024 07:01:39 GMT
• stealth biotherapeutics receives refusal to file letter from the fda Quantisnow Sun, 30 Jun 2024 06:46:11 GMT
• stealth biotherapeutics receives nasdaq notification regarding minimum market value of publicly held shares ... Quantisnow Sun, 30 Jun 2024 04:49:49 GMT
• stealth biotherapeutics to present at h.c. wainwright ophthalmology virtual healthcare conference Quantisnow Sun, 30 Jun 2024 04:23:55 GMT
• stealth biotherapeutics to present at jefferies virtual healthcare conference Quantisnow Sun, 30 Jun 2024 04:22:54 GMT
• stealth biotherapeutics presents positive sbt-272 preclinical data at 2021 annual northeast amyotrophic lateral ... Quantisnow Sun, 30 Jun 2024 03:54:59 GMT
• stealth biotherapeutics announces $8.5 million in equity financings Quantisnow Sun, 30 Jun 2024 03:13:17 GMT
• stealth biotherapeutics joins the rare disease company coalition Quantisnow Sun, 30 Jun 2024 01:59:04 GMT
• stealth biotherapeutics submits elamipretide new drug application to fda for treatment of barth syndrome Quantisnow Sun, 30 Jun 2024 01:33:34 GMT
• stealth biotherapeutics to present at mitochondria-targeted drug development summit Quantisnow Sun, 30 Jun 2024 01:30:47 GMT
• stealth biotherapeutics to showcase leadership in retinal mitochondrial health with clinical updates at ophthalmic ... Quantisnow Sun, 30 Jun 2024 01:30:37 GMT
• stealth biotherapeutics reports positive pre-ind meeting for duchenne muscular dystrophy Quantisnow Sun, 30 Jun 2024 01:30:25 GMT
• stealth biotherapeutics presents positive elamipretide data in pediatric cardiology at international society for heart ... Quantisnow Sun, 30 Jun 2024 01:29:53 GMT
• stealth biotherapeutics showcases new duchenne muscular dystrophy nonclinical data at the 2022 muscular ... Quantisnow Sun, 30 Jun 2024 01:29:51 GMT
• stealth biotherapeutics receives orphan drug designation from fda for elamipretide for the treatment of friedreich's ataxia Quantisnow Sun, 30 Jun 2024 01:29:44 GMT
• stealth biotherapeutics to host virtual event on the potential of elamipretide in treatment of geographic atrophy in ... Quantisnow Sun, 30 Jun 2024 01:29:15 GMT
• Advancing Elamipretide into Phase 3 ReNEW and ReGAIN Trials HCP Live Fri, 28 Jun 2024 07:00:00 GMT
• Exsilio Therapeutics Emerges from Stealth with $82 Million Series A Financing to Develop Redosable Genomic Medicines SynBioBeta Tue, 25 Jun 2024 07:00:00 GMT
• geographic atrophy drug market report 2034: epidemiology, latest fda approvals | aviceda therapeutics, iveric bio ... openPR Wed, 12 Jun 2024 15:19:00 GMT
• stealth biotherapeutics announces departure of chief financial officer Barchart Tue, 11 Jun 2024 15:15:00 GMT
• Stealth BioTherapeutics enrols first subject in dry AMD treatment trial Clinical Trials Arena Thu, 06 Jun 2024 07:00:00 GMT
• Stealth BioTherapeutics Announces First Patient Enrolled in Global Phase 3 Clinical Program for Elamipretide in Patients with Dry ... PR Newswire Wed, 05 Jun 2024 07:00:00 GMT
• alexion (alxn) collaborates with stealth biotherapeutics - yahoo sport Yahoo Sport Australia Sun, 19 May 2024 07:00:00 GMT
• brief-stealth biotherapeutics files for u.s. ipo of up to $86.3 mln Yahoo Lifestyle UK Sat, 18 May 2024 04:23:37 GMT
• everylife foundation announces scientific workshop on 'ultra-rare' diseases Morningstar Thu, 16 May 2024 07:00:00 GMT
• aacr annual meeting 2017 - stealth biotherapeutics The Pharma Letter Thu, 09 May 2024 16:00:14 GMT
• aacr annual meeting 2018 - rare diseases, stealth biotherapeutics The Pharma Letter Wed, 08 May 2024 11:03:07 GMT
• STEALTH BIOTHERAPEUTICS' BARTH SYNDROME NDA RECEIVES PRIORITY REVIEW DESIGNATION PR Newswire Tue, 07 May 2024 07:00:00 GMT
• stealth biotherapeutics to present at jmp citizens life sciences conference PR Newswire Mon, 06 May 2024 07:00:00 GMT
• stealth biotherapeutics (mito) sees hammer chart pattern: time to buy? Yahoo Movies Canada Thu, 02 May 2024 22:00:00 GMT
• stealth biotherapeutics announces participation at upcoming ophthalmology conferences BioSpace Wed, 01 May 2024 07:00:00 GMT
• [key companies] mitochondrial disease therapeutics market | santhera pharmaceuticals, reata pharmaceuticals ... Motions Online Tue, 30 Apr 2024 01:55:10 GMT
• mitochondrial myopathies industry startegy analysis} reata pharmaceuticals, stealth biotherapeutics, raptor ... Motions Online Mon, 29 Apr 2024 23:14:30 GMT
• aacr annual meeting 2018 - stealth biotherapeutics The Pharma Letter Mon, 29 Apr 2024 04:42:05 GMT
• impasse at us fda could mean stealth abandons barth syndrome treatment Pink Sheet Sun, 21 Apr 2024 16:19:17 GMT
• stealth’s elamipretide gets us fda review, but same questions linger Pink Sheet Sun, 21 Apr 2024 02:01:43 GMT
• stealth's elamipretide gets us fda review, but same questions linger Pink Sheet Sun, 21 Apr 2024 02:01:43 GMT
• pink sheet podcast: us fda adcomm open public hearings, clinical trial diversity plans, stealth's elamipretide ... Pink Sheet Fri, 12 Apr 2024 19:33:03 GMT
• ischemia reperfusion injury market is predicted to exhibit remarkable growth during the forecast period (2023-2032 ... Barchart Fri, 12 Apr 2024 14:14:00 GMT
• fda’s acceptance of stealth nda could be sign of improved orphan regulation BioCentury Tue, 09 Apr 2024 07:00:00 GMT
• fda's acceptance of stealth nda could be sign of improved orphan regulation BioCentury Tue, 09 Apr 2024 07:00:00 GMT
• STEALTH BIOTHERAPEUTICS ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR ELAMIPRETIDE FOR THE TREATMENT OF BARTH SYNDROME PR Newswire Mon, 08 Apr 2024 07:00:00 GMT
• FDA agrees to review a rare disease drug that its developer was about to give up on statnews.com Mon, 08 Apr 2024 07:00:00 GMT
• stealth bio gets fda adcomm for previously rejected ultra-rare disease drug Endpoints News Mon, 08 Apr 2024 07:00:00 GMT
• Barth Syndrome investigation: Families of children with rare, life-threatening disease push FDA to review drug application ABC7 New York Wed, 27 Mar 2024 07:00:00 GMT
• Nipocalimab receives Fast Track Designation to treat FNAIT Contemporary Pediatrics Tue, 26 Mar 2024 07:00:00 GMT
• novel compound seen to ease heart muscle disease in fa models Friedreich's Ataxia News Tue, 26 Mar 2024 07:00:00 GMT
• sbt-589 shows cardioprotective effects in mouse model of fa cardiomyopathy BioWorld Online Wed, 20 Mar 2024 07:00:00 GMT
• Stealth BioTherapeutics Presents Data of Novel Compound, SBT-589, in Friedreich's Ataxia Cardiac Models at the Wellcome Trust Mito... PR Newswire Tue, 19 Mar 2024 07:00:00 GMT
• key takeaways from the davio 2 study with rishi singh, md Modern Retina Tue, 19 Mar 2024 07:00:00 GMT
• [key companies] mitochondrial disease therapeutics market | santhera pharmaceuticals, reata pharmaceuticals ... Amoré Tue, 19 Mar 2024 04:14:50 GMT
• barth syndrome investigation: families of children with rare, life-threatening disease push fda to review drug application ABC7 New York Sat, 16 Mar 2024 07:00:00 GMT
• kenai emerges from stealth with $82m series a, targets parkinson’s BioSpace Fri, 01 Mar 2024 08:00:00 GMT
• dry age-related macular degeneration pipeline insights report 2024 | molecular partners, stealth biotherapeutics ... MENAFN.COM Wed, 21 Feb 2024 08:08:01 GMT
• rexlemestrocel-l for children with hlhs receives orphan-drug designation Contemporary Pediatrics Thu, 15 Feb 2024 08:00:00 GMT
• mitochondrial myopathies market size [2023-2029] -reata pharmaceuticals, stealth biotherapeutics, raptor ... Rough Cut Reviews Mon, 08 Jan 2024 07:29:11 GMT
• claris bio emerges from stealth with a new investor and GlobeNewswire Thu, 04 Jan 2024 08:00:00 GMT
• mitochondrial disorders treatment market developments 2029 |khondrion, mitobridge, neurovive pharmaceutical ... Argyle Report Wed, 20 Dec 2023 13:22:00 GMT
• 'We’ve exhausted all avenues': A small biotech may give up on its ultra-rare disease drug over frustration with FDA statnews.com Mon, 18 Dec 2023 08:00:00 GMT
• the legal pathway for experimental, ultra-rare disease treatments is rocky and expensive STAT Mon, 18 Dec 2023 08:00:00 GMT
• 'we've exhausted all avenues': a small biotech may give up on its ultra-rare disease drug over frustration with fda STAT Mon, 18 Dec 2023 08:00:00 GMT
• readout newsletter: illumina, structure therapeutics, point news STAT Mon, 18 Dec 2023 08:00:00 GMT
• mitochondrial stabilizers may play a role in treatment of dry amd Healio Tue, 12 Dec 2023 08:00:00 GMT
• mitochondrial myopathies market is booming in the globe by 2029 |reata, stealth biotherapeutics, raptor, raym ... Argyle Report Fri, 08 Dec 2023 00:29:12 GMT
• geographic atrophy pipeline analysis, 2023 updates | latest fda, ema, and pmda approvals | annexon ... Digital Journal Wed, 06 Dec 2023 16:18:22 GMT
• mitochondrial disorders treatment market sees huge growth for new normal: launching new countries |khondrion ... salisburyandstonehenge Tue, 05 Dec 2023 01:50:36 GMT
• stealth biotherapeutics to present at the baird 2023 biotech discovery series PR Newswire Mon, 04 Dec 2023 08:00:00 GMT
• the week's 10 biggest funding rounds: databank and bluevoyant ... Crunchbase News Fri, 01 Dec 2023 17:36:32 GMT
Stealth BioTherapeutics Corp(NASDAQ:MITO) 
Stealth BioTherapeutics Corp, a clinical-stage biotechnology company, focuses on the discovery, development, and commercialization of therapies for diseases involving mitochondrial dysfunction. Its lead product candidate, Elamipretide, has the potential to treat rare genetic and common age-related m...
Website: http://www.stealthbt.com
Founded: 2006
Full Time Employees: 29 (May 2021)
Sector: Healthcare
Industry: Biotechnology