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INTERVIEW #SpeakPharma
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11 Oct 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/stealth-biotherapeutics-announces-positive-vote-from-fda-advisory-committee-meeting-supporting-potential-approval-of-elamipretide-for-the-treatment-of-barth-syndrome-302273995.html
10 Oct 2024
// ENDPTS
https://endpts.com/fda-again-raises-doubts-on-stealths-ultra-rare-disease-drug-ahead-of-adcomm/
10 Oct 2024
// FIERCE BIOTECH
https://www.fiercebiotech.com/biotech/impossible-fda-adcomm-ends-favor-stealths-ultra-rare-disease-med
27 Sep 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/stealth-biotherapeutics-to-present-at-ubs-virtual-ophthalmology-day-302260755.html
18 Sep 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/stealth-biotherapeutics-presents-new-bevemipretide-sbt-272-data-at-keystone-symposium-targeting-dry-age-related-macular-degeneration-302251010.html
12 Sep 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/stealth-biotherapeutics-announces-participation-at-upcoming-ophthalmology-conferences-302246484.html
Details:
MTP-131 (elamipretide) is an investigational mitochondrial protective agent , which is currently being evaluated for the treatment of patients with Barth syndrome.
Lead Product(s): Elamipretide
Therapeutic Area: Rare Diseases and Disorders Brand Name: Bendavia
Study Phase: Phase II/ Phase IIIProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 10, 2024
Lead Product(s) : Elamipretide
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Stealth BioTherapeutics Announces Positive Vote Supporting Elamipretide For Barth Syndrome
Details : MTP-131 (elamipretide) is an investigational mitochondrial protective agent , which is currently being evaluated for the treatment of patients with Barth syndrome.
Product Name : Bendavia
Product Type : Peptide
Upfront Cash : Inapplicable
November 10, 2024
Details:
MTP-131 (elamipretide) is an investigational mitochondrial protective agent , which is currently being evaluated for the treatment of patients with Barth syndrome.
Lead Product(s): Elamipretide
Therapeutic Area: Rare Diseases and Disorders Brand Name: Bendavia
Study Phase: Phase II/ Phase IIIProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 09, 2024
Lead Product(s) : Elamipretide
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Stealth BioTherapeutics Schedules FDA Advisory Committee Meeting for Elamipretide
Details : MTP-131 (elamipretide) is an investigational mitochondrial protective agent , which is currently being evaluated for the treatment of patients with Barth syndrome.
Product Name : Bendavia
Product Type : Peptide
Upfront Cash : Inapplicable
September 09, 2024
Details:
MTP-131 (elamipretide) is an investigational mitochondrial-targeting peptide agent, which is being evaluated for the treatment of patients with barth syndrome.
Lead Product(s): Elamipretide
Therapeutic Area: Rare Diseases and Disorders Brand Name: Bendavia
Study Phase: Phase II/ Phase IIIProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 04, 2024
Lead Product(s) : Elamipretide
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Stealth Biotherapeutics Announces FDA Acceptance of NDA for Elamipretide in Barth Syndrome
Details : MTP-131 (elamipretide) is an investigational mitochondrial-targeting peptide agent, which is being evaluated for the treatment of patients with barth syndrome.
Product Name : Bendavia
Product Type : Peptide
Upfront Cash : Inapplicable
August 04, 2024
Details:
MTP-131 (elamipretide) is an investigational mitochondrial protective agent , which is currently being evaluated for the treatment of patients with Barth syndrome.
Lead Product(s): Elamipretide
Therapeutic Area: Rare Diseases and Disorders Brand Name: Bendavia
Study Phase: Phase II/ Phase IIIProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 29, 2024
Lead Product(s) : Elamipretide
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Stealth BioTherapeutics Completes Mid-Cycle Review for Elamipretide in Barth Syndrome
Details : MTP-131 (elamipretide) is an investigational mitochondrial protective agent , which is currently being evaluated for the treatment of patients with Barth syndrome.
Product Name : Bendavia
Product Type : Peptide
Upfront Cash : Inapplicable
July 29, 2024
Details:
MTP-131 (elamipretide) is an investigational mitochondrial protective agent being studied for Barth syndrome, designed to interact with cardiolipin in mitochondria.
Lead Product(s): Elamipretide
Therapeutic Area: Rare Diseases and Disorders Brand Name: Bendavia
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 05, 2024
Lead Product(s) : Elamipretide
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Stealth Biotherapeutics' Barth Syndrome NDA Receives Priority Review Designation
Details : MTP-131 (elamipretide) is an investigational mitochondrial protective agent being studied for Barth syndrome, designed to interact with cardiolipin in mitochondria.
Product Name : Bendavia
Product Type : Peptide
Upfront Cash : Inapplicable
July 05, 2024
Details:
MTP-131 (elamipretide) is an investigational mitochondrial-targeting peptide agent, which is being evaluated for the treatment of dry age-related macular degeneration.
Lead Product(s): Elamipretide
Therapeutic Area: Ophthalmology Brand Name: Bendavia
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 06, 2024
Lead Product(s) : Elamipretide
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Stealth BioTherapeutics Enrolls First Patient in Phase 3 Program for Elamipretide in AMD
Details : MTP-131 (elamipretide) is an investigational mitochondrial-targeting peptide agent, which is being evaluated for the treatment of dry age-related macular degeneration.
Product Name : Bendavia
Product Type : Peptide
Upfront Cash : Inapplicable
May 06, 2024
Details:
MTP-131 (elamipretide) is an investigational mitochondrial protective agent which is readily penetrates cell membranes and transiently localizes to the inner membrane of the mitochondria where it interacts with cardiolipin and investigated in Patients with Dry AMD.
Lead Product(s): Elamipretide
Therapeutic Area: Ophthalmology Brand Name: Bendavia
Study Phase: Phase IIProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 06, 2023
Lead Product(s) : Elamipretide
Therapeutic Area : Ophthalmology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : MTP-131 (elamipretide) is an investigational mitochondrial protective agent which is readily penetrates cell membranes and transiently localizes to the inner membrane of the mitochondria where it interacts with cardiolipin and investigated in Patients wi...
Product Name : Bendavia
Product Type : Peptide
Upfront Cash : Inapplicable
December 06, 2023
Details:
The funding will be used to evaluate Stealth's mitochondria-targeted molecule, SBT-272, a novel investigational small molecule that targets cardiolipin, a phospholipid within the inner mitochondrial membrane, for Parkinson's disease
Lead Product(s): SBT-272
Therapeutic Area: Neurology Brand Name: SBT-272
Study Phase: Phase IProduct Type: Other Large Molecule
Sponsor: Michael J. Fox Foundation for Parkinson’s Research
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Funding September 08, 2023
Details : The funding will be used to evaluate Stealth's mitochondria-targeted molecule, SBT-272, a novel investigational small molecule that targets cardiolipin, a phospholipid within the inner mitochondrial membrane, for Parkinson's disease
Product Name : SBT-272
Product Type : Other Large Molecule
Upfront Cash : Undisclosed
September 08, 2023
Details:
Pharmanovia will commercialize MTP-131 (elamipretide), an investigational mitochondrial protective agent, in Europe for the treatment of Barth syndrome, an ultra-rare cardiac condition caused by mitochondrial cardiolipin deficiency for which there are no approved treatments.
Lead Product(s): Elamipretide
Therapeutic Area: Rare Diseases and Disorders Brand Name: Bendavia
Study Phase: Phase IIIProduct Type: Peptide
Sponsor: Pharmanovia
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 30, 2023
Lead Product(s) : Elamipretide
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Pharmanovia
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Pharmanovia will commercialize MTP-131 (elamipretide), an investigational mitochondrial protective agent, in Europe for the treatment of Barth syndrome, an ultra-rare cardiac condition caused by mitochondrial cardiolipin deficiency for which there are no...
Product Name : Bendavia
Product Type : Peptide
Upfront Cash : Undisclosed
May 30, 2023
Details:
MTP-131 (elamipretide), is a peptide compound that readily penetrates cell membranes, and targets the inner mitochondrial membrane where it binds reversibly to cardiolipin.
Lead Product(s): Elamipretide
Therapeutic Area: Genetic Disease Brand Name: Bendavia
Study Phase: Phase IProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 05, 2022
Lead Product(s) : Elamipretide
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : MTP-131 (elamipretide), is a peptide compound that readily penetrates cell membranes, and targets the inner mitochondrial membrane where it binds reversibly to cardiolipin.
Product Name : Bendavia
Product Type : Peptide
Upfront Cash : Inapplicable
December 05, 2022
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