Stealth BioTherapeutics Receives Orphan Drug Designation from ...

Priority Review Granted for Stealth BioTherapeutics' Barth ...

However, elamipretide has received Orphan Drug ... Designations from the FDA and Orphan Drug Designation from the EMA for its treatment.

FDA grants orphan drug designation for Duchenne muscular ...

Stealth BioTherapeutics Corp. announced that the FDA has granted orphan drug designation to elamipretide for the treatment of Duchenne ...

Elamipretide Gets Orphan Drug Status for Friedreich Ataxia - MPR

Stealth BioTherapeutics receives Orphan Drug designation from FDA for elamipretide for the treatment of Friedreich's ataxia. News release ...

elamipretide - Barth Syndrome Foundation

September 6th, 2024: FDA announced that the Cardiovascular and Renal Drugs Advisory Committee has scheduled their meeting to review Stealth Biotherapeutic Inc.' ...

FDA accepts filing NDA for elamipretide for the treatment of Barth ...

Stealth BioTherapeutics, a clinical-stage biotechnology ... Orphan Drug Designation in 2018 and Rare Pediatric Disease Designation in 2020.

Stealth BioTherapeutics Completes Mid-Cycle Review Meeting on ...

NEEDHAM, Mass., July 29, 2024 /PRNewswire/ — Stealth BioTherapeutics Inc. ... If approved, elamipretide would be the first therapy for Barth ...

Stealth granted FDA meeting to revive elamipretide filing

Elamipretide is also being tested in primary mitochondrial myopathy, for which it recently received an orphan-drug designation from the European ...

Elamipretide receives orphan drug designation (ODD ... - medicines

https://www.biospace.com/article/releases/stealth-biotherapeutics-receives-orphan-drug-designation-from-the-european-medicines-agency-for-elamipretide-for- ...

FDA advisory committee recommends Stealth's elamipretide for ...

A US Food and Drug Administration (FDA) panel of experts has voted in support of Stealth BioTherapeutics' elamipretide for Barth syndrome.

Orphan Drug List Governing January 1 to March 31, 2019 - HRSA

Orphan Drug Designations and Approvals List as of 6/1/2023. Governs July 1 ... Stealth Biotherapeutics Inc. 139, 138, (R)-2-hydroxy-2-methyl-4-(2,4,5 ...

Musculoskeletal Disorders Archives - Pharmaceutical Business review

Stealth BioTherapeutics has received Orphan Drug Designation from the US Food and Drug Administration (FDA) Office of Orphan Products Development for ...

Elamipretide - Drugs.com

Stealth BioTherapeutics Announces Positive Vote from FDA Advisory Committee Meeting Supporting Potential Approval of Elamipretide for the ...

SRI earns FDA Orphan Drug Designation for pancreatic cancer

“FDA's orphan drug designation brings worthy attention to the demonstrated impact of SRI's TALL biotherapeutic for pancreatic cancer,” said ...

Elamipretide Wins FDA Orphan Drug Designation to Treat DMD

The US Food and Drug Administration (FDA) has granted orphan drug status to elamipretide for treating Duchenne muscular dystrophy (DMD).

Elamipretide Wins FDA Orphan Drug Status, Phase 2 Trial Starts

Stealth BioTherapeutics' lead candidate elamipretide for the treatment of Friedreich's ataxia was granted orphan drug status by the U.S. ...

F-1/A - SEC.gov

We have received Fast Track and Orphan Drug designations from the FDA for the development of elamipretide in this indication. We are conducting a Phase 3 ...

Stealth BioTherapeutics Announces Positive Vote from FDA ...

The NDA for elamipretide was granted priority review and has been assigned a Prescription Drug User Fee Act ("PDUFA") action date of January 29, ...

S-oxprenolol granted orphan drug status by FDA as ALS treatment

“We are pleased to receive orphan drug designation for S-oxprenolol in ALS, where loss of body mass and muscle wasting can have a significant ...

Elamipretide for Barth Syndrome receives priority review designation

Stealth BioTherapeutics, announced that the FDA has now determined that its New Drug ... Elamipretide has previously received Orphan Drug ...

Stealth BioTherapeutics Announces Positive Vote from FDA ...

The NDA for elamipretide was granted priority review and has been assigned a Prescription Drug User Fee Act ("PDUFA") action date of January 29, ...