FDA Grants Orphan Drug Designation to Elamipretide for DMD

FDA grants orphan drug designation for Duchenne muscular ...

announced that the FDA has granted orphan drug designation to elamipretide for the treatment of Duchenne muscular dystrophy. The company ...

Stealth BioTherapeutics Receives Orphan Drug Designation from ...

We believe our lead product candidate, elamipretide, has the potential to treat ophthalmic diseases entailing mitochondrial dysfunction, such as ...

Elamipretide Wins FDA Orphan Drug Designation to Treat DMD

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

Search Orphan Drug Designations and Approvals - FDA

Elamipretide HCl · 05/10/2022 · Treatment of Duchenne Muscular Dystrophy · Designated · Not FDA Approved for Orphan Indication.

FDA Grants Elamipretide Orphan Drug Designation for Duchenne ...

The Food and Drug Administration (FDA) has granted elamipretide (Bendavia; Stealth BioTherapeutics, Cayman Islands) orphan drug designation ...

FDA Grants Orphan Drug Designation to Elamipretide for DMD

The FDA granted Orphan Drug Designation to Stealth BioTherapeutic's elamipretide for patients with Duchenne muscular dystrophy (DMD).

FDA Grants Elamipretide Orphan Drug Designation for Duchenne ...

"We are pleased that the FDA has recognized the high unmet need for innovative treatments for Friedreich ataxia and DMD," said chief executive officer Reenie ...

FDA Grants Orphan Drug Designation to Elamipretide for DMD ...

The FDA has recently granted the Orphan Drug designation to elamipretide, an investigational treatment for Duchenne muscular dystrophy (DMD).

Stealth receives orphan drug designation for elamipretide to treat DMD

Stealth BioTherapeutics has received Orphan Drug Designation from the US FDA to treat Duchenne muscular dystrophy (DMD) patients.

Stealth Clinches Orphan Drug Designation in DMD - BioSpace

Stealth BioTherapeutics has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for elamipretide.

FDA Grants Orphan Drug Designation to Stealth BioTherapeutics ...

Elamipretide, which treats muscle weakness caused by mitochondrial disease, has received FDA Orphan Drug Designation.

Stealth BioTherapeutics Shares Rally following FDA Orphan Drug ...

Stealth BioTherapeutics Shares Rally following FDA Orphan Drug Designation To Elamipretide For Duchenne muscular dystrophy (DMD). by ...

Elamipretide Clinical Studies and Trials - Stealth BioTherapeutics

We have received Fast Track and Orphan Drug designation from the FDA for the development of elamipretide in this indication. The U.S. Food and Drug ...

FDA Grants Orphan Drug Designation to Becker and Duchenne ...

The newly applied orphan drug designation will allow Ractigen greater development incentives, including a 7-year marketing exclusivity from the ...

MMIT Reality Check on Duchenne Muscular Dystrophy (August 2022)

FDA Grants Orphan Drug Designation for Elamipretide. In May 2022, the FDA granted orphan drug designation to Stealth BioTherapeutics Corp.'s ...

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. ...

Plans Advancing for DMD Trial of Elamipretide in Aiding Cardiac ...

A branch of the U.S. Food and Drug Administration (FDA) known as the Division of Cardiology and Nephrology has given positive feedback to ...

MMIT Reality Check on Duchenne Muscular Dystrophy (3Q2023)

In May 2022, the FDA granted orphan drug designation to Stealth BioTherapeutics Corp.'s elamipretide for the treatment of patients with Duchenne ...

FDA Grants Orphan Drug Designation to Ifetroban for Treatment of ...

Key Takeaways · Ifetroban received FDA orphan drug and rare pediatric disease designations for cardiomyopathy in Duchenne muscular dystrophy.

Stealth BioTherapeutics Granted Orphan Drug Designation For ...

In November 2017, Stealth announced that the FDA granted Fast Track designation for elamipretide for the treatment of Barth syndrome. For ...