Stealth BioTherapeutics

Image of a neon sign with the word no lit up next to an unlit yes

FDA rejects another ultrarare disease prospect

The biotech’s investigational product is designed to treat an extraordinarily rare genetic metabolic disorder that impacts fewer than 1,000 Americans.

Gabrielle Masson Sep 8, 2025 10:59am

FDA aims for September approval decision for Stealth's drug

Aug 21, 2025 10:15am

Start Again written on a chalkboard on wooden table

Stealth Bio submits rare disease application for the third time

Aug 18, 2025 11:08am

FDA denies request to reconsider Stealth's ultrarare disease med

Aug 8, 2025 1:58pm

Stealth CEO questions FDA rejection of rare disease drug

May 29, 2025 2:27pm

Graphic image of a red thumbs down against a blue background

Stealth hit by FDA rejection to twice-delayed filing

May 29, 2025 7:46am