Stealth BioTherapeutics

accelerated

Biotech

FDA aims for September approval decision for Stealth's drug

The newfound urgency is likely fueled by a public outcry surrounding the FDA's several delays and subsequent refusal of the rare disease candidate.

Gabrielle Masson 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

question ask wonder who why

FDA denies request to reconsider Stealth's ultrarare disease med

Aug 8, 2025 1:58pm

rare diseases

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

red tape delay stop error tie down stall

FDA misses PDUFA date for Stealth’s ultra-rare disease candidate

Apr 30, 2025 9:00am