Stealth BioTherapeutics

red tape delay stop error tie down stall

Biotech

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

An approval decision for Stealth’s ultra-rare disease candidate has been delayed—again. This time, the FDA hasn't set a new date.

Gabrielle Masson Apr 30, 2025 9:00am

FDA stop sign

FDA delays decision on Stealth's ultrarare disease med

Jan 23, 2025 9:45am

FDA Adcomm

After agony, FDA adcomm favors Stealth's ultra-rare disease drug

Oct 10, 2024 6:20pm

stealth cloak mask hide sneaky shady

Stealth handed cloaking device as go-private merger advances

Aug 1, 2022 12:53pm

stealth fighter jets sneak hide

Stealth could get sneakier with Morningside's go-private pitch

Jun 27, 2022 11:00am

boardroom

Stealth granted FDA meeting to revive elamipretide filing

Jun 14, 2022 10:10am