Stealth BioTherapeutics

rare diseases
Biotech

Stealth CEO questions FDA rejection of rare disease drug

“We are kind of hanging on by our fingernails here to try to bring this drug to the patient community,” Stealth CEO Reenie McCarthy told Fierce Biotech.
Gabrielle Masson 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
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