From Setback to Breakthrough: A CEO’s Journey to a First-in-Class Approval with Reenie McCarthy episode artwork

EPISODE · Jul 7, 2026 · 36 MIN

From Setback to Breakthrough: A CEO’s Journey to a First-in-Class Approval with Reenie McCarthy

from Clinical Trialblazers · host Parexel

In this episode of Clinical Trialblazers, host Alberto Grignolo sits down with Reenie McCarthy, the CEO of Mighty Therapeutics, formerly known as Stealth BioTherapeutics. Reenie shares her path from venture investor to biotech CEO and the years-long effort to develop and secure approval for a first-in-class therapy targeting mitochondrial dysfunction. She discusses the scientific, regulatory, and funding challenges of advancing a novel treatment through clinical development, as well as the critical role of patient advocacy and the lessons learned from setbacks that ultimately helped shape the company's success. The conversation also explores the future of mitochondrial medicine and Mighty Therapeutics' mission to bring innovative treatments to patients with serious unmet needs.   We hope you enjoyed this week’s episode of Clinical Trialblazers. Please take a moment to rate and review this podcast wherever you listen.Special thanks to our production partner, Wonder Media Network. Our producer is Brittany Martinez, our editor is Gianna Palmer and our production assistant is Joia Putnoi.

Episode metadata supplied by the publisher feed · Published Jul 7, 2026

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In this episode of Clinical Trialblazers, host Alberto Grignolo sits down with Reenie McCarthy, the CEO of Mighty Therapeutics, formerly known as Stealth BioTherapeutics. Reenie shares her path from venture investor to biotech CEO and the years-long effort to develop and secure approval for a first-in-class therapy targeting mitochondrial dysfunction. She discusses the scientific, regulatory, and funding challenges of advancing a novel treatment through clinical development, as well as the critical role of patient advocacy and the lessons learned from setbacks that ultimately helped shape the company's success. The conversation also explores the future of mitochondrial medicine and Mighty Therapeutics' mission to bring innovative treatments to patients with serious unmet needs.

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From Setback to Breakthrough: A CEO’s Journey to a First-in-Class Approval with Reenie McCarthy

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