Biotech Firm Seeks Support After FDA Rejection

Stealth BioTherapeutics, a small biotech company, has taken the rare step of publicly sharing a rejection letter from the FDA. The company aims to gather support for its ultra-rare disease drug, which the FDA did not approve. This move highlights the challenges small biotechs face in gaining regulatory approval for niche treatments. By disclosing the letter, Stealth BioTherapeutics seeks to engage stakeholders and possibly influence future FDA decisions. The company’s strategy underscores the complexities of navigating regulatory pathways for rare disease therapies, where patient advocacy and public support can play crucial roles in the approval process.