IPS HEART's iPSC-Derived Cell Therapy, ISX9-CPC, Secures 8th FDA Regulatory Milestone

Reports

2

Domains carrying it

2

First reported

6 August 2026

Latest report

17 August 2026

◆ Sectors

◆ Where

United States

◆ Timeline

1. 6 August 2026IPS HEART Secures 8th FDA Regulatory Milestone with Rare Pediatric Drug Designation for ...biospace.com
2. 17 August 2026IPS HEART's iPSC-Derived Cell Therapy, ISX9-CPC, Secures 8th FDA Regulatory Milestonebioinformant.com

◆ Connected developments

Situations Wire finds semantically close to this one. Proximity, not cause.

• Capricor soars on potential FDA review extension, filing amendments9 reports · 6 domains · 25 August 2026
• Regeneron Pharmaceuticals Announces FDA Approval of Pasatru for Adults With ...11 reports · 8 domains · 31 August 2026
• Safety concerns spur FDA to again halt testing of Regenxbio gene therapy3 reports · 3 domains · 31 August 2026
• FDA Allows First Gene Therapy Clinical Trial for Ultra-Rare Pediatric Neurodegenerative Disease2 reports · 2 domains · 4 September 2026
• Lexeo's PKP2 cardiomyopathy gene therapy adds RMAT status3 reports · 3 domains · 11 August 2026
• Pasatru's FDA Approval Puts Regeneron's Rare-Disease Playbook To The Test2 reports · 2 domains · 22 August 2026

◆ Share

◆ Evidence

2 reports · 2 domains

• IPS HEART's iPSC-Derived Cell Therapy, ISX9-CPC, Secures 8th FDA Regulatory Milestonebioinformant.com · 17 August 2026
• IPS HEART Secures 8th FDA Regulatory Milestone with Rare Pediatric Drug Designation for ...biospace.com · 6 August 2026