Disc: FDA agrees Phase 3 of bitopertin in EPP can support CRL response, potential traditional approval

 

Disc Medicine gets FDA agreement that Phase 3 APOLLO trial of bitopertin in EPP can support CRL response, potential traditional approval

• Following a Type A meeting, Disc plans to resubmit its CRL response by end-2026.
• FDA decision on bitopertin in EPP is expected by mid-2027.

https://finviz.com/stock?t=IRON&p=d