Cue the Music - Type A Meeting Sets Stage for APOLLO Use as CRL Resubmission

研报英文原文证据摘录

Cue the Music - Type A Meeting Sets Stage for APOLLO Use as CRL Resubmission

June 9, 2026 | 09:35 ET~

Disc Medicine Biotechnology

Evan David Seigerman Analyst

evan.seigerman@bmo.com (212) 444-4328

IRON-NSDQ Rating Price: Jun-8 Target Total Rtn

Outperform $65.80 $100.00 52% Malcolm Hoffman, CFA VP Associate

malcolm.hoffman@bmo.com (646) 438-2627

Conor MacKay VP Associate

conor.mackay@bmo.com (347) 988-4235

Legal Entity: BMO Capital Markets Corp.Cue the Music - Type A Meeting Sets Stage for

APOLLO Use as CRL Resubmission

Bottom Line:

Disc and FDA align on use of APOLLO to satisfy CRL, potentially clearing a path 2YR Price Volume Chart

to a full approval submission. Alignment with FDA was likely largely assumed by 100

investors, but we still see the Type A meeting announcement as a positive for the 90

company, lowering regulatory uncertainty and setting a clear path where APOLLO could 70

be used for an FDA resubmission. If positive and submitted, APOLLO data could position 60 65

50 3Disc for commercial approval in mid-2027. 4

40 2

Key Points 30 Dec Jun Dec Jun 0

LHS: Price ($) / RHS: Volume (mm) Source: FactSet

Alignment with FDA on pivotal APOLLO trial is a noted positive for Disc Medicine,

providing more confidence in the regulatory path for bitopertin. Disc Medicine

management indicated that following the company's Type A meeting with FDA, they

have reached an agreement with the administration that the Ph 3 APOLLO trial is

potentially able to provide data sufficient to respond to the company's outstanding

CRL. The trial can also be used to support a full approval, pending positive results. We

are largely unsurprised Disc and FDA reached alignment on the use of APOLLO for a

CRL response and potential approval, but such a decision is an incremental positive to