Optimistic For A Timely Apitegromab Approval Following Our Meeting With Management

Research evidence excerpt

Optimistic For A Timely Apitegromab Approval Following Our Meeting With Management

June 17, 2026

●Scholar Rock indicated that there could be several potential

paths if Catalent remains OAI, including EMA sending its own

inspectors to the Catalent facility, or pivoting to the second U.S.-

based fill-finish facility without need for restarting the clock.

●Based on our conversation with management, the EMA is aware

of the Form 483 observations at Catalent Indiana, and is waiting

for further clarity from the FDA as its first course of action.

●While the second fill-finish facility is not formally part of the MAA,

the company indicated it is in communication with EMA regarding the

readiness of the second fill-finish facility.

●Scholar Rock noted that there is precedent for adding an

additional fill-finish facility during an MAA review period.

●Based on our research, the EMA allows for the addition

of a new site during the scientific assessment period under

exceptional circumstances if the initial site is "no longer suitable

due to unforeseen circumstances from the applicant" and

"the new site fulfills all relevant regulatory requirements" (see

section 3.3.1 HERE).

●The company indicated that it has not identified a clear

precedent where an otherwise-complete MAA had to be

withdrawn and re-filed leading to a full restart of the review

process based solely on a fill-finish issue.

●Based on these findings, we think there are also several potential

paths to EMA approval in the near-term, though any specific pathway

remains subject to further EMA review and discussion. Should

apitegromab make it onto the July CHMP schedule, we would view this

as a clear sign of progress. There is no CHMP meeting in August, so the

next potential opportunity for review would be September.