Scholar Rock Holding Corp (SRRK.O): 2026 thoughts: Two paths support apitegromab 9/30 PDUFA

研报英文原文证据摘录

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06 Aug 2026 14:20:07 ET │ 12 pages

Scholar Rock Holding Corp (SRRK.O)

2Q26 thoughts: Two paths support apitegromab 9/30 PDUFA

CITI'S TAKE

The central debate remains whether the 9/30 PDUFA for apitegromab will

hold, and we come away with incrementally bolstered confidence that it

will. FDA is reviewing the second fill-finish package, has been responsive,

and has asked straightforward questions, while the facility provides a fully

independent approval path from Catalent. Commercial expectations

remain appropriately measured, with minimal 2026 revenue and a broader

ramp beginning in 2Q27. Medicare patients are likely to receive coverage

immediately, whereas commercially insured patients could encounter

denials and appeals while an unspecified J-code is used, with prescriptionto-infusion times ~60 days. The permanent J-code application is expected

to be submitted upon approval and could become effective by 4/1/2027,

reducing access timelines toward 15 days. Overall, greater confidence in an

upcoming approval, followed by broader and faster reimbursement

beginning in 2Q27, supports our positive outlook despite a measured initial

launch. Maintain Buy/HR; TP now $60 (from $58 TP).

Second facility adds confidence in 9/30 PDUFA — All data agreed upon with FDA,

including engineering and process-performance qualification data, have been

submitted, and no further product testing is required from the second site. On that,

it has passed recent FDA and EMA inspections, supports nearly three dozen

commercial products, and received multiple product approvals over the past year

without a pre-approval or pre-license inspection.

n

Buy / High Risk

Price (05 Aug 26 16:00)

US$47.87

Target price

US$60.00↑

from US$58.00

Expected share price return

25.3%

Expected dividend yield

0.0%

Expected total return

25.3%

Market Cap

US$5,736M

Price Performance

(RIC: SRRK.O, BB: SRRK US)

Catalent remains unresolved but is less relevant to US approval — Catalent

remains OAI, with limited visibility into when or how FDA will reclassify the site. If the

status continues, Catalent can be removed through a straightforward notification,

…