De-Risked Regulatory Path and Manufacturing Readiness Underpin Buy Rating on Apitegromab

Citi analyst Geoff Meacham maintained a Buy rating on Scholar Rock Holding yesterday and set a price target of $58.00.

Geoff Meacham has given his Buy rating due to a combination of factors tied to apitegromab’s regulatory trajectory and de-risked manufacturing setup. He views the recent BLA resubmission and the FDA’s agreement on the quickest approval route as meaningfully reducing regulatory uncertainty, especially with the late-September PDUFA date and the potential for earlier approval if the Catalent reinspection outcome is favorable.

Moreover, Meacham highlights the strategic advantage of having two fill-finish facilities, which provides operational flexibility and mitigates potential bottlenecks, while commercial preparations appear advanced enough to serve demand even using only the second site. He also notes that typical post-inspection steps, such as issuance of a Form 483, are not necessarily impediments to a positive reclassification, supporting his view that approval risk is manageable and justifying a Buy rating alongside an attractive expected return profile.

In another report released today, Barclays also maintained a Buy rating on the stock with a $53.00 price target.

SRRK’s price has also changed moderately for the past six months – from $37.240 to $49.160, which is a 32.01% increase.