SRRK discloses FDA ‘official action indicated’ status at Catalent site

Rhea-AI Filing Summary

Scholar Rock (SRRK) reported an update under Other Events. On October 10, 2025, the company was informed by Novo Nordisk that the U.S. Food and Drug Administration has classified the Catalent Indiana, LLC facility as “official action indicated.”

The classification follows a Form FDA 483 issued to Catalent Indiana, LLC on July 14, 2025. The filing does not provide additional details or actions beyond noting the FDA’s inspection outcome.

Insights

Regulatory affairs analyst

FDA classifies Catalent Indiana as OAI; implications depend on next steps.

Scholar Rock disclosed that FDA designated the Catalent Indiana, LLC site “official action indicated” after a prior Form FDA 483. OAI generally means the agency found significant compliance issues during inspection.

Potential FDA responses to an OAI classification can include additional enforcement or required remediation before certain activities proceed. The notice here is limited to the classification itself; no specific program or timing details are included.

Key anchors are the Form FDA 483 on July 14, 2025 and Novo Nordisk’s notice on October 10, 2025. Any operational impact, if any, would depend on FDA and facility actions that are not detailed in this excerpt.

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): October 10, 2025

Scholar Rock Holding Corporation
(Exact Name of Registrant as Specified in Charter)

Delaware	001-38501	82-3750435
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification Number)
301 Binney Street, 3rd Floor, Cambridge, MA 02142
(Address of Principal Executive Offices) (Zip Code)

(857) 259-3860

(Registrant's telephone number, including area code)

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	SRRK	The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01. Other Events.

On October 10, 2025, Novo Nordisk informed Scholar Rock Holding Corporation (the “Company”) that, following the Form FDA 483 issued to Catalent Indiana, LLC (owned by Novo Nordisk) on July 14, 2025, the U.S. Food and Drug Administration has determined that the inspection classification of this facility is “official action indicated”.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Scholar Rock Holding Corporation
Date: October 14, 2025	By:	/s/ Junlin Ho
		Junlin Ho
		General Counsel & Corporate Secretary

FAQ

What did Scholar Rock (SRRK) disclose in this 8-K?

The company reported that the FDA classified the Catalent Indiana, LLC facility as “official action indicated” on notice from Novo Nordisk dated October 10, 2025.

Which facility received the FDA classification noted by SRRK?

The Catalent Indiana, LLC facility, which is owned by Novo Nordisk.

What prior FDA step preceded the OAI classification?

A Form FDA 483 was issued to Catalent Indiana, LLC on July 14, 2025.

What does “official action indicated (OAI)” generally signify?

It indicates the FDA identified significant issues during inspection and may take further regulatory actions.

Did Scholar Rock specify impacts to its programs or timelines?

The disclosure notes the FDA’s inspection outcome; no additional details were provided.