8-K - Scholar Rock Holding Corporation | StockGist

AI Analysis

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Scholar Rock Holding Corporation resubmitted its Biologics License Application for apitegromab to the FDA on March 31, 2026, anticipating a regulatory decision by late September 2026.

Key Takeaways

1Scholar Rock resubmitted its BLA for apitegromab to the FDA on March 31, 2026, for treating spinal muscular atrophy in children and adults.

2The company anticipates FDA acceptance within 30 days and a review period of up to six months, with a PDUFA action date expected in late September 2026.

3The resubmission includes Catalent Indiana LLC and a second U.S.-based fill-finish facility, following alignment with FDA guidance from a March 3, 2026 Type C meeting.

4The EMA review of the Marketing Authorisation Application for apitegromab is progressing, with a decision anticipated mid-2026.

5The company received a Complete Response Letter in September 2025 related to observations at Catalent Indiana, which did not cite other approvability concerns.

Current Report Details

Event Type

Regulation Fd

Other Event

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

. Regulation FD Disclosure.** On March 31, 2026, Scholar Rock Holding Corporation (the “Company”) issued a press release announcing it resubmitted its biologics

Regulation Fd

8.01

. Other Events.** On March 31, 2026, the Company announced that it resubmitted its BLA to the FDA for apitegromab for the treatment of children and adults with

Other Event

9.01

. Financial Statements and Exhibits.** (d) Exhibits | Exhibit No. | | Description | |---|---|---| | | | | | 99.1 | | Press Release issued by the Company on

Exhibits Only

Source Document

Exhibits (2)

8-K

FORM 8-K

99.1

EXHIBIT 99.1