Scholar Rock Holding Corporation filed a Form 8-K on November 10, 2026, disclosing that its subsidiary Scholar Rock Inc. entered into an asset purchase agreement to sell a Rare Pediatric Disease Priority Review Voucher to BioNTech US Inc. for $205 million in cash, and separately announced financial results for the quarter ended September 30, 2026.

Key Highlights

  • PRV sale price: BioNTech US Inc. agreed to pay Scholar Rock Inc. $205 million in cash upon closing of the Priority Review Voucher sale.
  • Agreement date: The asset purchase agreement was entered into on November 9, 2026, by Scholar Rock Inc., a wholly owned subsidiary of Scholar Rock Holding Corporation.
  • Voucher origin: The FDA awarded the Priority Review Voucher to Scholar Rock on September 11, 2026, upon approval of its biologics license application for ISEMBYLD™ (apitegromab-mstn).
  • Closing condition: The transaction remains subject to customary closing conditions, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
  • Quarterly results: The company issued a press release on November 10, 2026, announcing financial and operating results for the quarter ended September 30, 2026.
  • Exchange listing: Scholar Rock Holding Corporation's common stock (par value $0.001 per share) trades on NASDAQ:SRRK under The Nasdaq Global Select Market.

Scholar Rock's $205 Million PRV Transaction with BioNTech US

According to the filing, Scholar Rock Inc., a wholly owned subsidiary of Scholar Rock Holding Corporation, entered into a PRV Asset Purchase Agreement with BioNTech US Inc. on November 9, 2026. Under the terms of that agreement, Scholar Rock Inc. agreed to sell a Rare Pediatric Disease Priority Review Voucher to BioNTech US Inc. The company disclosed that the buyer agreed to pay $205 million, payable in cash, upon the closing of the sale.

The filing states that the FDA awarded the Priority Review Voucher on September 11, 2026, in connection with its approval of Scholar Rock's biologics license application for ISEMBYLD™ (apitegromab-mstn). The PRV Asset Purchase Agreement, the filing notes, "contains customary representations, warranties, covenants, and indemnification provisions subject to certain limitations." The company disclosed that the transaction remains subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

The filing also covers two additional items. Under Item 2.02, Scholar Rock reported that it issued a press release on November 10, 2026, announcing its financial and operating results for the quarter ended September 30, 2026, furnished as Exhibit 99.1. Under Item 7.01, the company disclosed that it would use presentation slides during a conference call scheduled for 8:00 am ET on November 10, 2026, covering its fiscal quarter results and a business update, with those slides furnished as Exhibit 99.2. The filing was signed by Junlin Ho, General Counsel and Corporate Secretary.

What Was Disclosed

Scholar Rock Holding Corporation disclosed the sale of a Rare Pediatric Disease Priority Review Voucher to BioNTech US Inc. for $205 million in cash, the FDA's prior award of that voucher upon ISEMBYLD™ approval, and the company's third-quarter 2026 financial results announcement.