一次情報の記録
重要製造施設の査察
SRRK:Catalent Indiana工場、OAI判定後にFDA警告書を受領
FDA issued warning letter to Catalent Indiana (Novo Nordisk) following July 2025 Form 483; facility inspection classified as official action indicated. Company held Type A meeting Nov 12 2025 and still guides BLA resubmission and launch of apitegromab in SMA during 2026.
主要事実
- 提出
- 2025年12月2日 12:00
- イベント
- 製造施設の査察
- 方向
- ネガティブ
- アセット
- apitegromab
- 出典
- SEC 8-K
- 信頼度
- 出典あり
出典の抜粋
false 0001727196 0001727196 2025-12-02 2025-12-02 iso4217:USD xbrli:shares iso4217:USD xbrli:shares 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): December 2, 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