一次情報の記録
重要その他
Grace Therapeutics、GTx-104のCRLに関するType Aミーティング議事録を受領
The FDA minutes confirm the April 23, 2026 CRL cited only manufacturing cGMP issues at the contract manufacturer and requested additional leachables data and excipient toxicology assessments; no clinical safety or efficacy deficiencies were identified. Grace is advancing a dual-source manufacturing strategy, including technology transfer to a U.S.-based second site, to support NDA resubmission.
主要事実
- 提出
- 2026年7月28日 11:16
- イベント
- その他
- 方向
- 中立
- アセット
- nimodipine
- 出典
- SEC 8-K
- 信頼度
- 出典あり
出典の抜粋
EX-99.1 2 ef20078866_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Grace Therapeutics Announces Receipt of Type A Meeting Minutes from U.S. Food and Drug Administration FDA Did Not Identify Any Clinical Safety or Efficacy Deficiencies and Did Not Request Additional Clinical Data Company Advancing a Dual-Source Manufacturing Strategy, Adding a U.S.-Based Site, Toward NDA Resubmission Princeton, NJ, July 28, 2026 (GLOBE NEWSWIRE)—Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aSAH patients, today announced receipt of the U.S. Food and Drug Administration (FDA) meeting minutes f