Mesoblast (ASX:MSB) said it aligned with the US Food and Drug Administration (FDA) on the items required for filing a Biologics License Application for its Revascor drug candidate in the treatment of patients with ischemic heart failure with reduced ejection fraction and inflammation, according to a Tuesday Australian bourse filing.
The firm plans to file by the end of the year for accelerated approval in patients with end-stage ischemic heart failure with reduced ejection fraction implanted with a left ventricular assist device.
Formal minutes for the firm's most recent Type B meeting provided by the regulator confirmed alignment with US FDA on items regarding chemistry, manufacturing, and controls, potency assays for commercial product release, as well as proposed design and primary endpoint for the confirmatory trial post-approval.
The firm's shares rose 6% in recent trading on Tuesday.
免責聲明:投資有風險,本文並非投資建議,以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請,作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考,不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證,投資者應自行研究並在投資前尋求專業建議。