主导产品获得FDA优先审查，PolyPid股价上涨

2026-07-30 02:20

PolyPid (PYPD) added more than 7% on Wednesday after the Israeli biopharma received the FDA's priority review for a marketing application seeking U.S. approval for its lead product candidate D-PLEX100.
The company said that the FDA accepted its New Drug Application for D-PLEX100, targeted as a preventive treatment for surgical site infections that patients undergoing abdominal colorectal surgery can develop.
The regulator has issued November 28, 2026, as the target action date, roughly one quarter ahead of PolyPid’s (PYPD) previous guidance disclosed with Q1 results for fiscal 2027 in May.
The decision allows the company to receive a $15M milestone payment from Azurity Pharmaceuticals in line with a commercial deal signed with the U.S. biopharma earlier this month.
With priority review expediting the FDA deliberations, the company said it plans to launch D-PLEX100 in early 2027.

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