PYPD

PolyPid Ltd. (PYPD) Q2 2026 Earnings Call Transcript

PolyPid NASDAQ: PYPD said its second-quarter 2026 was marked by the FDA's acceptance of its new drug application for D-PLEX100 and a commercialization agreement with Azurity Pharmaceuticals covering the United States and Canada.

FDA Accepted D-PLEX₁₀₀ NDA with Priority Review; PDUFA Goal Date of November 28, 2026, Approximately One Quarter Ahead of Previously Communicated Guidance

PETACH TIKVA, Israel, July 30, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today announced that it will report its second quarter 2026 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, August 12, 2026. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations.

PDUFA target action date of November 28, 2026, approximately one quarter ahead of Company's previously communicated guidance

Israeli biotech PolyPid said on Tuesday it had agreed a deal with Azurity Pharmaceuticals ​to commercialise a drug aimed at preventing surgical ‌site infections in the U.S. and Canada, under which it could receive more than $320 million.

PETACH TIKVA, Israel, July 21, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to elevating treatment effectiveness, right where care begins, today announced that it has entered into an exclusive commercial partnership agreement (the “Agreement”) with Azurity Pharmaceuticals (“Azurity”), a privately held specialty pharmaceutical company, for the commercialization of D-PLEX100 in the United States and Canada for the prevention of surgical site infections (“SSIs”).

If approved, D-PLEX100 would address a critical unmet medical need in the prevention of surgical site infections

PETACH TIKVA, Israel, May 20, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to improving patient outcomes by elevating treatment effectiveness, right where care begins, today announced that the Company's management will participate in investor meetings at the Craig-Hallum 23rd Annual Institutional Investor Conference on Thursday, May 28, 2026, at the Depot Renaissance Hotel in Minneapolis, MN.

PolyPid NASDAQ: PYPD said its first quarter marked a transition from late-stage clinical development toward regulatory submission and commercial preparation for D-PLEX100, its lead product candidate for preventing surgical site infections in abdominal colorectal surgery.