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8- 10.1Pre-market26.10.01 22:206-KKey event#●●●#●●●
PolyPid Ltd.Bullish
The European Medicines Agency (EMA) has validated and initiated a formal review of PolyPid's Marketing Authorization Application (MAA) for D-PLEX100, a product candidate for preventing surgical site infections. Simultaneously, the drug is under FDA Priority Review in the United States, with a PDUFA goal date set for November 28, 2026.…more
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- 10.1Pre-market26.10.01 22:006-KKey event
PolyPid Ltd.
PolyPid has mutually agreed with ADVANZ PHARMA to terminate their 2022 exclusive license, distribution, and supply agreement for D-PLEX100 in Europe. As a result, the exclusive commercialization rights for the product in Europe have reverted to PolyPid, allowing the company to pursue new commercialization opportunities in Europe and other major markets.…more
$5.24+0.00%vs prev closeView filingShare - 8.12After-hours26.08.13 05:586-KKey event
PolyPid Ltd.
PolyPid reported a net loss of $15.58 million for the first half of 2026, with cash and cash equivalents totaling $6.56 million as of June 30. While the company has completed its NDA submission for D-PLEX 100 with an expected FDA decision in Q4 2026, it faces substantial doubt regarding its ability to continue operations without securing additional funding.…more
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News
GlobeNewswire- 4d agoPre-market26.10.21 21:00#●●●#●●●
PolyPid to Present D-PLEX100 Microbiology Data at IDWeek 2026
PolyPid will present exploratory pooled analysis from its clinical trials demonstrating that D-PLEX100 reduces bacterial burden and delays the onset of surgical-site infections. While these findings highlight the potential of the candidate, the company's NDA remains under ongoing FDA regulatory review.…more
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- 10.15Pre-market26.10.15 21:30
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PolyPid will host a virtual Investor Day to outline its 'PolyPid 2030' long-term strategy and new pipeline candidates. The event will provide updates on the FDA review status of D-PLEX100 and introduce a new treatment candidate for diabetic foot infections.…more
$5.24+0.00%vs prev close - 10.1Pre-market26.10.01 22:15
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The European Medicines Agency has validated PolyPid's marketing authorization application for its surgical site infection prevention candidate, D-PLEX₁₀₀. The company is simultaneously pursuing FDA approval in the U.S., with a PDUFA goal date set for late November 2026.…more
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