PolyPid Provides Corporate Update and Reports Third Quarter 2026 Financial Results
Globe Newswire•11/11/2026•07:30 ET
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Key Highlights
- ➤D-PLEX₁₀₀ NDA receives FDA Priority Review with November 28, 2026 PDUFA goal date
- ➤Azurity preparing potential early-2027 U.S. launch across more than 1,700 hospitals
- ➤PolyPid receives $30 million from Azurity and remains eligible for over $290 million
- ➤EMA validates D-PLEX₁₀₀ application; European commercialization rights revert to PolyPid
- ➤Third-quarter net loss narrows to $5.8 million, or $0.24 per share
- ➤Cash, equivalents and short-term deposits total $15.5 million at September 30
Expert Statements
Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid
“With our PDUFA goal date fast approaching, this is a defining moment for PolyPid”
Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid
“We have a committed partner in Azurity preparing to bring D-PLEX₁₀₀ to surgeons and patients in the U.S., subject to approval, and we now hold full rights to D-PLEX₁₀₀ in Europe.”
Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid
“As D-PLEX₁₀₀ moves toward commercialization, we are leveraging the Kynatrix technology to strengthen our pipeline.”
Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid
“At our recent investor day, we presented how it can reach beyond surgical site infections, starting with PD01B in diabetic foot infections, a serious condition where systemic antibiotics often fall short.”
Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid
“We are now focused on executing our PolyPid 2030 plan, and we look forward to sharing our progress.”
D-PLEX₁₀₀ NDA Under FDA Priority Review with PDUFA Goal Date of November 28, 2026; U.S. Commercial Launch Preparations Ongoing
Expanding D-PLEX₁₀₀ Globally: MAA Submitted and Validated by the EMA and European Commercialization Rights to D-PLEX₁₀₀ Regained
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