Datavault AI Signs $2.0 Billion Structured Financing Term Sheet W…
Robo.ai Announces Completion of 100% Acquisition of Neurovia AI, …
Sphere 3D and Cathedra Bitcoin Announce Closing of Business Combi…
Hyperscale Data Subsidiary Ault Global Commodities Enters into Ag…
NUBURU Expands Defense & Security Platform Momentum with Tier-One…
Optimum Launches Effort to Drive a Consensual Repositioning of it…
Datavault AI Signs $2.0 Billion Structured Financing Term Sheet W…
Robo.ai Announces Completion of 100% Acquisition of Neurovia AI, …
Sphere 3D and Cathedra Bitcoin Announce Closing of Business Combi…
Hyperscale Data Subsidiary Ault Global Commodities Enters into Ag…
NUBURU Expands Defense & Security Platform Momentum with Tier-One…
Optimum Launches Effort to Drive a Consensual Repositioning of it…
PolyPid (Nasdaq:PYPD) has completed its rolling New Drug Application submission to the U.S. FDA for D-PLEX100, a lead candidate to prevent surgical site infections in colorectal surgery.
The NDA is backed by a Phase 3 trial showing 60% relative SSI risk reduction, with an expected FDA decision in Q1 2027.
AI-generated analysis. Not financial advice.
PYPD was down 0.84% with low volume as biotech peers like VTVT (-5.58%) and ATNM (-2.38%) also moved down, pointing to broader Healthcare/Biotech pressure rather than a purely idiosyncratic move.
Clinical and regulatory milestones for D-PLEX₁₀₀ have usually been followed by positive price moves, with one notable negative reaction despite favorable SHIELD II data.
Over the past several months, PolyPid has moved steadily toward NDA completion for D-PLEX₁₀₀. In Dec 2025, positive FDA pre‑NDA minutes supported a rolling submission. In Mar 2026, the company received a $4.3M PDUFA fee waiver and began the NDA, followed by additional Phase 3 SHIELD II efficacy and pharmacokinetic data in Apr 2026. Today’s completed NDA submission extends this sequence of late‑stage regulatory progress.
In the last five clinical-trial-driven D-PLEX₁₀₀ updates, PYPD moved an average of 2.25%, typically reacting favorably to positive regulatory and Phase 3 data milestones.
Clinical and regulatory news has progressed from supportive pre‑NDA FDA minutes and PDUFA fee waiver, to initiating a rolling NDA in early 2026, and now completing the full NDA submission for D-PLEX₁₀₀.
This announcement marks completion of the rolling NDA submission for D-PLEX₁₀₀, supported by Phase 3 SHIELD II data showing a 60% SSI risk reduction with strong statistical significance (p=0.0013). The candidate already holds FDA Breakthrough Therapy, Fast Track, and QIDP designations, with a PDUFA action date targeted for Q1 2027. Investors may track FDA review milestones, cash runway disclosures, and further partnership updates as this regulatory process advances.
AI-generated analysis. Not financial advice.
If approved, D-PLEX100 would address a critical unmet medical need in the prevention of surgical site infections
PDUFA target action date currently planned for the first quarter of 2027
PETACH TIKVA, Israel, June 01, 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 the successful completion of its New Drug Application (“NDA”) submission on a rolling review basis to the U.S. Food and Drug Administration (“FDA”) for D-PLEX100, the Company’s lead product candidate for the prevention of surgical site infections (“SSIs”) in patients undergoing colorectal surgery. The Company anticipates a potential FDA decision in the first quarter of 2027 under the Prescription Drug User Fee Act (“PDUFA”) review timeline.
The NDA is supported by positive results from the Company’s pivotal Phase 3 SHIELD II trial that met its primary endpoint and all key secondary endpoints, and demonstrated a
“Completing the NDA submission for D-PLEX100 is a defining milestone for PolyPid and the culmination of years of disciplined clinical and regulatory work,” said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. “With the full application now before the FDA, we are focused on supporting the agency’s review, finalizing our U.S. commercial partnership discussions, and preparing for the potential approval and launch of a novel approach to the prevention of SSIs.”
About D-PLEX100
D-PLEX100 is PolyPid’s lead product candidate, designed to prevent surgical site infections following abdominal colorectal surgery. Built on the Company’s proprietary Kynatrix™ technology, D-PLEX100 is administered locally at the surgical site at the time of wound closure and delivers a sustained, controlled release of doxycycline for approximately 30 days, with minimal systemic exposure. In the Phase 3 SHIELD II trial, D-PLEX100 met its primary endpoint and key secondary endpoints, demonstrating a
About PolyPid
PolyPid Ltd. (Nasdaq: PYPD) is an innovative biopharmaceutical company dedicated to elevating treatment effectiveness, right where care begins. The Company develops long-acting, controlled-release drugs designed to deliver therapy precisely at the site of care, addressing critical unmet medical needs across a wide and diverse pipeline spanning surgical care, metabolic diseases, and beyond. PolyPid’s lead product, D-PLEX100, successfully met its primary and all key secondary endpoints in the landmark Phase 3 SHIELD II trial for the prevention of surgical site infections. Guided by a commitment to precision and innovation, PolyPid is redefining how therapies perform and raises the standard of patient care. For additional Company information, please visit http://www.polypid.com and follow us on Twitter (X) and LinkedIn.
Forward-looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses its anticipation about the potential FDA decision and the timing thereof, benefits and advantages of D-PLEX100, the Company’s focus on supporting the FDA’s review, finalization of its U.S. commercial partnership discussions, and preparation for the potential approval and launch of a novel approach to the prevention of SSIs. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission, including, but not limited to, the risks detailed in the Company’s Annual Report on Form 20-F filed on February 25, 2026. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.
Company Contact:
PolyPid Ltd.
Ori Warshavsky
908-858-5995
IR@Polypid.com
Investor Relations Contact:
Arx Investor Relations
North American Equities Desk
polypid@arxhq.com
Continue reading with these related stories
© 2020-2026 StockTitan.net – Your Edge is Information
Information only. Not investment advice.
Leave a Reply