PolyPid (Nasdaq: PYPD) files FDA NDA for D-PLEX100 infection drug

Rhea-AI Filing Summary

PolyPid Ltd. has completed its New Drug Application submission to the U.S. FDA for D-PLEX100, its lead drug candidate to prevent surgical site infections in patients undergoing colorectal surgery. The FDA review is following a PDUFA timeline with a target action date in the first quarter of 2027.

The NDA is backed by the Phase 3 SHIELD II trial, where D-PLEX100 met its primary and all key secondary endpoints and showed a 60% relative risk reduction in surgical site infections versus standard of care (p=0.0013). D-PLEX100 delivers local, controlled release of doxycycline at the wound site for about 30 days and has FDA Breakthrough Therapy, Fast Track and Qualified Infectious Disease Product designations, supporting eligibility for Priority Review.

Insights

Biopharma regulatory analyst

PolyPid’s NDA for D-PLEX100 moves its lead asset to the FDA decision stage, backed by strong Phase 3 data.

PolyPid has finished its FDA New Drug Application for D-PLEX100 to prevent surgical site infections after colorectal surgery. The Phase 3 SHIELD II trial met primary and key secondary endpoints and reported a 60% relative risk reduction in infections versus standard care (p=0.0013), indicating a clinically meaningful effect size.

D-PLEX100 uses local, controlled doxycycline delivery at the wound for about 30 days, aiming to keep drug where infections start while limiting systemic exposure. The product holds FDA Breakthrough Therapy, Fast Track and QIDP designations, which support eligibility for Priority Review and potential market exclusivity advantages if approved.

The company expects an FDA decision under the PDUFA timeline in the first quarter of 2027. Until then, value will hinge on the FDA’s assessment of efficacy, safety and manufacturing, as well as PolyPid’s progress on U.S. commercial partnership discussions and launch preparations referenced in its statement.

Key Figures

PDUFA target action date: First quarter of 2027 SSI risk reduction: 60% relative risk reduction Statistical significance: p=0.0013 +1 more

4 metrics

PDUFA target action date First quarter of 2027 Planned FDA decision timing for D-PLEX100 NDA

SSI risk reduction 60% relative risk reduction D-PLEX100 vs standard of care in Phase 3 SHIELD II

Statistical significance p=0.0013 Primary efficacy result in SHIELD II trial

Drug release duration Approximately 30 days Controlled local doxycycline release from D-PLEX100

Key Terms

New Drug Application, PDUFA, Breakthrough Therapy, Qualified Infectious Disease Product, +2 more

6 terms

New Drug Application regulatory

"announced the successful completion of its New Drug Application (“NDA”) submission"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

PDUFA regulatory

"potential FDA decision in the first quarter of 2027 under the Prescription Drug User Fee Act (“PDUFA”) review timeline"

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

Breakthrough Therapy regulatory

"D-PLEX100 has been granted Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product"

A breakthrough therapy is a regulatory designation granted to an experimental drug or treatment when early clinical evidence indicates it could offer a substantial improvement over existing options for a serious or life‑threatening condition. For investors it matters because the label brings faster, more intensive interaction with regulators and can shorten development and review time—like a VIP fast‑track toward potential approval, reducing time and risk before a product can reach the market.

Qualified Infectious Disease Product regulatory

"Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (“QIDP”) designations by the FDA"

A qualified infectious disease product is a drug or biologic given a special regulatory label because it targets serious or life‑threatening infections and meets public‑health needs. The label brings incentives such as faster regulatory review, development tax benefits, and extra time with market exclusivity—think of it as a VIP pass and an extended storefront lease that can speed approval and delay generic competition. For investors, that can raise a candidate’s commercial value, lower development risk and make partnerships or buyouts more likely.

surgical site infections medical

"lead product candidate for the prevention of surgical site infections (“SSIs”) in patients undergoing colorectal surgery"

Surgical site infections are infections that occur where a surgical cut was made, caused by bacteria or other germs entering the wound during or after an operation. They matter to investors because higher infection rates can increase hospital costs, lead to regulatory action, product recalls, lawsuits, and damaged reputations—similar to how a manufacturing defect forces costly recalls and repairs—so they affect revenue, margins, and risk for companies in healthcare and medical products.

controlled-release medical

"develops long-acting, controlled-release drugs designed to deliver therapy precisely at the site of care"

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Form 6-K: How Foreign Companies Report to the SEC →

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the Month of: June 2026

Commission File Number: 001-38428

PolyPid Ltd.

(Translation of registrant’s name into English)

18 Hasivim Street

Petach Tikva 495376, Israel

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

☒ Form 20-F      ☐ Form 40-F

CONTENTS

Attached hereto and incorporated herein is PolyPid Ltd.’s (the “Registrant”) press release issued on June 1, 2026, titled “PolyPid Completes New Drug Application Submission to FDA for D-PLEX₁₀₀.”

The first two paragraphs and the section titled “Forward-looking Statements” in the press release are incorporated by reference into the Registrant’s registration statements on Form F-3 (File No. 333-276826, File No. 333-280658, File No. 333-281863, File No. 333-284376 and File No. 333-289034)  and Form S-8 (File No. 333-239517, File No. 333-271060, File No. 333-277703, File No. 333-280662 and File No. 333-289570) filed  with the Securities and Exchange Commission to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished. 

1

EXHIBIT INDEX

Exhibit No.
99.1		Press Release issued by PolyPid Ltd. on June 1, 2026, titled “PolyPid Completes New Drug Application Submission to FDA for D-PLEX100.”

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	POLYPID LTD.
Date: June 1, 2026	By:	/s/ Dikla Czaczkes Akselbrad
		Name:	Dikla Czaczkes Akselbrad
		Title:	Chief Executive Officer

3

Exhibit 99.1

PolyPid Completes New Drug Application Submission to FDA for D-PLEX₁₀₀

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 1, 2026 -- 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 60% relative risk reduction in SSIs compared to standard of care (p=0.0013). D-PLEX₁₀₀ has been granted Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (“QIDP”) designations by the FDA, supporting eligibility for Priority Review.

“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 60% relative risk reduction in SSIs compared to standard of care (p=0.0013). D-PLEX₁₀₀ has been granted Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (QIDP) designations by the FDA.

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

FAQ

What did PolyPid (PYPD) announce about D-PLEX100 in this 6-K?

PolyPid announced it has completed a full FDA New Drug Application submission for D-PLEX100, its lead drug to prevent surgical site infections after colorectal surgery, moving the program into formal regulatory review under the PDUFA framework.

How effective was PolyPid’s D-PLEX100 in the Phase 3 SHIELD II trial?

In the Phase 3 SHIELD II trial, D-PLEX100 met its primary and key secondary endpoints and achieved a 60% relative risk reduction in surgical site infections versus standard of care, with a p-value of 0.0013, indicating strong statistical significance.

When is the expected FDA decision date for PolyPid’s D-PLEX100 NDA?

PolyPid anticipates a potential FDA decision on the D-PLEX100 NDA in the first quarter of 2027, under the Prescription Drug User Fee Act (PDUFA) review timeline, giving investors a clear regulatory milestone for this lead asset.

What special FDA designations has D-PLEX100 received, according to PolyPid (PYPD)?

D-PLEX100 has received Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (QIDP) designations from the FDA. These programs can support expedited development and review, and QIDP can provide additional exclusivity if the drug is approved.

How is D-PLEX100 administered and what is its mechanism of action?

D-PLEX100 is applied locally at the surgical site at wound closure and uses PolyPid’s Kynatrix technology to deliver a sustained, controlled release of doxycycline for about 30 days, aiming to prevent infections with minimal systemic antibiotic exposure.

What strategic steps is PolyPid (PYPD) planning around a potential D-PLEX100 approval?

PolyPid states it is focused on supporting the FDA’s review of D-PLEX100, finalizing U.S. commercial partnership discussions, and preparing for a potential approval and launch of this new surgical site infection prevention approach, contingent on a favorable FDA decision.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE ISSUED BY POLYPID LTD. ON JUNE 1, 2026, TITLED "POLYPID COMPLETES 15.6 KB