PolyPid (Nasdaq: PYPD) gets FDA Priority Review and $15M milestone

Rhea-AI Filing Summary

PolyPid Ltd. announced that the U.S. Food and Drug Administration accepted for filing its New Drug Application and granted Priority Review for D-PLEX100 to prevent surgical site infections in patients undergoing abdominal colorectal surgery. The FDA reported no filing review issues and set a PDUFA target action date of November 28, 2026, about one quarter earlier than the company’s previously communicated first-quarter 2027 timing.

Acceptance of the NDA triggers a $15 million milestone payment from Azurity Pharmaceuticals, completing $30 million in upfront and near-term milestones under their U.S. and Canada commercialization partnership. D-PLEX100 uses PolyPid’s Kynatrix technology to release doxycycline locally for 30 days and in the Phase 3 SHIELD II trial achieved its primary endpoint and a 60% relative risk reduction (p=0.0013) in surgical site infection incidence, and it holds FDA Breakthrough Therapy Designation.

Positive

• FDA Priority Review for D-PLEX100 with no filing review issues and an earlier November 28, 2026 PDUFA date for colorectal surgical site infection prevention.
• $15 million milestone payment from Azurity triggered by NDA acceptance, completing $30 million in upfront and near-term milestones under the U.S. and Canada commercialization partnership.

Negative

• None.

Filing Explained

The July 29 Form 6-K incorporates specified sections of its accompanying press release into PolyPid’s existing Form F-3 and Form S-8 registration statements, adding that disclosure to those filings’ records.

Key Figures

PDUFA target action date: November 28, 2026 Milestone payment: $15 million Upfront and near-term milestones: $30 million +5 more

8 metrics

PDUFA target action date November 28, 2026 FDA target action date for D-PLEX100 Priority Review

Milestone payment $15 million Milestone from Azurity triggered by FDA acceptance of D-PLEX100 NDA

Upfront and near-term milestones $30 million Total upfront and near-term milestone payments under Azurity partnership

Relative risk reduction 60% Reduction in SSI incidence at secondary endpoint in Phase 3 SHIELD II trial

p-value for SSI reduction 0.0013 p-value associated with 60% relative risk reduction in SHIELD II

Drug release duration 30 days Duration of high local doxycycline concentration from D-PLEX100 at surgical site

Priority Review timeline approximately six months Priority Review shortens FDA target review from ten months to approximately six months

Standard review timeline ten months Standard FDA target review timeline before Priority Review designation

Key Terms

Priority Review, PDUFA target action date, Breakthrough Therapy Designation, surgical site infections, +1 more

5 terms

Priority Review regulatory

"granted the NDA a Priority Review for D-PLEX100 for the prevention"

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

PDUFA target action date regulatory

"set a Prescription Drug User Fee Act (“PDUFA”) target action date"

The PDUFA target action date is the deadline set by the U.S. Food and Drug Administration (FDA) by which it aims to decide whether to approve or reject a new drug application. This date helps investors gauge when a company’s new medication might reach the market, potentially influencing sales and revenue expectations. It acts as a key milestone signaling progress in the drug approval process.

Breakthrough Therapy Designation regulatory

"D-PLEX100 received Breakthrough Therapy Designation from the U.S. Food"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

surgical site infections medical

"for the prevention of surgical site infections (“SSIs”) in patients"

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.

relative risk reduction medical

"demonstrated positive results and a 60% (p= 0.0013) relative risk reduction"

Relative risk reduction measures how much a treatment or action lowers the chance of an outcome compared with no treatment, expressed as a percentage. If 10 out of 100 people in a control group experience an event and 5 out of 100 do with the treatment, the relative risk reduction is 50%. Investors use it to gauge headline effectiveness but should also check the actual change in event rates and the study size, since percentages can overstate real-world impact.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What did PolyPid (PYPD) announce regarding the FDA review of D-PLEX100?

PolyPid reported that the FDA accepted its NDA for D-PLEX100 and granted Priority Review for preventing surgical site infections in abdominal colorectal surgery, with a PDUFA target action date of November 28, 2026, about one quarter earlier than its prior first-quarter 2027 timing.

How does the FDA’s NDA acceptance for D-PLEX100 affect PolyPid (PYPD) financially?

FDA acceptance of the D-PLEX100 NDA triggers a $15 million milestone payment from Azurity Pharmaceuticals, completing $30 million in upfront and near-term milestone payments under their exclusive U.S. and Canada commercialization partnership signed on July 17, 2026.

What is the significance of Priority Review for PolyPid (PYPD) and D-PLEX100?

Priority Review shortens the FDA’s target review timeline for D-PLEX100 from ten months to approximately six months, potentially bringing a decision on preventing surgical site infections in abdominal colorectal surgery sooner than standard review procedures.

What clinical results support PolyPid’s (PYPD) D-PLEX100 NDA?

In the Phase 3 SHIELD II trial, D-PLEX100 achieved its primary endpoint and showed a 60% relative risk reduction (p=0.0013) in surgical site infection incidence after abdominal colorectal surgery with large incisions, providing key efficacy data for the NDA.

What is D-PLEX100 and how does it work according to PolyPid (PYPD)?

D-PLEX100 is PolyPid’s lead product candidate, designed to prevent abdominal surgical site infections by using its Kynatrix delivery technology to provide a prolonged, continuous release of doxycycline at the surgical site, maintaining a high local antibiotic concentration for 30 days.

Does D-PLEX100 have any special FDA designations mentioned by PolyPid (PYPD)?

Yes. D-PLEX100 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of surgical site infections in patients undergoing elective colorectal surgery, highlighting the potential importance of the therapy in this high-risk setting.

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: July 2026 (Report No. 3)

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 July 29, 2026, titled “PolyPid Announces FDA Acceptance of NDA with Priority Review for D-PLEX₁₀₀.”

The first, third and fourth 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 July 29, 2026, titled “PolyPid Announces FDA Acceptance of NDA with Priority Review 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: July 29, 2026	By:	/s/ Dikla Czaczkes Akselbrad
		Name	: Dikla Czaczkes Akselbrad
		Title:	Chief Executive Officer

3

Exhibit 99.1

 

PolyPid Announces FDA Acceptance of NDA with Priority Review for D-PLEX₁₀₀

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

FDA Identified No Filing Review Issues

Acceptance triggers $15 million milestone payment, completing $30 million in upfront and near-term milestone payments under recently announced U.S. and Canada commercialization partnership

PETACH TIKVA, Israel, July 29, 2026 - PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), an innovative biopharmaceutical company dedicated to elevating treatment effectiveness, right where care begins, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for filing the New Drug Application (“NDA”) and granted the NDA a Priority Review for D-PLEX₁₀₀ for the prevention of surgical site infections (“SSIs”) in patients undergoing abdominal colorectal surgery. The FDA did not identify any filing review issues and set a Prescription Drug User Fee Act (“PDUFA”) target action date of November 28, 2026, approximately one quarter ahead of the Company’s previously communicated first quarter 2027 guidance. Priority Review shortens the FDA’s target review timeline from ten months to approximately six months.

“The FDA’s acceptance of our NDA with Priority Review, arriving with no filing review issues and an accelerated action date, is a defining regulatory milestone for PolyPid in our development of D-PLEX₁₀₀ as a potential new option to patients for the prevention of surgical site infections, pending the outcome of FDA’s review,” said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. “We believe this outcome reflects the quality of our regulatory submission and the rigor of our development program for D-PLEX₁₀₀. Together with our commercial partner Azurity, we are fully aligned on supporting the Agency’s review, and on bringing D-PLEX_100, if approved, as a new option to patients for the prevention of SSIs following abdominal colorectal surgery.”

The FDA’s acceptance of the NDA triggers a $15 million milestone payment from Azurity Pharmaceuticals (“Azurity”), completing the $30 million in upfront and near-term milestone payments previously announced under the exclusive commercial partnership signed on July 17, 2026.

The Company will continue to support the FDA’s review of the NDA through the November 28, 2026 PDUFA action date, ahead of a potential U.S. commercial launch of D-PLEX₁₀₀ by Azurity in early 2027.

About D-PLEX₁₀₀

D-PLEX₁₀₀, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site  with the goal of preventing abdominal surgical site infections (“SSIs”). Following the administration of D-PLEX₁₀₀ into the surgical site, PolyPid’s delivery technology, Kynatrix, is designed to pair with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. In the Phase 3 SHIELD II trial, D-PLEX₁₀₀ recently demonstrated positive results in achieving its primary end point and a 60% (p= 0.0013) relative risk reduction at the secondary end point in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX₁₀₀ received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.

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 raise 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 the anticipated timing of the FDA’s review and potential approval of the D-PLEX₁₀₀ NDA, the PDUFA target action date, the potential impact of Priority Review on the FDA’s review timeline, D-PLEX₁₀₀ as a potential new option to patients for the prevention of surgical site infections, pending the outcome of FDA’s review, and the Company’s and Azurity’s expectations regarding the timing of a potential U.S. commercial launch of D-PLEX₁₀₀. 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

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE ISSUED BY POLYPID LTD. ON JULY 29, 2026, TITLED "POLYPID ANNOUNCES 15.3 KB