PolyPid details positive FDA pre-NDA feedback on D-PLEX100

PolyPid Ltd. filed a Form 6-K to furnish a press release dated December 3, 2025 announcing positive U.S. FDA pre-NDA meeting minutes for its D-PLEX100 product, which support a planned New Drug Application submission.

Rhea-AI Filing Summary

PolyPid Ltd. filed a Form 6-K to furnish a press release dated December 3, 2025 announcing positive U.S. FDA pre-NDA meeting minutes for its D-PLEX100 product, which support a planned New Drug Application submission. The filing states that the first three paragraphs of the press release and its forward-looking statements section are incorporated by reference into several existing PolyPid shelf and equity compensation registration statements on Forms F-3 and S-8, so that those registration documents now include this updated regulatory information.

Insights

Biotech regulatory analyst

PolyPid reports FDA feedback that supports moving D-PLEX100 toward an NDA filing.

The company discloses that it received positive U.S. FDA pre-NDA meeting minutes for D-PLEX100, and that this feedback supports an eventual New Drug Application submission. A pre-NDA meeting typically confirms what data the agency expects to see and how it should be presented, so positive minutes usually indicate alignment on the content and structure of a potential filing.

By incorporating key parts of the press release into multiple Form F-3 and Form S-8 registration statements, PolyPid updates the official disclosure set tied to its financing and equity plans. While this is not a product approval, it signals that the D-PLEX100 program has advanced to a stage where an NDA is being prepared, and future regulatory milestones around that filing would likely appear in subsequent disclosures.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did PolyPid (PYPD) report in its December 2025 Form 6-K?

PolyPid reported that it issued a press release titled “PolyPid Announces Positive FDA Pre-NDA Meeting Minutes for D-PLEX100 Supporting NDA Submission.” The Form 6-K is used to furnish that release to investors.

What is the significance of the positive FDA pre-NDA meeting minutes for PolyPid (PYPD)?

The company states that the FDA provided positive pre-NDA meeting minutes for D-PLEX100, which support a future NDA submission. This indicates regulatory feedback that helps guide how PolyPid prepares a potential New Drug Application.

Which PolyPid registration statements are updated by this 6-K filing?

The filing incorporates parts of the press release by reference into PolyPid’s Form F-3 and Form S-8 registration statements identified in the document, so those registrations now include this FDA-related disclosure.

Does this PolyPid (PYPD) 6-K announce FDA approval for D-PLEX100?

No. The disclosure refers to positive FDA pre-NDA meeting minutes for D-PLEX100 that support an NDA submission. It does not state that D-PLEX100 has received marketing approval.

What document is attached to PolyPid’s December 2025 Form 6-K?

The Form 6-K includes as Exhibit 99.1 a press release issued on December 3, 2025 titled “PolyPid Announces Positive FDA Pre-NDA Meeting Minutes for D-PLEX100 Supporting NDA Submission.”

Who signed PolyPid’s December 2025 Form 6-K?

The Form 6-K was signed on behalf of PolyPid Ltd. by Dikla Czaczkes Akselbrad, who is identified as the company’s Chief Executive Officer.

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Accepted by SEC EDGAR 12/03/2025 - 08:35 AM Learn about SEC filing dates

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: December 2025

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 December 3, 2025, titled “PolyPid Announces Positive FDA Pre-NDA Meeting Minutes for D-PLEX₁₀₀ Supporting NDA Submission.”

The first three paragraphs and the section captioned “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. 

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EXHIBIT INDEX

Exhibit No.
99.1		Press release issued by PolyPid Ltd. on December 3, 2025, titled “PolyPid Announces Positive FDA Pre-NDA Meeting Minutes for D-PLEX100 Supporting NDA Submission.”

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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: December 3, 2025	By:	/s/ Dikla Czaczkes Akselbrad
		Name:	Dikla Czaczkes Akselbrad
		Title:	Chief Executive Officer

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