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

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.

Rhea-AI Summary

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.

Positive

• NDA for D-PLEX100 completed with U.S. FDA on a rolling basis
• Pivotal Phase 3 SHIELD II met primary and all key secondary endpoints
• 60% relative reduction in surgical site infections versus standard care (p=0.0013)
• D-PLEX100 holds FDA Breakthrough Therapy, Fast Track and QIDP designations
• PDUFA target action date anticipated in first quarter of 2027

Negative

• Regulatory approval and potential commercialization depend on FDA decision expected in Q1 2027

Argus Jun 1 session

+7.42% close to close Open Argus

Details

News Market Reaction – PYPD

On Jun 1, the day this news came out, PYPD closed 7.42% above the previous close.

Data tracked by StockTitan Argus for the Jun 1 session.

Key Figures

SSI risk reduction: 60% relative risk reduction Primary endpoint p-value: p=0.0013 High-severity SSI risk reduction: 64% relative risk reduction +5 more

SSI risk reduction

60% relative risk reduction

Phase 3 SHIELD II vs standard of care in SSIs

Primary endpoint p-value

p=0.0013

Phase 3 SHIELD II primary endpoint

High-severity SSI risk reduction

64% relative risk reduction

Patients with ASEPSIS > 20 in SHIELD II

High-severity p-value

p=0.0103

ASEPSIS > 20 subgroup in SHIELD II

Sustained release duration

763 hours (~32 days)

Local doxycycline release in SHIELD II PK data

Systemic exposure level

Below 100 ng/mL

Plasma doxycycline levels vs oral dosing

PDUFA fee waiver

$4.3 million

Waiver for D-PLEX₁₀₀ NDA fee

PDUFA target date

Q1 2027

FDA action date currently planned

Previous Clinical trial Reports

5 past events · Latest: Apr 28

Same Type 5 events

1. Apr 28

   Phase 3 efficacy data

   24h Move

   -3.3%

   Reported SHIELD II severity and infection risk reduction data for D-PLEX₁₀₀.

2. Apr 13

   PK data update

   24h Move

   +2.1%

   Presented SHIELD II pharmacokinetic data showing sustained local doxycycline release.

3. Mar 31

   NDA initiation

   24h Move

   +4.0%

   Initiated rolling NDA submission to FDA for D-PLEX₁₀₀ after SHIELD II results.

4. Mar 17

   PDUFA fee waiver

   24h Move

   +3.6%

   Received $4.3M PDUFA fee waiver and reiterated 60% SSI risk reduction.

5. Dec 03

   Pre-NDA meeting minutes

   24h Move

   +4.8%

   FDA pre‑NDA minutes supported rolling NDA submission for colorectal SSI prevention.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

new drug application, nda, pdufa, breakthrough therapy, +4 more

8 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.

nda regulatory

"completion of its New Drug Application (“NDA”) submission on a rolling review basis"

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

pdufa regulatory

"under the Prescription Drug User Fee Act ("PDUFA") review timeline"

PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.

breakthrough therapy regulatory

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

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.

fast track regulatory

"has been granted Breakthrough Therapy, Fast Track, and Qualified Infectious"

A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.

qualified infectious disease product regulatory

"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.

qidp regulatory

"Qualified Infectious Disease Product (“QIDP”) designations by the FDA"

A QIDP (Qualified Infectious Disease Product) is a regulatory designation for drugs or biologics that treat serious bacterial or fungal infections. It signals faster review and gives additional market protection after approval, like an extra patent-like time window, which can delay competitors — think of it as a temporary “no-competition” zone enforced by the regulator. For investors, QIDP status can speed a product to market and meaningfully enhance revenue potential and valuation.

surgical site infections medical

"lead product candidate 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.

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

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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 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

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

What did PolyPid (PYPD) announce about the FDA NDA for D-PLEX100 on June 1, 2026?

PolyPid announced completion of its New Drug Application submission to the U.S. FDA for D-PLEX100. According to PolyPid, the rolling NDA covers prevention of surgical site infections in colorectal surgery patients, with review under the Prescription Drug User Fee Act timeline.

What are the Phase 3 SHIELD II trial results supporting PolyPid’s D-PLEX100 NDA (PYPD)?

The Phase 3 SHIELD II trial met its primary and all key secondary endpoints. According to PolyPid, D-PLEX100 achieved a 60% relative risk reduction in surgical site infections versus standard of care, with statistical significance reported at p=0.0013.

When is the FDA PDUFA target action date for PolyPid’s D-PLEX100 (PYPD) NDA?

PolyPid anticipates a potential FDA decision in the first quarter of 2027. According to PolyPid, the D-PLEX100 NDA is being reviewed under the Prescription Drug User Fee Act timeline, giving investors a preliminary window for a regulatory outcome.

What FDA designations has PolyPid’s D-PLEX100 (PYPD) received and why are they important?

D-PLEX100 has received Breakthrough Therapy, Fast Track and Qualified Infectious Disease Product designations. According to PolyPid, these designations support eligibility for Priority Review, potentially accelerating assessment and underscoring the therapy’s focus on a serious infectious disease need.

What medical need could D-PLEX100 (PYPD) address if approved by the FDA?

D-PLEX100 is intended to prevent surgical site infections in colorectal surgery patients. According to PolyPid, the product aims to address a critical unmet medical need by elevating local treatment effectiveness where care begins during and immediately after surgery.

How might FDA approval of D-PLEX100 impact PolyPid (PYPD) and its commercialization plans?

FDA approval could enable PolyPid to launch D-PLEX100 in the U.S. colorectal surgery market. According to PolyPid, the company is finalizing U.S. commercial partnership discussions and preparing for a potential approval and product launch, pending the FDA’s decision.