PolyPid Initiates D-PLEX₁₀₀ NDA Submission to the FDA

Rhea-AI Summary

PolyPid (Nasdaq: PYPD) has initiated a rolling New Drug Application (NDA) submission to the FDA for D-PLEX₁₀₀, aimed at preventing surgical site infections in colorectal surgery. The company submitted CMC and nonclinical modules under Fast Track and expects the clinical section in Q2 2026.

The move follows positive Phase 3 SHIELD II results and a pre-NDA meeting with the FDA; PolyPid says U.S. commercialization partnership discussions are on track as it advances toward potential approval and launch.

Positive

• Initiated rolling NDA submission under FDA Fast Track
• Submitted CMC and nonclinical NDA modules
• Cites positive Phase 3 SHIELD II trial results
• Clinical NDA section expected in Q2 2026
• U.S. commercialization partnership negotiations described as on track

Negative

• Regulatory approval not yet granted; NDA still under review
• Key NDA clinical module remains pending until Q2 2026
• Commercialization depends on successful approval and partnership execution

Key Figures

Regulatory timeline: Completion in Q2 2026 Trial phase: Phase 3 NDA type: Rolling NDA under Fast Track

3 metrics

Regulatory timeline Completion in Q2 2026 Expected completion of rolling NDA submission

Trial phase Phase 3 SHIELD II trial for D-PLEX₁₀₀ in colorectal surgery SSIs

NDA type Rolling NDA under Fast Track D-PLEX₁₀₀ submission to FDA for SSI prevention in colorectal surgery

Market Reality Check

Price: $4.21 Vol: Volume 72,395 is 36% abov...

normal vol

$4.21 Last Close

Volume Volume 72,395 is 36% above the 20-day average of 53,289. normal

Technical Price 4.21 is trading above the 200-day MA at 3.84 and 17.8% below the 52-week high of 5.12.

Peers on Argus

Biotech peers showed mixed moves: names like PDSB and VERU appeared in momentum ...

3 Up 1 Down

Biotech peers showed mixed moves: names like PDSB and VERU appeared in momentum scans moving up, while CUE was down. With PYPD down 1.64% and sector signals mixed, trading pointed to stock-specific dynamics rather than a coordinated sector rotation.

Previous Clinical trial Reports

5 past events · Latest: Mar 17 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 17	PDUFA fee waiver	Positive	+3.6%	FDA granted $4.3M PDUFA fee waiver and highlighted strong SHIELD II data.
Dec 03	Pre-NDA FDA feedback	Positive	+4.8%	FDA pre‑NDA minutes supported rolling NDA based on SHIELD II data package.
Jun 16	Funding via warrants	Positive	-3.8%	Raised $26.7M through warrant exercises tied to SHIELD II success and NDA prep.
Jun 09	Phase 3 topline data	Positive	+2.8%	Phase 3 SHIELD II met primary and key secondary endpoints with SSI reductions.
Mar 11	Phase 3 enrollment done	Positive	+3.6%	Completed SHIELD II enrollment with DSMB support and outlined NDA plans.

Pattern Detected

Clinical and regulatory milestones for D-PLEX₁₀₀ have usually been followed by positive price reactions, with one notable negative reaction around warrant-related funding.

Recent Company History

Over the past year, PolyPid’s trajectory has centered on advancing D‑PLEX₁₀₀ from Phase 3 completion toward regulatory submission. Key clinical milestones included successful SHIELD II enrollment and positive topline data, followed by FDA pre‑NDA meeting minutes supporting a rolling NDA. Subsequent financing tied to Phase 3 success helped fund NDA and launch preparation. A recent PDUFA fee waiver and strong SHIELD II efficacy data further de‑risked the program. Today’s rolling NDA initiation continues this progression toward potential approval and commercialization.

Historical Comparison

+2.2% avg move · Clinical and regulatory milestones for D‑PLEX₁₀₀ have historically produced average moves of 2.2%, w...

clinical trial

+2.2%

Average Historical Move clinical trial

Clinical and regulatory milestones for D‑PLEX₁₀₀ have historically produced average moves of 2.2%, with mostly positive reactions to data readouts and FDA interactions.

Events show a clear progression: SHIELD II enrollment completion, positive Phase 3 topline results, FDA pre‑NDA support for a rolling NDA, funding to back submission and launch, and a PDUFA fee waiver, now culminating in initiation of the NDA submission itself.

Market Pulse Summary

This announcement advances D‑PLEX₁₀₀ into the formal regulatory phase, with a rolling NDA under Fast...

Analysis

This announcement advances D‑PLEX₁₀₀ into the formal regulatory phase, with a rolling NDA under Fast Track and completion targeted in Q2 2026. It builds directly on prior Phase 3 SHIELD II success and supportive FDA pre‑NDA feedback. Investors may track progress of remaining NDA modules, timing and terms of any U.S. commercialization partnership, and how the company manages funding needs as it moves from clinical development toward a potential launch in colorectal surgical site infection prevention.

Key Terms

new drug application, nda, u.s. food and drug administration, fda, +3 more

7 terms

new drug application regulatory

"announced that it has initiated a 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

"initiated a New Drug Application (“NDA”) submission to the U.S. Food and Drug"

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.

u.s. food and drug administration regulatory

"submission to the U.S. Food and Drug Administration (the “FDA”) for D-PLEX₁₀₀"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

fda regulatory

"Application (“NDA”) submission to the U.S. Food and Drug Administration (the “FDA”)"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

fast track designation regulatory

"The NDA is being submitted under the FDA’s Fast Track designation, which allows"

A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.

rolling review regulatory

"Fast Track designation, which allows for rolling review."

A rolling review is a regulatory process where health authorities examine data on a drug or vaccine as it becomes available instead of waiting for a complete file at the end. For investors, this can speed up the timeline to approval and reduce uncertainty because regulators assess progress in real time—think of reading and approving chapters of a book as they’re finished rather than waiting for the whole manuscript, which can bring forward potential market access and revenue.

chemistry, manufacturing and controls (cmc) technical

"The submission includes the Chemistry, Manufacturing and Controls (CMC) and"

Chemistry, manufacturing and controls (CMC) is the set of scientific and operational steps that show how a drug or biologic is made, what goes into it, and how its quality is consistently checked—think of it as the recipe, the factory process, and the quality checklist for a medicine. Investors care because strong CMC reduces risks around regulatory approval, production delays, batch failures and unexpected costs, directly affecting a product’s ability to reach market and generate revenue.

AI-generated analysis. Not financial advice.

PolyPid Submits First Modules as Part of Rolling NDA Review; Completion expected in Second Quarter of 2026 

U.S. Commercialization Partnership Negotiations on Track

PETACH TIKVA, Israel, March 31, 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 that it has initiated a New Drug Application (“NDA”) submission to the U.S. Food and Drug Administration (the “FDA”) for D-PLEX₁₀₀ for the prevention of surgical site infections (“SSIs”) in patients undergoing colorectal surgery.

The NDA is being submitted under the FDA’s Fast Track designation, which allows for rolling review. The submission includes the Chemistry, Manufacturing and Controls (CMC) and nonclinical sections of the NDA, with additional components, including the clinical section, expected to be submitted in the second quarter of 2026.

“This submission marks a pivotal milestone for PolyPid as we advance D-PLEX₁₀₀ into its regulatory approval phase,” said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. “Following the positive results from our successful Phase 3 SHIELD II trial and constructive feedback from our previously announced pre-NDA meeting with the FDA, we are pleased to initiate the NDA submission. We are highly focused on executing toward potential approval and commercialization, with the goal of bringing D-PLEX₁₀₀ to patients undergoing surgery, while advancing discussions for a U.S. commercialization partnership.”

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 to prevent SSIs. Following the administration of D-PLEX₁₀₀ into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs 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. D-PLEX₁₀₀ recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p= 0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX₁₀₀ received Breakthrough Therapy Designation from the FDA 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 progress of the rolling NDA submission for D-PLEX₁₀₀ and the expected timing thereof, the Company’s expectations regarding potential approval of D-PLEX₁₀₀, and potential commercial partnership for the U.S. market. 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 on March 31, 2026 about D-PLEX₁₀₀?

PolyPid initiated a rolling NDA submission to the FDA for D-PLEX₁₀₀ for SSI prevention. According to the company, CMC and nonclinical modules were submitted under Fast Track, with the clinical section expected in Q2 2026.

Which NDA modules did PolyPid submit first for D-PLEX₁₀₀ (PYPD)?

PolyPid submitted the CMC and nonclinical sections first as part of a rolling NDA. According to the company, additional modules including the clinical section will follow, expected in Q2 2026.

How does Fast Track affect PolyPid's (PYPD) D-PLEX₁₀₀ NDA timeline?

Fast Track enables a rolling review, allowing staggered module submissions to the FDA. According to the company, this allowed CMC and nonclinical modules to be submitted now, with clinical data to follow in Q2 2026.

What clinical evidence supports PolyPid's (PYPD) NDA for D-PLEX₁₀₀?

PolyPid cites positive results from its Phase 3 SHIELD II trial as supporting evidence for the NDA. According to the company, these results and a constructive pre-NDA meeting informed the submission strategy.

What are the next regulatory and commercial steps for PolyPid (PYPD)?

The next steps are submission of the NDA clinical section and continued FDA review toward approval. According to the company, clinical modules are expected in Q2 2026 and U.S. commercialization discussions remain on track.