PolyPid Announces Positive FDA Pre-NDA Meeting Minutes for D-PLEX₁₀₀ Supporting NDA Submission

Rhea-AI Summary

PolyPid (Nasdaq: PYPD) announced written pre‑NDA meeting minutes from the U.S. FDA that support a rolling NDA submission for D‑PLEX100 to prevent surgical site infections in abdominal colorectal surgery.

The FDA agreed the company’s existing clinical data package, including results from the Phase 3 SHIELD II trial, appears adequate to support NDA submission and review, and agreed to a rolling NDA allowing the first completed sections to be submitted in early 2026. The company said the objectives of the pre‑NDA meeting were accomplished and an in‑person meeting scheduled for December 3, 2025 is no longer necessary.

Positive

• FDA agreement that clinical data package appears adequate for NDA
• Rolling NDA review permits submission of first sections in early 2026
• Phase 3 SHIELD II data included in the agreed submission package
• Breakthrough Therapy designation supports expedited regulatory engagement

Negative

• None.

News Market Reaction

+4.76%

2 alerts

+4.76% News Effect

+$3M Valuation Impact

$63M Market Cap

0.0x Rel. Volume

On the day this news was published, PYPD gained 4.76%, reflecting a moderate positive market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $3M to the company's valuation, bringing the market cap to $63M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

SSI risk reduction: 58% relative risk reduction Composite endpoint reduction: 38% reduction ASEPSIS score reduction: 62% reduction +5 more

8 metrics

SSI risk reduction 58% relative risk reduction Phase 3 SHIELD II SSIs after abdominal colorectal surgery (p<0.005)

Composite endpoint reduction 38% reduction Primary endpoint: SSIs, mortality, reinterventions (10.9% vs 18.1%, p<0.005)

ASEPSIS score reduction 62% reduction Key secondary endpoint in Phase 3 SHIELD II trial

Trial enrollment 800 patients SHIELD II Phase 3 trial enrollment completed

Funding via warrants $26.7M Warrant exercise proceeds tied to positive SHIELD II results

Q3 2025 net loss $7.5M Third quarter 2025 financial results

Cash & equivalents $18.8M Balance as of September 30, 2025, funding operations into 2026

ATM program size $15,000,000 Maximum aggregate ordinary share offering under ATM program

Market Reality Check

Price: $4.71 Vol: Volume 37,190 is below th...

low vol

$4.71 Last Close

Volume Volume 37,190 is below the 20-day average of 88,878 (relative volume 0.42). low

Technical Price $3.98 is trading above the 200-day MA at $3.27 and 2.2% below the 52-week high of $4.07.

Peers on Argus

PYPD was modestly positive before this news, while close biotech peers showed mi...

1 Down

PYPD was modestly positive before this news, while close biotech peers showed mixed moves: CAMP and KPTI up (10.89%, 7.36%), CUE and VTVT down (-0.94%, -5.15%). Only VTVT appeared on the momentum scanner, moving down 6.36% without news, suggesting today’s setup for PYPD was stock-specific rather than a broad sector move.

Historical Context

5 past events · Latest: Dec 03 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 03	Pre-NDA feedback	Positive	+4.8%	FDA pre‑NDA minutes support rolling NDA submission for D‑PLEX100.
Nov 25	KOL event	Positive	+1.7%	Announcement of ROTH-hosted KOL webinar on D-PLEX100’s clinical and economic case.
Nov 12	Earnings & update	Neutral	-0.3%	Q3 2025 loss with NDA timing, FDA meeting plans, and GMP inspection update.
Nov 06	Award & data	Positive	+0.3%	Therapeutics award plus SHIELD II data showing 58% SSI risk reduction.
Oct 29	Earnings preview	Positive	+2.4%	Earnings call scheduling with reminder of early 2026 NDA plan for D-PLEX100.

Pattern Detected

Recent news flow has been dominated by D-PLEX100 clinical and regulatory progress, with most announcements followed by modest positive price reactions, suggesting the stock has historically responded constructively to pipeline and NDA-related updates.

Recent Company History

Over the last few months, PolyPid has steadily advanced D-PLEX100 toward an NDA. A Nov 12, 2025 update reaffirmed an NDA timeline for early 2026 alongside Q3 results and an IMOH GMP inspection. Earlier in November, D-PLEX100 earned a BioTech Breakthrough award backed by Phase 3 SHIELD II data showing a 58% SSI risk reduction (p<0.005). Today’s pre‑NDA minutes confirming adequacy of the Phase 3 data and a rolling NDA process build directly on this regulatory and clinical trajectory.

Market Pulse Summary

This announcement confirms that existing Phase 3 SHIELD II data appear adequate for a rolling NDA su...

Analysis

This announcement confirms that existing Phase 3 SHIELD II data appear adequate for a rolling NDA submission for D‑PLEX100, with first sections planned for early 2026. It follows prior milestones including trial completion, positive topline results, and financing earmarked for NDA and launch preparations. Investors may monitor progress toward full NDA filing, additional regulatory interactions, and future financing activity as the company advances a single lead asset toward potential approval.

Key Terms

pre-New Drug Application, New Drug Application, NDA, U.S. Food and Drug Administration, +4 more

8 terms

pre-New Drug Application regulatory

"announced that it has received a formal pre-New Drug Application (“NDA”) meeting"

A pre-new drug application is a formal meeting or exchange between a drug developer and regulators that happens before the company files a full application to get a new medicine approved. It’s like a rehearsal with the referee to confirm the paperwork, data and testing plans are on track; for investors, it can lower the chance of surprise delays, clarify regulatory risks and give a better sense of filing readiness and likely timelines.

New Drug Application regulatory

"supporting the NDA submission of D-PLEX100, the Company’s lead product"

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

"The FDA also agreed to a rolling NDA review, allowing PolyPid to submit"

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

"meeting minutes from the U.S. Food and Drug Administration (“FDA”) supporting"

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

"The FDA agreed that the Company’s existing clinical data package"

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.

Phase 3 medical

"including results from the Phase 3 SHIELD II trial, appears adequate"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

Breakthrough Therapy designation regulatory

"combined with our Breakthrough Therapy designation, validates our regulatory strategy"

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.

rolling NDA review regulatory

"The FDA also agreed to a rolling NDA review, allowing PolyPid to submit"

A rolling NDA review is a regulatory process where a drugmaker submits parts of its New Drug Application to the regulator as they are completed, and the regulator begins evaluating each section immediately instead of waiting for the entire package. For investors this can shorten and reduce uncertainty around the approval timeline—like having a builder start installing windows before the house is finished—potentially bringing revenue or setback signals sooner than a traditional single submission.

AI-generated analysis. Not financial advice.

NDA to be Submitted on a Rolling Basis, Beginning Early 2026

PETACH TIKVA, Israel, Dec. 03, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it has received a formal pre-New Drug Application (“NDA”) meeting minutes from the U.S. Food and Drug Administration (“FDA”) supporting the NDA submission of D-PLEX₁₀₀, the Company’s lead product candidate for the prevention of surgical site infections in abdominal colorectal surgeries.

The FDA agreed that the Company’s existing clinical data package, including results from the Phase 3 SHIELD II trial, appears adequate to support NDA submission and review. The FDA also agreed to a rolling NDA review, allowing PolyPid to submit the first completed sections in early 2026.

Based on the FDA’s Pre-NDA meeting written response, the Company concludes that the objectives of the pre-NDA meeting have been accomplished and has determined that the in-person meeting, originally scheduled for December 3, 2025, is no longer necessary.

"We are pleased with the pre-NDA meeting feedback we received from the FDA, which confirmed agreement on the content and format for our planned NDA submission, and appreciate the agency's collaborative engagement throughout this process," said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. "The agreement on the adequacy of the clinical data package for submission, combined with our Breakthrough Therapy designation, validates our regulatory strategy and keeps us firmly on track to bring this potentially transformative treatment to patients."

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 surgical site infections (“SSIs”). Following the administration of D-PLEX₁₀₀ into the surgical site, the PLEX (Polymer-Lipid Encapsulation matriX) technology 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 58% (p< 0.005) relative risk reduction 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 a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. Following positive phase 3 results, New Drug Application (NDA) submission of D-PLEX₁₀₀, PolyPid's lead product candidate, for the prevention of abdominal colorectal surgical site infections, is expected in early 2026. In addition, the Company has an innovative pipeline in oncology, obesity and diabetes.

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 expected NDA submission and timing thereof, that the Company’s clinical data package appears adequate to support NDA submission and review, and that the agreement on adequacy of the clinical data package for submission, combined with its Breakthrough Therapy designation, validates its regulatory strategy and keeps the Company firmly on track to bring this potentially transformative treatment to patients. 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 26, 2025. 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 December 3, 2025 about D‑PLEX100?

PolyPid announced FDA pre‑NDA meeting minutes that support a rolling NDA submission for D‑PLEX100 and state the clinical data package appears adequate for review.

When can PolyPid submit the first sections of the D‑PLEX100 NDA for PYPD?

The FDA agreed to a rolling NDA review, allowing PolyPid to submit the first completed sections in early 2026.

Does the FDA consider PolyPid's Phase 3 SHIELD II data sufficient for a D‑PLEX100 NDA (PYPD)?

The FDA agreed the company’s existing clinical data package, including Phase 3 SHIELD II results, appears adequate to support NDA submission.

How does the Breakthrough Therapy designation affect PolyPid's (PYPD) regulatory pathway?

PolyPid said its Breakthrough Therapy designation, combined with FDA feedback, validates its regulatory strategy and supports expedited engagement.

Was the in‑person pre‑NDA meeting for PolyPid (PYPD) on December 3, 2025 held?

No; the company determined the in‑person meeting scheduled for December 3, 2025 was no longer necessary after receiving the FDA’s written response.