PolyPid Receives PDUFA Fee Waiver from FDA for D-PLEX₁₀₀’s New Drug Application

PolyPid (Nasdaq: PYPD) received a $4.3 million PDUFA fee waiver from the FDA for the NDA of D-PLEX₁₀₀, enabling the company to focus resources on commercialization preparations.

Rhea-AI Summary

PolyPid (Nasdaq: PYPD) received a $4.3 million PDUFA fee waiver from the FDA for the NDA of D-PLEX₁₀₀, enabling the company to focus resources on commercialization preparations. The company reported Phase 3 SHIELD II showed a 60% relative risk reduction in surgical site infections (p=0.0013).

PolyPid is on track to begin its rolling NDA submission by the end of March 2026 and said it is in advanced U.S. commercial partnership discussions.

Positive

• PDUFA waiver of approximately $4.3M reduces near-term cash burden
• Phase 3 SHIELD II: 60% relative risk reduction (p=0.0013) in SSIs

Negative

• None.

Argus Mar 17 session

+3.64% close to close Open Argus

Details

News Market Reaction – PYPD

On Mar 17, the day this news came out, PYPD closed 3.64% above the previous close.

Data tracked by StockTitan Argus for the Mar 17 session.

Key Figures

PDUFA fee waived: $4.3 million SSI risk reduction: 60% P-value: p=0.0013 +1 more

PDUFA fee waived

$4.3 million

Small business Prescription Drug User Fee Act waiver for D-PLEX₁₀₀ NDA

SSI risk reduction

60%

Relative risk reduction in surgical site infections in Phase 3 SHIELD II trial

P-value

p=0.0013

Statistical significance for SSI risk reduction in SHIELD II

Trial phase

Phase 3

SHIELD II trial for D-PLEX₁₀₀ in abdominal colorectal surgeries

Previous Clinical trial Reports

5 past events · Latest: Dec 03

Same Type 5 events

1. Dec 03

   Pre-NDA FDA feedback

   24h Move

   +4.8%

   FDA pre‑NDA minutes supported rolling NDA submission based on SHIELD II data package.

2. Jun 16

   Funding after trial win

   24h Move

   -3.8%

   Secured $26.7M via warrant exercises following strong SHIELD II results for D-PLEX₁₀₀.

3. Jun 09

   Phase 3 topline data

   24h Move

   +2.8%

   Phase 3 SHIELD II topline showed significant SSI reductions and all key endpoints met.

4. Mar 11

   Phase 3 enrollment done

   24h Move

   +3.6%

   Completed SHIELD II enrollment with DSMB support and outlined plans for NDA submission.

5. Oct 21

   SHIELD I publication

   24h Move

   -8.1%

   SHIELD I failed its primary endpoint; benefit seen only in higher‑risk, long‑incision patients.

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

Key Terms

prescription drug user fee act, pdufa, new drug application, nda, +2 more

6 terms

prescription drug user fee act regulatory

"the U.S. Food and Drug Administration (FDA) has granted a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee"

A federal program that lets drug makers pay fees to the U.S. regulator to fund and speed up the review of new medicines and label changes. Investors care because it affects how quickly a drug can move from testing to market and how predictable approval timelines and regulatory interactions are — like buying a faster lane at a busy checkpoint that can reduce uncertainty about a product’s commercial timing.

pdufa regulatory

"has granted a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of approximately $4.3 million"

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.

new drug application regulatory

"fee of approximately $4.3 million for the New Drug Application (NDA) for D-PLEX₁₀₀"

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 Company remains on track to submit the first sections of its rolling NDA by the end of this month"

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.

phase 3 medical

"following the successful Phase 3 SHIELD II trial which demonstrated a 60% (p=0.0013) relative risk reduction"

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.

surgical site infections medical

"lead product candidate for the prevention of surgical site infections (SSIs) in abdominal colorectal surgeries"

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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FDA Grants $4.3 Million Small Business Waiver, Enabling Focus on Commercialization Preparations

Company On Track to Initiate NDA Submission by the End of this Month

PETACH TIKVA, Israel, March 17, 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 the U.S. Food and Drug Administration (FDA) has granted a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of approximately $4.3 million for the New Drug Application (NDA) for D-PLEX₁₀₀, the Company's lead product candidate for the prevention of surgical site infections (SSIs) in abdominal colorectal surgeries.

This meaningful waiver advances PolyPid toward its upcoming NDA submission initiation and enables the Company to focus its resources on commercialization preparations, following the successful Phase 3 SHIELD II trial which demonstrated a 60% (p=0.0013) relative risk reduction in surgical site infections and met its primary and all key secondary endpoints. The Company remains on track to submit the first sections of its rolling NDA by the end of this month, following positive feedback from the FDA during the pre-NDA meeting communication completed in December 2025.

"We are pleased to receive this PDUFA fee waiver days before our planned NDA submission," said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. "Following our landmark Phase 3 SHIELD II results and productive engagement with the FDA on our rolling NDA review approach, we continue to make significant progress toward bringing D-PLEX₁₀₀ to market. With D-PLEX₁₀₀ seeking to address a significant unmet need in a major surgical infection prevention market, we are in advanced stages of commercial partnership discussions for the U.S. market while preparing for what we expect to be a transformative year for PolyPid."

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, 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 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 initiation and progress of the rolling NDA submission for D-PLEX₁₀₀, the Company’s expectations regarding potential approval of D-PLEX₁₀₀, the potential benefits and clinical impact of D-PLEX₁₀₀ for the prevention of SSIs, the Company’s plans and preparations for potential commercialization, including commercial partnership discussions for the U.S. market, and the Company’s expectations regarding the continued advancement of D-PLEX₁₀₀ toward potential market introduction. 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 does the $4.3 million PDUFA fee waiver mean for PolyPid (PYPD)?

The waiver reduces immediate regulatory filing costs and preserves cash runway for commercialization. According to the company, the FDA granted a small business PDUFA waiver of approximately $4.3 million to support NDA preparation for D-PLEX₁₀₀.

When will PolyPid (PYPD) submit its rolling NDA for D-PLEX₁₀₀?

PolyPid plans to begin submitting NDA sections by the end of March 2026. According to the company, this follows positive pre-NDA feedback from the FDA and advances toward a rolling NDA submission.

What were the key SHIELD II Phase 3 results cited by PolyPid (PYPD)?

SHIELD II met primary and all key secondary endpoints with a 60% relative risk reduction in SSIs. According to the company, the trial result was statistically significant (p=0.0013) for abdominal colorectal surgeries.

How does the PDUFA waiver affect commercialization plans for D-PLEX₁₀₀ (PYPD)?

The waiver lets the company reallocate funds toward commercialization and partnership efforts. According to the company, the waiver enables focus on U.S. commercial partnership discussions and market preparation for D-PLEX₁₀₀.

Is PolyPid (PYPD) in talks for U.S. commercial partnerships for D-PLEX₁₀₀?

Yes; PolyPid said it is in advanced stages of U.S. commercial partnership discussions. According to the company, these discussions are occurring as it prepares for NDA submission and potential market launch.