PolyPid Granted FDA Waiver of $4.3M PDUFA Fee
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 17 2026
0mins
Should l Buy PYPD?
PolyPid announced that the FDA has granted a small business waiver of the Prescription Drug User Fee Act, or PDUFA, fee of approximately $4.3M for the New Drug Application, or NDA, for D-PLEX, the company's lead product candidate for the prevention of surgical site infections in abdominal colorectal surgeries. This waiver advances PolyPid toward its upcoming NDA submission initiation and enables the company to focus its resources on commercialization preparations. 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.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy PYPD?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on PYPD
Wall Street analysts forecast PYPD stock price to rise
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 4.390
Low
9.00
Averages
11.00
High
13.00
Current: 4.390
Low
9.00
Averages
11.00
High
13.00
About PYPD
Polypid Ltd is a biopharmaceutical company at the clinical stage, based in Israel . The company focuses on the development, production and commercialization of new, locally administered therapies to improve surgical results. The main product is PLEX technology, which is located in the place of surgery and ensures controlled and continuous delivery of medicines.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
PolyPid Submits NDA for D-PLEX₁₀₀ to Prevent Surgical Infections
- NDA Submission: PolyPid has submitted a New Drug Application for D-PLEX₁₀₀ to the FDA, aimed at preventing surgical site infections in colorectal surgery patients, marking a pivotal step into the regulatory approval phase with further submissions expected in Q2 2026.
- Successful Clinical Trials: D-PLEX₁₀₀ demonstrated a significant 60% relative risk reduction (p=0.0013) in surgical site infections in the Phase 3 SHIELD II trial, providing robust clinical data that enhances its market competitiveness.
- Fast Track Designation: The drug has received FDA's Fast Track designation, allowing for rolling review, which enables PolyPid to expedite its product launch to meet urgent market needs for effective infection prevention therapies.
- Commercial Partnership Negotiations: PolyPid is actively pursuing negotiations for a U.S. commercialization partnership, aiming to accelerate the market introduction of D-PLEX₁₀₀ through strategic collaborations, thereby enhancing the company's influence in the biopharmaceutical sector.
See More
PolyPid to Participate in Upcoming Investor Conferences
- Investor Conference Schedule: PolyPid will participate in the Citizens Life Sciences Conference on March 10, 2026, in Miami, which is expected to attract significant investor interest and enhance the company's visibility in the biopharmaceutical sector.
- Event Details: Additionally, PolyPid will attend the 38th Annual ROTH Conference on March 23, 2026, at the Ritz-Carlton in Dana Point, California, showcasing the market potential of its innovative drugs.
- Product Development Progress: PolyPid's lead product, D-PLEX₁₀₀, successfully met all primary and key secondary endpoints in the SHIELD II trial, demonstrating its effectiveness in preventing surgical site infections and solidifying the company's competitive position in the industry.
- Company Vision and Mission: As a biopharmaceutical company dedicated to enhancing treatment effectiveness, PolyPid aims to address critical medical needs in surgical care and metabolic diseases through the development of long-acting controlled-release drugs, thereby raising the standard of patient care.
See More
PolyPid Ltd. Q4 2025 Earnings Call Insights
- Key Trial Success: PolyPid completed the SHIELD II Phase III trial in 2025, with D-PLEX100 demonstrating a significant reduction in surgical site infections, achieving all primary and key secondary endpoints, marking a major advancement in the medical technology sector.
- Regulatory Progress: Recent positive feedback from the FDA supports PolyPid's plan to initiate a rolling NDA submission for D-PLEX100 by the end of Q1 2026, indicating that the existing clinical data package is adequate for NDA submission and review, boosting market confidence.
- Improved Financials: R&D expenses for Q4 2025 were $6.2 million, down from $7 million in the same period last year, while net loss remained at $8.5 million, with loss per share decreasing from $1.13 to $0.41, reflecting the company's efforts in cost control.
- Strategic Partnership Advancement: Management noted that discussions with U.S. partners have reached advanced stages, with 2026 expected to be a transformative year for the company, emphasizing the clinical value and market potential of D-PLEX100.
See More
PolyPid Q4 Earnings Miss Expectations with GAAP EPS of -$0.41
- Earnings Report Shortfall: PolyPid's Q4 GAAP EPS of -$0.41 misses expectations by $0.08, indicating challenges in profitability that may affect investor confidence and market perception.
- Cash Flow Status: As of December 31, 2025, the company reported cash, cash equivalents, and short-term deposits of $12.9 million, down from $15.6 million in the previous year, reflecting pressure on financial management and liquidity.
- Operational Funding Outlook: The company believes its current cash balance will be sufficient to fund operations into the second half of 2026, despite the risk of declining funds, indicating a strategic approach to navigating upcoming milestones.
- Future Development Potential: PolyPid is actively advancing the D-PLEX100 project aimed at tackling surgical site infections, which, if successful, could significantly enhance the company's market competitiveness and profitability in the healthcare sector.
See More
PolyPid Advances D-PLEX100 Commercialization Efforts
- Partnership Progress: PolyPid is advancing discussions with potential U.S. partners for D-PLEX₁₀₀, having moved into advanced stages, indicating strong market recognition and demand, which is expected to accelerate revenue growth for the company.
- Positive Regulatory Feedback: The company received favorable feedback from the FDA during the pre-NDA meeting, with plans to initiate a rolling NDA submission by the end of Q1 2026, paving the way for market access and enhancing competitiveness in the surgical site infection prevention sector.
- Improved Financial Performance: R&D expenses for Q4 2025 decreased to $6.2 million from $7.0 million in Q4 2024, reflecting the completion of the SHIELD II Phase 3 trial, which is expected to improve the company's financial health and bolster investor confidence.
- Leadership Change: The appointment of Brooke Story as Chair of the Board brings extensive experience in medical technology and surgical solutions, which is anticipated to enhance the company's governance structure and strategic execution capabilities.
See More
PolyPid Names Brooke Story as Board Chairman
Appointment Announcement: PolyPid Ltd. has appointed Brooke Story as Chairman of the Board of Directors, effective December 11, 2025.
Expertise and Experience: Brooke Story brings over 25 years of leadership experience in the MedTech industry, having held senior roles at BD and Medtronic, and is expected to leverage her expertise in surgical infection prevention.
CEO's Statement: CEO Dikla Czaczkes Akselbrad highlighted Story's appointment as a pivotal moment for PolyPid, emphasizing her role in transforming clinical success into commercial reality.
Current Roles: In addition to her new position at PolyPid, Ms. Story serves as a non-executive director on the Board of LivaNova PLC.
See More
PolyPid Submits NDA for D-PLEX₁₀₀ to Prevent Surgical Infections
- NDA Submission: PolyPid has submitted a New Drug Application for D-PLEX₁₀₀ to the FDA, aimed at preventing surgical site infections in colorectal surgery patients, marking a pivotal step into the regulatory approval phase with further submissions expected in Q2 2026.
- Successful Clinical Trials: D-PLEX₁₀₀ demonstrated a significant 60% relative risk reduction (p=0.0013) in surgical site infections in the Phase 3 SHIELD II trial, providing robust clinical data that enhances its market competitiveness.
- Fast Track Designation: The drug has received FDA's Fast Track designation, allowing for rolling review, which enables PolyPid to expedite its product launch to meet urgent market needs for effective infection prevention therapies.
- Commercial Partnership Negotiations: PolyPid is actively pursuing negotiations for a U.S. commercialization partnership, aiming to accelerate the market introduction of D-PLEX₁₀₀ through strategic collaborations, thereby enhancing the company's influence in the biopharmaceutical sector.
See More
PolyPid to Participate in Upcoming Investor Conferences
- Investor Conference Schedule: PolyPid will participate in the Citizens Life Sciences Conference on March 10, 2026, in Miami, which is expected to attract significant investor interest and enhance the company's visibility in the biopharmaceutical sector.
- Event Details: Additionally, PolyPid will attend the 38th Annual ROTH Conference on March 23, 2026, at the Ritz-Carlton in Dana Point, California, showcasing the market potential of its innovative drugs.
- Product Development Progress: PolyPid's lead product, D-PLEX₁₀₀, successfully met all primary and key secondary endpoints in the SHIELD II trial, demonstrating its effectiveness in preventing surgical site infections and solidifying the company's competitive position in the industry.
- Company Vision and Mission: As a biopharmaceutical company dedicated to enhancing treatment effectiveness, PolyPid aims to address critical medical needs in surgical care and metabolic diseases through the development of long-acting controlled-release drugs, thereby raising the standard of patient care.
See More
PolyPid Ltd. Q4 2025 Earnings Call Insights
- Key Trial Success: PolyPid completed the SHIELD II Phase III trial in 2025, with D-PLEX100 demonstrating a significant reduction in surgical site infections, achieving all primary and key secondary endpoints, marking a major advancement in the medical technology sector.
- Regulatory Progress: Recent positive feedback from the FDA supports PolyPid's plan to initiate a rolling NDA submission for D-PLEX100 by the end of Q1 2026, indicating that the existing clinical data package is adequate for NDA submission and review, boosting market confidence.
- Improved Financials: R&D expenses for Q4 2025 were $6.2 million, down from $7 million in the same period last year, while net loss remained at $8.5 million, with loss per share decreasing from $1.13 to $0.41, reflecting the company's efforts in cost control.
- Strategic Partnership Advancement: Management noted that discussions with U.S. partners have reached advanced stages, with 2026 expected to be a transformative year for the company, emphasizing the clinical value and market potential of D-PLEX100.
See More
PolyPid Q4 Earnings Miss Expectations with GAAP EPS of -$0.41
- Earnings Report Shortfall: PolyPid's Q4 GAAP EPS of -$0.41 misses expectations by $0.08, indicating challenges in profitability that may affect investor confidence and market perception.
- Cash Flow Status: As of December 31, 2025, the company reported cash, cash equivalents, and short-term deposits of $12.9 million, down from $15.6 million in the previous year, reflecting pressure on financial management and liquidity.
- Operational Funding Outlook: The company believes its current cash balance will be sufficient to fund operations into the second half of 2026, despite the risk of declining funds, indicating a strategic approach to navigating upcoming milestones.
- Future Development Potential: PolyPid is actively advancing the D-PLEX100 project aimed at tackling surgical site infections, which, if successful, could significantly enhance the company's market competitiveness and profitability in the healthcare sector.
See More
PolyPid Advances D-PLEX100 Commercialization Efforts
- Partnership Progress: PolyPid is advancing discussions with potential U.S. partners for D-PLEX₁₀₀, having moved into advanced stages, indicating strong market recognition and demand, which is expected to accelerate revenue growth for the company.
- Positive Regulatory Feedback: The company received favorable feedback from the FDA during the pre-NDA meeting, with plans to initiate a rolling NDA submission by the end of Q1 2026, paving the way for market access and enhancing competitiveness in the surgical site infection prevention sector.
- Improved Financial Performance: R&D expenses for Q4 2025 decreased to $6.2 million from $7.0 million in Q4 2024, reflecting the completion of the SHIELD II Phase 3 trial, which is expected to improve the company's financial health and bolster investor confidence.
- Leadership Change: The appointment of Brooke Story as Chair of the Board brings extensive experience in medical technology and surgical solutions, which is anticipated to enhance the company's governance structure and strategic execution capabilities.
See More
PolyPid Names Brooke Story as Board Chairman
Appointment Announcement: PolyPid Ltd. has appointed Brooke Story as Chairman of the Board of Directors, effective December 11, 2025.
Expertise and Experience: Brooke Story brings over 25 years of leadership experience in the MedTech industry, having held senior roles at BD and Medtronic, and is expected to leverage her expertise in surgical infection prevention.
CEO's Statement: CEO Dikla Czaczkes Akselbrad highlighted Story's appointment as a pivotal moment for PolyPid, emphasizing her role in transforming clinical success into commercial reality.
Current Roles: In addition to her new position at PolyPid, Ms. Story serves as a non-executive director on the Board of LivaNova PLC.
See More
