PolyPid Submits NDA for D-PLEX₁₀₀ to Prevent Surgical Infections
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 31 2026
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Should l Buy PYPD?
Source: Newsfilter
- 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.
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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: 4.580
Low
9.00
Averages
11.00
High
13.00
Current: 4.580
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 Announces SHIELD II Trial Results on D-PLEX100
- Clinical Trial Results: PolyPid's SHIELD II trial demonstrated a 64% relative risk reduction (p=0.0103) in patients with ASEPSIS scores over 20 when treated with D-PLEX100 compared to standard care, highlighting its significant efficacy in reducing postoperative infection risks.
- Reduction in Infection Events: The use of D-PLEX100 resulted in a 60% decrease in surgical site infection (SSI) events, which not only improved patient recovery but also reduced reliance on intravenous antibiotics, thereby enhancing hospital resource utilization.
- Significant Economic Benefits: By decreasing high-severity infection events, PolyPid anticipates substantial reductions in hospital costs, including physician and nursing time, as well as antibiotic stewardship resources, ultimately improving hospital economics.
- Academic Conference Presentation: PolyPid will present the analysis of ASEPSIS scores at the 2026 Surgical Infection Society Annual Meeting, further emphasizing the importance of D-PLEX100 in preventing infections post-surgery and enhancing its market recognition.
See More
PolyPid Presents Key Data on D-PLEX100 at ESCMID 2026
- Sustained Drug Release: In the SHIELD II trial, D-PLEX100 demonstrated sustained local antibiotic release for up to 763 hours (approximately 32 days), effectively preventing surgical site infections and significantly enhancing patient safety post-surgery.
- Controlled Drug Delivery: The absence of a burst effect indicates a stable and controlled drug release process, ensuring prolonged antimicrobial activity at the surgical incision site, thereby addressing key limitations of conventional systemic prophylactic antibiotics.
- Minimal Systemic Exposure: Plasma doxycycline levels remained below 100 ng/mL, far lower than levels seen with oral dosing, which not only reduces the risk of side effects but also enhances patient safety during treatment.
- Clinical Presentation Opportunity: PolyPid will present this data at the ESCMID Global 2026 congress on April 19, 2026, further solidifying D-PLEX100's potential in preventing infections in elective colorectal surgeries involving large incisions.
See More
PolyPid Unveils New Data on D-PLEX100 at ESCMID 2026
- Clinical Trial Data Presentation: PolyPid will present new pharmacokinetic data on D-PLEX₁₀₀ at the 2026 ESCMID Congress, highlighting its potential application in abdominal colorectal surgery, which is expected to attract industry attention and boost the company's stock price.
- Sustained Release Characteristics: D-PLEX₁₀₀ demonstrates a sustained release of doxycycline for up to 763 hours post-surgery, showcasing its effectiveness in preventing surgical site infections and potentially transforming traditional antibiotic usage.
- Minimal Systemic Exposure: Plasma concentrations of doxycycline remain below 100 ng/mL, indicating the safety and efficacy of local application compared to oral administration, which may prompt a reevaluation of antibiotic resistance issues.
- Breakthrough Therapy Designation: D-PLEX₁₀₀ has received FDA Breakthrough Therapy designation, underscoring its significant potential in preventing surgical site infections, which is likely to create more market opportunities and enhance investor confidence for PolyPid.
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 Announces SHIELD II Trial Results on D-PLEX100
- Clinical Trial Results: PolyPid's SHIELD II trial demonstrated a 64% relative risk reduction (p=0.0103) in patients with ASEPSIS scores over 20 when treated with D-PLEX100 compared to standard care, highlighting its significant efficacy in reducing postoperative infection risks.
- Reduction in Infection Events: The use of D-PLEX100 resulted in a 60% decrease in surgical site infection (SSI) events, which not only improved patient recovery but also reduced reliance on intravenous antibiotics, thereby enhancing hospital resource utilization.
- Significant Economic Benefits: By decreasing high-severity infection events, PolyPid anticipates substantial reductions in hospital costs, including physician and nursing time, as well as antibiotic stewardship resources, ultimately improving hospital economics.
- Academic Conference Presentation: PolyPid will present the analysis of ASEPSIS scores at the 2026 Surgical Infection Society Annual Meeting, further emphasizing the importance of D-PLEX100 in preventing infections post-surgery and enhancing its market recognition.
See More
PolyPid Presents Key Data on D-PLEX100 at ESCMID 2026
- Sustained Drug Release: In the SHIELD II trial, D-PLEX100 demonstrated sustained local antibiotic release for up to 763 hours (approximately 32 days), effectively preventing surgical site infections and significantly enhancing patient safety post-surgery.
- Controlled Drug Delivery: The absence of a burst effect indicates a stable and controlled drug release process, ensuring prolonged antimicrobial activity at the surgical incision site, thereby addressing key limitations of conventional systemic prophylactic antibiotics.
- Minimal Systemic Exposure: Plasma doxycycline levels remained below 100 ng/mL, far lower than levels seen with oral dosing, which not only reduces the risk of side effects but also enhances patient safety during treatment.
- Clinical Presentation Opportunity: PolyPid will present this data at the ESCMID Global 2026 congress on April 19, 2026, further solidifying D-PLEX100's potential in preventing infections in elective colorectal surgeries involving large incisions.
See More
PolyPid Unveils New Data on D-PLEX100 at ESCMID 2026
- Clinical Trial Data Presentation: PolyPid will present new pharmacokinetic data on D-PLEX₁₀₀ at the 2026 ESCMID Congress, highlighting its potential application in abdominal colorectal surgery, which is expected to attract industry attention and boost the company's stock price.
- Sustained Release Characteristics: D-PLEX₁₀₀ demonstrates a sustained release of doxycycline for up to 763 hours post-surgery, showcasing its effectiveness in preventing surgical site infections and potentially transforming traditional antibiotic usage.
- Minimal Systemic Exposure: Plasma concentrations of doxycycline remain below 100 ng/mL, indicating the safety and efficacy of local application compared to oral administration, which may prompt a reevaluation of antibiotic resistance issues.
- Breakthrough Therapy Designation: D-PLEX₁₀₀ has received FDA Breakthrough Therapy designation, underscoring its significant potential in preventing surgical site infections, which is likely to create more market opportunities and enhance investor confidence for PolyPid.
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
