PolyPid Submits NDA for D-PLEX100
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 01 2026
0mins
PolyPid announced the completion of its new drug application, or NDA, submission on a rolling review basis to the FDA for D-PLEX100, the company's lead product candidate for the prevention of surgical site infections in patients undergoing colorectal surgery. The company anticipates a potential FDA decision in the first quarter of 2027 under the Prescription Drug User Fee Act review timeline.
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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: 4.570
Low
9.00
Averages
11.00
High
13.00
Current: 4.570
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 Site Infections
- NDA Submission: PolyPid has successfully submitted a New Drug Application for D-PLEX100 to the FDA, aimed at preventing surgical site infections following colorectal surgery, with a potential FDA decision expected in Q1 2027, which could significantly enhance postoperative care outcomes for patients.
- Clinical Trial Results: In the pivotal Phase 3 SHIELD II trial, D-PLEX100 met its primary and all key secondary endpoints, demonstrating a 60% relative risk reduction in surgical site infections compared to standard care (p=0.0013), establishing a strong foundation for its market potential.
- FDA Designations: D-PLEX100 has received Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (QIDP) designations from the FDA, which not only expedite the review process but also enhance its competitive position in the market, potentially attracting more investor interest.
- Commercial Partnership Discussions: PolyPid is actively engaging in discussions with U.S. commercial partners to ensure a swift launch of D-PLEX100 post-FDA approval, further solidifying the company's market position and influence in the biopharmaceutical sector.
See More
PolyPid Q1 Earnings Beat Expectations
- Earnings Surprise: PolyPid reported a Q1 GAAP EPS of -$0.35, beating expectations by $0.08, indicating an improvement in financial performance that may boost investor confidence.
- Cash Position: As of March 31, 2026, the company had $10.9 million in cash, cash equivalents, and short-term deposits, down from $12.9 million on December 31, 2025, reflecting challenges in cash management.
- Sufficient Funding: The company believes its current cash resources will be adequate to fund operations into the second half of 2026, suggesting confidence in navigating upcoming challenges and milestones.
- Upcoming Milestones: PolyPid is actively pursuing several significant upcoming milestones, which, if achieved, could positively impact the company's future growth and market performance.
See More
PolyPid Initiates NDA Submission for D-PLEX₁₀₀
- NDA Submission Progress: On March 30, 2026, PolyPid initiated the NDA submission for D-PLEX₁₀₀, with the first modules submitted and completion expected imminently, marking a critical step towards FDA approval that could accelerate product launch and enhance market competitiveness.
- FDA Fee Waiver: The FDA granted PolyPid a waiver of approximately $4.3 million for the PDUFA fee, allowing the company to focus resources on commercialization preparations, thereby reducing financial burdens and enhancing market entry capabilities.
- European Regulatory Advancement: The company has scheduled meetings with the EMA in Q2 2026 to discuss the planned MAA submission for D-PLEX₁₀₀, expected to be submitted in Q3 2026, indicating potential for international market expansion.
- Improved Financial Position: As of March 31, 2026, PolyPid reported cash and short-term deposits of $10.9 million, a decrease from $12.9 million in December 2025, yet raised approximately $4 million through shareholder warrant exercises, strengthening its financial stability.
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 Site Infections
- NDA Submission: PolyPid has successfully submitted a New Drug Application for D-PLEX100 to the FDA, aimed at preventing surgical site infections following colorectal surgery, with a potential FDA decision expected in Q1 2027, which could significantly enhance postoperative care outcomes for patients.
- Clinical Trial Results: In the pivotal Phase 3 SHIELD II trial, D-PLEX100 met its primary and all key secondary endpoints, demonstrating a 60% relative risk reduction in surgical site infections compared to standard care (p=0.0013), establishing a strong foundation for its market potential.
- FDA Designations: D-PLEX100 has received Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product (QIDP) designations from the FDA, which not only expedite the review process but also enhance its competitive position in the market, potentially attracting more investor interest.
- Commercial Partnership Discussions: PolyPid is actively engaging in discussions with U.S. commercial partners to ensure a swift launch of D-PLEX100 post-FDA approval, further solidifying the company's market position and influence in the biopharmaceutical sector.
See More
PolyPid Q1 Earnings Beat Expectations
- Earnings Surprise: PolyPid reported a Q1 GAAP EPS of -$0.35, beating expectations by $0.08, indicating an improvement in financial performance that may boost investor confidence.
- Cash Position: As of March 31, 2026, the company had $10.9 million in cash, cash equivalents, and short-term deposits, down from $12.9 million on December 31, 2025, reflecting challenges in cash management.
- Sufficient Funding: The company believes its current cash resources will be adequate to fund operations into the second half of 2026, suggesting confidence in navigating upcoming challenges and milestones.
- Upcoming Milestones: PolyPid is actively pursuing several significant upcoming milestones, which, if achieved, could positively impact the company's future growth and market performance.
See More
PolyPid Initiates NDA Submission for D-PLEX₁₀₀
- NDA Submission Progress: On March 30, 2026, PolyPid initiated the NDA submission for D-PLEX₁₀₀, with the first modules submitted and completion expected imminently, marking a critical step towards FDA approval that could accelerate product launch and enhance market competitiveness.
- FDA Fee Waiver: The FDA granted PolyPid a waiver of approximately $4.3 million for the PDUFA fee, allowing the company to focus resources on commercialization preparations, thereby reducing financial burdens and enhancing market entry capabilities.
- European Regulatory Advancement: The company has scheduled meetings with the EMA in Q2 2026 to discuss the planned MAA submission for D-PLEX₁₀₀, expected to be submitted in Q3 2026, indicating potential for international market expansion.
- Improved Financial Position: As of March 31, 2026, PolyPid reported cash and short-term deposits of $10.9 million, a decrease from $12.9 million in December 2025, yet raised approximately $4 million through shareholder warrant exercises, strengthening its financial stability.
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
