PolyPid Submits NDA Application for D-PLEX100
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 13 2026
0mins
"The first quarter of 2026 marked an important transition for PolyPid, as we moved from late-stage development to the final stage prior to drug approval, the regulatory review stage, with the initiation of our NDA submission for D-PLEX100," said Dikla Czaczkes Akselbrad, CEO of PolyPid. "With submission completion expected shortly and our U.S. commercial partnership discussions now in late stages, we are looking forward to implementing our launch plans. At the same time, additional Phase 3 data continues to reinforce D-PLEX100's clinical and economic value proposition. We look forward to providing further updates as these milestones unfold."
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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: 4.830
Low
9.00
Averages
11.00
High
13.00
Current: 4.830
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 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 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 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 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
