PolyPid Ltd. operates as a phase 3 biopharma company. Its proprietary PLEX technology pairs with medications, enables precise delivery of drugs at effective release rates, over pre-determined durations ranging from several days to months. The firm's product candidates are designed to address unmet medical needs by delivering active pharmaceutical ingredients, or APIs, locally at predetermined release rates and durations over extended periods ranging from days to several months. The company was founded by Noam Emanuel on February 28, 2008 and is headquartered in Petach Tikva, Israel.
Clinical Trials
22
13 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2008
Active, not recruiting
13
59.1%
Completed
6
27.3%
Recruiting
2
9.1%
Terminated
1
4.5%
No approval data available
- PolyPid received positive FDA pre-NDA meeting minutes confirming that existing clinical data, including Phase 3 SHIELD II results, appears adequate to support NDA submission for D-PLEX100. - The FDA agreed to a rolling NDA review process, allowing PolyPid to submit completed sections incrementally starting in early 2026. - D-PLEX100 demonstrated a statistically significant 58% relative risk reduction in surgical site infection incidence in Phase 3 trials for abdominal colorectal surgery. - The company's stock gained 3.4% following the announcement, reflecting investor confidence in the regulatory pathway for this breakthrough therapy-designated product.
- PolyPid successfully completed its fourth consecutive Good Manufacturing Practice inspection by the Israeli Ministry of Health, confirming commercial manufacturing readiness for D-PLEX₁₀₀. - The inspection validates the company's quality systems under EU-Israel regulatory equivalence, meeting standards for commercial production in European markets. - D-PLEX₁₀₀ demonstrated a statistically significant 58% relative risk reduction in surgical site infections in Phase 3 SHIELD II trial for abdominal colorectal surgery. - The company plans to submit a New Drug Application to the FDA in early 2026, with the inspection serving as preparation for subsequent FDA facility review.
- PolyPid Ltd. has appointed Dr. Nurit Tweezer-Zaks as Chief Medical Officer, effective August 18, 2025, following positive Phase 3 SHIELD II trial results for their lead product candidate D-PLEX100. - Dr. Tweezer-Zaks transitions from the company's Board of Directors to lead medical strategy as PolyPid prepares for New Drug Application submission expected in early 2026. - The appointment comes at a pivotal time as the company advances its pipeline including D-PLEX100 for preventing abdominal colorectal surgical site infections and a recently unveiled GLP-1 program.
- PolyPid has unveiled a long-acting GLP-1 receptor agonist delivery platform that aims to provide therapeutic drug levels for approximately 60 days with a single subcutaneous administration. - The platform releases GLP-1 in a linear fashion, overcoming the burst release issues seen with current weekly injection regimens and potentially eliminating the need for frequent dosing. - The technology utilizes PolyPid's proprietary PLEX polymer-lipid matrix system, which has been clinically validated in over 1,000 patients across two Phase 3 trials with no major safety concerns. - This development targets the rapidly expanding diabetes and weight management market, which is projected to reach $100 billion by 2030 according to Goldman Sachs and J.P. Morgan Research.
- PolyPid's SHIELD II Phase 3 trial for D-PLEX100, targeting surgical site infections, is set to conclude enrollment at 800 patients following DSMB recommendation. - Top-line results from the SHIELD II trial are expected in Q2 2025, with a rolling NDA submission to the FDA planned for Q3 2025. - D-PLEX100 has Fast Track and Breakthrough Therapy Designation, potentially leading to Priority Review and a possible FDA approval in early 2026. - PolyPid is also collaborating with ImmunoGenesis to develop novel solid tumor treatments using PLEX technology and a STING agonist.
- PolyPid's SHIELD II Phase 3 trial for D-PLEX100, aimed at preventing surgical site infections in abdominal colorectal surgeries, will continue enrollment to 800 patients. - The decision follows a positive recommendation from the Data Safety Monitoring Board (DSMB) based on unblinded efficacy data from the first 430 patients. - PolyPid secured a private placement financing of up to $41 million, extending its cash runway beyond potential NDA approval into Q3 2025. - Top-line results from the SHIELD II trial are anticipated in Q2 2025, with a potential New Drug Application (NDA) submission to follow.
- PolyPid has received a Nasdaq notification for failing to meet the minimum stockholders' equity requirement, reporting $2.158 million against the required $2.5 million. - The company has until January 9, 2025, to submit a plan to regain compliance, with a possible extension of up to 180 days if the plan is accepted by Nasdaq. - PolyPid's future hinges on the SHIELD II Phase 3 trial results expected in December 2024, which could unlock up to $24.6 million in additional funding through warrant exercises. - Continued trading of PolyPid's shares (PYPD) on the Nasdaq Capital Market is permitted during the compliance period, pending the review of their submitted plan.
- PolyPid's SHIELD II trial, evaluating D-PLEX100 for surgical site infection prevention in colorectal surgeries, anticipates full enrollment by December 2024. - An interim analysis of the SHIELD II trial is expected this quarter, potentially leading to early conclusion or continuation based on efficacy results. - PolyPid reported $9.5 million in cash, sufficient to fund operations into early 2025, with possible access to an additional $24.6 million through financing. - The company anticipates a strategic partnership for U.S. commercialization of D-PLEX100 and plans to submit a New Drug Application by 2026, pending trial outcomes.
- PolyPid reported its Q3 results, highlighting the ongoing progress of the SHIELD II trial, which is evaluating a novel approach to surgical site infection prevention. - The SHIELD II trial is a significant step forward in addressing the unmet need for effective surgical site infection prevention strategies. - The company's innovative approach has the potential to improve patient outcomes and reduce healthcare costs associated with surgical site infections.
- PolyPid has completed enrollment of 430 patients in the SHIELD II Phase 3 trial of D-PLEX100, triggering an unblinded interim analysis. - The interim analysis outcome, expected later this quarter, could lead to early trial conclusion, sample size re-assessment, or continuation to planned recruitment. - SHIELD II is expected to complete enrollment of up to 630 patients in December 2024, with top-line results anticipated in the first quarter of 2025. - D-PLEX100 aims to prevent surgical site infections (SSIs) following abdominal colorectal surgeries, addressing a critical unmet need.
