PolyPid | MedPath

PolyPid's D-PLEX100 Poised for Potential 2026 Launch After SHIELD II Trial Update

5 months ago

• 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 D-PLEX100 Phase 3 Trial Advances with Positive DSMB Recommendation and $41 Million Financing

5 months ago

• 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 Faces Nasdaq Non-Compliance Amidst Anticipation for Phase 3 Trial Results

6 months ago

• 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 for D-PLEX100 Nears Completion, Interim Analysis Expected Soon

6 months ago

• 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's SHIELD II Trial Progresses Amid Q3 Results

6 months ago

• 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's D-PLEX100 SHIELD II Trial Completes Patient Enrollment for Interim Analysis

6 months ago

• 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.

PolyPid Gains Momentum with Positive Phase 3 Outlook for D-PLEX100

7 months ago

• PolyPid's stock is gaining traction following a Buy rating from Craig-Hallum, driven by promising Phase 3 data expectations for D-PLEX100 in preventing surgical site infections (SSI). • The upcoming Phase 3 SHIELD II trial results are anticipated to be a catalyst, potentially unlocking a $1.5 billion market for high-risk surgical patients. • Despite a net loss reported in Q2 2024, PolyPid completed patient enrollment for the interim analysis of the SHIELD II trial, with top-line results expected in Q1 2025.

PolyPid's D-PLEX100 Phase 3 Trial Reaches Interim Analysis Milestone

8 months ago

• PolyPid has completed enrollment for the unblinded interim analysis of its SHIELD II Phase 3 trial of D-PLEX100. • The trial evaluates D-PLEX100 for surgical site infection prevention in abdominal colorectal surgery patients. • Interim analysis results, expected this quarter, could lead to early trial conclusion or sample size re-assessment. • Top-line results are anticipated in Q1 2025, with potential for additional funding based on trial outcomes.