Polypid Ltd. Stock Price, News & Analysis

PolyPid Ltd. announced top-line results from its SHIELD I Phase 3 study of D-PLEX100 for preventing surgical site infections (SSIs) in abdominal surgery. The trial did not achieve its primary endpoint of reducing SSIs and mortality overall, with a 23% reduction in SSIs (p=0.1520). However, a subgroup analysis of patients with incision lengths over 20 cm showed a significant 54% reduction in SSIs (p<0.0032). The independent Data Safety Monitoring Board found no safety concerns. PolyPid plans to discuss results with the FDA and further assess next steps.

PolyPid Ltd. (Nasdaq: PYPD) announced the presentation of Phase 2 clinical and animal study data for D-PLEX100 at the 2022 Military Health System Research Symposium from September 12-15, 2022. The podium presentation will address D-PLEX100's efficacy in reducing surgical site infection rates and drug-resistant bacteria in surgical trauma injuries. This presentation will be led by Noam Emanuel, PhD, Co-Founder and Chief Scientific Officer. D-PLEX100 is currently in Phase 3 trials aimed at preventing surgical site infections.

PolyPid Ltd. (Nasdaq: PYPD) announced an exclusive licensing agreement with ADVANZ PHARMA for D-PLEX100, targeting over $110 million in upfront and milestone payments, plus potential royalties. The agreement aims to commercialize D-PLEX100 for preventing surgical site infections in Europe. The independent Data Safety Monitoring Board recommended concluding the Phase 3 SHIELD I trial after 950 patient enrollments. Top-line results are expected by the end of Q3 2022, with potential NDA submission in 2023. For Q2 2022, the company reported a loss of $11.8 million, increasing R&D expenses to $8.4 million.

PolyPid Ltd. (Nasdaq: PYPD) has partnered with ADVANZ PHARMA to commercialize D-PLEX₁₀₀ in Europe for preventing surgical site infections (SSIs) in abdominal and cardiac surgeries. The agreement offers PolyPid an upfront payment of $2.6 million and a total of up to $23.5 million in developmental milestones. Additionally, PolyPid anticipates up to $89 million in sales-related milestones and royalties on net sales. This collaboration leverages ADVANZ PHARMA's expertise and resources to enhance access to this vital therapy, pending approval.

PolyPid Ltd. (Nasdaq: PYPD) announced the upcoming release of its Q2 2022 financial results and operational highlights on August 10, 2022, before U.S. market open. A conference call is set for 8:30 a.m. Eastern Time to discuss the results and business updates. PolyPid is a late-stage biopharma company focused on improving surgical outcomes, leveraging its PLEX technology for drug delivery. Their lead candidate, D-PLEX100, is in Phase 3 trials targeting surgical site infections.

PolyPid Ltd. (Nasdaq: PYPD) announced that Phase 2 clinical data for its lead product candidate D-PLEX₁₀₀ will be presented at the Midwest Surgical Association 2022 Annual Meeting on August 8, 2022. This podium presentation, titled Reduction in Surgical Site Infections by Localized Administration with D-PLEX₁₀₀ in Patients with Multiple Risk Factors Undergoing Colorectal Surgery, will be given by Senior Medical Director Dr. Anthony J. Senagore. D-PLEX₁₀₀ aims to prevent infections post-abdominal surgery.

PolyPid Ltd. (Nasdaq: PYPD) has announced the appointment of Dikla Czaczkes Akselbrad as the new CEO, effective July 1, 2022. Formerly the Executive Vice President and CFO, Akselbrad brings over 20 years of experience in life sciences. Her leadership is expected to be vital as the company prepares for a potential New Drug Application submission and the commercialization of D-PLEX100. The company recently completed its SHIELD I Phase 3 study, with top-line results anticipated by the end of the current quarter.

PolyPid Ltd. (Nasdaq: PYPD) announced a webinar on June 23, 2022, featuring key opinion leaders discussing the costs of managing surgical site infections (SSIs). Presentations will include insights from Dr. Kyle Cologne and Dr. Elliot Goodman. The company's leadership will also provide an update on the SHIELD I Phase 3 clinical trial for D-PLEX₁₀₀, aimed at preventing SSIs in abdominal surgery. This marks a significant milestone following the completion of patient enrollment. Interested participants can register for the event online.

PolyPid Ltd. (Nasdaq: PYPD) announced that data from its Phase 2 clinical trial of D-PLEX₁₀₀ for preventing surgical site infections in elective colorectal surgery will be presented at the ASM Microbe 2022 conference on June 9-13, 2022. The study evaluates D-PLEX₁₀₀ alongside standard infection prophylaxis. Dr. Judith Steenbergen will present findings on the impact of the doxycycline-eluting formulation. PolyPid's D-PLEX₁₀₀ is a lead candidate in Phase 3 trials, targeting soft tissue infections.