Welcome to our dedicated page for Polypid Ltd. news (Ticker: PYPD), a resource for investors and traders seeking the latest updates and insights on Polypid Ltd. stock.
PolyPid Ltd. (Nasdaq: PYPD) is publicly described as a late-stage biopharma company aiming to improve surgical outcomes through locally administered, controlled, prolonged-release therapeutics. News about PolyPid often centers on the development and regulatory progress of its lead product candidate, D-PLEX100, and on milestones related to its proprietary PLEX (Polymer-Lipid Encapsulation matriX) drug delivery technology.
Investors and observers following PYPD news will find updates on clinical trial results, particularly from the Phase 3 SHIELD II trial of D-PLEX100 in abdominal colorectal surgeries. Company press releases report that this trial met its primary and key secondary endpoints and demonstrated reductions in surgical site infections and related outcomes when D-PLEX100 was added to standard of care.
Regulatory developments are another major theme in PolyPid’s news flow. The company has announced that D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration and has reported positive pre-NDA meeting minutes supporting a New Drug Application submission. News items also describe the FDA’s agreement to a rolling NDA review, which PolyPid highlights as an important step in its regulatory strategy.
Corporate and operational updates appear regularly, including GMP inspection outcomes for the company’s manufacturing facility by the Israeli Ministry of Health, which PolyPid states support its readiness for potential commercial production. Additional news covers participation in medical and investor conferences, board and management changes such as the appointment of a new chairman of the board, and financial results reported via quarterly updates.
For readers tracking PYPD, this news stream provides insight into PolyPid’s clinical progress, regulatory interactions, manufacturing readiness and capital markets activity, all framed around its goal of improving surgical outcomes with prolonged-release therapeutics.
PolyPid Ltd. (PYPD) announced significant updates regarding its Phase 3 SHIELD I trial of D-PLEX100, with approximately 900 patients enrolled. An unblinded interim analysis is expected soon, which could lead to early trial adjustments. The company secured a $15 million non-dilutive term loan to enhance cash flow and support commercialization efforts for D-PLEX100. Financial results show a loss of $11.9 million for Q1 2022, up from $8.7 million year-over-year, as R&D expenses increased. Cash reserves are sufficient to sustain operations into Q2 2023.
PolyPid Ltd. (Nasdaq: PYPD) announced it will release its first quarter 2022 financial results on May 11, 2022, before U.S. market opening.
A conference call and webcast will follow at 8:30 AM ET to discuss the results and operational highlights.
PolyPid focuses on improving surgical outcomes with its proprietary PLEX technology, currently advancing its lead product D-PLEX100 in Phase 3 trials for preventing surgical site infections.
PolyPid Ltd. (Nasdaq: PYPD) announced the presentation of clinical data at the 13th European and Global CLINAM Summit for Nanomedicine, focusing on D-PLEX100. The study demonstrated D-PLEX100 as an effective surgical site infection prevention agent in colorectal surgery patients, limiting antimicrobial resistance (AMR) without increasing postoperative colonization by multi-drug resistant organisms. This emphasizes the potential of PolyPid's proprietary PLEX technology in enhancing surgical outcomes. The presentation will be accessible on their website after the summit.
PolyPid Ltd. (Nasdaq: PYPD) announced plans to present clinical data evaluating the addition of D-PLEX100 to standard infection prophylaxis in elective colorectal surgery. This presentation will occur at the Surgical Infection Society 2022 Annual Meeting on April 23-26, 2022. The study titled ‘Incisional microenvironments and reduction in SSIs in patients treated with a local doxycycline-eluting formulation’ will be led by Dr. Anthony Senagore. PolyPid aims to enhance surgical outcomes through its proprietary PLEX technology, with D-PLEX100 currently in Phase 3 trials.
PolyPid Ltd. (Nasdaq: PYPD) has secured a loan facility of up to $15 million with Kreos Capital to extend its cash runway into the second quarter of 2023. The funds will support commercialization efforts for D-PLEX100, aimed at preventing surgical site infections, as well as advancing the OncoPLEX development platform. The loan consists of three tranches, with specific conditions for release based on clinical trial results. The senior secured loan carries an interest rate of 9.25%, adjustable upon achieving certain milestones.
PolyPid Ltd. (Nasdaq: PYPD) will present clinical data for its lead product D-PLEX100 at the SAGES 2022 Annual Meeting in Denver from March 16-19, 2022. The poster presentation evaluates D-PLEX100's effectiveness in reducing surgical site infections in elective colorectal surgery when combined with standard prophylaxis. Dr. Anthony Senagore, Senior Medical Director, will lead the oral review. D-PLEX100 is currently in Phase 3 trials aimed at preventing infections after abdominal and sternal surgeries.
PolyPid Ltd. (Nasdaq: PYPD) announced the enrollment of the 750th patient in its pivotal Phase 3 SHIELD I study evaluating D-PLEX100 for preventing surgical site infections (SSIs) in abdominal surgery. An unblinded interim analysis is expected in Q2 2022, allowing potential early trial conclusion based on efficacy or futility. The FDA has indicated that a single pivotal study may suffice for D-PLEX100's approval, given adequate results. D-PLEX100 uses a novel technology for prolonged antibiotic release at the surgical site.
PolyPid Ltd. (Nasdaq: PYPD) announced its participation in the Barclays Global Healthcare Conference from March 15-17, 2022. The company will present on March 16 at 9:00 AM Eastern Time. PolyPid specializes in Phase 3 biopharmaceutical developments, focusing on targeted, locally administered, prolonged-release therapeutics via its proprietary PLEX technology. Its lead product candidate, D-PLEX100, is undergoing clinical trials aimed at preventing surgical site infections.
Investors interested in the conference can contact Barclays representatives for meetings.
PolyPid Ltd. (Nasdaq: PYPD) announced that the FDA approved an unblinded interim analysis for its Phase 3 SHIELD I trial of D-PLEX100, aimed at preventing surgical site infections in abdominal surgeries. The company is on track to enroll 750 patients by Q1 2022, with the interim analysis expected in Q2 2022. Financial results for Q4 2021 show a loss of $13.2 million, up from $7.5 million in Q4 2020, while full-year losses totaled $42.3 million. As of Dec 31, 2021, cash reserves were $32.2 million, expected to sustain operations through 2022.
PolyPid Ltd. (Nasdaq: PYPD) announced it will release its fourth quarter and full year 2021 financial results on February 9, 2022, before the U.S. market opens. The company will hold a conference call at 8:30 AM ET to discuss these results and provide operational updates. PolyPid specializes in developing targeted, long-lasting therapeutics through its proprietary PLEX technology, with its lead product candidate, D-PLEX100, currently undergoing Phase 3 trials aimed at preventing surgical site infections.
FAQ
What is the current stock price of Polypid Ltd. (PYPD)?
What is the market cap of Polypid Ltd. (PYPD)?
