PolyPid Ltd.

Oct 1, 2026

European Medicines Agency Validates PolyPid’s Marketing Authorization Application for D-PLEX₁₀₀

PolyPid Ltd. announced that the European Medicines Agency has validated its Marketing Authorization Application for D-PLEX 100, a product aimed at preventing surgical site infections. This validation marks the start of a formal review process by the EMA. Concurrently, the FDA has accepted the NDA for D-PLEX 100 under Priority Review, with a goal date set for November 28, 2026.

Oct 1, 2026

PYPDGeneral

PolyPid Regains European Commercialization Rights for D-PLEX₁₀₀, Expanding Global Commercialization Opportunities

PolyPid Ltd. has regained exclusive European commercialization rights for its product D-PLEX™1800 after terminating its agreement with ADVANZ PHARMA. The company has achieved significant milestones, including a successful Phase 3 trial and FDA submission. This positions D-PLEX™1800 as an attractive opportunity for pharmaceutical companies in the surgical site infection market.

Sep 15, 2026

PolyPid Announces Participation in Upcoming Fall Investor Conferences

PolyPid Ltd. announced its participation in several upcoming investor conferences, including the 5th Annual ROTH Healthcare Opportunities Conference and the Lytham Partners Fall 2026 Investor Conference. The company aims to engage with investors and discuss its innovative biopharmaceutical solutions. PolyPid's lead product, D-PLEX 100, has shown promising results in clinical trials, enhancing its market position.

Aug 12, 2026

PolyPid Provides Corporate Update and Reports Second Quarter 2026 Financial Results

PolyPid has provided a corporate update highlighting the FDA's acceptance of its D-PLEX180 NDA with a priority review status. The PDUFA goal date is now set for November 28, 2026, which is approximately one quarter earlier than previously expected. Additionally, the company has secured a commercialization partnership with Azurity Pharmaceuticals, achieving $30 million in upfront and near-term milestones.

Jul 30, 2026

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PolyPid to Report Second Quarter 2026 Financial Results and Operational Highlights on August 12, 2026

PolyPid Ltd. will announce its second quarter 2026 financial results and operational highlights on August 12, 2026. The company will host a conference call and webcast at 8:30 AM ET to discuss these results. PolyPid is focused on developing long-acting, controlled-release drugs to enhance treatment effectiveness.

Jul 29, 2026

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PolyPid Announces FDA Acceptance of NDA with Priority Review for D-PLEX₁₀₀

PolyPid Ltd. announced that the FDA has accepted its New Drug Application (NDA) for D-PLEX 100, granting it Priority Review for preventing surgical site infections in colorectal surgery. The FDA's acceptance, which identified no filing review issues, sets a PDUFA target action date of November 28, 2026. This milestone triggers a $15 million payment from Azurity Pharmaceuticals, completing a total of $30 million in upfront and milestone payments under their partnership.

PolyPid Announces Exclusive Partnership with Azurity Pharmaceuticals for the Commercialization of D-PLEX₁₀₀ in the U.S. and Canada

PolyPid has entered an exclusive partnership with Azurity Pharmaceuticals for the commercialization of D-PLEX100 in the U.S. and Canada, aimed at preventing surgical site infections. The agreement includes an upfront payment of $15 million and potential milestone payments exceeding $300 million. The U.S. launch is targeted for Q1 2027, following positive Phase 3 trial results.

Jun 10, 2026

PYPDGeneral

NOTICE FOR THE ANNUAL AND EXTRAORDINARY GENERAL MEETING TO BE HELD ON JULY 15, 2026 E XHIBIT 99.1 polypid Ltd. Notice of ANNUAL and EXTRAORDINARY General Meeting of shareholders to be held on

PolyPid Ltd. has announced that it will hold its Annual and Extraordinary General Meeting on July 15, 2026, at 2:00 p.m. Israel time. The meeting will take place at the company's office in Petach Tikva, Israel, and shareholders of record as of June 15, 2026, are eligible to vote. Detailed instructions regarding proxy voting and attendance have been provided to ensure shareholder participation.

PolyPid Completes New Drug Application Submission to FDA for D-PLEX 100 If approved, D-PLEX 100 would address a critical unmet medical need in the prevention of surgical site infections PDUFA target action date currently

PolyPid Ltd. has completed its New Drug Application submission to the FDA for D-PLEX100, aimed at preventing surgical site infections particularly in colorectal surgeries. The application follows the positive results from the pivotal Phase 3 SHIELD II trial, which met all primary and secondary endpoints, showing significant efficacy. The company is expecting a potential FDA approval decision in the first quarter of 2027, having received several expedited review designations from the FDA.

May 20, 2026

PolyPid to Participate in the Craig-Hallum 23rd Annual Institutional Investor Conference

PolyPid Ltd. will participate in the Craig-Hallum 23rd Annual Institutional Investor Conference on May 28, 2026. The event will take place at the Depot Renaissance Hotel in Minneapolis, MN, where the company's management will hold investor meetings. PolyPid is recognized for developing innovative long-acting drugs aimed at enhancing treatment effectiveness.

PolyPid Provides Corporate Update and Reports First Quarter 2026 Financial Results

PolyPid Ltd. has initiated the NDA submission for its lead product D-PLEX1800 aimed at preventing surgical site infections. The company is in the late stages of discussions for a U.S. commercial partnership and has presented positive Phase 3 data at medical congresses. Financially, the company reported a net loss of $7.7 million for Q1 2026, with sufficient cash resources to support operations into the second half of the year.

May 6, 2026

PolyPid to Report First Quarter 2026 Financial Results and Operational Highlights on May 13, 2026

PolyPid Ltd. will announce its first quarter 2026 financial results and operational highlights on May 13, 2026. The company will host a conference call and webcast at 8:30 AM ET to discuss these results and provide updates on its business operations. PolyPid focuses on developing innovative long-acting drugs for various medical needs.

Apr 28, 2026

PolyPid to Present Data from SHIELD II Phase 3 Trial Demonstrating Reduced Severity of Surgical Site Infection at Surgical Infection Society 2026 Annual Meeting

PolyPid Ltd. announced it will present data from its Phase 3 SHIELD II trial at the Surgical Infection Society's annual meeting. The analysis shows a significant reduction in the severity of surgical site infections (SSIs) following colorectal surgery when using D-PLEX100. This could lead to better patient outcomes and reduced hospital resource use. The presentation will be led by Dr. Robert G. Sawyer.

Apr 14, 2026

PYPDPhases

PolyPid to Present New Phase 3 SHIELD II Data Demonstrating D-PLEX₁₀₀ Sustained Local Release at ESCMID Global 2026

PolyPid Ltd. will present new pharmacokinetic data from the Phase 3 SHIELD II trial for D-PLEX100 at the ESCMID Global 2026. The data indicates that D-PLEX100 can deliver doxycycline continuously for 30 days at the surgical site, significantly reducing the risk of surgical site infections. This innovative approach addresses a key limitation of conventional antibiotics.

Mar 31, 2026

PolyPid Initiates D-PLEX NDA Submission to the FDA

PolyPid Ltd. has initiated the NDA submission for its lead product D-PLEX100 to the FDA for preventing surgical site infections in colorectal surgery patients. This submission is part of a rolling review process under the Fast Track designation, with the completion expected in the second quarter of 2026. The company reported positive results from the Phase 3 SHIELD II trial and is focusing on potential commercialization partnerships. The product aims to deliver a prolonged antibiotic effect at the surgical site using its innovative delivery technology.

Mar 17, 2026

PolyPid Receives PDUFA Fee Waiver from FDA for D-PLEX₁₀₀’s New Drug Application

PolyPid Ltd. announced that the FDA has granted a $4.3 million PDUFA fee waiver for its New Drug Application (NDA) for D-PLEX100, aimed at preventing surgical site infections. This waiver supports the company's upcoming NDA submission, following positive results from the Phase 3 SHIELD II trial, which demonstrated a 60% reduction in infection risk. PolyPid is also in discussions for commercial partnerships in the U.S.

Feb 25, 2026

PolyPid Announces Participation in Upcoming Investor Conferences

PolyPid Ltd. has announced its participation in two upcoming investor conferences in March 2026. The conferences include the Citizens 2026 Life Sciences Conference and the 38th Annual ROTH Conference, where investors can schedule one-on-one meetings with senior management. The company focuses on developing long-acting, controlled-release drugs to enhance treatment effectiveness.

Feb 11, 2026

PolyPid Provides Corporate Update and Reports Fourth Quarter and Full-Year 2025 Financial Results

PolyPid Ltd. has provided a corporate update and reported its financial results for 2025. The company successfully completed the SHIELD II Phase 3 trial for its lead product, D-PLEX 1800, and is in advanced discussions for U.S. commercial partnerships. Positive feedback from the FDA supports a rolling NDA review, with submission expected by the end of Q1 2026. The CEO expressed optimism for 2026 as a pivotal year for the company's transition to commercialization.