PolyPid Ltd.

PolyPid Unveils Expanded Pipeline Strategy, Introducing PD01B, a New Kynatrix™ Based Product Candidate for the Treatment of Diabetic Foot Infections

PolyPid unveiled an expanded pipeline strategy introducing PD01B, a new Kynatrix-based candidate for controlled-release local antibiotic treatment of diabetic foot infections. PD01B will be developed as a new NDA, with an FDA pre-IND meeting and first-in-human study expected in the second half of 2027. The company also confirmed all scheduled FDA interactions for D-PLEX100 remain on track ahead of its November 28, 2026 PDUFA goal date, with a U.S. launch expected in early 2027, EMA decision in H2 2027, and CMS NTAP decision in August 2027.

•4d ago

PolyPid to Present D-PLEX₁₀₀ Microbiology Data at IDWeek 2026

PolyPid will present an oral late-breaking presentation at IDWeek 2026 on pooled microbiology data for D-PLEX100 from three randomized trials covering 2,185 patients. In the 134-patient culture-positive SSI subset, heavy bacterial growth was less frequent with D-PLEX100 plus standard of care than with standard of care alone (16% vs 27%, p=0.034), and breakthrough infections occurred later (median 10.0 vs 6.5 days), with no increase in multidrug-resistant organisms. The findings are exploratory and supportive of the previously reported SHIELD II Phase 3 result of a 60% relative risk reduction in surgical-site infections; the company's NDA remains under FDA review.

•11d ago

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

The EMA has validated PolyPid's Marketing Authorization Application for D-PLEX100, its lead candidate for preventing post-abdominal-surgery incisional infections, initiating formal review under the Centralized Procedure. The application, submitted September 14, 2026, is supported by the positive pivotal Phase 3 SHIELD II trial, which showed a 60% relative risk reduction in surgical site infections versus standard of care (p=0.0013). In parallel, the FDA is reviewing the D-PLEX100 NDA under Priority Review with a PDUFA goal date of November 28, 2026, and PolyPid retains ex-U.S./Canada rights where it is exploring strategic options for the European market.

•1mo ago

PolyPid Provides Corporate Update and Reports Second Quarter 2026 Financial Results

PolyPid announced that the FDA accepted the NDA for D-PLEX₁₀₀ with Priority Review, setting a PDUFA goal date of November 28, 2026, which is approximately one quarter ahead of previous guidance. Following the acceptance, the company achieved milestones triggering $30 million in upfront payments from partner Azurity Pharmaceuticals, which will handle exclusive U.S. and Canada commercialization with potential tiered royalties up to the mid-twenties. PolyPid reported a Q2 net loss of $7.8 million, or $0.35 per share, and noted that the recent milestone payments extend its financial runway into 2028.

•2mo ago

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

The FDA accepted PolyPid's NDA for D-PLEX(100) and granted Priority Review, setting a PDUFA target action date of November 28, 2026, which is approximately one quarter ahead of the company's previous guidance. The acceptance triggers a $15 million milestone payment from commercial partner Azurity Pharmaceuticals, completing $30 million in total upfront and near-term milestone payments under the partnership agreement. D-PLEX(100) is designed to prevent surgical site infections in patients undergoing abdominal colorectal surgery and recently demonstrated a 60% relative risk reduction in the Phase 3 SHIELD II trial.

•3mo ago

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

PolyPid entered into an exclusive commercial partnership with Azurity Pharmaceuticals to commercialize D-PLEX(100) in the U.S. and Canada for the prevention of surgical site infections. The agreement provides PolyPid with $15 million upfront and an additional $15 million upon FDA NDA acceptance, plus eligibility for up to $300 million in milestones and tiered royalties ranging from mid-teen to mid-twenties percentages. Azurity will fund future clinical development for potential label expansion and targets a U.S. commercial launch for D-PLEX(100) in the first quarter of 2027.

•3mo ago

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 announced it will present detailed analysis from the Phase 3 SHIELD II trial of D-PLEX(100) at the Surgical Infection Society Annual Meeting. The data showed a 64% relative risk reduction in patients with clinically significant wound infections compared to standard of care. Additionally, previously reported results indicated a 60% reduction in SSI incidence, reinforcing the product's potential for improved patient outcomes and reduced hospital costs.

•6mo ago