Welcome to our dedicated page for Polypid news (Ticker: PYPD), a resource for investors and traders seeking the latest updates and insights on Polypid stock.
PolyPid Ltd. develops locally administered, controlled-release therapeutics based on its proprietary PLEX drug-delivery technology. The company’s lead product candidate, D-PLEX100, is designed for prevention of surgical site infections in abdominal colorectal surgery, and company updates commonly cover Phase 3 SHIELD II data, pharmacokinetics, FDA interactions, New Drug Application activity, and manufacturing-readiness topics.
PolyPid news also includes financial results, operational highlights, investor-conference participation, and broader pipeline references spanning surgical care, oncology, obesity, diabetes, and other metabolic-disease applications. Recurring disclosures focus on clinical and regulatory progress, product-candidate development, and the financing and business updates typical of a late-stage biopharmaceutical issuer.
PolyPid (Nasdaq: PYPD) reported second-quarter 2026 results and key regulatory and commercial milestones for D-PLEX₁₀₀ for prevention of surgical site infections in abdominal colorectal surgery.
The FDA accepted the D-PLEX₁₀₀ NDA with Priority Review and set a PDUFA goal date of November 28, 2026, about one quarter earlier than PolyPid’s prior guidance. No filing review issues were identified. PolyPid also signed an exclusive U.S. and Canada commercialization agreement with Azurity Pharmaceuticals, unlocking $30 million in upfront and near-term milestone payments following NDA acceptance and making the company eligible for up to approximately $320 million in total milestones plus tiered royalties from mid-teen to mid-twenties percentages. Azurity will fund additional clinical development for potential label expansion, while PolyPid retains ex-U.S./Canada commercial rights and global manufacturing.
For Q2 2026, PolyPid reported a net loss of $7.8 million ($0.35 per share) versus $10.0 million ($0.78 per share) a year earlier, with operating expenses modestly lower. As of June 30, 2026, cash and cash equivalents were $6.6 million, excluding the $30 million from Azurity. According to PolyPid, its current cash plus expected proceeds from the Azurity agreement should fund operations into 2028.
PolyPid (Nasdaq: PYPD) will release its second quarter 2026 financial results and operational highlights before U.S. market open on Wednesday, August 12, 2026. Management will host a conference call and webcast at 8:30 AM Eastern Time to review results and discuss business operations.
Registration for the call is recommended at least five minutes before start, with a separate webcast link available for listen-only participants. PolyPid is a biopharmaceutical company focused on long-acting, controlled-release drugs; its lead product D-PLEX₁₀₀ met primary and key secondary endpoints in the Phase 3 SHIELD II surgical site infection prevention trial.
PolyPid (Nasdaq: PYPD) reported that the U.S. FDA has accepted for filing and granted Priority Review to its NDA for D-PLEX₁₀₀ to prevent surgical site infections in patients undergoing abdominal colorectal surgery. The FDA set a PDUFA target action date of November 28, 2026, roughly one quarter earlier than PolyPid’s prior first-quarter 2027 guidance, and identified no filing review issues. Priority Review shortens the target review timeline from ten months to about six months.
According to PolyPid, NDA acceptance triggers a $15 million milestone payment from its U.S. and Canada commercial partner Azurity Pharmaceuticals, completing $30 million in upfront and near-term milestones under their exclusive commercialization agreement. D-PLEX₁₀₀ previously met primary and key secondary endpoints in the Phase 3 SHIELD II trial, including a 60% relative risk reduction in SSI incidence, and has Breakthrough Therapy Designation for prevention of SSIs in elective colorectal surgery.
PolyPid (Nasdaq: PYPD) signed an exclusive commercial partnership with Azurity Pharmaceuticals for D-PLEX100 in the U.S. and Canada for prevention of surgical site infections. PolyPid will receive $15 million upfront at signing and a further $15 million upon expected FDA acceptance of the NDA in August 2026, plus eligibility for up to approximately $300 million in additional regulatory, development, and sales-based milestones.
Upon commercialization, PolyPid will manufacture and supply D-PLEX100 to Azurity for a transfer price and receive tiered royalties from mid-teen to mid-twenties percentages. Azurity may fund additional clinical programs for label expansion in North America. PolyPid retains commercial rights outside the U.S. and Canada and full ownership of its PLEX and Kynatrix platforms. The deal follows positive Phase 3 SHIELD II data, including achievement of the primary endpoint and a 60% relative risk reduction at a key secondary endpoint, with a U.S. launch targeted for Q1 2027.
PolyPid (Nasdaq:PYPD) has completed its rolling New Drug Application submission to the U.S. FDA for D-PLEX100, a lead candidate to prevent surgical site infections in colorectal surgery.
The NDA is backed by a Phase 3 trial showing 60% relative SSI risk reduction, with an expected FDA decision in Q1 2027.
PolyPid (Nasdaq:PYPD) announced that its management will participate in investor meetings at the Craig-Hallum 23rd Annual Institutional Investor Conference on Thursday, May 28, 2026, at the Depot Renaissance Hotel in Minneapolis, MN.
Interested investors should contact their Craig-Hallum representative to arrange meetings with PolyPid.
PolyPid (Nasdaq:PYPD) reported first quarter 2026 results and regulatory progress for D-PLEX₁₀₀. The NDA to the FDA was initiated March 30, 2026 under rolling review, with completion expected imminently and a PDUFA fee waiver of about $4.3 million.
EMA meetings are planned in Q2 2026, with an MAA filing targeted for Q3 2026. U.S. commercial partnership talks are in late stages. Q1 2026 net loss was $7.7 million ($0.35 per share). Cash and equivalents were $10.9 million, supported by $4.0 million warrant proceeds and full repayment of a $0.8 million venture loan.
PolyPid (Nasdaq: PYPD) will report first quarter 2026 financial results and operational highlights before U.S. markets open on Wednesday, May 13, 2026.
The company will host a conference call and webcast at 8:30 AM Eastern Time. Registration is recommended at least 5 minutes before the call; a webcast option is available for listeners.
PolyPid (Nasdaq: PYPD) announced presentation of Phase 3 SHIELD II ASEPSIS score analysis showing a 64% relative risk reduction (p=0.0103) in patients with ASEPSIS>20 and a previously reported 60% RRR in SSI incidence (p=0.0013) after abdominal colorectal surgery. D-PLEX100 holds FDA Breakthrough Therapy designation for SSI prevention.
The data suggest fewer high-severity wound infections and potential reductions in antibiotic use, hospital stay, and resource utilization; results will be presented May 6, 2026 at the Surgical Infection Society annual meeting.
PolyPid (Nasdaq: PYPD) will present Phase 3 SHIELD II pharmacokinetic data for D-PLEX100 at ESCMID Global 2026 on April 19, 2026. Key results show a sustained, controlled local doxycycline release detectable for 763 hours (~32 days) with plasma levels below 100 ng/mL, indicating minimal systemic exposure versus oral dosing.
The poster (P2740) is authored by Prof. Antonino Spinelli and presented by Eyal Shoshani in Session 05b on April 19, 12:00–13:30 CEST.