PolyPid’s D-PLEX100 has been granted FDA Priority Review following acceptance of the company’s New Drug Application, with a regulatory decision expected in November 2026.

The US Food and Drug Administration (FDA) has accepted PolyPid’s NDA for filing and granted Priority Review to D-PLEX100, an investigational therapy being developed to prevent surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2026, approximately one quarter earlier than PolyPid’s previously communicated guidance for a decision in the first quarter of 2027.

The FDA did not identify any filing review issues as part of its acceptance of the NDA.

Priority Review reduces the FDA’s target review timeline from the standard 10 months to approximately six months. However, the designation does not guarantee approval, and D-PLEX100 remains an investigational product pending the outcome of the FDA’s review.

Dikla Czaczkes Akselbrad, CEO of PolyPid, said: “The FDA’s acceptance of our NDA with Priority Review, arriving with no filing review issues and an accelerated action date, is a defining regulatory milestone for PolyPid in our development of D-PLEX100 as a potential new option to patients for the prevention of surgical site infections, pending the outcome of FDA’s review.”

She added: “We believe this outcome reflects the quality of our regulatory submission and the rigor of our development program for D-PLEX100.”

FDA decision expected in November following NDA acceptance

The FDA acceptance also triggers a $15 million milestone payment from Azurity Pharmaceuticals, PolyPid’s commercial partner for D-PLEX100. The payment completes $30 million in upfront and near-term milestone payments under the exclusive commercial partnership announced in July 2026.

PolyPid and Azurity are now expected to support the FDA’s review ahead of the November 28 PDUFA action date. If approved, Azurity is targeting a potential U.S. commercial launch of D-PLEX100 in early 2027.

D-PLEX100 is PolyPid’s lead product candidate and is designed to provide prolonged, localised antibacterial activity at the surgical site. The therapy uses PolyPid’s Kynatrix delivery technology to provide controlled release of the broad-spectrum antibiotic doxycycline directly at the site of surgery.

According to PolyPid, the technology is designed to maintain a high local concentration of doxycycline for up to 30 days, with the aim of preventing SSIs following abdominal colorectal surgery.

Surgical site infections are a significant complication associated with surgery and can lead to additional treatment, prolonged hospital stays and increased healthcare costs. Antibiotic-resistant bacteria can further complicate the management of infections following surgical procedures.

The company is developing D-PLEX100 as a local treatment intended to address bacterial infection risk directly at the surgical site, while potentially limiting systemic exposure to the antibiotic.

D-PLEX100 showed positive Phase 3 results

The NDA submission was supported by data from the Phase 3 SHIELD II trial, in which D-PLEX100 achieved its primary endpoint and demonstrated a 60% relative risk reduction in SSI incidence at a secondary endpoint among patients undergoing abdominal colorectal surgery with large incisions.

The reported secondary endpoint result was statistically significant, with a p-value of 0.0013.

D-PLEX100 has also received Breakthrough Therapy Designation from the FDA for the prevention of SSIs in patients undergoing elective colorectal surgery.

The latest regulatory milestone brings PolyPid’s lead programme closer to a potential U.S. approval and commercial launch, subject to the outcome of the FDA review.

If approved, D-PLEX100 could provide a new approach to preventing SSIs following abdominal colorectal surgery, using PolyPid’s local drug delivery technology to maintain prolonged antibacterial activity at the site of surgical intervention.

The FDA is expected to issue its decision by November 28, 2026.