FDA approves D-PLEX100 (extended-release doxycycline) for prevention of surgical site infections in colorectal surgery on or before the disclosed PDUFA goal date of 2026-11-28

The proposition

What was claimed

The FDA takes an approval action on PolyPid's New Drug Application for D-PLEX100 (doxycycline in an extended-release polymer-lipid matrix) for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery, with an approval action date on or before 2026-11-28, the PDUFA goal date disclosed in Exhibit 99.1 to PolyPid's Form 6-K furnished 2026-08-12.

Authority

US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US)

Target rungA step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung

Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc.

Forecast classThe group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates

FDA action by goal date

Scope

Prevention of surgical site infections in abdominal colorectal surgery

The clock

Dates that constrain the record

resolution window

Today

Evidence cutoff2026-10-06 Registered2026-10-06 Window opens2026-10-07 Deadline2026-11-28

Evidence cutoff

2026-10-06

Registered

2026-10-06

Window opens

2026-10-07

Deadline

2026-11-28

Evidence cutoff

2026-10-06
Nothing after this date informed the estimate.

Registered

2026-10-06
Frozen and hashed.

Resolution window

2026-10-07 → 2026-11-28
When the adjudicator can read the outcome.

Event by

2026-11-28
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar

ledger 78267586fe018127a09ef07cd55d477d78dbace1df7d6bdad0b43c4e4704ac9e Copy · operator record jc-1791309827457-ff8e2936

Resolution

The rule that settles the forecast

Doxycycline is marketed under many applications, so this one is identified by holder and indication. At the cutoff openFDA listed no PolyPid application (SRC-007, SRC-008). Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=sponsor_name:POLYPID*&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=sponsor_name:AZURITY*&limit=100, read together, contain an NDA held by PolyPid, or by Azurity or another holder to which PolyPid has assigned it (SRC-004), whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-11-28, and whose Drugs@FDA approval letter or label indicates the product for preventing or reducing surgical site infections. An approval for a narrower surgical population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-11-28: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-11-28 resolves NO as occurred_after_deadline. 2026-11-28 is a Saturday; an approval action dated that day still counts. Read no earlier than 2026-12-12. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by PolyPid, Azurity or D-PLEX) governs, under the same holder and indication test. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands.

Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=sponsor_name:POLYPID*&limit=100, https://api.fda.gov/drug/drugsfda.json?search=sponsor_name:AZURITY*&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/

Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far.

What this record will show once it resolves

Frozen covariatesThe facts about the evidence and the authority's process that were frozen with the forecast at its cutoff

The state of the record at the cutoff

Recorded as they stood on 2026-10-06, including the one field whose value was unknown then. It is left unknown rather than filled in.

review pathway

priority review (SRC-001, SRC-002); Breakthrough Therapy Designation (SRC-002); Fast Track and rolling submission (SRC-006)

submission type

original NDA; company intends Section 505(b)(2) (SRC-006)

evidence class

one pivotal randomized Phase 3 trial, SHIELD II, D-PLEX100 plus standard of care vs standard of care alone (SRC-006)

pivotal n

405 (D-PLEX100 + SoC) vs 393 (SoC) in the primary-endpoint analysis; 975 patients with incision >=7 cm in the overall population used for the second key secondary endpoint (SRC-006)

endpoint type

composite primary endpoint of deep and superficial SSI, all-cause mortality and reintervention at the index incision: 10.9% vs 18.1%, 40% reduction, p<0.005 (SRC-006)

approved competitors in class

unknown — not stated in the archived sources

months since last guideline revision

not applicable — no guideline is the subject of this proposition

panel cycle position

not applicable — the act is an FDA approval action

sponsor request status

NDA submission completed (rolling); FDA accepted it on July 27, 2026 with Priority Review and identified no filing review issues (SRC-001)

odac referral

none announced in the archived sources

sponsor state change

exclusive US/Canada license and supply agreement with Azurity effective July 17, 2026; PolyPid must assign the approved NDA to Azurity after approval (SRC-003, SRC-004)