PolyPid is a late-stage company whose D-PLEX100, a slow-release antibiotic placed in the surgical wound, is under FDA review to prevent infections after colorectal surgery; it is not approved.
PolyPid's case rests on D-PLEX100 approval and Azurity's planned early 2027 launch. SHIELD II met its primary and key secondary endpoints. Azurity's $30 million was earned, with further milestones and royalties possible. June 30, 2026 cash of $6.6 million excludes those payments; management's funding guidance into 2028 also assumes potential proceeds. EMA validated the application, while European rights reverted to PolyPid. PD01B adds diabetic foot infection potential, with a pre-IND meeting and first-in-human study planned for the second half of 2027.
Thesis checklist
0 risks need attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: FDA approves D-PLEX100
Does FDA approve D-PLEX100 for preventing infections after abdominal colorectal surgery, and with what indication?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
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D-PLEX100 awaits November 28, 2026 FDA decision; Azurity targets early 2027 launch
Phase 3-backed SSI prevention drug at PDUFA with $11M cash and ~$7.7M/qtr burn — survival to approval is the single condition
NDA filed on strong Phase 3 SSI data, Azurity deal extends runway — approval in Q1 2027 is the sole binary
D-PLEX 100 NDA under FDA review for colorectal SSI prevention; approval decision tests whether Phase 3 efficacy translates to first-in-class commercial launch
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.
Drug pages: D-PLEX100
Disease areas: Other cancers, Infectious diseases
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
2 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.