Kiniksa Pharmaceuticals [KNSA]
As of 2026-07-29 · Catalyst Criteria: MEASURED
Rule applied: no date is invented. Where Kiniksa has not announced a date, the entry states the company's own guidance language and, separately, the observed historical pattern — clearly labelled as a pattern, not a date. A fabricated catalyst date is worse than an absent calendar.
| # | Date | Event | Status | Why it matters to the implied path |
|---|---|---|---|---|
| 1 | 2026-07-28 | Q2 2026 results; FY2026 ARCALYST guidance raised to $980–995m from $930–945m; KPL-387 Phase 2 interval data; PASTORALE Phase 3 initiated | OCCURRED — the reason this memo exists | Third consecutive quarter of raises. Penetration disclosed at 21% |
| 2 | by 2026-12-31 | KPL-1161 Phase 1 first-in-human initiation | Company-guided, restated 2026-07-28: "on track to initiate a Phase 1 trial by the end of this year" | The quarterly-dosing asset. A slip is the first evidence the pipeline is behind |
| 3 | 2028-03-18 | ARCALYST Orphan Drug Exclusivity for pericarditis expires (7 years from the 2021-03-18 approval) | Statutory — fixed | Opens the skinny-label biosimilar pathway. Five method-of-use patents run to 2038 behind it. Inside the 5-year modelling window |
| 4 | 2028 / 2029 | KPL-387 potential commercial availability | Company-guided, 2026-07-28: "We expect to bring this potential additional treatment option to patients in the 2028/2029 timeframe" | The successor asset, and the one with no Regeneron profit share. Arrives after ODE lapses — the sequencing is deliberate |
| # | Expected window | Event | Observed pattern | What to watch |
|---|---|---|---|---|
| 5 | late October 2026 | Q3 2026 results | Q3 released 2023-10-31, 2024-10-29, 2025-10-28. 2026 date not announced | Penetration is not disclosed in Q3 (only Q2 and Q4). Watch prescriber count, duration of therapy, and a possible fourth 2026 guidance raise — 2025 saw four |
| 6 | January 2027 | Corporate update / preliminary FY2026 revenue / initial FY2027 guidance | Issued 2025-01-13 and 2026-01-12, around the JPMorgan Healthcare Conference. 2027 date not announced | The single most important event for the 12-month target. Initial FY2027 ARCALYST guidance is the first hard read on whether the penetration pace holds. Also the release that historically carries the year-end penetration figure (18% at Q4'25, 13% at Q4'24) |
| 7 | late February 2027 | FY2026 results and 10-K | Filed 2024-02-28, 2025-02-25, 2026-02-24. 2027 date not announced | Full-year gross-to-net, inventory, updated patent/exclusivity disclosure |
| 8 | ~July 2027 | Q2 2027 results | Q2 released 2024-07-23, 2025-07-29, 2026-07-28 | Mid-year penetration disclosure — the direct test of the +4.9pp/yr the screen-parameter case requires |
| # | Event | Status | Impact |
|---|---|---|---|
| 9 | PASTORALE Phase 3 topline | Event-driven by design ("time to first adjudicated pericarditis recurrence during the randomised-withdrawal period"), ~85 participants, enrolling and dosing as of 2026-07-28. No topline date has been given and none is assumed here. Working back from the 2028/2029 availability guidance implies data in roughly 2027–2028, but that is an inference | Binary for the successor franchise. A miss removes the migration path and leaves a single weekly injectable facing a 2028 ODE step-down |
| 10 | Cardiol Therapeutics MAVERIC Phase 3 topline (NCT06708299, oral CardiolRx in recurrent pericarditis, FDA orphan designation) | Company 6-K filings in 2026 describe enrolment as "approaching completion." No topline date announced. | The only identified pivotal competitor in the same indication. Success creates a cheap oral step-edit ahead of a $335k/yr injectable — a net-price and access risk, which is where the margin lives |
| 11 | Samsung Biologics CDMO transition completion | FDA approved Samsung as replacement CDMO for ARCALYST drug substance in June 2026; $140.4m of non-cancelable minimums remain ($53.1m within one year) | Completion should let the elevated inventory (3.6 quarters of COGS at 2026-03-31) normalise. Failure to normalise by mid-2027 is a flag |
| 12 | Abiprubart strategic alternatives | FY2025 10-K: the company plans "to explore strategic alternatives." No process, timeline or counterparty disclosed | Immaterial to revenue; a disposal would be a small cash inflow and a confirmation of focus |
| 13 | Huadong ARCALYST milestones | Up to ~$50.0m in contingent sales-based milestones remain outstanding | 50% payable onward to Regeneron. Small and non-recurring — should not be modelled into the base |
| 14 | Genentech (vixarelimab) milestones | ~$570.0m of contingent development, regulatory and sales-based payments remain, plus low-double-digit to mid-teens royalties | Optionality only. Kiniksa has no control over the timeline and none is disclosed. Not in any case in this memo |
PASS. Four dated or company-guided events and four with a strong, multi-year, filing-verified recurrence pattern sit inside the next eighteen months, and each maps directly to a parameter in the implied-path test:
Per criteria.md, time works for a long, so a dated event is not required to own a compounder. Here they
exist anyway, and — unusually — the thesis's core variable is a number the company itself publishes.