Alnylam Pharmaceuticals [ALNY] — Catalyst Calendar
2026-07-29 · Catalyst Criteria: MEASURED — dated events that would confirm or refute the implied path. Blocks nothing. Time works for a long, so a dated event is not required to own a compounder.
Sourcing rule applied without exception: every entry below is traceable to a filed document. Where a date is not disclosed, the entry says so. No date is inferred, rounded or invented. A fabricated catalyst date is worse than an absent calendar.
Sources are abbreviated as: - Q1-26 8-K = 8-K Ex-99.1 filed 2026-04-30 (Q1-2026 earnings release) - FY25 8-K = 8-K Ex-99.1 filed 2026-02-12 (Q4/FY2025 earnings release) - FY25 10-K = 10-K filed 2026-02-12 - Q1-26 10-Q = 10-Q filed 2026-04-30
Confirmed and dated
| Date | Event | Why it matters | Source |
|---|---|---|---|
| 2026-04-30 (occurred) | Q1-2026 results. Product revenue $1,036m (+121%); total TTR $910m (+153%); first $1bn product-revenue quarter. FY2026 guidance reiterated. | Baseline for everything in this memo | Q1-26 8-K |
| 2026-04-30 (occurred) | TRITON-CM enrolment expanded 1,250 → ~1,750 patients using a pre-specified protocol option, because enrolment is running ahead of plan. Launch still expected by 2030 if positive. | Larger trial = later readout but higher power. The "faster than anticipated" enrolment is itself a demand signal for ATTR-CM | Q1-26 8-K |
| 2026-04-30 (occurred) | Regeneron submitted the cemdisiran NDA to FDA for generalised myasthenia gravis. Additional global filings planned during 2026. | Converts a collaboration into a royalty stream. ALNY's royalty line is currently Leqvio-only | Q1-26 8-K |
| 2026-04 (occurred) | New HELIOS-B analyses at ACC.26: quality-of-life benefit; consistent effect across the disease spectrum including the most advanced patients and diastolic dysfunction; real-world adherence to quarterly HCP-administered dosing | Supports first-line positioning, which is the pricing and share argument | Q1-26 8-K |
| 2026-04 (occurred) | Collaborations announced with Viz.ai (AI-enabled ATTR-CM care pathway) and the American Heart Association (three-year, ten-site learning collaborative) | Direct attack on the diagnosis funnel, which is the binding constraint in ATTR-CM | Q1-26 8-K |
| 2026-04 (occurred) | Phase 1 initiated for ALN-2232 (ACVR1C, adipose-targeted) in obesity and weight management | The obesity mention-frequency emergence made flesh |
Q1-26 8-K |
| 2025-11 (occurred) | AHA 2025: cardiac MRI showed amyloid regression in 22% of vutrisiran-treated patients, none on placebo; kidney function preserved; reduced death/CV events in advanced CKD | Structural, not symptomatic, endpoint. The strongest single piece of clinical evidence in the file | FY25 8-K |
Guided to a period, not a date — stated as the company states it
| Window | Event | Why it matters | Source |
|---|---|---|---|
| H1-2026 | Complete enrolment in cAPPricorn-1 Phase 2 (mivelsiran, cerebral amyloid angiopathy) | Gates the CAA readout | Q1-26 8-K |
| H1-2026 | Initiate Phase 2 of mivelsiran in Alzheimer's disease | First CNS expansion beyond CAA | Q1-26 8-K |
| H1-2026 | Initiate Phase 2 of ALN-6400 in a second bleeding disorder | Pipeline breadth | Q1-26 8-K |
| H2-2026 | ALN-6400 Phase 1 (healthy volunteers) and Phase 2 (hereditary haemorrhagic telangiectasia) results | One of four named H2-2026 readouts | Q1-26 8-K |
| H2-2026 | ALN-HTT02 Phase 1 results in Huntington's disease | CNS delivery proof point | Q1-26 8-K |
| H2-2026 | ALN-2232 Phase 1 results in obesity / weight management | The single readout capable of changing the narrative multiple rather than the numbers | Q1-26 8-K |
| 2026, date not announced | 10th RNAi Roundtable series — Alnylam scientists and programme leaders plus medical thought leaders. The company states "a detailed schedule and registration information will be announced separately." | Pipeline framing event | Q1-26 8-K |
| By 2030 | nucresiran launch in ATTR-CM, assuming positive TRITON-CM data and regulatory approval | The franchise-extension asset. Sits beyond the 12-month window but inside the 5-year implied path | Q1-26 8-K |
Recurring reporting checkpoints
| Event | Expected timing | Basis for the expectation | Status |
|---|---|---|---|
| Q2-2026 results | late July / early August 2026 | Prior years: 2025-07-31, 2024-08-01, 2023-08-03 | EXPECTED — date not announced by the company as of 2026-07-29. Not confirmed. |
| Q3-2026 results | late October / early November 2026 | Prior years: 2025-10-30, 2024-10-31, 2023-11-02 | EXPECTED — not confirmed |
| FY2026 results and FY2027 guidance | February 2027 | Prior years: 2026-02-12, 2025-02-13, 2024-02-15 | EXPECTED — not confirmed |
These three are the events that actually resolve this memo. The implied-path test and the 12-month target both stand or fall on whether the guided FY2026 product revenue of $4,900–5,300m is delivered. Q1 delivered $1,036m, roughly 20% of the midpoint, which requires acceleration through the year — so the Q2 print is the first genuine test.
Structural dates that are not "events" but bound the analysis
| Date / period | Item | Source |
|---|---|---|
| 2027 | 1.00% convertible senior notes due 2027 — partially repurchased in December 2025 | FY25 10-K; 8-K 2025-12-11 |
| 2028 | 0.00% convertible senior notes due 2028 | FY25 10-K |
| ongoing | $1,697.2m of liabilities related to the sale of future royalties and development funding, unwinding through interest expense ($40m Leqvio + $26m development funding in Q1-2026 alone) | Q1-26 10-Q |
| announced, no completion date given | $250m investment in the Norton, Massachusetts siRELIS enzymatic-ligation manufacturing facility, expected to "meaningfully expand capacity" and "significantly reduce production costs" | FY25 8-K |
Deliberately absent
The following would normally appear on a calendar of this kind and are omitted because no filed source supports a date:
- Any FDA action date (PDUFA) for cemdisiran. Regeneron has submitted the NDA; no acceptance or PDUFA date is disclosed in Alnylam's filings.
- Any TRITON-CM or TRITON-PN readout date. Enrolment was expanded in April 2026; the company gives a launch expectation of "by 2030" and no data date.
- Any ZENITH Phase 3 (zilebesiran) readout date. The trial is named in R&D expense commentary; no timing is given.
- Any competitor event (BridgeBio acoramidis, Pfizer tafamidis). These are material to the Downside Criteria but Alnylam's filings do not date them, and I have not gone to third-party sources to construct a date I would then present as researched.
- Medicare Part D negotiation dates for the TTR class. Not disclosed in Alnylam's filings; not asserted.
These absences are the calendar's most important content. The name has four dated H2-2026 pipeline readouts and no dated regulatory or competitive event inside twelve months. A book relying on catalysts to force a re-rating should note that the only genuine 12-month catalysts here are earnings prints against guidance.