Intellia Therapeutics said the FDA accepted the lonvo-z BLA, granted priority review, set a PDUFA goal date of MARCH 10, 2027, and currently does not plan an advisory committee.
NTLA · Intellia Therapeutics, Inc.
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Intellia Therapeutics said the FDA accepted lonvo-z’s BLA, granted Priority Review and set a March 10, 2027 target action date, supporting a planned first quarter 2027 U.S. launch if approved.
Metrics snapshot
Useful current figures from the complete screener profile.
Quarterly results
* Q4 derived as the full year minus Q1 to Q3.
AI Brief
Q2 FY26 earnings call · Aug 6, 2026TL;DR. Intellia reported positive Phase 3 HAELO data for lonvo-z in HAE supporting a potential first-half 2027 U.S. launch, resumed enrollment in nex-z Phase 3 ATTR trials and identified an HLA allele linked to liver transaminase elevations, and ended Q2 with $628.4M in cash (runway into 2028) but a wider net loss of $106.6M.
- + Expects FDA BLA acceptance for lonvo-z in 2H 2026 with a planned U.S. launch in 1H 2027, supported by completed commercial team hiring.
- + Resumed enrollment/dosing in both nex-z Phase 3 trials in Q2 with Magnitude-2 enrollment expected to complete in 2H 2026.
- + Identified HLA C0501 allele linked to severe liver transaminase elevations, enabling mitigation and patient selection, with management framing it as confidence-building.
- + Cash position strengthened to $628.4M with runway expected at least into 2028, following a $195M equity raise.
- − Collaboration revenue fell to $7.7M from $14.2M, driven by reduced revenue from Regeneron.
- − G&A expenses rose to $37.8M from $27.2M as commercial infrastructure and legal costs increased.
- − Disappointing competitor CardioTransform data raises uncertainty for combination ATTR strategy and may require Magnitude trial design changes.
AI-generated from the earnings call and 8-K · may contain errors · not investment advice
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Key metrics
the company's own KPIs, from written earnings releases and filings| Metric | Latest | Period | YoY |
|---|---|---|---|
| all-cause mortality rate for matched NAC ATTR-CM cohort | 12.7 | the three months ended June 30, 2026 filing | — |
| all-cause mortality rate for nex-z treated ATTR-CM patients (post-hoc analysis) | 3.9 | the three months ended June 30, 2026 filing | — |
| mean monthly attack rate in the lonvo-z arm | 0.26 | HAELO six-month efficacy evaluation period (weeks 5 to 28) | — |
| mean monthly attack rate in the placebo arm | 2.1 | HAELO six-month efficacy evaluation period (weeks 5 to 28) | — |
| mean monthly rate of attacks requiring on-demand treatment in the lonvo-z arm | 0.19 | HAELO six-month efficacy evaluation period (weeks 5 to 28) | — |
| mean monthly rate of attacks requiring on-demand treatment in the placebo arm | 1.79 | HAELO six-month efficacy evaluation period (weeks 5 to 28) | — |
| mean monthly rate of moderate/severe attacks in the lonvo-z arm | 0.11 | HAELO six-month efficacy evaluation period (weeks 5 to 28) | — |
| mean monthly rate of moderate/severe attacks in the placebo arm | 1.23 | HAELO six-month efficacy evaluation period (weeks 5 to 28) | — |
| NAC matched ATTR-CM cohort size (post-hoc analysis) | 1,792 | the three months ended June 30, 2026 filing | — |
| patients enrolled in HAELO Phase 3 trial | 80 | the three months ended June 30, 2026 filing | — |
| patients entirely attack free and therapy free in the lonvo-z arm (HAELO, weeks 5 to 28) | 62% | the three months ended June 30, 2026 filing | — |
| patients entirely attack free and therapy free in the placebo arm | 11% | HAELO six-month efficacy evaluation period (weeks 5 to 28) | — |
| patients in MAGNITUDE Phase 3 trial | 1,200 | the three months ended June 30, 2026 filing | — |
| patients in MAGNITUDE-2 Phase 3 trial | 50 | the three months ended June 30, 2026 filing | — |
| Phase 1 ATTRv-PN patients reaching 36 months of follow-up | 12 | the three months ended June 30, 2026 filing | — |
| Phase 1 ATTRv-PN patients receiving a one-time dose of 0.3 mg/kg or higher | 33 | the three months ended June 30, 2026 filing | — |
Figures exactly as the company stated them in writing · click a metric with a to chart its history · period links open the stating document · "filing" marks figures stated in the 10-K/10-Q · YoY needs an exactly comparable prior-year period
Versus peers
Biotechnology — same industry group| Company | Mkt cap | YTD | Rev growth Y/Y | P/E | Short % shares |
|---|---|---|---|---|---|
|
NTLA
this stock
Intellia Therapeutics, Inc.
|
$1.36B | +7.9% | +16.9% | — | 31.6% |
|
VRTX
Vertex Pharmaceuticals Inc
|
$136.56B | +18.8% | +46.2% | 34.7 | 1.9% |
|
REGN
Regeneron Pharmaceuticals, Inc.
|
$98.84B | +23.8% | +20.8% | 21.1 | 2.1% |
|
MRNA
Moderna, Inc.
|
$90.38B | +657.4% | +4.3% | — | 8.2% |
|
CSLLY
Csl Ltd
|
$66.05B | — | — | — | 0.0% |
Peers by industry group · P/E from as-reported trailing EPS · short % is of shares outstanding
At a glance
key data from every section- Filed
- Nov 13, 2026
- This year
- 26
Intellia Therapeutics said the FDA accepted the lonvo-z BLA, granted priority review, set a PDUFA goal date of MARCH 10, 2027, and currently does not plan an advisory committee.
ViewPerformance
| 5D | 20D | 120D | MTD | YTD | |
|---|---|---|---|---|---|
| NTLA | -14.5% | -15.1% | -23.1% | -22.2% | +7.9% |
| SPY | +2.6% | -1.2% | +0.5% | -0.2% | +10.6% |
| vs SPY | -17.1% | -13.9% | -23.6% | -22.0% | -2.7% |