Intellia Therapeutics Announces Third Quarter 2026 Financial Results and Business Updates - GlobeNewswire
GlobeNewswire · Nov 5, 1:00 PM
Intellia concludes Phase III ATTRv-PN study enrolment - Yahoo Finance
Yahoo Finance · Nov 5, 11:38 AM
Intellia Therapeutics Completes Enrollment in Phase 3 - GlobeNewswire
GlobeNewswire · Nov 4, 1:00 PM
Market reactionShares fell 11% on Nov 5.
Intellia is a clinical-stage company developing one-time CRISPR gene-editing treatments; its lead, lonvo-z for hereditary angioedema, is under FDA review, and none of its products is approved.
Intellia's case rests on lonvo-z, a one-time CRISPR treatment for hereditary angioedema that cut attacks by 87% versus placebo in the Phase 3 HAELO trial. FDA set a March 10, 2027 decision date under Priority Review, and Intellia plans a U.S. launch in the first half of 2027 if approved. Nex-z, its ATTR amyloidosis treatment with Regeneron, resumed Phase 3 enrollment after a 2025 clinical hold over severe liver enzyme rises in a patient who later died. Cash of $628.4 million should fund operations at least into 2028.
Thesis checklist
1 risk needs 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
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: FDA approves lonvo-z
Does FDA approve lonvo-z on time with a broad HAE label?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
Select an event marker to read the update below. Marker colors show Thesis status.
FDA accepted Intellia's BLA for lonvo-z in hereditary angioedema with Priority Review and a March 10, 2027 decision date; both nex-z Phase 3 trials resumed enrollment after FDA lifted its clinical holds
lonvo-z's clean Phase 3 win drives the near-term BLA, while nex-z's liver safety determines whether the ATTR franchise succeeds
Intellia's lonvo-z BLA tests whether a one-time CRISPR HAE therapy can win market share against entrenched prophylaxis standards; nex-z safety holds the second key
MAGNITUDE/MAGNITUDE-2 trial pause for safety signal
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: Lonvoguran ziclumeran (NTLA-2002)
Disease areas: Neuromuscular diseases, Obesity, diabetes and heart disease, Rare genetic and metabolic diseases
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
6 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.