Intellia Completes ATTRv-PN Enrollment as Lonvo-z Launch Nears

The Tip Desk · November 7, 2026 · 3 min read

Cash, cash equivalents and marketable securities were $614.8 million as of September 30, 2026, and the company said existing resources should fund operations at least into 2028.

Intellia Therapeutics (NTLA), a biopharmaceutical company developing CRISPR gene-editing medicines, said the U.S. Food and Drug Administration accepted a biologics license application for lonvoguran ziclumeran in September and granted Priority Review with a Prescription Drug User Fee Act target action date of March 10, 2027. The agency advised it is not currently planning an advisory committee. The company said it is on track to complete commercial readiness in advance of that date and plans a U.S. launch in the first quarter of 2027.

Lonvo-z is designed as a one-time in vivo CRISPR treatment for hereditary angioedema that would inactivate the KLKB1 gene. If approved, Intellia said it would be the world’s first in vivo CRISPR-based therapy and the only one-time treatment for HAE. The company said it completed deployment of its field organization and deepened engagement with HAE treatment centers and payers in preparation for the planned launch.

During the third quarter, Intellia completed enrollment in the MAGNITUDE-2 Phase 3 trial of nexiguran ziclumeran in hereditary ATTR amyloidosis with polyneuropathy, exceeding a targeted randomization of 60 patients, and advanced enrollment in MAGNITUDE in ATTR-CM. It also began providing investigators with HLA genotyping results for patients enrolled or entering screening in the ongoing nex-z Phase 3 trials. Nex-z is being developed with Regeneron.

Collaboration revenue was $7.2 million for the three months ended September 30, 2026, compared with $13.8 million a year earlier, a decrease the company attributed primarily to a reduction in revenue from Regeneron. Net loss was $127.5 million, or $0.91 a share, compared with $101.3 million, or $0.92 a share, a year earlier. The 2026 quarter included an unrealized loss of $10.4 million on changes in the fair value of investments, versus an unrealized gain of $3.4 million in the year-ago quarter. Operating loss was $122.3 million.

Research and development expenses were $83.3 million, compared with $94.7 million a year earlier. The company said the decline was driven primarily by lower external costs related to lonvo-z, lower stock-based compensation and lower research materials and contracted services costs, partially offset by higher headcount-related expenses. Stock-based compensation in R&D was $7.4 million.

General and administrative expenses were $46.1 million, compared with $30.5 million a year earlier, which the company said was driven primarily by consulting costs associated with the continued buildout of its commercial infrastructure and higher legal, facility-related and compensation expenses. Stock-based compensation in G&A was $7.0 million.

Cash, cash equivalents and marketable securities were $614.8 million as of September 30, 2026, compared with $605.1 million as of December 31, 2025. Intellia said existing cash resources are expected to fund operations at least into 2028 and well beyond lonvo-z’s anticipated U.S. approval and commercial launch in the first quarter of 2027. That guidance excludes potential commercial revenues from lonvo-z and potential future funding from a term loan facility.

In September, Intellia entered into a non-dilutive senior secured term loan facility with OrbiMed for up to $400 million, which the company said provides greater financial and operational flexibility as it advances toward the planned U.S. approval and launch of lonvo-z. In October, the company appointed Jing L. Marantz, M.D., Ph.D., as Executive Vice President and Chief Medical Officer.

President and Chief Executive Officer John Leonard said the company has assembled the teams and capabilities needed to support a successful launch in HAE while continuing to advance nex-z Phase 3 trials and pipeline expansion. Intellia said new lonvo-z patient perspectives and Phase 1/2 durability data are scheduled for an investor webcast and presentations at ACAAI 2026.