Intellia Therapeutics, Inc.

Intellia Therapeutics Appoints Jing L. Marantz, M.D., Ph.D., as Chief Medical Officer

Intellia Therapeutics appointed Jing L. Marantz, M.D., Ph.D., as Executive Vice President and Chief Medical Officer, effective October 26, 2026. Dr. Marantz brings more than 25 years of drug development experience, most recently as CMO of Scholar Rock, where she led the U.S. approval of ISEMBYLD for Spinal Muscular Atrophy. She will lead translational, development, regulatory and medical affairs functions as Intellia prepares to commercialize its first potential in vivo gene editing product and advances Phase 3 trials in transthyretin amyloidosis.

•19d ago

Intellia Therapeutics Announces FDA Acceptance of Biologics License Application with Priority Review for Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE)

The FDA accepted Intellia's Biologics License Application for lonvoguran ziclumeran (lonvo-z) in hereditary angioedema and granted Priority Review, setting a PDUFA target action date of March 10, 2027. The agency also advised it does not currently plan to hold an advisory committee on the application. The BLA is backed by the fully enrolled 80-patient Phase 3 HAELO trial, which met its primary and all key secondary endpoints: an 87% reduction in mean monthly attacks versus placebo, with 62% of lonvo-z patients attack- and therapy-free for six months compared with 11% on placebo. No serious adverse events were observed in the lonvo-z arm. If approved, lonvo-z would be the world's first in vivo CRISPR-based therapy and the only one-time treatment for HAE, positioning Intellia for a first-in-class launch in a rare disease affecting roughly one in 50,000 people.

•1mo ago

Intellia Therapeutics Secures Non-Dilutive Debt Facility with OrbiMed for up to $400 Million

Intellia Therapeutics (NTLA) secured a $400 million non-dilutive senior secured term loan facility with healthcare investment firm OrbiMed, with $75 million funded at closing. The remaining capital consists of five milestone-based tranches of up to $225 million tied primarily to lonvo-z progress, plus $100 million available only by mutual agreement over the facility's five-year term. Management framed the debt as funding the planned U.S. approval and commercial launch of lonvo-z in hereditary angioedema and advancing nex-z in transthyretin amyloidosis without equity dilution. TD Cowen advised Intellia; full loan terms will be filed on Form 8-K.

•1mo ago

Intellia Therapeutics Announces Second Quarter 2026 Financial Results and Business Updates

Intellia reported Q2 collaboration revenue of $7.7 million with a net loss of $0.80 per share, ending the quarter with $628.4 million in cash to fund operations into 2028. The company announced positive Phase 3 HAELO data for lonvo-z, showing an 87% reduction in hereditary angioedema attacks, with results published in the New England Journal of Medicine. A Biologics License Application for lonvo-z is expected to be accepted by the FDA in the second half of 2026, targeting a U.S. launch in the first half of 2027. For nex-z in ATTR amyloidosis, enrollment reinitiated in Phase 3 trials with completion of the MAGNITUDE-2 study anticipated in the second half of 2026.

•2mo ago

Intellia Therapeutics Reports Additional Positive Phase 3 Results for Lonvoguran Ziclumeran (lonvo-z) in Patients with Hereditary Angioedema

Intellia Therapeutics reported additional positive Phase 3 data for its CRISPR-based therapy lonvo-z in hereditary angioedema, presented at the EAACI Congress and published in the New England Journal of Medicine. The trial met its primary endpoint with an 87% reduction in monthly attacks versus placebo, and 62% of patients were entirely attack-free during the six-month evaluation period. With a BLA already submitted to the FDA in April, these results support the company’s expectation of regulatory approval and a U.S. launch in the first half of 2027.

•4mo ago

Intellia Therapeutics to Report Additional Phase 3 HAELO Data for Lonvoguran Ziclumeran (lonvo-z) in Late-Breaking Oral Presentation at EAACI 2026

Intellia Therapeutics will present Phase 3 HAELO trial data for its CRISPR-based gene editing therapy lonvo-z in a late-breaking oral presentation at the EAACI 2026 Congress. The presentation, titled 'HAELO, a Phase 3, Global, Randomised, Double-Blind, Placebo-Controlled Study of Lonvoguran Ziclumeran,' is scheduled for June 13, 2026, and will be delivered by Dr. Danny Cohn. Lonvo-z is positioned as a potential one-time curative treatment for hereditary angioedema (HAE) and holds multiple regulatory designations including FDA Orphan Drug and RMAT status.

•5mo ago

Intellia Therapeutics Reports Positive Phase 3 Results in Hereditary Angioedema, Marking a Global First for In Vivo Gene Editing

Intellia Therapeutics reported positive topline results from the Phase 3 HAELO trial of lonvo-z, demonstrating an 87% reduction in HAE attacks compared to placebo. The trial met all key secondary endpoints, with 62% of patients remaining attack- and therapy-free over six months and no serious adverse events observed in the treatment arm. Based on these results, the company initiated a rolling BLA submission to the FDA and targets a potential U.S. launch in the first half of 2027.

•6mo ago

Intellia Therapeutics Initiates Rolling Submission of Biologics License Application to FDA for Lonvoguran Ziclumeran (lonvo-z) as a One-Time Treatment for Hereditary Angioedema

Intellia initiated a rolling BLA submission for lonvo-z, seeking FDA approval for the world's first in vivo CRISPR-based gene editing therapy for hereditary angioedema. The submission is backed by positive Phase 3 HAELO data where a one-time dose met primary and key secondary endpoints, freeing most patients from attacks and ongoing therapy. The company anticipates completing the submission in the second half of 2026 and plans a commercial launch in the first half of 2027.

•6mo ago