We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
NTLA Completes Enrollment in Pivotal Study on HAE Candidate, Stock Up
Read MoreHide Full Article
Key Takeaways
Intellia completed enrollment in the pivotal phase III HAELO study of lonvo-z for HAE.
Top-line HAELO data is expected in early 2026, with a U.S. launch targeted for 1H 2027.
First patient in the HAELO study dosed in January 2025, as full enrollment was completed in nine months.
Shares of Intellia Therapeutics (NTLA - Free Report) soared 29.8% yesterday after the company announced that it has completed enrollment in the phase III HAELO study evaluating its investigational candidate, lonvoguran ziclumeran (lonvo-z, also known as NTLA-2002) for treating patients with hereditary angioedema (“HAE”).
Top-line data from the pivotal HAELO study is expected in the first half of 2026.
Intellia remains on track to submit a potential biologics license application for lonvo-z, its novel in vivo CRISPR gene editing therapy, for treating HAE in the second half of 2026. Upon potential approval, the company plans to launch lonvo-z in the United States in the first half of 2027.
NTLA's Price Performance
Year to date, shares of Intellia have rallied 38.2% compared with the industry’s rise of 3.3%.
Image Source: Zacks Investment Research
NTLA's Recent Development Activities With Lonvo-z
In January 2025, Intellia dosed the first patient in the phase III HAELO study evaluating lonvo-z for treating HAE. The study evaluated the safety and efficacy of lonvo-z in adults with type I or type II HAE.
The key endpoint of the study is to see the number of HAE attacks and the number of patients who achieve attack-free status from week five through week 28 of treatment.
Enrollment of patients in the HAELO study has now been completed within nine months since the dosing of the first patient.
Despite the current treatment options that require chronic administration for disease control, HAE attacks still occur. Lonvo-z aims to prevent HAE attacks by suppressing the plasma kallikrein activity.
In October 2024, NTLA initiated the HAELO study on lonvo-z for treating HAE.
NTLA Developing Another Candidate Nex-z
Intellia is developing its investigational in vivo genome-editing candidate, nexiguran ziclumeran (nex-z, also known as NTLA-2001). The company has collaborated with Regeneron Pharmaceuticals (REGN - Free Report) for the development of nex-z.
Nex-z is part of the company’s co-development and co-promotion agreement with Regeneron. While NTLA is the lead party in the deal for nex-z, REGN shares 25% of the development costs and commercial profits.
Nex-z is being studied for two indications — ATTR amyloidosis with polyneuropathy (ATTRv-PN) and ATTR amyloidosis with cardiomyopathy (ATTR-CM). The phase III MAGNITUDE study evaluating nex-z to treat ATTR-CM is currently enrolling patients.
Intellia dosed the first patient in the phase III MAGNITUDE 2 study evaluating nex-z for the treatment of patients with ATTRv-PN in April 2025. Enrollment in this study is expected to be completed by the first half of 2026.
If the data from the MAGNITUDE-2 study is found to be positive, it will enable global regulatory filings for nex-z.
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have narrowed from $3.93 to $3.74. Loss per share estimates for 2026 have narrowed from $4.27 to $4.12 during the same period. AKRO stock has surged 66.1% year to date.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 49.24%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2025 loss per share have narrowed from 87 cents to 71 cents. Loss per share estimates for 2026 have narrowed from 65 cents to 60 cents during the same period. ADPT stock has soared 129.6% year to date.
Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, the average surprise being 23.99%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
NTLA Completes Enrollment in Pivotal Study on HAE Candidate, Stock Up
Key Takeaways
Shares of Intellia Therapeutics (NTLA - Free Report) soared 29.8% yesterday after the company announced that it has completed enrollment in the phase III HAELO study evaluating its investigational candidate, lonvoguran ziclumeran (lonvo-z, also known as NTLA-2002) for treating patients with hereditary angioedema (“HAE”).
Top-line data from the pivotal HAELO study is expected in the first half of 2026.
Intellia remains on track to submit a potential biologics license application for lonvo-z, its novel in vivo CRISPR gene editing therapy, for treating HAE in the second half of 2026. Upon potential approval, the company plans to launch lonvo-z in the United States in the first half of 2027.
NTLA's Price Performance
Year to date, shares of Intellia have rallied 38.2% compared with the industry’s rise of 3.3%.
Image Source: Zacks Investment Research
NTLA's Recent Development Activities With Lonvo-z
In January 2025, Intellia dosed the first patient in the phase III HAELO study evaluating lonvo-z for treating HAE. The study evaluated the safety and efficacy of lonvo-z in adults with type I or type II HAE.
The key endpoint of the study is to see the number of HAE attacks and the number of patients who achieve attack-free status from week five through week 28 of treatment.
Enrollment of patients in the HAELO study has now been completed within nine months since the dosing of the first patient.
Despite the current treatment options that require chronic administration for disease control, HAE attacks still occur. Lonvo-z aims to prevent HAE attacks by suppressing the plasma kallikrein activity.
In October 2024, NTLA initiated the HAELO study on lonvo-z for treating HAE.
NTLA Developing Another Candidate Nex-z
Intellia is developing its investigational in vivo genome-editing candidate, nexiguran ziclumeran (nex-z, also known as NTLA-2001). The company has collaborated with Regeneron Pharmaceuticals (REGN - Free Report) for the development of nex-z.
Nex-z is part of the company’s co-development and co-promotion agreement with Regeneron. While NTLA is the lead party in the deal for nex-z, REGN shares 25% of the development costs and commercial profits.
Nex-z is being studied for two indications — ATTR amyloidosis with polyneuropathy (ATTRv-PN) and ATTR amyloidosis with cardiomyopathy (ATTR-CM). The phase III MAGNITUDE study evaluating nex-z to treat ATTR-CM is currently enrolling patients.
Intellia dosed the first patient in the phase III MAGNITUDE 2 study evaluating nex-z for the treatment of patients with ATTRv-PN in April 2025. Enrollment in this study is expected to be completed by the first half of 2026.
If the data from the MAGNITUDE-2 study is found to be positive, it will enable global regulatory filings for nex-z.
Intellia Therapeutics, Inc. Price
Intellia Therapeutics, Inc. price | Intellia Therapeutics, Inc. Quote
NTLA's Zacks Rank & Stocks to Consider
Intellia currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Akero Therapeutics (AKRO - Free Report) and Adaptive Biotechnologies (ADPT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have narrowed from $3.93 to $3.74. Loss per share estimates for 2026 have narrowed from $4.27 to $4.12 during the same period. AKRO stock has surged 66.1% year to date.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 49.24%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2025 loss per share have narrowed from 87 cents to 71 cents. Loss per share estimates for 2026 have narrowed from 65 cents to 60 cents during the same period. ADPT stock has soared 129.6% year to date.
Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, the average surprise being 23.99%.