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NTLA Falls 4% Despite Strong Phase III HAE Data, Initiates Rolling BLA
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Key Takeaways
Intellia shares fell 4% despite the phase III data meeting all endpoints for lonvo-z in HAE.
NTLA's lonvo-z cut HAE attacks by 87% vs. placebo, with 62% of patients attack-free in the study.
Intellia began its rolling BLA submission, targeting completion in H2 2026 and a launch in 2027.
Shares of Intellia Therapeutics (NTLA - Free Report) declined 4% on Monday despite positive top-line data from the global phase III HAELO clinical trial evaluating lonvo-z for the treatment of patients with hereditary angioedema (HAE). Lonvo-z is a one-time, outpatient CRISPR-based therapy designed to inactivate the KLKB1 gene, thereby reducing kallikrein and bradykinin levels.
Key Highlights of NTLA’s Phase III HAELO Study
The phase III randomized, placebo-controlled HAELO study evaluated the safety and efficacy of a one-time 50-milligram dose of lonvo-z in patients aged 16 years and older with type I or type II HAE. Data from the study demonstrated that a one-time infusion of lonvo-z reduced HAE attacks by 87% compared with placebo over the six-month evaluation period. Patients treated with lonvo-z had a much lower average monthly attack rate (0.26) versus 2.10 in the placebo group.
The study met its primary endpoint. It also met all key secondary endpoints with strong statistical significance, including a notably higher proportion of patients who were completely free from both attacks and ongoing therapy (62% versus 11% with placebo). The treatment was well-tolerated, with mild-to-moderate side effects.
Hereditary angioedema (HAE) is a rare genetic disorder marked by recurrent, potentially life-threatening swelling caused by excess bradykinin.
However, it seems that investors were not impressed by the data reported by the company and its stock declined.
Year to date, shares of NTLA have risen 45% against the industry’s 1.2% decline.
Image Source: Zacks Investment Research
NTLA Initiates Rolling Submission of BLA for lonvo-z
In a separate press release, Intellia announced that it has begun a rolling submission of a biologics license application (BLA) to the FDA seeking approval for lonvo-z for the treatment of HAE.
The company expects to complete the BLA submission in the second half of 2026. If accepted, the FDA will determine whether the application qualifies for priority review and will set a target decision date. Intellia plans to commercially launch lonvo-z in the first half of 2027, as the world’s first in vivo CRISPR-based gene editing therapy, if approved.
NTLA’s Zacks Rank & Stocks to Consider
Intellia Therapeutics currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.59 to $2.87. Over the same period, EPS estimates for 2027 have surged from $3.01 to $3.25. CPRX shares have gained 25.5% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 90 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.94 to $3.00. Over the same period, EPS estimates for 2027 have surged from $3.22 to $3.29. INDV shares have lost 4.4% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.22 to $9.02. Over the same period, EPS estimates for 2027 have risen from $9.90 to $10.23. Year to date, shares of ANIP have gained 0.8%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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NTLA Falls 4% Despite Strong Phase III HAE Data, Initiates Rolling BLA
Key Takeaways
Shares of Intellia Therapeutics (NTLA - Free Report) declined 4% on Monday despite positive top-line data from the global phase III HAELO clinical trial evaluating lonvo-z for the treatment of patients with hereditary angioedema (HAE). Lonvo-z is a one-time, outpatient CRISPR-based therapy designed to inactivate the KLKB1 gene, thereby reducing kallikrein and bradykinin levels.
Key Highlights of NTLA’s Phase III HAELO Study
The phase III randomized, placebo-controlled HAELO study evaluated the safety and efficacy of a one-time 50-milligram dose of lonvo-z in patients aged 16 years and older with type I or type II HAE. Data from the study demonstrated that a one-time infusion of lonvo-z reduced HAE attacks by 87% compared with placebo over the six-month evaluation period. Patients treated with lonvo-z had a much lower average monthly attack rate (0.26) versus 2.10 in the placebo group.
The study met its primary endpoint. It also met all key secondary endpoints with strong statistical significance, including a notably higher proportion of patients who were completely free from both attacks and ongoing therapy (62% versus 11% with placebo). The treatment was well-tolerated, with mild-to-moderate side effects.
Hereditary angioedema (HAE) is a rare genetic disorder marked by recurrent, potentially life-threatening swelling caused by excess bradykinin.
However, it seems that investors were not impressed by the data reported by the company and its stock declined.
Year to date, shares of NTLA have risen 45% against the industry’s 1.2% decline.
Image Source: Zacks Investment Research
NTLA Initiates Rolling Submission of BLA for lonvo-z
In a separate press release, Intellia announced that it has begun a rolling submission of a biologics license application (BLA) to the FDA seeking approval for lonvo-z for the treatment of HAE.
The company expects to complete the BLA submission in the second half of 2026. If accepted, the FDA will determine whether the application qualifies for priority review and will set a target decision date. Intellia plans to commercially launch lonvo-z in the first half of 2027, as the world’s first in vivo CRISPR-based gene editing therapy, if approved.
NTLA’s Zacks Rank & Stocks to Consider
Intellia Therapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy), and Indivior Pharmaceuticals (INDV - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) , which carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.59 to $2.87. Over the same period, EPS estimates for 2027 have surged from $3.01 to $3.25. CPRX shares have gained 25.5% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 90 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.94 to $3.00. Over the same period, EPS estimates for 2027 have surged from $3.22 to $3.29. INDV shares have lost 4.4% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.22 to $9.02. Over the same period, EPS estimates for 2027 have risen from $9.90 to $10.23. Year to date, shares of ANIP have gained 0.8%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.