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FDA Accepts & Gives Priority Review to Intellia's BLA for HAE Drug
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Key Takeaways
Intellia's BLA for lonvo-z received FDA acceptance and priority review for treating HAE.
The FDA is expected to pass a final decision on the lonvo-z BLA by March 10, 2027.
Intellia filed the BLA for lonvo-z based on positive results from the Phase III HAELO study.
Intellia Therapeutics (NTLA - Free Report) announced that the FDA has accepted the biologics license application (BLA) seeking approval for lonvoguran ziclumeran (lonvo-z; formerly NTLA-2002), an in vivo CRISPR-based gene-editing therapy, for the treatment of hereditary angioedema (HAE).
With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected on March 10, 2027.
If approved, lonvo-z will become the world’s first in vivo CRISPR-based therapy and the only one-time treatment for HAE.
The regulatory body has informed Intellia that it does not currently plan to hold an advisory committee meeting to discuss the BLA for lonvo-z.
In April 2026, Intellia initiated a rolling submission of a BLA to the FDA seeking approval for lonvo-z for the treatment of HAE.
NTLA’s Price Performance
Year to date, shares of Intellia have rallied 41.7% compared with the industry’s increase of 11.2%.
Image Source: Zacks Investment Research
NTLA’s Recent Progress With Lonvo-z
The BLA for lonvo-z was based on positive data from the global phase III HAELO study.
The phase III HAELO study met its primary endpoint and all key secondary endpoints, with a one-time infusion of lonvo-z reducing attacks by 87% compared with placebo over the six-month efficacy evaluation period.
In June 2026, the company reported additional positive data from the HAELO study, further highlighting lonvo-z's potential to deliver meaningful disease control for HAE patients.
HAE is a rare genetic disorder marked by recurrent, potentially life-threatening swelling caused by excess bradykinin.
The company plans to commercially launch lonvo-z in the first half of 2027, upon potential approval in the United States.
NTLA’s Other Pipeline Progress
Besides lonvo-z, Intellia’s other lead candidate, nexiguran ziclumeran (nex-z; formerly NTLA-2001), a CRISPR-based gene-edited therapy, is being developed in collaboration with Regeneron Pharmaceuticals (REGN - Free Report) .
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 evaluated in two late-stage studies, MAGNITUDE and MAGNITUDE-2, for treating ATTR amyloidosis with cardiomyopathy (ATTR-CM) and ATTR amyloidosis with polyneuropathy (ATTRv-PN), respectively. If the data from the studies are found to be positive, it should likely enable global regulatory filings for nex-z.
NTLA’s Zacks Rank & Stocks to Consider
Intellia currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 2.9% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 bottom line have moved from a loss of 12 cents per share to earnings of $1.05 per share. Earnings estimates for 2027 have increased from 16 cents to 95 cents during the same time. ANIK’s shares have surged 119% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
View the Zacks #1 Rank List
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FDA Accepts & Gives Priority Review to Intellia's BLA for HAE Drug
Key Takeaways
Intellia Therapeutics (NTLA - Free Report) announced that the FDA has accepted the biologics license application (BLA) seeking approval for lonvoguran ziclumeran (lonvo-z; formerly NTLA-2002), an in vivo CRISPR-based gene-editing therapy, for the treatment of hereditary angioedema (HAE).
With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected on March 10, 2027.
If approved, lonvo-z will become the world’s first in vivo CRISPR-based therapy and the only one-time treatment for HAE.
The regulatory body has informed Intellia that it does not currently plan to hold an advisory committee meeting to discuss the BLA for lonvo-z.
In April 2026, Intellia initiated a rolling submission of a BLA to the FDA seeking approval for lonvo-z for the treatment of HAE.
NTLA’s Price Performance
Year to date, shares of Intellia have rallied 41.7% compared with the industry’s increase of 11.2%.
Image Source: Zacks Investment Research
NTLA’s Recent Progress With Lonvo-z
The BLA for lonvo-z was based on positive data from the global phase III HAELO study.
The phase III HAELO study met its primary endpoint and all key secondary endpoints, with a one-time infusion of lonvo-z reducing attacks by 87% compared with placebo over the six-month efficacy evaluation period.
In June 2026, the company reported additional positive data from the HAELO study, further highlighting lonvo-z's potential to deliver meaningful disease control for HAE patients.
HAE is a rare genetic disorder marked by recurrent, potentially life-threatening swelling caused by excess bradykinin.
The company plans to commercially launch lonvo-z in the first half of 2027, upon potential approval in the United States.
NTLA’s Other Pipeline Progress
Besides lonvo-z, Intellia’s other lead candidate, nexiguran ziclumeran (nex-z; formerly NTLA-2001), a CRISPR-based gene-edited therapy, is being developed in collaboration with Regeneron Pharmaceuticals (REGN - Free Report) .
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 evaluated in two late-stage studies, MAGNITUDE and MAGNITUDE-2, for treating ATTR amyloidosis with cardiomyopathy (ATTR-CM) and ATTR amyloidosis with polyneuropathy (ATTRv-PN), respectively. If the data from the studies are found to be positive, it should likely enable global regulatory filings for nex-z.
NTLA’s Zacks Rank & Stocks to Consider
Intellia currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) and Anika Therapeutics (ANIK - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 2.9% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 bottom line have moved from a loss of 12 cents per share to earnings of $1.05 per share. Earnings estimates for 2027 have increased from 16 cents to 95 cents during the same time. ANIK’s shares have surged 119% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.