{"id":842691,"date":"2026-09-10T07:50:14","date_gmt":"2026-09-10T07:50:14","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/842691\/"},"modified":"2026-09-10T07:50:14","modified_gmt":"2026-09-10T07:50:14","slug":"fda-accepts-gives-priority-review-to-intellias-bla-for-hae-drug","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/842691\/","title":{"rendered":"FDA Accepts & Gives Priority Review to Intellia’s BLA for HAE Drug"},"content":{"rendered":"\n

Intellia Therapeutics\u00a0NTLA 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). <\/p>\n

With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected on March 10, 2027. <\/p>\n

If approved, lonvo-z will become the world’s first in vivo CRISPR-based therapy and the only one-time treatment for HAE. <\/p>\n

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. <\/p>\n

In April 2026, Intellia initiated a rolling submission of a BLA to the FDA seeking approval for lonvo-z for the treatment of HAE. <\/p>\n

NTLA’s Price Performance <\/p>\n

Year to date, shares of Intellia have rallied 41.7% compared with the industry’s increase of 11.2%. <\/p>\n

\"Zacks<\/a> Zacks Investment Research <\/p>\n

Image Source: Zacks Investment Research <\/p>\n

NTLA’s Recent Progress With Lonvo-z <\/p>\n

The BLA for lonvo-z was based on positive data from the global phase III HAELO study. <\/p>\n

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. <\/p>\n

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. <\/p>\n

HAE is a rare genetic disorder marked by recurrent, potentially life-threatening swelling caused by excess bradykinin. <\/p>\n

The company plans to commercially launch lonvo-z in the first half of 2027, upon potential approval in the United States. <\/p>\n

NTLA’s Other Pipeline Progress <\/p>\n

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. <\/p>\n

While NTLA is the lead party in the deal for nex-z, REGN shares 25% of the development costs and commercial profits. <\/p>\n

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. <\/p>\n

NTLA’s Zacks Rank & Stocks to Consider <\/p>\n

Intellia currently carries a Zacks Rank #3 (Hold). <\/p>\n

Some better-ranked stocks in the biotech sector are Repligen RGEN and Anika Therapeutics ANIK, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see\u00a0the complete list of today’s Zacks #1 Rank stocks here. <\/p>\n","protected":false},"excerpt":{"rendered":"Intellia Therapeutics\u00a0NTLA announced that the FDA has accepted the biologics license application (BLA) seeking approval for lonvoguran ziclumeran…\n","protected":false},"author":2,"featured_media":842692,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[58],"tags":[356786,10350,246,97,131214,243,356787,2548],"class_list":["post-842691","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-anika-therapeutics","tag-bla","tag-fda","tag-health","tag-intellia-therapeutics","tag-medication","tag-positive-data","tag-zacks-investment-research"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/842691","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=842691"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/842691\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/842692"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=842691"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=842691"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=842691"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}