Shares of Intellia Therapeutics NTLA have plunged 55.2% over the past three months.The steep decline follows a significant regulatory setback related to nexiguran ziclumeran (nex-z), NTLA’s lead pipeline candidate. It is being developed in collaboration with Regeneron Pharmaceuticals REGN for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM) and ATTR amyloidosis with polyneuropathy (ATTRv-PN).
In October 2025, Intellia temporarily halted dosing and patient enrollment in its late-stage MAGNITUDE and MAGNITUDE-2 studies, which were evaluating nex-z, its lead gene-editing therapy, for treating two cardiovascular indications, ATTR-CM and ATTRv-PN, respectively.
The studies were halted after a patient experienced grade 4 liver transaminase elevations and increased total bilirubin following dosing with nex-z and later died.
This triggered a clinical hold from the FDA on the investigational new drug applications and raised widespread concerns about the safety and future of the program.
With the formal clinical hold in place, Intellia has suspended its milestone guidance for nex-z and will provide an update once a regulatory path forward is established. The company is working with investigators and regulators to understand the issue and develop additional risk-mitigation strategies.
Over the past year, shares of Intellia Therapeutics have declined 28% against the industry’s 15.2% rise.
Image Source: Zacks Investment ResearchMoreover, the regulatory and safety setbacks concerning nex-z have cast significant uncertainty over the timeline and approval chances for Intellia's other in vivo candidate, lonvoguran ziclumeran (lonvo-z), being developed for the treatment of hereditary angioedema (“HAE”).
Intellia completed enrolling patients in the pivotal phase III HAELO study evaluating lonvo-z for treating HAE in September 2025. The company expects to share top-line data from the same by mid-2026, with a potential commercial launch in the U.S. market in the first half of 2027.
Mixed Q3 Results & Dependence on Collaboration Revenues
Intellia’s third-quarter results showed mixed financial performance, with revenues slightly missing estimates. The company reported a loss of 92 cents per share (including one-time expenses of change in fair value of investments), narrower than the Zacks Consensus Estimate of a loss of $1.02. Total revenues were $13.8 million for the third quarter of 2025.
Its top line currently comprises only collaboration revenues from its partners, like Regeneron Pharmaceuticals. While NTLA leads the deal for nex-z, REGN shares 25% of the development costs and commercial profits.
However, without a marketed product, Intellia remains solely dependent on collaboration revenues, which dampens investor confidence in the company’s near-term prospects.
Intellia Therapeutics, Inc. Price
Intellia Therapeutics, Inc. price | Intellia Therapeutics, Inc. Quote
NTLA’s Zacks Rank & Stocks to Consider
Intellia Therapeutics currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP and CorMedix CRMD. Both currently sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have increased from $7.29 to $7.56. Over the same period, EPS estimates for 2026 have surged from $7.81 to $8.08. Shares of ANIP have surged 43.6% over the past year.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.
Over the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87, while 2026 EPS estimates have risen from $2.49 to $2.88 over the same period. Shares of CRMD have surged 53.3% over the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
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Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report ANI Pharmaceuticals, Inc. (ANIP): Free Stock Analysis Report CorMedix Inc (CRMD): Free Stock Analysis Report Intellia Therapeutics, Inc. (NTLA): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).
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