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Intellia Therapeutics to Present Longer-Term Data from the Ongoing Phase 1 Clinical Trial of Nexiguran Ziclumeran (nex-z) for the Treatment of Hereditary Transthyretin (ATTR) Amyloidosis with Polyneuropathy
Globenewswire· 2025-09-22 11:30
Longer-term data to be presented at the 5th International ATTR Amyloidosis Meeting for Patients and Doctors on September 25 highlighting up to three years of patient follow-up and additional insight into ATTRv-PN disease-relevant measuresCAMBRIDGE, Mass., Sept. 22, 2025 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced that longer-term data from the ongoing Phase 1 tria ...
Intellia Therapeutics: Full Trial Enrollment Wows Market - Underlines Buy Thesis (NTLA)
Seeking Alpha· 2025-09-19 18:31
Group 1 - The article highlights the success of a buy call on Intellia Therapeutics, Inc. (NASDAQ: NTLA), which has resulted in a significant increase in share value since the recommendation was made on August 15th [1] - The investing group Haggerston BioHealth provides insights for both novice and experienced biotech investors, including catalysts to monitor, buy and sell ratings, and detailed financial forecasts for major pharmaceutical companies [1] - The author, Edmund Ingham, has extensive experience in the biotech, healthcare, and pharmaceutical sectors, having compiled detailed reports on over 1,000 companies [1]
Intellia Therapeutics: Full Trial Enrollment Wows Market - Underlines Buy Thesis
Seeking Alpha· 2025-09-19 18:31
Group 1 - The article highlights the success of a buy call on Intellia Therapeutics, Inc. (NASDAQ: NTLA) made on August 15, which has resulted in a significant increase in the stock's value [1] - The investing group Haggerston BioHealth offers insights for both novice and experienced biotech investors, including catalysts to monitor and buy/sell ratings [1] - The group provides comprehensive financial analyses, including product sales forecasts, integrated financial statements, discounted cash flow analysis, and market-by-market analysis for major pharmaceutical companies [1] Group 2 - The author, Edmund Ingham, has over five years of experience in covering biotech, healthcare, and pharma sectors, having prepared detailed reports on more than 1,000 companies [1]
NTLA Completes Enrollment in Pivotal Study on HAE Candidate, Stock Up
ZACKS· 2025-09-19 17:26
Core Insights - Intellia Therapeutics' shares increased by 29.8% following the completion of enrollment in the phase III HAELO study for its investigational candidate lonvoguran ziclumeran (lonvo-z) aimed at treating hereditary angioedema (HAE) [1][8] - Top-line data from the pivotal HAELO study is anticipated in the first half of 2026, with a potential biologics license application submission planned for the second half of 2026 [2][8] - The company aims to launch lonvo-z in the U.S. in the first half of 2027 [2] Company Developments - Intellia began dosing the first patient in the phase III HAELO study in January 2025, with full enrollment completed within nine months [6][7][8] - The study focuses on the safety and efficacy of lonvo-z in adults with type I or type II HAE, measuring the number of HAE attacks and the number of patients achieving attack-free status [6][8] - Lonvo-z is designed to prevent HAE attacks by suppressing plasma kallikrein activity, addressing the limitations of current chronic treatment options [9] Additional Candidate Development - Intellia is also developing nexiguran ziclumeran (nex-z) in collaboration with Regeneron Pharmaceuticals, targeting ATTR amyloidosis with polyneuropathy (ATTRv-PN) and ATTR amyloidosis with cardiomyopathy (ATTR-CM) [10][11] - The phase III MAGNITUDE study for nex-z in treating ATTR-CM is currently enrolling patients, with the first patient in the MAGNITUDE-2 study for ATTRv-PN dosed in April 2025 [11] - Positive data from the MAGNITUDE-2 study could lead to global regulatory filings for nex-z [12] Stock Performance - Year-to-date, Intellia's shares have risen by 38.2%, significantly outperforming the industry average increase of 3.3% [5]
Strength Seen in Intellia Therapeutics (NTLA): Can Its 29.8% Jump Turn into More Strength?
ZACKS· 2025-09-19 14:21
Core Points - Intellia Therapeutics, Inc. (NTLA) shares increased by 29.8% to $16.11, with a trading volume higher than average, following a 21.6% gain over the past four weeks [1][2] - The stock's rally was driven by the completion of enrollment in the pivotal phase III HAELO study for its investigational candidate, lonvoguran ziclumeran (lonvo-z), aimed at treating hereditary angioedema (HAE) [2] - Top-line data from the HAELO study is anticipated in the first half of 2026, with a potential biologics license application submission planned for the second half of 2026 [3] - If approved, the company intends to launch lonvo-z in the United States in 2027 [3] - The company is projected to report a quarterly loss of $1.01 per share, reflecting a year-over-year increase of 24.6%, while revenues are expected to reach $14.38 million, up 57.8% from the previous year [3] - The consensus EPS estimate for the quarter has been revised 0.5% higher in the last 30 days, indicating a positive trend that may lead to price appreciation [5] - Intellia Therapeutics holds a Zacks Rank of 3 (Hold), indicating a neutral outlook [6] Industry Context - Intellia Therapeutics is part of the Zacks Medical - Biomedical and Genetics industry, which includes other companies like CG Oncology, Inc. (CGON) [6] - CGON's stock closed 2.9% higher at $38.82, with a 47.8% return over the past month, while its consensus EPS estimate has remained unchanged at -$0.57, representing a 90% decrease compared to the previous year [6][7]
Intellia Therapeutics Completes Enrollment in the Global Phase 3 HAELO Study of Lonvoguran Ziclumeran (lonvo-z) for Hereditary Angioedema
Globenewswire· 2025-09-18 11:30
Core Insights - Intellia Therapeutics has completed enrollment in the global Phase 3 HAELO study for lonvoguran ziclumeran (lonvo-z) targeting hereditary angioedema (HAE) with topline data expected in the first half of 2026 [1][2] - The company plans to submit a biologics license application (BLA) in the second half of 2026, aiming for a U.S. launch in the first half of 2027 [1][6] Company Overview - Intellia Therapeutics is a clinical-stage gene editing company focused on CRISPR-based therapies [1][7] - The company aims to address unmet medical needs through innovative gene editing technologies [7] Study Details - The Phase 3 HAELO study is a randomized, double-blind, placebo-controlled trial involving at least 60 adults and adolescents aged 16 years and older with Type I or Type II HAE [2][4] - Key endpoints include the number of HAE attacks and the number of patients achieving attack-free status from week 5 through week 28 [2][4] Treatment Potential - Lonvo-z is designed to be a one-time treatment for HAE, utilizing CRISPR technology to inactivate the KLKB1 gene, which is crucial for preventing HAE attacks [4][5] - Interim Phase 1/2 clinical data indicated significant reductions in attack rates and consistent decreases in kallikrein levels [4] Regulatory Designations - Lonvo-z has received multiple regulatory designations, including Orphan Drug and RMAT Designation from the FDA, Innovation Passport from the U.K. MHRA, and PRIME Designation from the European Medicines Agency [4]
2 More Stocks With 1,000% Upside
Investor Place· 2025-09-14 16:00
Investment Opportunities - Identifying stocks that can rise 1,000% or more is essential for building significant wealth, as these investments can dramatically increase portfolio value [1][2] - Tronox Holdings Plc (TROX), a major producer of titanium dioxide, is highlighted as a potential investment with a projected return to the $20 range, representing a 4X return from current levels [3] - Intellia Therapeutics Inc. (NTLA) has seen its shares drop significantly but shows potential for a 1,000% upside due to promising drug trials and significant backing from Regeneron Pharmaceuticals Inc. [11][12] - WeRide Inc. (WRD), a leading robotaxi firm in China, is positioned for substantial growth with a potential 1,000% upside through 2030 as it expands into international markets [18] Market Trends - The Chinese auto market is evolving rapidly, with local manufacturers producing advanced vehicles that compete with Western models, particularly in the robotaxi sector [13][14] - The number of self-driving taxis in China is expected to grow significantly, with estimates suggesting up to 4 million robotaxis by 2030 [14] Investment Strategies - A quantitative system called Apogee has been developed to identify high-quality stocks that have fallen significantly but show signs of recovery, focusing on the "down a lot, up a little" strategy [3][21] - The system has already identified several companies with potential for substantial gains, emphasizing the importance of recognizing turnaround signals in stock performance [21]
Cathie Wood Goes Bargain Hunting: She Just Bought 2 Stocks That Wall Street Thinks Will Climb 50% and 190%
The Motley Fool· 2025-09-11 07:45
Group 1: Cathie Wood's Investment Strategy - Cathie Wood focuses on seizing opportunities, viewing stock price drops as chances to increase investments at favorable prices, resulting in an 80% increase in her Ark Innovation fund over the past year [1][2] - Wood invests in innovative technology companies, regardless of their current product launches or revenue streams, demonstrating patience for long-term growth [2] Group 2: CRISPR Therapeutics - CRISPR Therapeutics specializes in CRISPR gene editing technology, which addresses faulty genes related to diseases by cutting DNA at specific locations [5] - The company achieved a significant milestone with the approval of its first treatment, Casgevy, for blood disorders, although the treatment process is complex and requires time to generate significant revenue [6][7] - CRISPR Therapeutics has launched 75 treatment centers and collected cells from 115 patients, and it has $1.7 billion in cash to support its ongoing programs [7][8] - The stock has decreased by 20% from its 2025 high, and Wall Street predicts a potential 50% increase in the next 12 months, positioning the company for long-term gains [9] Group 3: Intellia Therapeutics - Intellia Therapeutics also develops CRISPR gene editing candidates, with its lead project NTLA-2002 targeting hereditary angioedema (HAE) [10] - Earlier trials of NTLA-2002 showed a remarkable 98% reduction in the monthly HAE attack rate after three years [11] - The company plans to submit NTLA-2002 for regulatory review in the second half of next year and has over $630 million in cash to support operations through the first half of 2027 [12] - Wall Street forecasts a potential 190% gain for Intellia's stock, indicating strong bullish sentiment despite the absence of a market product [13]
Intellia Therapeutics: It May Be Time To Get Excited And Buy (Upgrade)
Seeking Alpha· 2025-08-15 16:24
Group 1 - The article discusses the performance of Intellia Therapeutics, Inc. (NASDAQ: NTLA), a company focused on developing gene therapies using CRISPR technology, highlighting a significant decline in its share price as of late May [1] - The Haggerston BioHealth investing group provides insights for both novice and experienced biotech investors, including catalysts to monitor, buy and sell ratings, and forecasts for major pharmaceutical companies [1] - The article emphasizes the importance of understanding key trends and catalysts that drive valuations in the biotech, pharma, and healthcare industries [1]
Intellia Q2 Loss Narrower Than Expected, Pipeline Progress in Focus
ZACKS· 2025-08-08 16:21
Core Insights - Intellia Therapeutics reported a second-quarter 2025 loss of $0.99 per share, which is an improvement from a loss of $1.31 per share in the same quarter last year and better than the Zacks Consensus Estimate of a loss of $1.03 [1][4] - Total revenues for the second quarter of 2025 were $14.2 million, exceeding the Zacks Consensus Estimate of $13 million, and showing significant year-over-year growth driven by collaboration revenues with Regeneron Pharmaceuticals [2][4] - Research and development expenses decreased by 15% year-over-year to $97 million, attributed to lower employee-related expenses and stock-based compensation [4][5] - As of June 30, 2025, Intellia had cash and marketable securities totaling $630.5 million, down from $707.1 million as of March 31, 2025, which is expected to fund operations into the first half of 2027 [6] Pipeline Developments - Intellia is advancing its investigational in vivo genome-editing candidate, nexiguran ziclumeran (nex-z, also known as NTLA-2001), for two indications: ATTR amyloidosis with polyneuropathy and ATTR amyloidosis with cardiomyopathy [7][8] - The Phase III MAGNITUDE study is currently evaluating the safety and efficacy of nex-z, with ongoing enrollment; however, a participant experienced grade 4 liver transaminase elevations, raising safety concerns [9] - Intellia has also initiated the Phase III HAELO study for NTLA-2002, targeting hereditary angioedema, with patient randomization expected to be completed in the third quarter of 2025 [11] Financial Performance - Year-to-date, Intellia's stock has declined by 1.7%, compared to a 1.2% decline in the industry [2] - General and administrative expenses decreased by 14% year-over-year to $27.2 million, primarily due to reduced stock-based compensation [5]