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Intellia Therapeutics to Hold Conference Call to Discuss Fourth Quarter and Full-Year 2025 Financial Results and Business Updates
Globenewswire· 2026-02-19 12:30
CAMBRIDGE, Mass., Feb. 19, 2026 (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 the company will host a conference call on February 26, 2026, at 8 a.m. ET to discuss its fourth quarter and full-year 2025 financial results and business updates. To join a webcast of the call, please visit this link. To join the teleconference, U.S. callers should dial 1-833-316-05 ...
H.C. Wainwright Boosts Intellia (NTLA) Price Target After MAGNITUDE-2 Hold Lifted
Yahoo Finance· 2026-02-15 13:41
Intellia Therapeutics, Inc. (NASDAQ:NTLA) ranks among the best innovative stocks to buy according to Wall Street analysts. H.C. Wainwright reiterated a Buy rating on Intellia Therapeutics, Inc. (NASDAQ:NTLA) while boosting its price target to $25 from $15 on January 28, following the removal of a clinical hold on the company’s MAGNITUDE-2 study. Pixabay/Public Domain The updated protocol raises the target enrollment to around 60 patients from the originally intended 50, implying a focus on improving ris ...
Take the Zacks Approach to Beat the Markets: Hershey's, Fastenal, Kennametal in Focus
ZACKS· 2026-02-09 14:05
Market Overview - The S&P 500 and Nasdaq Composite declined by 0.1% and 1.9% respectively, while the Dow Jones Industrial Average increased by 2.5% last week, indicating a mixed performance across major indexes [1] - The divergence in market performance was attributed to a rotation in investor preferences rather than overall market weakness, with rising Treasury yields making high-valuation growth stocks less appealing [1] Sector Performance - Optimism regarding economic resilience led to increased buying in cyclically sensitive and defensive sectors, with industrials benefiting from infrastructure and manufacturing strength, financials gaining from higher yields, and energy rising with firmer oil prices [2] - This shift underscores a focus on earnings stability and tangible cash flows among investors [2] Zacks Research Performance - Kennametal Inc. (KMT) shares surged by 44.8% since being upgraded to a Zacks Rank 1 (Strong Buy) on December 8, outperforming the S&P 500's 0.7% increase [3] - Inventiva S.A. (IVA) also saw a return of 42.4% since its upgrade to Zacks Rank 1 on the same date [4] - An equal-weight portfolio of Zacks Rank 1 stocks outperformed the equal-weight S&P 500 index by 7 percentage points, returning 17.81% compared to 10.85% for the index [4] Zacks Recommendations - Clearway Energy, Inc. (CWENA) and Pursuit Attractions and Hospitality, Inc. (PRSU) saw share increases of 16.7% and 5.4% respectively since their upgrades to Outperform on December 10 and December 11 [6] - The Zacks Recommendation system aims to predict stock performance over the next 6 to 12 months, based on trends in earnings estimate revisions [7] Focus List and Portfolios - Celanese Corporation (CE) gained 32.9% over the past 12 weeks since being added to the Zacks Focus List, while Intellia Therapeutics, Inc. (NTLA) returned 29% over the same period [9] - The Zacks Focus List portfolio returned 22.1% in 2025, outperforming the S&P 500 index's 17.9% gain [10] - The Earnings Certain Admiral Portfolio (ECAP) returned -1.67% for 2025, underperforming the S&P 500 index's 17.9% gain, but had a return of 16.26% in 2024 compared to the S&P 500's 24.89% [14] Dividend Portfolio Performance - Illinois Tool Works Inc. (ITW) and Fastenal Company (FAST) returned 19.6% and 16.8% respectively over the past 12 weeks, benefiting from investor interest in quality dividend stocks amid market volatility [16] - The Earnings Certain Dividend Portfolio (ECDP) returned -0.6% for 2025, underperforming the Dividend Aristocrat ETF's 6.8% gain [17] Top 10 Stocks Performance - Monolithic Power Systems (MPWR) increased by 31.4% since January 5, 2026, compared to the S&P 500 Index's 1.1% increase [20] - The Top 10 portfolio has produced a cumulative return of 2,472.7% since 2012, significantly outperforming the S&P 500 index's 561.6% return [21]
This Cathie Wood Stock Is Already Up 41% This Year, But Is It a Buy?
The Motley Fool· 2026-02-07 14:05
Core Viewpoint - Intellia Therapeutics is experiencing a recovery in its stock price following regulatory approval for one of its clinical studies, indicating potential for continued growth in the gene-editing biotech sector [2][5]. Company Overview - Intellia Therapeutics is currently ranked 25th on Ark Invest's holdings list and has seen its shares increase by 41% [2]. - The company's market capitalization stands at $1.4 billion, with a current stock price of $12.28 [8]. Product Pipeline - Intellia's leading candidates, lonvo-z and nex-z, target rare diseases, with nex-z recently receiving clearance from the FDA to proceed with one of its phase 3 studies [4][5]. - Nex-z aims to treat transthyretin amyloidosis, affecting approximately 50,000 patients with the hereditary form and between 200,000 to 500,000 with the wild type [8][9]. - Lonvo-z targets hereditary angioedema (HAE), which has around 150,000 patients globally [9]. Market Potential - The market for HAE is projected to reach $6.3 billion by 2030, while the transthyretin amyloidosis market is expected to be valued at $16.8 billion by the same year [10]. - Despite the large addressable markets, Intellia faces significant clinical and regulatory challenges that could impact its share price [10]. Financial Metrics - Intellia Therapeutics has a gross margin of 78.27% [8]. - The stock has shown volatility, with a 52-week range of $5.90 to $28.25 [8]. Investment Considerations - The biotech sector, particularly companies focused on gene editing, carries inherent risks due to the complexity and cost of treatments, which may hinder market traction even after regulatory approval [6][10]. - Investors should be cautious, as the stock remains risky, particularly for those not comfortable with high volatility [11].
Intellia Therapeutics: 2 Major Catalysts Will Determine Stock's Trajectory In 2026
Seeking Alpha· 2026-02-05 18:55
Core Viewpoint - The article emphasizes the importance of staying updated on stocks within the biotech, pharma, and healthcare sectors, highlighting the key trends and catalysts that influence market valuations. Group 1: Company and Industry Insights - The investing group Haggerston BioHealth, led by a biotech consultant with over 5 years of experience, provides detailed reports on more than 1,000 companies in the biotech, healthcare, and pharma industries [1]. - Haggerston BioHealth offers insights for both novice and experienced investors, including catalysts to monitor, buy and sell ratings, product sales forecasts, and integrated financial statements [1]. - The group conducts discounted cash flow analysis and market-by-market analysis for major pharmaceutical companies, aiding investors in making informed decisions [1].
肾病领域双靶点多肽药物MT1013达成独家商业化合作
Xin Lang Cai Jing· 2026-02-05 12:24
Core Viewpoint - The strategic partnership between Macao and Yunding Xinyao grants the latter exclusive commercialization rights for the innovative dual-target peptide drug MT1013 in China and the Asia-Pacific region (excluding Japan), marking a significant step in the company's global expansion and realization of innovative drug value [1][6]. Group 1: Strategic Partnership - Macao has officially announced a strategic collaboration with Yunding Xinyao, granting exclusive commercialization rights for MT1013 [1][6]. - The agreement includes an upfront payment of 200 million RMB and potential milestone payments up to 1.04 billion RMB, indicating a strong financial incentive for both parties [1][6]. Group 2: Drug Innovation and Mechanism - MT1013 is a first-in-class peptide drug developed by Macao, targeting both calcium-sensing receptor (CaSR) and osteogenic growth peptide (OGP) pathways, representing a shift from passive bone resorption inhibition to active bone formation promotion [2][7]. - The drug aims to comprehensively regulate PTH secretion, correct calcium and phosphorus metabolism, and directly enhance bone health [2][7]. Group 3: Clinical Data and Efficacy - Key Phase II clinical trial data for MT1013 demonstrate significant efficacy and therapeutic potential, with a Phase III registration trial currently underway for SHPT patients undergoing maintenance hemodialysis [4][10]. - MT1013 shows superior performance in achieving triple targets of iPTH, blood calcium, and blood phosphorus levels, along with excellent phosphorus-lowering effects and a significant reduction in cardiovascular risk marker FGF-23 [8][10]. - After 52 weeks of treatment, patients exhibited significant improvements in bone density and sustained enhancements in bone metabolism markers [8][10].
Baird Updates Intellia Therapeutics, Inc. (NTLA)’s Financial Model Following Nex-Z Clinical Hold Removal
Yahoo Finance· 2026-02-02 14:37
Group 1 - Intellia Therapeutics, Inc. (NTLA) is ranked seventh in a list of the 20 Best Biotech Stocks Under $20 to Buy Now [1] - Baird raised its price target on NTLA to $7 from $4 while maintaining a Neutral rating, following the FDA's lifting of the clinical hold on the Nex-z hATTR-PN trial [1][2] - H.C. Wainwright analyst increased the price target on NTLA to $25 from $15 and maintained a Buy rating, noting that the FDA's decision indicates manageable risks for Nex-Z and raised the probability of approval for Nex-Z to 35% from 25% [2] Group 2 - Intellia Therapeutics is a clinical-stage biotechnology company focused on CRISPR-based gene editing therapies for serious genetic diseases, utilizing proprietary in vivo and ex vivo platforms [3] - The company is advancing multiple programs aimed at providing durable, curative solutions and expanding the potential of gene editing [3]
Weekly Buzz: Intellia Gets FDA Nod For ATTRv-PN Trial; Aprea's APR-1051 Paces; CALC Halts KOURAGE
RTTNews· 2026-01-30 17:37
FDA Approvals & Rejections - Intellia Therapeutics has received FDA approval to resume its MAGNITUDE-2 Phase 3 trial for nexiguran ziclumeran (nex-z) targeting hereditary transthyretin amyloidosis with polyneuropathy, increasing target enrollment from 50 to 60 patients [2][4] - Outset Medical's next-generation Tablo Hemodialysis System has been granted FDA 510(k) clearance, making it the first dialysis device to meet enhanced cybersecurity standards, with shipping expected to begin in Q2 2026 [6][7] - OKYO Pharma has received positive feedback from the FDA for its Phase 2b/3 trial design for Urcosimod, a candidate for neuropathic corneal pain, with plans to start the trial in the first half of 2026 [8][9] - REGENXBIO has faced clinical holds on its RGX-111 and RGX-121 gene therapy programs due to a case of CNS tumor in a child treated with RGX-111, although no similar findings were reported in other patients [10][11] - Almirall has received NMPA approval for Seysara in China for treating moderate-to-severe acne vulgaris, expanding its dermatology portfolio in the region [12][13] Clinical Trials - Breakthroughs - Aprea Therapeutics reported early clinical activity for APR-1051 in endometrial cancer, achieving a 50% reduction in target lesion size in a patient with PPP2R1A-mutated uterine serous carcinoma [19][21] - Fractyl Health's Revita demonstrated positive results in weight maintenance after GLP-1 drug discontinuation, showing a 4.5% weight regain compared to 7.5% in the sham group [22][24] - Ascletis Pharma announced positive Phase 3 results for Denifanstat in moderate-to-severe acne vulgaris, focusing on long-term safety in a trial with 240 patients [25][26] - GRI Bio reported new gene expression data from its Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis, showing significant improvements in lung injury and fibrosis progression [27][28] - Cardiff Oncology announced encouraging results from its Phase 2 trial of Onvansertib in RAS-mutated metastatic colorectal cancer, with a well-tolerated regimen and plans to advance to a registrational program [31][32] - Genentech's CT-388 Phase 2 trial for obesity showed a significant placebo-adjusted weight loss of 22.5% at 48 weeks, with a high percentage of participants achieving significant weight loss [34][36] - Sarepta Therapeutics reported positive three-year results from its EMBARK study for ELEVIDYS in Duchenne muscular dystrophy, showing significant slowing of disease progression in treated patients [38][41] Deals - YD Bio Limited has signed a letter of intent to acquire Safe Save Medical for approximately $26.87 million, aiming to enhance its capabilities in advanced cellular therapeutics [14][15][17]
NTLA Stock Up More Than 6% as FDA Lifts ATTRv-PN Study Clinical Hold
ZACKS· 2026-01-28 15:45
Core Insights - The FDA has lifted the clinical hold on Intellia Therapeutics' investigational new drug application for the phase III study MAGNITUDE-2, which evaluates nexiguran ziclumeran (nex-z) in patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN) [2][5] - Following this regulatory update, Intellia's shares increased by nearly 6.3%, and the company's stock has risen 46.6% over the past year, outperforming the industry average of 17.2% [2] Recent Developments - In October 2025, Intellia halted dosing and patient enrollment in its late-stage MAGNITUDE and MAGNITUDE-2 studies due to a serious adverse event involving a patient who experienced severe liver issues and subsequently died [4] - The FDA's clinical hold was a response to these safety concerns, but Intellia has since aligned with the FDA on study modifications and risk-mitigation measures, including enhanced liver safety monitoring [5][6] Study Details - MAGNITUDE-2 is a randomized, double-blind, placebo-controlled phase III study designed to assess the efficacy and safety of nex-z in patients with ATTRv-PN, with planned enrollment increased from approximately 50 to 60 patients [9] - The primary endpoints of the study include changes in the modified neuropathy impairment score and serum transthyretin levels [9] Collaboration and Financials - Nex-z is Intellia's lead program, developed in partnership with Regeneron Pharmaceuticals, which shares 25% of the R&D costs and profits [6][8] - Intellia's current revenue primarily comes from collaboration with partners like Regeneron, and the drug has received Orphan Drug and Regenerative Medicine Advanced Therapy designations from the FDA [8]
Intellia Therapeutics (NTLA) Surges 6.3%: Is This an Indication of Further Gains?
ZACKS· 2026-01-28 13:36
Core Viewpoint - Intellia Therapeutics, Inc. (NTLA) shares experienced a 6.3% increase, closing at $14.83, driven by notable trading volume and a 52.6% gain over the past four weeks [1][2]. Group 1: Company Developments - The recent price surge is attributed to increased investor confidence following the FDA's lifting of the clinical hold on the MAGNITUDE-2 study for nexiguran ziclumeran (nex-z) in patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN) [2]. - Intellia has aligned with the FDA on study modifications and risk-mitigation measures, including enhanced liver safety monitoring, and plans to resume patient enrollment and dosing promptly [2]. Group 2: Financial Expectations - The company is expected to report a quarterly loss of $0.99 per share, reflecting a year-over-year change of +20.2%, with revenues projected at $11.85 million, down 7.9% from the previous year [3]. - The consensus EPS estimate for the quarter has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4]. Group 3: Industry Context - Intellia Therapeutics holds a Zacks Rank of 3 (Hold) within the Zacks Medical - Biomedical and Genetics industry, while Vanda Pharmaceuticals (VNDA), another stock in the same industry, finished 3.1% higher at $8.02 and has returned 8.1% over the past month [5]. - Vanda's consensus EPS estimate has changed +7.7% over the past month to -$2.18, representing a significant year-over-year change of -2625%, and it currently holds a Zacks Rank of 2 (Buy) [6].