Bronstein, Gewirtz & Grossman, LLC Announces an Investigation Against Intellia Therapeutics, Inc. (NTLA) and Encourages Stockholders to Learn More About the Investigation ...

Intellia Therapeutics, Inc. Investigation Ongoing: Contact Levi & Korsinsky to Discuss Your Rights - NTLA ...

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Intellia Therapeutics, Inc - NTLA ...

Bronstein, Gewirtz & Grossman, LLC Encourages Intellia Therapeutics, Inc. (NTLA) Investors to Inquire about Securities Investigation ...

Investment Opportunities - The analyst has a beneficial long position in shares of NTLA, PFE, SGMO, CRSP, and EDIT through stock ownership, options, or other derivatives [2] - The analyst focuses on innovative companies developing breakthrough therapies and/or pharmaceuticals with catalysts for potential acquisitions [1] Healthcare Sector Focus - Cutting-edge biotech companies targeting CAR-T therapies and gene therapies were previously a major trend in the healthcare sector [1] - The analyst has a background in the medical field and a passion for biotech and life-saving therapies [1] Research and Analysis Services - The analyst leads an investing group called Compounding Healthcare, which offers several model healthcare portfolios, a weekly newsletter, a daily watchlist, and a chat feature for dialogue and questions [1] - The analyst's subscription marketplace service, Compounding Healthcare, provides more in-depth information on investment opportunities and methods [1]

On Thursday, Intellia Therapeutics Inc NTLA outlined its strategic priorities for 2025, emphasizing the acceleration of late-stage programs for NTLA-2002 and nex-z.These therapies target hereditary angioedema (HAE) and transthyretin (ATTR) amyloidosis, respectively.Intellia prioritized NTLA-2002 and nex-z while discontinuing the NTLA-3001 program and other early-stage initiatives.The reorganization will result in a 27% workforce reduction and a projected $8 million restructuring charge in early 2025.Intelli ...

Shares of Intellia Therapeutics, Inc. (NTLA) were down in pre-market trading on Jan. 10 after the company announced a strategic reorganization to prioritize its portfolio of late-stage pipeline candidates and key anticipated milestones for 2025.As part of this portfolio reorganization, NTLA is planning to prioritize the development of its investigational in vivo genome-editing candidate, Nexiguran ziclumeran (nex-z, also known as NTLA-2001), which is being studied for two indications, ATTR amyloidosis with ...

Strategic Priorities and Milestones - Intellia Therapeutics announced its strategic priorities and key anticipated 2025 milestones, focusing on transforming patient lives through CRISPR-based therapies [1] - The company aims to transition from a late-stage development company to a commercial-ready organization by the end of 2026 [7] - Key priorities include driving clinical execution for NTLA-2002 and nex-z, advancing commercial readiness, and preparing for the first U S commercial launch [8][9] Pipeline Advancements - NTLA-2002 for Hereditary Angioedema (HAE): Phase 3 HAELO study enrollment to complete in the second half of 2025, with a Biologics License Application submission planned for the second half of 2026 [5] - Nex-z for Transthyretin (ATTR) Amyloidosis: Over 550 patients expected to be enrolled in the Phase 3 MAGNITUDE study by year-end 2025, with strong enrollment momentum [5][12] - NTLA-3001 discontinued to focus resources on NTLA-2002 and nex-z, resulting in a net workforce reduction of approximately 27% in 2025 [5][6] Financial and Operational Updates - Intellia ended Q4 2024 with approximately $862 million in cash, cash equivalents, and investments, providing a cash runway into the first half of 2027 [6] - The company expects to incur $8 million in charges related to the strategic reorganization in Q1 2025 [6] - Cost savings from workforce reduction and pipeline prioritization will support operations through the anticipated first commercial launch in the U S [5][6] Leadership Changes - Laura Sepp-Lorenzino, Ph D , Chief Scientific Officer, announced her retirement effective December 31, 2025, transitioning to a Senior Scientific Advisor role [6] - Birgit Schultes, Ph D , promoted to Executive Vice President and Chief Scientific Officer, effective January 13, 2025, bringing over 20 years of experience in drug development and biotechnology [6] Clinical Data and Presentations - Phase 2 data for NTLA-2002 presented at the 2024 ACAAI Scientific Meeting demonstrated potential to end chronic prophylaxis treatment with a one-time infusion [6] - Phase 1/2 data for NTLA-2002 and Phase 1 data for nex-z to be presented in 2025, including longer-term efficacy and safety measures [13] - First clinical evidence for nex-z presented at the 2024 AHA Scientific Sessions showed rapid, deep, and durable reductions in serum TTR, potentially halting or reversing disease progression [12] Commercial Readiness - Intellia plans to complete the buildout of its commercial leadership team by the second half of 2025 [13] - The company will expand medical education activities in HAE and ATTR amyloidosis and initiate pre-approval information exchange with payers in 2025 [13] - John Leonard, M D , President and CEO, will present a company overview at the 43rd Annual J P Morgan Healthcare Conference on January 13, 2025 [9]

Intellia Therapeutics, Inc. (NTLA) has put up a dismal performance in 2024. Shares of the company have plunged 60.4% compared with the industry’s decline of 13.7%. The deterioration was more pronounced in the past five months. The stock has also underperformed the sector and the S&P 500 Index during this time frame.Intellia is a leading clinical-stage gene editing company focused on developing innovative CRISPR-based therapies. While these innovative therapies have been in the spotlight following the FDA ap ...

Regulatory Designation and Impact - The FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Intellia Therapeutics' investigational in vivo genome-editing candidate, Nexiguran ziclumeran (nex-z, also known as NTLA-2001), for the treatment of hereditary transthyretin (ATTR) amyloidosis with polyneuropathy (ATTRv-PN) [1] - The RMAT designation facilitates early interactions with the FDA, including discussions on surrogate or intermediate endpoints, and supports accelerated approval and potential priority review of the biologics license application (BLA) [2] - Shares of Intellia rose 3.4% following the announcement, although the stock has declined 51.6% year-to-date compared to the industry's 9% decline [3] Clinical Development and Collaborations - Interim data from a phase I study showed that a one-time treatment with nex-z led to rapid, deep, and durable TTR reduction, which is likely to halt and potentially reverse the disease [4] - Intellia has a co-development and co-promotion agreement with Regeneron Pharmaceuticals for nex-z, with Regeneron sharing 25% of the development costs and commercial profits [5] - The FDA cleared Intellia's investigational new drug (IND) application for the pivotal phase III MAGNITUDE-2 study, which will evaluate nex-z for ATTRv-PN, with patient enrollment expected to begin outside the U.S. by the end of 2024 [6] Ongoing Studies and Future Prospects - The phase III MAGNITUDE study is currently evaluating the safety and efficacy of nex-z in patients with ATTR amyloidosis with cardiomyopathy (ATTRv-CM), with enrollment ongoing [7] - Positive data from the MAGNITUDE study could enable global regulatory filings for nex-z, making its successful development crucial for Intellia [7] Industry Context and Peer Performance - Intellia currently holds a Zacks Rank 3 (Hold), while other biotech companies like Spero Therapeutics (SPRO) and Castle Biosciences (CSTL) are ranked 1 (Strong Buy) [8] - Spero Therapeutics' 2024 loss per share estimates narrowed from $1.59 to $1.13, and its 2025 estimates narrowed from $1.54 to $0.54, with shares declining 21.7% year-to-date [9] - Castle Biosciences' 2024 loss per share estimates narrowed from $0.58 to $0.08, and its 2025 estimates narrowed from $2.13 to $1.88, with shares surging 36.8% year-to-date [10] - Castle Biosciences has consistently beaten earnings estimates in the past four quarters, with an average surprise of 172.72% [11]