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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 9, 2025 INTELLIA THERAPEUTICS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37766 36-4785571 (State or Other Jurisdiction of Incorporation) 40 Erie Street, Suite 130 Cambridge, Massachusetts 02139 (Address of Principal Executive Offices) (Zip Code) (Commissio ...

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 ...

Intellia Therapeutics, Inc. (NTLA) announced that the FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational in vivo genome-editing candidate, Nexiguran ziclumeran (nex-z, also known as NTLA-2001). The regulatory body granted the RMAT designation to nex-z for the treatment of hereditary transthyretin (ATTR) amyloidosis with polyneuropathy (ATTRv-PN). The RMAT designation provides the candidate with increased opportunities to meet FDA officials, as well as arrang ...

CAMBRIDGE, Mass, Nov. 25, 2024 (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 U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to nexiguran ziclumeran (nex-z, also known as NTLA-2001) for the treatment of hereditary transthyretin (ATTR) amyloidosis with polyneuropathy (ATTRv-PN). Nex-z is an in viv ...

Shares of biotech Intellia Therapeutics (NTLA 5.18%) are down by around 33% over the past 30 days, amid the publication of some new data from an early stage clinical trial on Nov. 16 and its third-quarter earnings on Nov. 7.Usually, updates like those two would act as positive catalysts for a stock, assuming there was good news to share.In this case, there wasn't exactly any bad news, but the stock is clearly still smarting from the damage in October, when some clinical results from its gene editing program ...

I'm an investment analyst with clinical experience in healthcare and an MBA, expanding my focus from biotech to a range of sectors. I've had the privilege of sharing my insights on Seeking Alpha since 2017, emphasizing financial modeling techniques like DCF analysis to identify underlying assumptions in stock valuations. I provide scenario-based forecasts to help readers gauge reasonable outcomes. Influenced by works like Superforecasting and Antifragile, I advocate for disciplined risk management through a ...

Consistently rapid, deep and durable reduction in serum TTR accompanied by evidence of disease stabilization or improvement after a one-time treatment of nex-z, supporting the hypothesis that greater TTR reduction may lead to a greater clinical benefit in ATTR amyloidosis Favorable trends consistently observed across multiple markers of cardiac disease progression at month 12 compared to baseline in an ATTR-CM population with a high proportion of advanced heart failure patientsConsistent trend observed to d ...