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Intellia Therapeutics, Inc. reports clinical, regulatory and financing developments as a clinical-stage biopharmaceutical company using CRISPR gene editing and other core technologies. Its recurring updates center on in vivo and ex vivo therapeutic approaches for genetically defined diseases, including lonvoguran ziclumeran, or lonvo-z, for hereditary angioedema and nexiguran ziclumeran, or nex-z, for ATTR amyloidosis with cardiomyopathy and polyneuropathy.
Company announcements also cover Phase 3 clinical data, FDA interactions, biologics license application activity, quarterly financial results, common stock offerings, equity incentive grants and investor conference participation. These updates reflect Intellia's progress from gene-editing research and clinical development toward regulatory and commercial planning for its lead programs.
Intellia Therapeutics (NASDAQ:NTLA) has presented interim results from its Phase 1 trial of NTLA-2001, a CRISPR-based treatment for ATTR amyloidosis with cardiomyopathy. Results showed a remarkable 90% mean serum TTR reduction following a single dose, sustained for four to six months. NTLA-2001 was generally well-tolerated, with minimal adverse reactions. This study marks a significant step in exploring the potential of NTLA-2001 to permanently inactivate the TTR gene, offering a promising future for patients with this life-threatening condition.
Intellia Therapeutics (NTLA) reported significant interim results from its clinical trials for NTLA-2001 and NTLA-2002 in the third quarter of 2022. NTLA-2001 showed mean serum transthyretin protein reductions of 93% and 92% at doses of 0.7 mg/kg and 1.0 mg/kg, respectively. The firm has strong cash reserves of $848.7 million and expects to initiate Phase 2 of NTLA-2002 by early 2023. Collaboration revenue increased to $13.3 million, while R&D expenses rose to $96.7 million. The net loss was reported at $113.2 million, indicating an increase compared to the previous year.
Intellia Therapeutics (NASDAQ: NTLA) announced new interim clinical data from its Phase 1/2 study of NTLA-2002, showcasing safety, kallikrein reduction, and attack rate information. This investigational CRISPR/Cas9 therapy aims to prevent angioedema attacks in hereditary angioedema (HAE) patients. Key presentation details include:
- Date: Nov 12, 2022
- Presenter: Dr. Hilary Longhurst
A live webcast to discuss the data will be held on Nov 14, 2022. NTLA-2002 represents a novel approach to a rare genetic disorder affecting 1 in 50,000 people.
Intellia Therapeutics, Inc. (NASDAQ:NTLA) will present its Q3 2022 financial results and operational highlights on a conference call scheduled for November 3, 2022, at 8 a.m. ET. Investors can participate by dialing 1-833-316-0545 (U.S.) or 1-412-317-5726 (international). A live webcast will also be available on the company’s website. Intellia focuses on developing genome editing therapies through CRISPR technology, aiming to address various diseases with its in vivo and ex vivo programs.
Intellia Therapeutics (NASDAQ:NTLA) announced upcoming presentations at two investor conferences in October 2022. The Chardan’s 6th Annual Genetic Medicines Conference is scheduled for October 3, 2022, at 8:30 a.m. ET in a fireside chat format. The 2022 Truist Securities Genetic Medicine Summit will include a genome editing panel on October 20, 2022, at 9:00 a.m. ET. A live webcast of the Chardan presentation will be available on Intellia's website, with a replay accessible for 30 days.
Intellia Therapeutics announced promising interim results from the Phase 1 study of NTLA-2001, a CRISPR/Cas9 therapy for transthyretin (ATTR) amyloidosis. At doses of 0.7 mg/kg and 1.0 mg/kg, mean serum transthyretin (TTR) reductions of 93% and 92% were observed at day 28. The treatment was well-tolerated, with transitory infusion reactions as the only adverse events. These outcomes suggest NTLA-2001 may provide a single-dose treatment option for patients with cardiomyopathy manifestations of ATTR amyloidosis. Further discussions on this data are scheduled for an investor event today.
Intellia Therapeutics and Regeneron Pharmaceuticals announced promising interim results from the Phase 1 study of NTLA-2001, a CRISPR therapy for transthyretin (ATTR) amyloidosis. The trial exhibited significant mean serum transthyretin reductions of 93% and 92% at doses of 0.7 mg/kg and 1.0 mg/kg, respectively, on day 28. The treatment was well-tolerated, with minimal adverse reactions. Follow-ups indicated sustained reductions over two to six months. Intellia plans to expand the study with a fixed dose of 0.7 mg/kg and aims for a pivotal trial, potentially including U.S. patients.
Intellia Therapeutics (NASDAQ:NTLA) announced positive interim results from its Phase 1/2 study of NTLA-2002, a CRISPR-based treatment for hereditary angioedema (HAE). A single dose of 25 mg resulted in a 91% reduction in HAE attacks over 16 weeks, with two patients remaining attack-free. At 75 mg, the treatment achieved a 92% reduction in plasma kallikrein levels. NTLA-2002 was well-tolerated, with mild adverse events. The company plans to proceed with a Phase 2 dose-expansion in H1 2023. These findings validate Intellia's genome editing platform, highlighting its potential to address various genetic diseases.
SparingVision, a French biotech focused on genomics in ophthalmology, has secured Series B financing co-led by Jeito Capital and the University of Pittsburgh Medical Center Enterprise. The $XX million funding will accelerate development of its lead treatments, SPVN06 and SPVN20, targeting retinitis pigmentosa. The investment supports first-in-human studies and further innovations in their pipeline. SparingVision aims to bring mutation-agnostic genomic therapies to patients suffering from inherited retinal diseases and dry age-related macular degeneration.
Intellia Therapeutics announced a virtual investor event on September 16, 2022, to present interim data from its ongoing Phase 1/2 studies of NTLA-2002 and NTLA-2001. NTLA-2002 aims to treat hereditary angioedema and will provide initial safety and kallikrein protein reduction data. NTLA-2001 targets ATTR amyloidosis, and an update on its cardiomyopathy arm will also be shared. Both candidates utilize CRISPR technology for gene editing, showing promise in their respective clinical trials. This event will be accessible online, and a replay will be available for 30 days.