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Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) is a leading biotechnology company headquartered in Carlsbad, California. Founded in 1989, Ionis has been pioneering the discovery and development of antisense drugs, with an impressive portfolio of over 1300 patents. Ionis focuses on creating innovative RNA-targeted therapies for complex diseases, particularly in the areas of cardiovascular, metabolic, neurological, and rare genetic disorders.
Ionis has successfully brought several groundbreaking medicines to market. Notable achievements include the development of Spinraza, in collaboration with Biogen, which was launched in 2016 to treat spinal muscular atrophy, a rare neuromuscular disorder. In 2023, Biogen also launched Qalsody for ALS, further extending the impact of Ionis' antisense technology.
Through its cardiovascular-focused subsidiary, Akcea Therapeutics, Ionis has introduced drugs like Tegsedi for ATTR amyloidosis and Waylivra in Europe for cardiology indications. The company continues to advance its pipeline with promising candidates such as olezarsen, an investigational RNA-targeted therapy for familial chylomicronemia syndrome (FCS). Ionis' ongoing Phase 3 trials for olezarsen have shown promising results, with significant reductions in triglyceride levels and improvements in related health outcomes.
Ionis' commitment to innovation and patient care is also evident in its robust financial health and strategic partnerships. With a deep understanding of disease biology and cutting-edge technology, Ionis continues to drive advancements in RNA therapies and gene editing, aiming to deliver life-changing medicines for patients around the world.
Recently, Ionis announced positive clinical trial results for several of its investigational drugs and plans to pursue regulatory approvals for these therapies. The company's pipeline is well-positioned to address unmet medical needs in various therapeutic areas, promising a steady flow of new treatments in the coming years.
For more detailed information about Ionis Pharmaceuticals, its products, and career opportunities, visit their official website at www.ionispharma.com.
Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced the topline results from Biogen's Phase 3 VALOR study of tofersen, an antisense medicine for SOD1 amyotrophic lateral sclerosis (ALS). Although the primary endpoint was not met, secondary measures indicated trends favoring tofersen. The study involved 108 participants, showing 38% and 67% differences in key biomarkers for faster and slower progressors, respectively. Biogen plans to engage regulatory bodies for next steps, while expanding its early access program for SOD1-ALS patients.
Ionis Pharmaceuticals (NASDAQ: IONS) will present 14 posters and two symposiums at the 3rd European ATTR Amyloidosis meeting from September 6-8, 2021. Highlighting advancements in its ATTR amyloidosis portfolio, the presentations will focus on the investigational antisense medicine, eplontersen, which is being evaluated in two phase 3 trials for transthyretin amyloid cardiomyopathy (ATTR-CM) and polyneuropathy (ATTR-PN). Ionis aims to enhance treatment options for patients impacted by this disease.
Ionis Pharmaceuticals (Nasdaq: IONS) announced its participation in upcoming virtual investor conferences, including the 2021 Wells Fargo Healthcare Conference on September 10, the Morgan Stanley 19th Annual Global Healthcare Conference on September 13, and the Bank of America Global Healthcare Conference 2021 on September 15. Presentation details may change, with updates available on the company's website. A live webcast will be offered, with replays accessible within 48 hours. Ionis is a leader in RNA-targeted therapy, with three marketed medicines and a strong pipeline.
Ionis Pharmaceuticals reported Q2 2021 financial results, with total revenues of $126 million and a net loss of $36 million (non-GAAP). The company is well capitalized, ending the quarter with $2.1 billion in cash and investments. Key advancements include full enrollment in the Phase 3 NEURO-TTRansform study and ongoing studies for tofersen and pelacarsen. Ionis aims for more than $600 million in revenue for 2021, while operational changes have streamlined costs. The company anticipates significant data readouts in H2 2021, potentially leading to numerous new product launches by 2026.
Ionis Pharmaceuticals announced significant progress for pelacarsen, a potential treatment for lipoprotein(a)-driven cardiovascular disease, as the Lp(a) HORIZON study reached 50% enrollment with 4,000 participants. This Phase 3 study aims to support the drug's indication for reducing cardiovascular risk. Ionis received a $25 million milestone payment from Novartis and is eligible for up to $675 million in additional milestones, along with mid-teens to low 20% royalties on pelacarsen sales. This investigational medicine utilizes LICA technology to target elevated Lp(a) levels, a significant risk factor for cardiovascular diseases.
Ionis Pharmaceuticals (NASDAQ: IONS) has successfully completed enrollment in its pivotal Phase 3 NEURO-TTRansform study, exceeding its target with over 160 patients participating. The study focuses on eplontersen for treating hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN). Eplontersen, an investigational drug using Ionis' LICA technology, showed up to 94% reductions in transthyretin (TTR) in Phase 1 trials. An interim analysis is expected by mid-2022, with a potential NDA filing by year-end 2022.
Biogen and Ionis Pharmaceuticals reported positive topline data from a Phase 1b clinical trial of BIIB080, aimed at treating mild Alzheimer's disease. The trial demonstrated significant dose-dependent reductions in tau protein levels in cerebrospinal fluid, achieving mean reductions of 30% to 49% across various dosing schedules. All participants completed the treatment phases, with no serious adverse events reported. These findings underscore the potential of BIIB080 and Ionis' antisense technology in addressing neurodegenerative diseases, paving the way for further clinical investigations.
Ionis Pharmaceuticals (NASDAQ: IONS) announced a live webcast scheduled for August 4, 2021, at 11:30 a.m. ET, to discuss its Q2 2021 financial results along with updates on its pipeline and business progress. Ionis has been a leader in RNA-targeted therapy for over 30 years, with three marketed medicines and a strong late-stage pipeline. The webcast will be accessible via their investor relations page, and a replay will be available for a limited time.
Ionis Pharmaceuticals has entered an exclusive licensing agreement with Bicycle Therapeutics to enhance its LIgand Conjugated Antisense (LICA) medicines. The deal grants Ionis access to Bicycle's proprietary Bicycles, targeting transferrin receptor 1 to improve delivery of oligonucleotides. Ionis made a $45 million upfront payment, which includes a license fee and equity investment. This partnership aims to boost Ionis' drug discovery capabilities, potentially leading to better treatment options for patients.
Ionis Pharmaceuticals announced that Executive VP and CSO C. Frank Bennett has received the 23rd Jacob and Louise Gabbay Award for his contributions to antisense therapy. The award honors significant advances in biomedical sciences and includes a cash prize and medallion. Bennett shares the recognition with Adrian R. Krainer and is acknowledged for his pivotal role in developing SPINRAZA, the key treatment for spinal muscular atrophy. He is a founding member of Ionis and has received several prestigious awards for his ongoing research in RNA-targeted therapies.
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