Welcome to our dedicated page for Ionis Pharmaceuticals news (Ticker: IONS), a resource for investors and traders seeking the latest updates and insights on Ionis Pharmaceuticals stock.
Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) is a biotechnology company that focuses on RNA-targeted medicines for serious diseases, and its news flow reflects this emphasis on clinical, regulatory and commercial milestones. Company updates frequently highlight progress in neurology and cardiometabolic programs, as well as developments in rare conditions where few or no disease-modifying treatments exist.
Recent Ionis news has featured pivotal clinical trial readouts, such as Phase 3 CORE and CORE2 results for olezarsen in severe hypertriglyceridemia, showing large reductions in triglyceride levels and acute pancreatitis events with favorable safety and tolerability. The company has also reported positive pivotal data for zilganersen in Alexander disease, describing evidence of disease-modifying impact in this rare and often fatal neurological condition.
Regulatory and commercial milestones are another major theme. Ionis has announced FDA approval of TRYNGOLZA (olezarsen) for familial chylomicronemia syndrome and DAWNZERA (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema in adults and adolescents 12 years and older. News items also cover FDA Breakthrough Therapy designations for olezarsen in severe hypertriglyceridemia and zilganersen in Alexander disease, as well as European regulatory opinions and anticipated launches.
Partnered program updates appear regularly, including GSK’s Phase 3 B-Well 1 and B-Well 2 results for bepirovirsen in chronic hepatitis B, Novartis’ Lp(a) HORIZON study of pelacarsen in cardiovascular disease, and AstraZeneca collaborations on WAINUA and eplontersen. Investors can also find coverage of Ionis’ financing activities, such as convertible note offerings, and its participation in healthcare and investor conferences.
For followers of IONS stock, this news page provides a centralized view of Ionis’ clinical trial milestones, FDA and EMA interactions, product launches, collaboration updates and capital markets events, helping readers understand how the company’s RNA-targeted pipeline and marketed medicines are evolving over time.
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) has appointed Joseph T. Baroldi as executive vice president and chief business officer, effective January 31, 2022, and Eric P. Bastings, M.D., as vice president of development strategy. Baroldi, with over 20 years of experience, previously served as COO at Avidity Biosciences and held various roles at Ionis. Dr. Bastings brings over 20 years of regulatory experience from the FDA. The appointments aim to enhance business development and clinical leadership, crucial for advancing Ionis' innovative neurology pipeline.
Ionis Pharmaceuticals (Nasdaq: IONS) announced that Roche is initiating a new Phase 2 trial to assess tominersen for Huntington's disease (HD) after halting the Phase 3 GENERATION HD1 study. Post-hoc analyses indicate potential benefits of tominersen for younger adult patients with lower disease burden. The trial's design will be revealed in future presentations starting January 20, 2022. Tominersen aims to reduce huntingtin protein levels, addressing the underlying cause of HD. This development is seen as a positive step for the HD community, according to Ionis executives.
Ionis Pharmaceuticals announced that CEO Brett P. Monia, Ph.D., will provide a company overview at the virtual 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 9:45 a.m. ET. A live webcast will be accessible via the Investors & Media section of their website, with a replay available within 48 hours. Ionis has over 30 years of leadership in RNA-targeted therapy and boasts a strong late-stage pipeline focusing on neurological and cardiometabolic treatments.
Biogen and Ionis Pharmaceuticals announced a strategic collaboration whereby Biogen exercised its option to acquire a worldwide, exclusive license to develop and commercialize BIIB115/ION306, an investigational antisense oligonucleotide targeting spinal muscular atrophy (SMA). This initiative aims to address unmet patient needs and is supported by a $60 million upfront payment from Biogen. Plans include advancing BIIB115 into clinical trials to evaluate its safety and efficacy, with Biogen handling all development costs.
Ionis Pharmaceuticals, a leader in RNA-targeted therapies, has finalized a collaboration agreement with AstraZeneca for the development and commercialization of eplontersen, an investigational treatment for transthyretin amyloidosis (ATTR). The agreement follows the end of the antitrust review period and includes an upfront payment of $200 million, along with potential milestone payments totaling up to $3.4 billion. Ionis will receive royalties ranging from low double-digit to mid-20s percentages based on region.
Ionis Pharmaceuticals has announced a strategic collaboration with AstraZeneca to develop and commercialize eplontersen, an investigational treatment for transthyretin amyloidosis (ATTR). The agreement includes a $200 million upfront payment, potential milestone payments of up to $485 million, and sales-related milestones up to $2.9 billion. Ionis will lead Phase 3 trials for hereditary ATTR and will manufacture eplontersen, while AstraZeneca will handle commercial supply outside the U.S. The collaboration aims to enhance patient access and shareholder value as they prepare for a potential NDA submission by the end of 2022.
Ionis Pharmaceuticals will host a virtual investor day on December 9, 2021, at 11:00 a.m. Eastern Time. The session aims to outline the company's strategy, advancements, and progress in commercializing its leading programs. It will feature discussions on key technological innovations and is expected to last around 2.5 hours. Interested investors can access the webcast through Ionis's official website, with a limited-time replay available.
Ionis has pioneered RNA-targeted therapies for over 30 years, with three marketed medicines and a strong late-stage pipeline.
Ionis Pharmaceuticals announced promising results from Pfizer's Phase 2b study of vupanorsen, showing statistically significant reductions in non-HDL cholesterol and triglycerides across all doses. This investigational therapy aims to reduce cardiovascular risks and severe hypertriglyceridemia. The study involved 286 participants and achieved its primary endpoint at 24 weeks. Despite some injection site reactions and increases in liver enzymes, there were no serious adverse events related to treatment. Full results are expected to be presented at a medical meeting next year.
Ionis Pharmaceuticals (NASDAQ: IONS) has announced the initiation of the Phase 3 OASIS-HAE study for donidalorsen, an investigational antisense drug targeting hereditary angioedema (HAE). This registrational trial aims to evaluate the efficacy of donidalorsen in reducing HAE attacks, with a participation of up to 84 patients. Positive Phase 2 data showed that donidalorsen was safe, well-tolerated, and resulted in a significant reduction of moderate to severe attacks. The company emphasizes its commitment to providing transformative treatments to the HAE patient community.
Ionis Pharmaceuticals (NASDAQ: IONS) announced presentations of its cardiovascular pipeline at the AHA Scientific Sessions from Nov. 13-15, 2021. Data from a Phase 1 study of ION449, aimed at lowering LDL-C levels, will feature prominently. ION449 is being developed in collaboration with AstraZeneca. Additionally, olezarsen, which targets triglyceride levels, will be discussed, with evaluations ongoing in two Phase 3 studies. A symposium on the prevalence of ATTR-CM in African American populations will also take place, highlighting health disparities.
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