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, based in Carlsbad, California, announced that Brett P. Monia, Ph.D., will present at the 41st Annual J.P. Morgan Healthcare Conference on January 11, 2023, at 9:45 a.m. PT (12:45 p.m. ET). The presentation will include a company overview followed by a Q&A session. A live webcast will be available on the Ionis website, with a replay accessible within 48 hours. Ionis has over 30 years of experience in RNA-targeted therapy and currently offers three marketed medicines alongside a robust late-stage pipeline.
On December 5, 2022, Ionis Pharmaceuticals announced the acceptance of its marketing authorization application (MAA) for tofersen by the European Medicines Agency (EMA) to treat SOD1-ALS. This follows the FDA's acceptance earlier in 2022, with a PDUFA date set for April 25, 2023. If approved, tofersen will be the first therapy targeting a genetic cause of ALS, which affects around 2% of ALS patients globally. The MAA includes data from several studies, and Biogen will maintain its early access program for tofersen across 34 countries.
Ionis Pharmaceuticals partners with Metagenomi to bolster its gene editing capabilities using Metagenomi's advanced systems. This collaboration aims to explore eight genetic targets, with initial research focused on four. Ionis will pay $80 million upfront, with potential milestone payments. The partnership aims to enhance therapeutic options, potentially transforming chronic therapies into curative treatments. A webcast will detail this announcement on Nov. 14, 2022, at 8 a.m. ET.
Ionis Pharmaceuticals (Nasdaq: IONS) reported positive interim results from a Phase 2 open-label extension study of donidalorsen for hereditary angioedema (HAE). After one year of treatment, patients experienced a 95% mean reduction in HAE attacks, with 99.6% of study days being attack-free. No new safety issues were identified, and adverse events did not lead to study discontinuation. The encouraging data were presented at the ACAAI Annual Meeting, reinforcing donidalorsen's potential as a leading HAE treatment.
Ionis Pharmaceuticals (Nasdaq: IONS) announced participation in several upcoming investor conferences. Key events include:
- Guggenheim 4th Annual Immunology and Neurology Day on November 14, 2022
- Stifel 2022 Healthcare Conference on November 15, 2022
- 5th Annual Evercore ISI HealthCONx and Piper Sandler 34th Annual Healthcare Conference on November 29, 2022
- Nasdaq 47th Investor Conference and BMO 2022 Growth & ESG Conference on December 7, 2022
Live webcasts and replays will be available on Ionis’ website.
Ionis Pharmaceuticals (NASDAQ: IONS) reported a 20% revenue increase for Q3 2022, totaling $160 million, driven by significant partner payments across various programs. Operating expenses remained stable at $219 million, while the net loss decreased to $47 million, reflecting improved operational efficiency. The company has increased its cash guidance to approximately $2.0 billion. Notably, positive Phase 3 study data for eplontersen and new facility construction underscore Ionis's growth potential. The company reaffirmed its annual guidance for revenue and expenses.
Ionis Pharmaceuticals announced that GSK presented positive results from the Phase 2b B-Clear study of bepirovirsen, an investigational treatment for chronic hepatitis B virus (CHB). The study demonstrated sustained clearance of hepatitis B surface antigen (HBsAg) and HBV DNA in patients for 24 weeks post-treatment. GSK plans to move bepirovirsen into Phase 3 trials in the first half of 2023. Initial findings suggest better responses in patients with low baseline HBsAg levels.
Ionis Pharmaceuticals presented positive Phase 2 results for IONIS-FB-LRx in treating immunoglobulin A nephropathy (IgAN), achieving a 44% mean reduction in proteinuria after 6 months. The study maintained kidney function in all patients and showed robust reductions in plasma complement Factor B and urinary complement fragment Ba. Roche plans to advance IONIS-FB-LRx into Phase 3 development in H1 2023, addressing a significant unmet medical need in IgAN treatment.
Ionis Pharmaceuticals announced positive Phase 2b results for fesomersen presented at Kidney Week 2022. This investigational medicine targets Factor XI reduction to prevent thrombosis in patients on hemodialysis. The study showed no increased risk of major bleeding, achieving median FXI reductions of 53.1%, 72.2%, and 86.6% across different doses. Additionally, incidences of dialysis circuit clotting and AV-access thrombosis decreased significantly. Ionis will regain rights to fesomersen from Bayer and is seeking a new partner for its market delivery.
Ionis Pharmaceuticals (Nasdaq: IONS) will host a live webcast on November 9, 2022, at 11:30 a.m. ET to discuss its financial results for the third quarter of 2022. The webcast can be accessed through Ionis’ investor relations website, and a replay will be available shortly after. With over 30 years in RNA-targeted therapy, Ionis has established itself as a leader in this field and currently markets three medicines while advancing a robust late-stage pipeline featuring key cardiovascular and neurological franchises.
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