Ionis Pharmaceuticals Stock Price, News & Analysis

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-L_Rx 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-L_Rx 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.

Ionis Pharmaceuticals has entered into a long-term lease agreement with Sudberry Properties to develop a new chemistry and manufacturing facility in Oceanside, California. The new 217,000-square-foot facility will enhance Ionis' production capabilities, expected to be operational by 2025, with active pharmaceutical ingredient manufacturing starting in mid-2026. The facility will incorporate sustainability features, including solar energy generation. Ionis maintains a right of first offer to purchase the property after the lease term.

Ionis Pharmaceuticals announced results from the Phase 2b SOLANO study for ION449 (AZD8233), showing a statistically significant 62.3% reduction in LDL-C after 28 weeks. Despite this success, AstraZeneca will not proceed to Phase 3 due to unmet pre-specified efficacy criteria. The drug was deemed generally safe and well-tolerated. AstraZeneca will analyze the results further for next steps. This study is crucial as hypercholesterolemia poses significant cardiovascular risks, with many patients not achieving LDL-C targets.