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CARLSBAD, Calif. - Ionis Pharmaceuticals, Inc. (NASDAQ:IONS), a $6.65 billion biotech company whose stock has gained nearly 28% over the past six months, announced positive results from its Phase 3 OASISplus study showing patients with hereditary angioedema (HAE) who switched to donidalorsen experienced a 62% further reduction in monthly attack rates compared to their previous treatments.
The study, published in The Journal of Allergy and Clinical Immunology In Practice, evaluated patients who transitioned from existing prophylactic treatments including lanadelumab, C1-esterase inhibitor, and berotralstat to donidalorsen administered every four weeks.
According to the results, patients followed a specific protocol to transition to donidalorsen without experiencing an increase in breakthrough attacks. After 16 weeks of treatment, attack rates decreased by 65%, 41%, and 73% for patients switching from lanadelumab, C1INH, and berotralstat, respectively.
The company reported that 84% of surveyed patients preferred donidalorsen over their prior therapy, citing better disease control, less administration time, and fewer injection site issues. Disease control measures improved, with 93% of patients reporting well-controlled disease after switching to donidalorsen compared to 67% at baseline.
Donidalorsen was well-tolerated with no serious treatment-related adverse events. Most side effects were mild or moderate, with injection site reactions being the most common.
HAE is a rare genetic condition causing recurrent attacks of severe swelling in various body parts, including the hands, feet, genitals, stomach, face, and throat. The condition affects more than 20,000 patients in the U.S. and Europe.
The New Drug Application for donidalorsen is currently under review with the U.S. Food and Drug Administration, with a target action date of August 21, 2025. If approved, it would be a first-in-class prophylactic treatment for HAE in patients 12 years and older. According to InvestingPro data, while Ionis is not currently profitable, analysts have set price targets ranging from $37 to $83, reflecting the market’s anticipation of potential FDA approval. Investors can access detailed analysis and 8 additional ProTips about Ionis through InvestingPro’s comprehensive research reports.
The information in this article is based on a press release statement from Ionis Pharmaceuticals. With the company’s next earnings report due in 9 days, InvestingPro subscribers can access real-time financial metrics, Fair Value analysis, and expert insights to make informed investment decisions.
In other recent news, Ionis Pharmaceuticals has been in the spotlight with several key developments. Barclays upgraded Ionis Pharmaceuticals from Equalweight to Overweight, raising its price target to $57.00, as the company prepares for Phase 3 trial results for Tryngolza, expected in the third quarter of 2025. Barclays expressed optimism about the trial’s success, particularly in achieving the primary endpoint related to triglyceride levels. Meanwhile, H.C. Wainwright maintained its buy rating for Ionis, setting a price target of $50.00, following promising clinical trial results for salanersen, a treatment for spinal muscular atrophy. Biogen, Ionis’s partner, reported positive interim results from a Phase 1 study of salanersen, showing significant reductions in neurofilament light chain levels and improvements in motor function in participants. Additionally, Ionis announced a leadership change, with Chief Development Officer Richard Geary planning to retire in January 2026, and Holly Kordasiewicz set to succeed him. Ionis also initiated a Phase 3 trial for ION582, an investigational treatment for Angelman syndrome, marking a significant step for this rare neurodevelopmental disorder. The trial aims to evaluate improvements in expressive communication and other health measures in affected individuals.
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