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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 (NASDAQ: IONS) announced that the FDA has granted Fast Track designation to olezarsen for treating familial chylomicronemia syndrome (FCS), a rare genetic disease characterized by dangerously high triglyceride levels and severe pancreatitis risk. This designation aims to expedite the review of drugs addressing unmet medical needs. Olezarsen, which inhibits apoC-III production, has completed enrollment in the Phase 3 BALANCE study, with data expected in the second half of 2023. Currently, there are no approved therapies for FCS in the U.S., highlighting the urgent need for effective treatment options for affected patients.
Ionis Pharmaceuticals announced that its Chief Scientific Officer, C. Frank Bennett, Ph.D., has been awarded the Rainwater Prize for Outstanding Innovation in Neurodegenerative Disease Research. Dr. Bennett shares this honor with renowned scientists Don W. Cleveland and Timothy M. Miller. This recognition is for their advancements in antisense technology aimed at treating conditions like ALS, Huntington's, and Alzheimer's disease. Notably, their collaboration has led to four investigational medicines, including tofersen, which is under regulatory review with a PDUFA action date of April 25, 2023.
Ionis Pharmaceuticals has announced a significant royalty agreement with Royalty Pharma, involving an upfront payment of $500 million and potential milestones of up to $625 million. This deal allows Royalty Pharma to acquire an interest in Ionis' royalties from SPINRAZA and pelacarsen, while Ionis retains the majority of royalties and milestone payments from Novartis. The investment aims to bolster Ionis' late-stage programs and innovative genetic medicines pipeline, highlighting confidence in the commercial potential of both therapies.
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.
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