Ionis Pharmaceuticals, Inc. IONS shares are trading higher Tuesday after the company announced the Phase 3 Balance study of olezarsen met the primary endpoint with a statistically significant reduction in triglyceride levels versus placebo.
What To Know: The topline results for the Phase 3 Balance study of olezarsen in people with familial chylomicronemia syndrome boosted Ionis stock on Tuesday. Furthermore, olezarsen demonstrated a favorable safety and tolerability profile. In preparation for the first possible independent launch, the company intends to file a New Drug Application with the FDA.
"These positive olezarsen topline results represent an important advance for people with FCS who live in constant fear of unpredictable and potentially fatal attacks of acute pancreatitis. With no currently FDA-approved treatments, people with FCS live with debilitating abdominal pain and must maintain an extremely restrictive diet consisting of less than 20 grams of fat per day," said Sam Tsimikas, senior vice president, global cardiovascular development at Ionis.
"In this study, people with FCS treated with olezarsen along with background therapy and a low-fat diet had a substantially reduced risk of recurrent attacks of acute pancreatitis. These results strengthen our confidence in olezarsen's potential to deliver benefits to FCS patients and in the larger population with SHTG following completion of ongoing Phase 3 studies."
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IONS Price Action: Shares of IONS were up 8.46% at $46.27 at the time of publication, according to Benzinga Pro.
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