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Catch up with FDA decisions, key trial results, and more.
Another quiet month for the US Food and Drug Administration (FDA), February was bookended by topline and full results from several key trials in heart failure (HF), atrial fibrillation (AF), and ischemic stroke. A significant amount of research was conducted over the last 3 weeks, resulting in a slew of new treatments rapidly approaching phase 3, and potentially submissions to the FDA.
As we ramp up to a busy March for cardiology, the HCPLive editorial team has collected 5 of the most impactful headlines of February 2026 – catch up on any news you might have missed below.
On February 26, 2026, the FDA accepted a supplemental New Drug Application for olezarsen, granting it priority review for the treatment of severe hypertriglyceridemia (sHTG). The application was submitted after the success of CORE and CORE2, a pair of double-blind randomized phase 3 trials comparing olezarsen to placebo. The FDA has set a Prescription User Drug Fee Act (PDUFA) date of June 30, 2026.
TLC-2716, an oral, liver-targeted liver X receptor inverse agonist from OrsoBio, met its primary efficacy endpoint in patients with sHTG and metabolic dysfunction-associated steatotic liver disease (MASLD). This phase 2a trial also illustrated TLC-2716’s reductive effects across total cholesterol, non-HDL cholesterol, and VLDL cholesterol among 30 patients.
The AZALEA-TIMI 71 phase 2b trial highlighted the efficacy of abelacimab for reducing bleeding in patients with atrial fibrillation (AF) compared to rivaroxaban. Most notably, these data were consistent across all age groups, indicating the FXI inhibitor’s efficacy among elderly patients, who are at increased risk for bleeding. Abelacimab’s substantial reduction of bleeding events may also address the lingering issue of bleed fears among patients who have AF, circumventing the fact that roughly 50% of patients with AF are not on anticoagulants.
Asundexian, another factor FXI inhibitor, demonstrated its superiority to placebo in preventing ischemic stroke in patients who have already experienced a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. These data from the pivotal phase 3 OCEANIC-STROKE trial highlighted a 26% reduction in ischemic stroke with no increase in risk of ISTH major bleeding, consistent across all subgroups.
Enlicitide decanoate has successfully demonstrated its efficacy in reducing LDL-C among patients with a history of or at risk for a major atherosclerotic cardiovascular disease (ASCVD) event. The oral macrocyclic peptide outperformed placebo, resulting in a mean LDL-C reduction of 57.1% versus placebo’s 3% mean increase.
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