Today, a brief rundown of news from United Therapeutics and Biogen, as well as updates from Eli Lilly, Novo Nordisk and Aurinia Pharmaceuticals that you may have missed.
Shares of United Therapeutics were up nearly 15% Monday morning on data from a late-stage clinical trial that assessed the company’s already-marketed drug Tyvaso in patients with a rare lung condition known as idiopathic pulmonary fibrosis. Another, similar trial had previously hit its main goal. According to United, the newer results — from a study titled TETON-1 — were even better. After a year of treatment, patients given Tyvaso showed an absolute change in “forced vital capacity” of 130.1 mL. FVC is a key test for potential IPF treatments, as it measures lung health by quantifying how much air a patient can forcefully exhale after taking a deep breath. Tyvaso is currently used for a lung-related illness called pulmonary arterial hypertension. The data from TETON-1 should “favorably shift the Tyvaso narrative away from the nuances” of the competitive PAH market and towards the “more ‘green field’ blockbuster opportunity” of IPF, according to Leerink Partners analyst Roanna Ruiz.
Biogen on Monday said the Food and Drug Administration approved a higher-dose version of the company’s spinal muscular atrophy drug Spinraza. The new regimen will be available in the coming weeks, according to Biogen, and allows for an accelerated loading phase. Two 50 milligram doses are administered 14 days apart, followed by 28 milligram maintenance dose injections every four months thereafter. The approval should keep Biogen’s SMA franchise “durable” and serve as a bridge until the company’s next-generation medicine, “salanersen,” comes to market, wrote Jefferies analyst Andrew Tsai in a note to clients. Tsai added that his team expects the Spinraza franchise, which generated roughly $1.5 billion in sales last year, to “remain resilient (or even grow)” despite the SMA market possibly getting more crowded over the next couple years.
The FDA has approved Novo Nordisk’s Awiqli as an adjunct treatment to diet and exercise to improve blood sugar control in adults with Type 2 diabetes. The FDA based its decision on data from four studies that enrolled nearly 2,700 patients and tested weekly shots of Awiqli. According to Novo, this is the first once‑weekly basal insulin option approved for adult Type 2 diabetes patients in the U.S., and thereby provides “a new treatment solution that fits different patient routines and preferences.” The Denmark-based drugmaker said it plans to launch Awiqli in its FlexTouch devices in the states in the second half of this year.
In other Biogen news, the company’s experimental drug litifilimab succeeded in a mid-stage study of patients with cutaneous lupus erythematosus, an autoimmune condition marked by skin inflammation, scaly rashes and oral sores. According to a Saturday announcement from Biogen, the first part of the “AMETHYST” trial met its main objective, with litifilimab demonstrating an 11.8% higher reduction in disease activity compared to a placebo after 16 weeks of treatment. The results were consistent with what researchers observed in “LILAC,” a separate CLE study. A targeted antibody drug, litifilimab is also being evaluated as a treatment for another kind of lupus known as SLE.
Aurinia Pharmaceuticals has agreed to acquire Kezar Life Sciences, a San Francisco-area biotech developing small molecule drugs for cancer and conditions where the immune system mistakenly attacks the body’s own healthy cells. For each share of Kezar’s common stock, Aurinia has agreed to hand investors just shy of $7 in cash, plus one non-transferable contingent value right that floats potential payments if certain goals are hit. The deal, announced Monday, comes after Kezar’s board of directors conducted a strategic review and unanimously determined that Aurinia’s proposal is in the best interests of the biotech and its stockholders. Kezar’s most advanced drug, zetomipzomib, is being evaluated as a possible treatment for autoimmune hepatitis, SLE and a kidney illness caused by SLE. Aurinia’s CEO Kevin Tang previously made a bid as an activist shareholder to acquire Kezar in 2024.
Eli Lilly’s Ebglyss kept moderate-to-severe eczema in check for up to four years in a late-stage clinical trial, the company disclosed Friday. The open-label extension study showed 80% of participants who were given a once-monthly maintenance injection of Ebglyss experienced a durable response without the need for topical corticosteroids. Three-quarters of participants achieved “EASI90” — a test that signals near-complete skin clearance — while 78% reported significant itch relief. An antibody drug, Ebglyss works by inhibiting an immune system-regulating protein called IL-13. Sanofi and Regeneron’s Dupixent also targets IL-13 as well as the related protein IL-4.
