FDA Approves Bexlutry, First Generic Radioligand Therapy, After Curium Wins Novartis Patent Dispute
核心洞察
The FDA approved Curium (搜索)'s Bexlutry (搜索), the first generic radioligand therapy, a copycat of Novartis' Lutathera that delivers radioactive lutetium to SSTR (搜索)-positive neuroendocrine tumors (搜索).
The approval covers foregut, midgut and hindgut SSTR (搜索)-positive neuroendocrine cancers and followed Curium (搜索)'s victory in a patent dispute with Novartis.
Arrowhead's dual-acting RNA interference therapy Aro-Dimer-Pa (搜索) cut PCSK9 and APOC3 protein levels by 72% and 88% after a single dose in an early-stage trial.
The Food and Drug Administration on Tuesday approved Bexlutry (搜索), the first generic radioligand therapy for cancer, awarding clearance to Curium (搜索) for a copycat version of Novartis' Lutathera. The approval was issued after Curium prevailed in a patent dispute with Novartis, according to BioPharma Dive.
Like Lutathera, Bexlutry (搜索) delivers radioactive lutetium to a protein called SSTR (搜索) found on the surface of certain neuroendocrine tumors (搜索). The approval covers use in treating SSTR-positive neuroendocrine cancers, which include foregut, midgut and hindgut tumors. The clearance marks the first generic entry into the targeted radiopharmaceutical space.
Arrowhead's Dual RNAi Therapy Silences Two Cardiovascular Genes
Arrowhead Pharmaceuticals said Tuesday that its dual-acting RNA interference therapy, Aro-Dimer-Pa (搜索), effectively silenced two genes implicated in cardiovascular disease in an early-stage trial. A single dose of the therapy reduced levels of the proteins PCSK9 and APOC3 circulating in the blood by 72% and 88%, respectively, according to the company.
Arrowhead is positioning the medicine as a treatment for mixed hyperlipidemia (搜索), a common condition characterized by high levels of bad cholesterol and fats in the blood. Cantor Fitzgerald analyst Prakhar Agrawal wrote that mixed hyperlipidemia represents a "very large" market opportunity and that Arrowhead now appears to have a "highly differentiated drug."
Corbus Cannabinoid Drug Shows Weight Loss, With Tolerability Questions
An experimental Corbus Pharmaceuticals drug helped people with obesity (搜索) lose as much as 5 percentage points more than a placebo after 12 weeks in an early-stage trial. The drug, CRB-913, targets a kind of cannabinoid receptor that regulates appetite, an approach that so far has yielded disappointing clinical results.
Jefferies analyst Amin Makarem described the early efficacy results reported Monday as "competitive" and suggesting "differentiated" tolerability compared to GLP-1 drugs. However, anywhere from 1.5% to nearly 10% of patients, depending on the dose, stopped treatment because of psychiatric side effects. Makarem noted those types of side effects are a concern with cannabinoid drugs and represent "the key debate" surrounding CRB-913. Corbus plans to start a Phase 2 study next year.
Sionna Cuts Workforce, Reworks Cystic Fibrosis Strategy
Sionna Therapeutics (搜索) will lay off nearly half its workforce and alter its clinical development strategy following disappointing results in a key cystic fibrosis (搜索) drug trial. On Monday, the company said an after-the-fact analysis unearthed multiple confounding factors in its failed trial, and it intends to incorporate the lessons learned into a new Phase 2 study testing a different regimen.
Sionna's explanation "seems reasonable, but it's still very hard to have conviction," wrote Stifel analyst Paul Matteis. The coming job cuts and other cost-saving moves will extend Sionna's financial runway into the second half of 2029 while it pursues its new strategy.
Contineum Depression Program Fails Phase 2
Contineum Therapeutics said Monday that an investigational drug it has been working on with Johnson & Johnson failed a Phase 2 trial in major depressive disorder (搜索). Compared to a placebo over the course of five days, the drug did not meaningfully improve scores on a widely used depression rating scale.
RBC Capital Markets analyst Brian Abrahams wrote that although the outcome was "disappointing," investors had "low expectations" for the study, noting that the company's "main value driver" is a fibrosis drug that is also in clinical testing. J&J will evaluate the depression data to inform the next steps for the program.
Novo Nordisk Rebrands as Novo Amid Market Pressure
Novo Nordisk will drop the "Nordisk" in its name as part of a corporate rebranding, the company said Monday. Going forward, "Novo" will be used as the company's "day-to-day" name while "Novo Nordisk" will remain its legal name, according to a Monday statement.
The rebrand comes ahead of a "capital markets" day next week, during which Novo intends to provide investors with an overview of its "updated corporate strategy." The company has lost more than two-thirds of its market value since mid-2024 and ceded its leadership position in obesity (搜索) treatment to rival Eli Lilly.