Recent News

• Lilly’s GIP/GLP-1 Candidate Brenipatide Shows Early Clinical Promise in Substance, Psych Disorders
  Gen Edge News – September 19, 2026
  Eli Lilly presented early positive clinical data supporting once-weekly dosing for its GIP/GLP-1 receptor agonist candidate brenipatide in substance use, psychiatric, and immunologic disorders—and detailed the design of Phase III trials that will assess the drug in major depressive disorder (MDD) and alcohol use disorder (AUD). Brenipatide is a dual-agonist of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors—the same modality as its blockbuster tirzepatide, marketed for type 2 diabetes in adults as Mounjaro® and for obesity as Zepbound®. The two drugs have racked up a combined $27.6 billion-plus in revenue for Lilly so far this year—$18.605 billion for Mounjaro, $9.088 billion for Zepbound—accounting for about 65% of Lilly’s total $42.773 billion in revenue between January and June 2026.
• Refreshed Novo corrals 3 new early-stage obesity drugs from Kallyope
  Fierce Biotech – September 18, 2026
  New-look Novo is digging deeper into its metabolic roots with three new obesity programs purchased from New York biotech Kallyope. The three new programs are not incretins, the class of gut hormones that includes GLP-1s like Novo’s semaglutide. Instead, one is a “potential first-in-class peptide,” another is a “follow-on small molecule” for a novel target and the third is a “small molecule receptor agonist,” Jacob Petersen, Novo’s head of global research, wrote in a LinkedIn post today. “The lead peptide-based candidate, K-554, is IND-ready,” Petersen wrote. Kallyope shared some details on K-554 in January when outlining the company’s strategic priorities for the year. At the time, the biotech said the drug candidate is a “novel, once weekly, non-incretin approach to regulating food intake” that leverages a different realm of biology than GLP-1s.
• Artelo’s ex-AstraZeneca cannabinoid agonist holds its own against GLP-1 drug semaglutide in obese mice
  Fierce Biotech – September 18, 2026
  Artelo Biosciences’ oral dual cannabinoid agonist showed weight loss comparable to the GLP-1 receptor agonist semaglutide in obese mice. When Artelo’s ART27.13 was used in combination with semaglutide, the active ingredient in GLP-1 drugs Ozempic and Wegovy, mice had double the weight loss compared with semaglutide alone. Interestingly, the company reported in a Sept. 16 release that the weight-loss effect was specific to obese mice, as lean mice dosed with ART27.13 alone did not show changes in body weight, fat mass or lean mass. “The consistency of these results across the initial pilot study and the follow-on study and in every measure we examined—body weight, food consumption, body composition and other metabolic parameters—is what gives us confidence in the signal,” Saoirse O’Sullivan, Ph.D., vice president of translational science at Artelo, said.
  
• After 50 Years of Failed Attempts, Is a Drug Vaccine Close?
  Med Scape – September 18, 2026
  In the early 1970s, a graduate student at Rockefeller University in New York City pitched an idea to his mentor, the physician who had given the world methadone maintenance: What if you could create a vaccine to train the immune system to intercept a drug before it reached the brain? The mentor, Vincent P. Dole, MD, was skeptical. Methadone already existed and was being used successfully. They also already had naloxone. Why would anyone choose a vaccine that took weeks to work over a pill that worked right now? The graduate student was Thomas Kosten, MD, now a professor of psychiatry at Baylor College of Medicine in Houston. Despite his mentor’s skepticism, Kosten spent the next five decades pursuing the idea.
  
• Ultragenyx’s $4 million gene therapy wins FDA approval for a rare brain and nervous system disorder
  San Francisco Business Times – September 17, 2026
  Regulators approved on Thursday Ultragenyx Pharmaceutical Inc.’s $3.95 million genetic fix for a rare neurodegenerative condition that often kills kids in their teens. It is the first and only Food and Drug Administration-approved treatment for Sanfilippo syndrome Type A, a onetime infusion therapy designed to drastically alter the course of a progressive disease that over a period of years steals cognition, speech and movement from children who initially appear healthy. Ultimately, the children end up bedridden. On a Thursday call with analysts, Ultragenyx CEO Emil Kakkis called the condition — also known as mucopolysaccharidosis type IIIA, or MPS IIIA — “one of the most heartbreaking diseases” he’s seen.
  
• A 3-Year-Old’s Metastatic Cancer Disappeared After Two Doses of Experimental Therapy
  Science Alert – September 15, 2026
  A powerful advance in cancer-fighting medicine has achieved an extraordinary new milestone. Chimeric Antigen Receptor (CAR) T cell therapy is an immunotherapy technique that involves taking a patient’s immune cells and genetically engineering them to become potent cancer-hunting predators. The treatment has shown huge promise in helping patients treat cancer, although its effectiveness has mostly been limited to treating blood cancers, not solid tumors. But an inspirational real-life success story involving a three-year-old patient shows scientists are making big progress with CAR T cell therapy against solid tumors too – and with potentially life-saving results.
  
• Novartis’ Rhapsido cuts MS progression in Phase 3 trial, teeing up Roche battle
  Bio Space – September 2, 2026
  Novartis’ investigational BTK inhibitor remibrutinib, approved last September as Rhapsido for chronic spontaneous urticaria, reduced relapse and disease progression in two late-stage studies of relapsing multiple sclerosis. The positive results set the pharma up for an FDA filing next year and a potential face-off against Roche, which is nearing the market with its own BTK asset. Topline results from Novartis’ Phase 3 REMODEL-1 and REMODEL-2 studies, disclosed Tuesday morning, showed that patients on remibrutinib had lower annualized relapse rates than comparators on an active control, the multiple sclerosis (MS) drug teriflunomide. The drug is marketed by Sanofi Genzyme as Aubagio but is now available in generic form. Novartis’ drug also resulted in stronger reductions in inflammatory brain lesions.
  
• New COVID-19 vaccines approved for 2026-27 to combat latest active viruses
  The Sacramento Bee – September 2, 2026
  Four new COVID-19 vaccines have been approved for distribution in the U.S. for 2026-27, the federal Food and Drug Administration just announced. On Aug. 27, the FDA issued letters to Moderna, Pfizer-BioNTech and Novavax-Sanofi authorizing new formulations of their vaccines. Moderna received approval for two new vaccines. The vaccines are designed to better combat the variants that are currently circulating in the United States, a May release by a panel reviewing the proposed changes said. But the new vaccines come with some restrictions on who can receive them. The FDA approved new versions of two Moderna vaccines, Spikevax and mNEXSPIKE, the Pfizer vaccine Comirnaty and Novavax-Sanofi’s Nuvaxovid vaccine. The Moderna and Pfizer vaccines use mRNA technology, while the Novavax-Sanofi vaccine uses a protein-based technology.
  
• GSK’s Pivotal Test for mRNA Flu Vaccine Aims to Show Two Targets Are Better Than One
  Med City News – September 1, 2026
  With respiratory virus season approaching, GSK is preparing to begin a Phase 3 clinical trial evaluating its experimental messenger RNA vaccine for seasonal influenza. The vaccine maker revealed the plans for the pivotal study after reporting Phase 2 results showing its shot led to higher immune responses against all influenza strains compared to currently available vaccines. These results in both younger and older adults were presented Tuesday at the OPTIONS XIII Conference for the Control of Influenza in Washington, D.C. Currently available flu vaccines spark an immune response to hemagglutinin (HA), a protein on the surface of the pathogen that helps it bind to a cell. GSK said growing evidence suggests targeting both HA and a second protein called neuraminidase (NA) could improve on protection, illness severity, and virus transmission.
  
• Low-dose THC keeps breast cancer cells in tumor models from reverting to an aggressive state
  Medical X Press – September 1, 2026
  Recent discoveries have revealed that breast cancer cells are more flexible than previously thought. Some can change from a differentiated state, when a mature cell has taken on a specific function, back to a more stem-like state. From there, they can become more invasive and resistant to treatment. A group of researchers has discovered a new way to help stop aggressive breast cancer cells from developing into treatment-resistant forms. They designed an experiment to prevent this cell-state reversal by using a cannabis compound, THC (tetrahydrocannabinol).
  
• RSV vaccine helps prevent hospitalizations, secondary outcomes, massive nursing home study finds
  McKnight’s – August 31, 2026
  The respiratory syncytial virus (RSV) vaccine showed a vaccine effectiveness (VE) of 73% against RSV-associated hospitalization among Medicare beneficiaries in nursing homes, according to an August study published in JAMA Internal Medicine. The study examined data on 597,430 Medicare beneficiaries in the Common Working File and Minimum Data Set (MDS). The primary outcome tracked was RSV-associated hospitalization; secondary outcomes included RSV-associated death or severe RSV-associated outcomes requiring an intensive care unit or critical care unit admission.