Backers of Boston-based Elicio Therapeutics Inc. may have jumped the gun as they ran away from the firm after data were made public from the phase II Amplify-7P study testing ELI-002 7P in adjuvant KRAS-mutation-driven pancreatic ductal adenocarcinoma (PDAC) following standard locoregional therapy. Wainwright analyst Robert Burns said the results are “more nuanced than they appear” and the sell-off represents “an attractive entry point” for investors. Shares (NASDAQ:ELTX) closed June 15 at $4.08, down $10.77, or 72%, in the wake of news that the trial missed the pre-specified primary endpoint of disease-free survival (DFS) in the intent-to-treat population. Read More
Despite some back-and-forth with the U.S. FDA regarding inclusion in the somewhat controversial Commissioner’s National Priority Voucher (CNPV) program, Sanofi SA’s Tzield (teplizumab) gained FDA clearance, expanding use of the CD3-directed monoclonal antibody as a disease-modifying therapy for patients with recently diagnosed stage 3 type 1 diabetes (T1D). Read More
Even though children make up a quarter of the population, healthcare technologies are not often designed with them in mind. Investment in pediatric innovation remains limited with investors often viewing returns in the space as less predictable. Nevertheless, a number of companies are looking to address this and are developing technologies for kids. Afterall, with huge investments going into longevity R&D, there is a compelling case for addressing health issues at the very early stage, delegates heard at the first annual Pediatric Innovation Summit, held as part of the HLTH Europe conference in Amsterdam on June 15. Read More
Treatment with first-generation CAR T cells regularly sent patients to the intensive care unit. Now, investigators are envisioning a future where CAR T treatment could occur on an outpatient basis. At Sunday’s late-breaking oral session of the 2026 Annual Congress of the European Hematology Association (EHA2026), Lei Fan told his audience that the first-in-human data “support further development of LB-2501 as a potential first-in-class, off-the-shelf, single infusion, no lymphodepletion, outpatient use CAR T therapy.” Fan is a professor of hematology at the First Affiliated Hospital of Nanjing Medical University. Read More
Chinese diabetes specialist Gan & Lee Pharmaceuticals is strengthening its position in metabolic disease after reporting positive phase III data for both once-weekly basal insulin candidate Ludefen and obesity therapy bofanglutide. Read More
Elixiron Immunotherapeutics Inc. announced positive interim open-label phase II Alzheimer’s disease (AD) study findings of enrupatinib, an oral brain-penetrant colony-stimulating factor 1 receptor inhibitor, with plans to move the asset into a biomarker-based and placebo-controlled study. Read More
After raising HK$1.255 billion (US$160 million) in its IPO on the Hong Kong Stock Exchange earlier this month, Longbio Pharma Co. Ltd.’s lead candidate, LP-003, met the primary endpoint of total nasal symptom scores during peak pollen season in moderate to severe seasonal allergic rhinitis. Read More
The Centers for Medicare & Medicaid Services (CMS) proposed a rule June 12 that would codify the Inflation Reduction Act of 2022’s Medicare Drug Price Negotiation Program, establish new negotiation and drug benefit policies, and modify the fixed combination drug policy – the latter of which would negatively impact biopharmas attempting to extend lifecycles of blockbuster products. Read More
Liraglutide, a glucagon-like peptide 1 (GLP-1) receptor agonist used in diabetes and obesity, could alleviate depression through a pathway that does not depend on the GLP-1 receptor but instead on the gut microbiota, since the treatment increases the presence of the bacterium Lactobacillus delbrueckii. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Arcadia, Adial, Azora, Enliven, Human Continuum, Parabilis, Regeneron. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Abbvie, Acousia, Ascendis, Biocryst, Cogent, Gan, Genmab, Hutchmed, Jazz, Kymera, Kyntra, MBX, Novartis. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Applied, Cepheid, Cognision, Gilead, Lateral, Novo Nordisk, Piccolo, Rocket, Spectrum. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Akeso, Alkermes, GSK, Novo Nordisk, Penumbra. Read More
