Moderna Inc. will soon find out if the tumult-ridden U.S. FDA’s switcheroo in mid-February will stick regarding mRNA-1010, a prospective new seasonal influenza vaccine. The Vaccines and Related Biological Products Advisory Committee on June 17 takes up the matter of the shot, which trails a curious history.

Demonstrating better tolerability and safety in comparison with standard of care, Edgewise Therapeutics Inc.’s EDG-7500 is moving toward a phase III trial for both obstructive and nonobstructive hypertrophic cardiomyopathy (HCM), the most common form of genetic heart disease. Boulder, Colo.-based Edgewise reported top-line phase II results from part D of the Cirrus-HCM trial, showing meaningful responses in terms of hemodynamics, biomarkers and patient-reported measures.

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.

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.

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.

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).

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.

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.

With full phase II results in hand, MBX Biosciences Inc. backers are stacking the odds of parathyroid hormone (PTH) peptide prodrug canvuparatide (canvu) against Yorvipath (palopegteriparatide} from Ascendis Pharma A/S, a PTH analog cleared by the U.S. FDA in August 2024 for hypoparathyroidism (HP).