Shares of Boston-based Elicio Therapeutics, Inc. (NASDAQ:ELTX) were trading at $4.06, down $10.78, or 72%, after the company made known the results from its randomized phase II Amplify-7P study testing ELI-002 7P in patients with adjuvant KRAS-mutation-driven pancreatic ductal adenocarcinoma (PDAC) following standard locoregional therapy. The trial fell short of its pre-specified primary disease-free survival (DFS) endpoint in the intent-to-treat population, although landmark analyses during active treatment indicated early benefit. Post-hoc landmark analyses showed a consistent upside in PDAC of about 14% in DFS at three and six months, Elicio said. The drug is described as a structurally novel investigational AMP cancer immunotherapy that targets tumors driven by KRAS gene mutations.

No CNPV needed: Sanofi’s Tzield gains accelerated nod in stage 3 T1D

Sanofi SA’s Tzield (teplizumab) gained U.S. 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). The accelerated nod, which followed some back-and-forth with the agency regarding inclusion in the controversial Commissioner’s National Priority Voucher (CNPV) program, was based on data from a surrogate endpoint assessing C-peptide decline, a fact that bodes well for potential competitors such as SAB Biotherapeutics Inc.’s SAB-142, currently in a potentially registrational trial using an FDA-approved C-peptide endpoint.

Children overlooked as pediatric innovation struggles for funding

Even though children make up a quarter of the population, health care 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. After all, with huge investments going into longevity research and development, 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 Monday.

Viva in vivo! At EHA, in vivo CAR T data continues to impress

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. LB-2501 (Legend Biotech USA Inc.) is a CD19/CD20 dual-targeting CAR T cell. So far, a total of 12 trial participants with relapsed or refractory B-cell non-Hodgkin lymphoma have received LB-2501 at two dose levels. At the higher dose, all six patients responded, with five complete responses (CR) and one partial response (PR). Several patients converted from a PR to a CR over time, which is a typical pattern for cell therapies.

Chinese challenger Gan & Lee gains momentum in metabolic disease

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 insulin Ludefen and obesity therapy bofanglutide. The dual readouts underscore the company’s effort to move beyond its roots as an insulin manufacturer to compete with global metabolic disease leaders like Novo Nordisk A/S and Eli Lilly and Co. Phase III Super-3 data for insulin Ludefen showed the trial met its primary endpoint in adults with type 2 diabetes previously treated with intensive insulin regimens, demonstrating superior glycated hemoglobin reduction compared with Lantus (Sanofi SA). Phase III Gradual-1 data of GLP-1 receptor agonist bofanglutide showed patients receiving the higher 48-mg dose lost an average of 18.54% of body weight after 52 weeks, compared with 1.11% for placebo.

Elixiron’s enrupatinib shows upbeat interim phase II AD results

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. “These are exactly the signals we were looking for – clean safety, meaningful target engagement in biomarker-selected patients, and a first glimpse that dampening neuroinflammation can translate to cognitive benefit,” said Elixiron CEO and Chief Medical Officer Hung-Kai Kevin Chen. “We are advancing to a larger, placebo-controlled study with clear momentum.” Elixiron’s enrupatinib is a blood-brain barrier-permeable selective small-molecule inhibitor of CSF-1R, designed to reduce the neuroinflammatory burden that can drive amyloid and tau pathology in AD.

Longbio’s LP-003 meets phase III allergy endpoints

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. A next-generation anti-immunoglobulin E antibody, LP-003 is the company’s flagship candidate and is being developed across multiple allergy indications, including seasonal allergic rhinitis, chronic spontaneous urticaria, asthma, food allergy, and chronic rhinosinusitis with nasal polyps. A potential successor or competitor to Genentech Inc./Novartis AG’s Xolair (omalizumab), LP-003 could become the first innovative anti-IgE therapy launched globally in more than 20 years.

Proposed CMS rule closes fixed combo drug loophole

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. The rule aims “to close the fixed combination drug loophole, which represents a negative headline risk for several names in our coverage,” noted RBC Capital Markets analyst Trung Huynh, listing Johnson & Johnson, Bristol Myers Squibb Co. and Merck & Co. Inc. as firms that have pursued subcutaneous combination products with Darzalex, Opdivo and Keytruda, respectively, as well as Regeneron Pharmaceuticals Inc., with its higher-dose formulations of Eylea HD.

Microbiota modulates the antidepressant effects of GLP-1 analogues

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. This symbiotic microorganism produces a lipid that modulates neuronal activity, normalizing the hyperactivation of brain regions in mice involved in emotional processing, which ultimately reduces depressive behaviors. Scientists in this study also observed the same effect with semaglutide, suggesting that it may be extrapolated to other GLP-1 analogues.

Also in the news

Abbvie, Acousia, Adial, Akeso, Alkermes, Applied, Arcadia, Ascendis, Biocryst, Cepheid, Cogent, Cognision, Enliven, Gan, Genmab, Gilead, GSK, Harbour Biomed, Human Continuum, Hutchmed, Jazz, Kymera, Kyntra, Lateral, Livanova, MBX, Novartis, Novo Nordisk, Parabilis, Penumbra, Piccolo, Regeneron, Rocket, Spectrum