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Precision immunology IPOs—Funding appetite returns to early-stage platforms
Electra Therapeutics has priced a scaled-up IPO that raised $350 million, with proceeds earmarked for what it describes as a potential first-in-class precision immunology drug aimed at a rare...
GLP-1/GIP in CNS and immune pathways—Lilly expands brenipatide dose-finding
Eli Lilly presented early clinical results for brenipatide, a once-weekly GIP/GLP-1 receptor agonist candidate, covering substance use, psychiatric, and immunologic indications. At Psych Congress...
CAR-T engineering—Tetraspanin boosts IL-2 signaling to reinvigorate potency
Researchers reported a CAR-T enhancement strategy using a tetraspanin protein to amplify IL-2 signaling inside engineered cells. The approach aims to address a common clinical challenge in CAR-T...
Cancer immunotherapy—Durable antibody response mapped through personalized neoantigen vaccine
Clinicians at Lausanne University Hospital and the Ludwig Institute for Cancer Research described a proof-of-concept personalized neoantigen vaccine in aggressive ovarian cancer that generated a...
Targeted oncology—Bispecific antibody cadonilimab gains survival edge in gastric cancer
Cadonilimab, a bispecific antibody targeting two immune-related pathways, showed a survival advantage over PD-1-based regimens in gastric cancer and gastroesophageal junction cancer, according to...
Next-gen diagnostics—FAPI-04 PET/CT outperforms FDG for liver metastases
A head-to-head comparison found gallium-68 labeled FAPI-04 PET/CT detected liver metastases with higher sensitivity and accuracy than fluorine-18 FDG PET/CT across a wide range of malignancies....
Rare disease—CLN8 revealed as key enzyme in lysosomal lipid recycling
Researchers published new mechanistic evidence for CLN8, a protein whose mutations cause Batten disease, showing it functions as a stereospecific acyltransferase involved in...
Device regulation—CareSens Air first CGM to meet proposed Europe accuracy criteria
i-SENS’ CareSens Air continuous glucose monitoring system became the first CGM device to meet proposed European clinical performance criteria, according to a pooled analysis published in Diabetes...
Aortic disease in Marfan syndrome—TRPV4 emerges as disease-relevant target
New findings identify chloride channel TRPV4 as a key player in Marfan syndrome aortic disease, pointing to a potential mechanistic lever behind progressive weakening of the aorta in patients with...
Lilly expands brenipatide’s early clinical footprint beyond metabolic disease
Eli Lilly presented early clinical data for brenipatide, a once-weekly GIP/GLP-1 receptor agonist candidate, supporting dose selection across substance use, psychiatric, and immunologic disorders....
FDA-style momentum for gene-therapy approvals: Ultragenyx clears MPS IIIA milestone
Ultragenyx secured its first approval for mucopolysaccharidosis type IIIA (MPS IIIA), closing a challenging multi-year development path. The approval marks a regulatory turning point for the...
EMA lifts multiple European approvals amid expanding oncology and dermatology pipeline
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval in September, according to a recap of the CHMP agenda. Among the...
Bavarian Nordic leadership transition lands after Sanofi executive appointment
Bavarian Nordic named Tarja Stenvall—previously a Sanofi executive—as its next President and CEO, effective Oct. 15. Stenvall succeeds Paul Chaplin, who had led the Danish vaccine company for more...
Microbiology and CAR-T safety: fatal toxicities test autoimmune CAR-T risk thesis
Autoimmune CAR-T developers are facing heightened scrutiny after reports of fatal toxicities linked to IEC-HS (immune effector cell–associated hemophagocytic syndrome), according to...
Regulators and oversight: change in approach to clinical recommendations after USPSTF leadership overhaul
The U.S. Preventive Services Task Force (USPSTF) is undergoing leadership changes after HHS Secretary Robert F. Kennedy Jr. named eight new members to complete the 16-seat panel. The announcement...
Anthropic opens a wet lab in the Bay Area, spotlighting real-world biology execution
Anthropic confirmed it has set up a wet lab in the San Francisco Bay Area, saying it is for physical biology work and not specifically for drug discovery, while declining to provide details about...
Funding for digital health: Ayble Health raises $16M to expand virtual digestive care
Ayble Health secured $16 million in Series A funding to support a virtual digestive health clinic, according to the company’s financing update. The round was led by Neon, with participation from...
Clinical innovation platform: neuron-targeted exosomes linked to shingles chronic pain mechanisms
New preclinical work suggests chronic pain from shingles, or post-herpetic neuralgia, may be driven by blood exosomes carrying proteins that block neuron growth. The finding points to...
AI in biomedical publishing: signatures of AI-assisted writing jump to near-ubiquity
A new analysis reports that AI-writing signatures in biomedical papers have surged dramatically, with the share rising from 52% in 2024 to 77% across 2025, and approaching nearly 90% by December...
FDA approval for first-in-class gene therapy in Sanfilippo A
The FDA has approved Ultragenyx’s one-time gene therapy rebisufligene etisparvovec (Fayuvi) for Sanfilippo syndrome type A (MPS IIIA), the first FDA-approved treatment for the underlying cause of...