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Lilly expands in vivo CAR-T platform via Kelonia acquisition
Eli Lilly agreed to buy Kelonia Therapeutics in a deal worth up to $7 billion, adding an early clinical in vivo CAR-T program targeting multiple myeloma. Lilly will pay $3.25 billion upfront with...
Gilead and Arcus pull back after additional TIGIT failure
Gilead is loosening its TIGIT partnership with Arcus after the Phase 3 domvanalimab study failed on its futility assessment, triggering trial culls and a broader renegotiation of options. Gilead’s...
Replimune begins major workforce reductions after FDA second rejection
Replimune is cutting jobs at its Massachusetts sites after the FDA issued a second rejection to its advanced melanoma candidate RP1. The company plans to eliminate 224 positions under WARN notices...
FDA expands proteogenomics tooling for opioid use disorder risk assessment
Solvd Health said the FDA approved its AvertD pharmacogenomic opioid use disorder test for blood-sample collection. The genotyping assay analyzes 15 genetic variants and extends beyond the earlier...
Cosmo advances to NDA filing after Phase III clascoterone 12-month data
Cosmo Pharmaceuticals said it plans to file an NDA in 2027 for clascoterone 5% topical solution following positive 12-month Phase III data in androgenetic alopecia. In its largest male AGA Phase...
Tortugas launches with $106M and a neurology pipeline
Tortugas Neurosciences debuted with $106 million and a clinical pipeline aimed at brain and neuropsychiatric disorders. The company is led by veterans from Sage Therapeutics and is building around...
Digital pathology AI model validated for immunotherapy selection in NSCLC
A deep learning pathomics model presented at AACR can stratify metastatic NSCLC patients by likely benefit from immune checkpoint inhibitors using routine pathology slides. Researchers from UT MD...
Tortugas and other neurology updates are not included; top regulatory/clinical and M&A items covered
No additional high-impact, biotech-exclusive regulatory or pipeline action was selected beyond the nine clusters above.
In vivo CAR-T dealmaking
Eli Lilly agreed to acquire Kelonia Therapeutics in a deal worth up to $7 billion, including a $3.25 billion upfront payment, to expand its “in vivo” CAR-T capabilities. Kelonia’s lead candidate,...
Immunotherapy setbacks in TIGIT lung cancer
Gilead and Arcus Biosciences pulled back further on their TIGIT collaboration after STAR-121 failed in Phase 3 in metastatic NSCLC. In filings, Gilead cited futility and terminated the trial’s...
Regulatory and financing shakeups after oncology rejection
Replimune accelerated cost cuts after the FDA issued a second complete response letter rejecting its advanced melanoma candidate RP1. The company plans layoffs across Massachusetts, cutting 144...
Obesity pipeline IPO and late-stage GLP-1/GIP competitor
Kailera Therapeutics priced its IPO at $16 per share to raise about $625 million in gross proceeds, entering the public markets with a Phase III obesity program. The company’s lead asset,...
New IL-2 approach in lupus via Treg restoration
A phase IIb trial in systemic lupus erythematosus reported that low-dose IL-2 restored regulatory T cells in a dose-dependent manner, according to findings published in Nature Communications. The...
Genomic diagnostics for cancers of unknown primary
Two DNA-methylation approaches aimed at identifying tissue of origin for cancers of unknown primary advanced at AACR 2026, targeting a major diagnostic bottleneck. One program from Guardant Health...
Proteomics platforms integrate into precision oncology workflows
Nomic Bio partnered with Broad Clinical Labs to embed its Nomic Omni 1000 immunoassay platform into BCL’s proteomics and multi-omics offerings. The collaboration is designed to connect large-scale...
Neuroimmunology and cancer immunotherapy: checkpoint targeting in early disease
Intralesional nivolumab generated responses in precancerous oral lesions in a phase I study presented at AACR 2026. Researchers reported that injecting Opdivo directly into lesions reduced lesion...
CAR-T in high-risk smoldering myeloma
Dana-Farber reported durable, profound responses from CAR T-cell therapy in high-risk smoldering multiple myeloma through the CAR-PRISM phase 2 trial. Investigators presented results showing deep...
Financing to advance chronic cough therapy into Phase III
Trevi Therapeutics raised $173 million in a public offering to move its lead chronic cough candidate, Haduvio, into Phase III. The company priced the sale at $13.00 per share and said the proceeds...
In vivo CAR-T deal transforms Lilly’s pipeline
Eli Lilly agreed to acquire Kelonia Therapeutics for up to $7 billion, adding an in vivo CAR-T platform aimed at generating anti-BCMA CAR T cells directly inside patients. The deal includes a...
Obesity pipeline gets a $625m IPO as Phase III advances
Kailera Therapeutics priced its IPO at $16 per share, aiming to raise about $625 million in gross proceeds to advance obesity programs and operations. The company plans to trade on Nasdaq under...