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Lilly to buy Kelonia in in vivo CAR-T push
Eli Lilly agreed to acquire Kelonia Therapeutics for up to $7 billion, adding an early in vivo CAR-T program for multiple myeloma to its genetic medicine pipeline. The deal structure includes a...
Merck FDA approval expands HIV regimen options
The FDA approved Merck’s once-daily HIV regimen Idvynso (doravirine/islatravir), giving clinicians a new option for adults with HIV-1 infection who are virologically suppressed and have no known...
FDA priority review for Merck-Daiichi B7-H3 ADC
The FDA granted priority review to Daiichi Sankyo and Merck’s B7-H3-directed antibody-drug conjugate ifinatamab deruxtecan. The acceptance covers an accelerated timeline under the BLA filing for...
Revolution Medicines’ daraxonrasib delivers pancreatic cancer data
Revolution Medicines reinforced momentum behind its KRAS program at the American Association for Cancer Research meeting with updated clinical results for daraxonrasib in advanced pancreatic...
Kyverna aims for FDA submission in stiff person syndrome CAR-T
Kyverna Therapeutics said it plans to submit its CAR-T therapy for stiff person syndrome to the FDA by mid-year after presenting study results showing improved mobility and reduced disability. The...
Gilead and Arcus end TIGIT study after Phase 3 failure
Gilead and Arcus Biosciences terminated additional TIGIT-focused studies after Phase 3 domvanalimab results failed to meet efficacy goals in metastatic non-small-cell lung cancer. In securities...
Biogen expands felzartamab rights with $850M TJ deal
Biogen consolidated full global rights to felzartamab through an $850 million deal with TJ Biopharma, closing the chapter on a multi-year licensing framework. The arrangement follows Biogen’s...
Nomic Bio partners with Broad Clinical Labs on proteomics integration
Nomic Bio struck a deal with Broad Clinical Labs to integrate its Nomic Omni 1000 proteomics immunoassay platform into BCL’s omics risk modeling workflows. Under the partnership, BCL will use the...
Cosmo Pharma advances baldness drug toward NDA
Cosmo Pharma said it plans to file for FDA approval of clascoterone 5% topical solution for androgenetic alopecia in early 2027 after positive 12-month Phase III results. The androgen receptor...
Tortugas launches with $106M for neuroscience pipeline
Neuro startup Tortugas Neurosciences launched with $106 million to develop in-house and licensed therapies targeting brain disorders. The company’s initial pipeline includes oral small molecules...
FDA authorizes Merck’s oral HIV regimen and adds new coverage options
The FDA has approved Merck & Co.’s once-daily HIV pill, strengthening the company’s push to remain a major HIV drug supplier as more biotechs have exited the space. The approval adds a new...
Merck secures additional HIV indication with Idvynso
Merck won U.S. FDA approval for Idvynso, a two-drug oral HIV regimen, ahead of its PDUFA window. The decision covers adults with HIV-1 who are already virologically suppressed and have no history...
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
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