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FDA priority review accelerates Daiichi/Merck B7-H3 ADC in extensive-stage small-cell lung cancer
The FDA accepted and granted priority review to Daiichi Sankyo and Merck’s B7-H3-directed ADC ifinatamab deruxtecan. The application seeks approval for patients with advanced extensive-stage...
Merck’s Welireg combo falls short in first-line kidney cancer trial
Merck reported that adding Welireg (belzutifan) to an existing Keytruda regimen did not produce a significant improvement in newly diagnosed patients with advanced kidney cancer. The negative...
Replimune faces second FDA rejection and responds with further workforce cuts
Replimune disclosed additional layoffs in Massachusetts after the FDA issued a second rejection of its advanced melanoma candidate RP1. The company said WARN notices cover 224 employees across its...
Biotech infrastructure funding: Alloy Therapeutics scales tech-enabled platform with $40M Series E
Alloy Therapeutics raised $40 million in a late-stage Series E to expand its tech-enabled biotech infrastructure business. The company said the funds will support scaling its discovery engine,...
Clinical innovation in CAR-T: Kyverna prepares for FDA submission for stiff person syndrome
Kyverna Therapeutics plans to submit its CAR-T cell therapy for stiff person syndrome (SPS) to the FDA by mid-year after improved mobility outcomes and reduced disabilities in presented results....
Carvykti trial explores CAR-T in high-risk smoldering multiple myeloma
Dana-Farber and collaborators presented CAR-T outcomes in high-risk smoldering multiple myeloma using Carvykti (ciltacabtagene autoleucel). In the reported phase 2 CAR-PRISM trial, 20 patients...
Diagnostics and MRD: Roche to expand Foundation Medicine’s MRD offering with SAGA deal
Roche announced that Foundation Medicine will acquire SAGA Diagnostics in a transaction valued at up to $595 million to expand its molecular residual disease (MRD) portfolio. The deal is expected...
Regulatory and policy pressure: Medicare delays obesity drug coverage pilot over insurer participation risk
CMS delayed a Medicare pilot intended to cover obesity medications after insurance plans indicated they would not participate at this time. The program, described in the report as tied to a...
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...