Get the Daily Brief
Latest Biotech News
Revolution Medicines delivers Phase 3 win and floods market with capital
Revolution Medicines priced a $2 billion concurrent stock and debt offering shortly after reporting Phase 3 top-line data for daraxonrasib, its RAS inhibitor for metastatic pancreatic ductal...
FDA clears Travere’s Filspari for FSGS after accelerated-to-full transition
Travere Therapeutics won full FDA approval for Filspari (sparsentan) in focal segmental glomerulosclerosis (FSGS), completing the company’s path from earlier accelerated clearances. The new...
Bain launches Beeline Medicines with BMS immunology assets
Bain Capital Life Sciences unveiled Beeline Medicines after licensing five immunology medicines from Bristol Myers Squibb, giving the shelved assets a new development home. Beeline’s pipeline is...
Eli Lilly acquires CrossBridge Bio to expand dual-payload ADC strategy
Eli Lilly agreed to acquire CrossBridge Bio for up to $300 million to bolster its oncology pipeline with dual-payload antibody-drug conjugate technology. The Houston-based biotech’s lead...
Terremoto bags $108M to advance AKT covalent inhibitors into clinic
Terremoto Biosciences raised $108 million in a Series C to develop small-molecule drugs targeting AKT, extending a covalent inhibitor strategy aimed at cancer and rare disease. The funding...
Regulatory shift: FDA drafts gene-editing safety guidance using NGS
The FDA released draft guidance on using next-generation sequencing to assess gene-editing safety in human gene therapy products, focusing on off-target adverse effects and genome integrity risks....
Amazon launches agentic AI platform for antibody drug discovery using wet-lab partners
Amazon Web Services introduced Amazon Bio Discovery, an agentic AI system intended to accelerate antibody discovery by coordinating foundation-model selection, candidate evaluation, and routing...
Immune reset cell therapy advances as Tr1x targets regulatory T cells
Tr1x described its allogeneic “immune reset” strategy using an iatric immune checkpoint approach centered on regulatory T cells (Tregs). The company positions its Tr1 cell therapy as a durable...
Tempus expands oncology testing distribution with Predicta’s GenoPredicta WGS assay
Tempus secured a distribution agreement with Predicta Biosciences to expand access to its whole-genome sequencing (WGS)-based GenoPredicta assay for multiple myeloma. The test is designed to...
New radiopharma alliance: Regeneron and Telix expand into precision theranostics
Regeneron and Telix agreed to a multi-program radiopharmaceutical collaboration valued at up to $4.3 billion, pairing Regeneron’s VelocImmune antibody platforms with Telix’s radiopharmaceutical...
Revolution Medicines’ daraxonrasib posts Phase 3 survival win and sparks record fundraise
Revolution Medicines said daraxonrasib, its oral RAS inhibitor for metastatic pancreatic ductal adenocarcinoma, more than doubled median overall survival versus chemotherapy in its Phase 3...
Eli Lilly pays up for dual-payload ADC platform CrossBridge Bio
Eli Lilly agreed to acquire CrossBridge Bio in a deal valued at up to $300 million to expand its oncology pipeline with dual-payload antibody-drug conjugates. CrossBridge’s lead program, CBB-120,...
Beeline Medicines exits stealth with Bain’s $300M Series A and BMS immunology assets
Bain Capital-backed Beeline Medicines launched out of stealth with plans to develop precision therapies for immune-mediated diseases, funded by a $300 million Series A. The startup built its...
FDA signals a path to speed first-in-human approvals
The US FDA said it is considering a faster Phase I “clinical trial notification” pathway for certain first-in-human studies, aiming to reduce time and duplication in the earliest stages of...
FDA ramps gene-editing safety assessment using NGS in draft guidance
The FDA released draft guidance on using next-generation sequencing and bioinformatics to assess the safety of genome-edited therapies, focusing on off-target edits and loss of genome integrity in...
Travere’s Filspari becomes first FDA-approved therapy for FSGS
The FDA approved Travere Therapeutics’ Filspari (sparsentan) for focal segmental glomerulosclerosis (FSGS), making it the first and only fully FDA-approved treatment in this indication. The...
Amazon launches Bio Discovery agentic AI platform for antibody drug discovery
AWS launched Amazon Bio Discovery, an AI platform that provides direct access to foundation models for antibody drug discovery and routes results into an in-the-loop wet-lab workflow. The service...
CRO/CDMO capacity and workflow upgrades: Fujifilm opens expanded Denmark QC lab
Fujifilm Biotechnologies opened a new 2,000-square-meter quality control laboratory at its commercial-scale Hillerød, Denmark site, adding capacity for bioassay and virology testing. The company...
Terremoto secures $108M Series C for next-generation AKT inhibitors
Terremoto Biosciences raised $108 million in a Series C financing to advance small-molecule drugs targeting AKT for cancer and rare diseases. The company described its approach as using covalency...
Tempus expands access to Predicta Biosciences WGS for multiple myeloma
Tempus announced a distribution agreement to provide Predicta Biosciences’ GenoPredicta whole-genome sequencing-based assay for multiple myeloma. GenoPredicta is intended to identify actionable...