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Alnylam inks AI deal with Inceptive Nucleics
Alnylam agreed a three-year, up-to-$2 billion strategic collaboration with Inceptive Nucleics, the AI startup co-founded by Jakob Uszkoreit, creator of the transformer architecture behind ChatGPT....
Cancer – pan-RAS inhibitor daraxonrasib extends survival
Revolution Medicines’ pan-RAS inhibitor daraxonrasib posted phase 3 results that nearly doubled overall survival in metastatic pancreatic ductal adenocarcinoma versus investigator-selected...
Regenerative and advanced cell therapy manufacturing
Cabaletta is pushing a CAR-T approach in autoimmune disease that it says could reduce or eliminate chemotherapy preconditioning. At EULAR 2026, the company described early patient updates...
Precision diagnostics – European IVDR certification for cancer syndromes
MRC Holland received CE-IVDR certification for the SALSA MLPA Probemix P008 PMS2 assay, a blood-based test for cancer-predisposition conditions linked to PMS2. The assay detects deletions and...
Oncology biotech funding – Ona Therapeutics raises for ADCs
Ona Therapeutics closed an oversubscribed $86.6 million Series B to advance two antibody-drug conjugates into human testing. The Barcelona-based biotech will use the funds primarily to push...
Cell therapy manufacturing scale-up – TSC-101 automation deal
Cellares and TScan Therapeutics agreed to evaluate automated manufacturing of TSC-101, TScan’s lead TCR-T therapy candidate for acute myeloid leukemia and myelodysplastic syndromes in the...
Gene therapy diagnostics – FDA breakthrough for invasive mold cfDNA panel
The FDA granted Zepto Life Technology breakthrough device designation for its FungiFlex Mold Panel, a blood-based diagnostic that aims to detect and distinguish circulating cell-free DNA from...
Aging and liver disease therapeutics – regulatory/clinical pipeline move
NewLimit’s funding and clinical plan places cell-age reprogramming directly into the liver disease pipeline, with early enrollment for fatty liver disease. The approach targets aging biology at...
Oncology drug efficacy and phase 3 readouts
Revolution Medicines’ pan-RAS inhibitor daraxonrasib delivered a major survival gain in phase 3 RASolute 302 for advanced pancreatic ductal adenocarcinoma, nearly doubling median survival versus...
ADC pipeline funding momentum
Ona Therapeutics raised $86.6 million in an oversubscribed Series B to advance two antibody-drug conjugates into human testing. The Barcelona-based biotech will prioritize clinical advancement of...
AI-enabled drug design partnerships
Alnylam signed a three-year, up-to-$2 billion strategic collaboration with Inceptive Nucleics to apply AI foundation models to RNAi therapeutics discovery. The partnership follows Inceptive...
China genomics and newborn screening with whole-genome sequencing
BGI and Fudan University led a prospective cohort study evaluating whole-genome sequencing–based newborn screening (NBS) in China, reporting that WGS identified single-gene conditions missed by...
FDA diagnostics—breakthrough device designation for invasive mold blood test
Zepto Life Technologies received FDA breakthrough device designation for its FungiFlex Mold Panel, a plasma-based assay designed to detect circulating cell-free DNA from invasive fungal pathogens....
CAR T program design—automation and scale-up for cell therapy manufacturing
Cellares and TScan Therapeutics agreed to evaluate automated clinical manufacturing of TSC-101, TScan’s lead TCR-T cell therapy candidate for AML and MDS patients undergoing allogeneic...
Gene editing licensing — Lilly partners for Ascidian RNA exon editors in inherited kidney disease
Eli Lilly entered a global research and licensing collaboration with Ascidian Therapeutics for RNA exon editing therapeutics targeting monogenic kidney diseases. The deal could reach up to $1.9...
Sickle cell drug setback—Fulcrum drops lead PRC2 program after FDA concerns
Fulcrum Therapeutics ended development of its sickle cell disease candidate pociredir and launched a strategic review after the FDA raised heightened concerns about malignancy risk for PRC2...
Clinical trial therapeutics—automated data expectations and FDA policy direction
The FDA signaled that its real-time clinical trials initiative could deliver tangible benefits beyond speed and cost reduction, including more actionable signals built into trial design. The...
Immune cell therapy—high-level first-in-human in vivo CAR T momentum
Legend Biotech disclosed early findings from an investigator-initiated study of its in vivo CAR-T approach in lymphoma, reporting response activity across the initial cohort. The company said the...
Oncology: pancreatic cancer breakthrough in Phase 3
Revolution Medicines reported Phase 3 RASolute 302 results for daraxonrasib, a pan-RAS inhibitor, showing a median overall survival of 13.2 months versus 6.7 months with chemotherapy in 500...
Cell therapy: in vivo CAR T early efficacy sparks market optimism
Legend Biotech began to validate its in vivo CAR T approach with early data from an investigator-initiated study in lymphoma. Initial results reported by the company showed tumor responses across...