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AI-augmented pathology biomarker workflows
Leica Biosystems expanded a computational pathology collaboration with AstraZeneca and Daiichi Sankyo, building an end-to-end research workflow to quantify the TROP2 Normalized Membrane Ratio...
Digital lab and sequencing platform scaling for ctDNA
Hartwig Medical Foundation expanded its partnership with Ultima Genomics by adopting the Ultima UG200 sequencing platform to scale whole-genome-informed ctDNA monitoring. The partners said the...
Cell and gene therapy platform advances
T-Curx received Swissmedic clinical trial approval for its nonviral, Siglec-6-targeted CAR T program TCX-001, clearing a first-in-human phase I study in Switzerland. The company said it plans to...
Rare disease funding and IPO momentum
Ethyreal launched with $101 million across venture rounds to develop a long-acting anti-TSHR monoclonal antibody, ETHY-001, for Graves’ disease and thyroid eye disease. The company disclosed...
Oncology drug development: MRD, targeted therapy, and immuno-oncology
Caribou linked its off-the-shelf CAR-T lymphoma program to updated efficacy evidence, reporting a 17.1-month median progression-free survival. The company said the data add to the rationale that...
Regulatory decision: FDA rejection on acromegaly drug
Camurus received another complete response letter from the FDA for its monthly subcutaneous extended-release acromegaly drug CAM-2029, which is expected to be branded Oclaiz in the U.S. The...
Clinical-stage leukemia updates and phase progression
Enliven Therapeutics shared updated early data for ELVN-001 in previously treated chronic myeloid leukemia (CML), with results discussed for a proposed go-forward 80 mg once-daily cohort. The...
Gene therapy for inherited eye disease
A Chinese research team reported safety and feasibility for a subretinal gene therapy delivering an AAV8 vector carrying RS1 in pediatric X-linked retinoschisis, publishing in the New England...
AI-driven drug discovery capital and partnerships
Prometheus raised $12 billion to build “artificial general engineers” aimed at accelerating biopharma workflows, according to a STAT+ report on the company’s capital push. The fundraising...
Roche/Foundation Medicine MRD assay expansion
Roche’s Foundation Medicine rebranded Saga Diagnostics’ minimal residual disease (MRD) platform following the company’s $595 million Saga acquisition earlier this year, positioning the test for...
FDA diagnostics authorization: Guardant CDx for Boehringer lung cancer
Guardant Health said the FDA approved its Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim’s Hernexeos (zongertinib) in HER2-mutant advanced non-small cell lung cancer. The...
AI-enabled clinical trial recruitment and automation funding
Prometheus, an AI “clinical engineering” startup, raised $12 billion to build “artificial general engineers” and expand use cases across biopharma workflows, including trial operations. The...
SonoThera ultrasound gene therapy financing
SonoThera secured an oversubscribed $125 million Series B to move its ultrasound-mediated genetic medicine platform into clinical development. The company framed the round as funding for two lead...
Biotech IPO: Parabilis priced at $670M, record for venture-backed
Parabilis priced an upsized IPO at $20 per share, raising $670 million—setting a new record for venture-backed biopharma listings. The company sold 3.5 million shares in the offering and said...
Late-stage pipeline shock: Camurus second CRL for Oclaiz
Camurus received a second complete response letter (CRL) from the FDA for its subcutaneous extended-release acromegaly drug CAM-2029 (Oclaiz in the U.S.), with the rejection tied to issues at a...
Regulatory approval: China clears Alphamab HER2 bispecific for gastric cancer
China’s National Medical Products Administration approved Suzhou Alphamab’s HER2 bispecific antibody anbenitamab (KN-026) for adults with locally advanced or metastatic HER2-positive gastric and...
Litigation: Grail class action over NHS-Galleri trial disclosures
Grail shareholders filed a class action lawsuit in the U.S. District Court for the Northern District of California accusing Grail and executives of making false and misleading statements about the...
Clinical and commercial validation: Enliven CML data supports phase III plan
Enliven Therapeutics updated early phase I results for ELVN-001 in chronic myeloid leukemia (CML), with the company’s proposed go-forward 80-mg cohort showing major molecular response increasing...
Partnership expansion: Hartwig adopts Ultima UG200 for ppmSeq ctDNA monitoring
Hartwig Medical Foundation expanded its partnership with Ultima Genomics by adopting the Ultima UG200 sequencing platform to increase sequencing scale and throughput while lowering overall costs...
Company financing and IPO activity
Biotech IPO activity stayed hot as Parabilis Medicines priced an upsized $670 million offering, underscoring investor willingness to back later-stage oncology developers with credible cash plans....