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Oncology – LAG-3 inhibitor fianlimab stumbles again in late-stage cancer
Regeneron’s LAG-3 inhibitor fianlimab missed a late-stage mark in melanoma, failing to significantly outperform Keytruda (pembrolizumab) in a Phase 3 setting in untreated patients with...
Dealmaking – Regeneron and Parabilis expand into peptide platform ADC-like strategy
Regeneron struck a collaboration with Parabilis Medicines to pursue new drugs across five undisclosed targets using Parabilis’ Helicon peptide platform. The structure includes $125 million upfront...
Diagnostics – cfDNA lung cancer screening tool lifts uptake in real-world trial
Delfi Diagnostics reported interim clinical-utility results for its FirstLook Lung cfDNA liquid-biopsy assay presented at the American Thoracic Society International Conference. In the...
Biotech funding – Violet Therapeutics raises for single-cell tracing platform
Violet Therapeutics raised $4.8 million in a seed extension financing as it advances its RABID-seq platform for mapping brain-cell interactions. The approach combines barcoded viral tracing with...
Rare disease / Neurodevelopment – Fragile X gets new preclinical target via EPAC2
UCLA Health researchers identified EPAC2 as a potential drug target for Fragile X syndrome after work in genetically engineered Fmr1 knockout mice. The study, published in Neuron, reported that...
Cancer therapeutics – Universal framework claim surfaces via award recognition
A research team associated with Davis Joseph announced a “universal framework” for treating cancer regardless of the organ of origin, and the work received the 2025 Ciechanover International...
Hematology / Emergency medicine – Whole blood versus components in prehospital trauma trial
A nationwide clinical trial from the University of Pittsburgh and UPMC found that whole blood and blood components were equally effective for prehospital resuscitation in patients with severe...
Infectious disease – WHO escalates DRC Ebola outbreak to PHEIC
The WHO classified the ongoing Bundibugyo ebolavirus outbreak in the Democratic Republic of Congo as a public health emergency of international concern (PHEIC). The escalation reflects...
AstraZeneca hypertension approvals expand Baxfendy’s addressable market
The FDA approved AstraZeneca’s baxdrostat, extending access to the company’s adrenal-suppression hypertension approach for certain patients, AstraZeneca said Monday. The approval adds regulatory...
Merck’s next-generation ADC wins global Phase 3 traction
Merck reported its sac-TMT antibody-drug conjugate achieved a first global Phase 3 win ahead of schedule, marking a milestone for the company’s late-stage pipeline. The candidate, developed with...
Regeneron and Parabilis deepen ADC-like collaboration for difficult targets
Regeneron entered a new $2.3 billion agreement with Parabilis Medicines to develop a new type of antibody-drug conjugate-like therapy aimed at harder-to-reach or harder-to-engage targets....
MD Anderson advances CD94-targeted CAR T under new FDA IND
MD Anderson received FDA IND clearance to start a phase I trial of JV-394, a CAR T-cell therapy targeting CD94-positive T and natural killer lymphomas. The study will enroll patients with relapsed...
Quince exits after rare-disease failure via reverse merger with Orphai
Quince Therapeutics announced it will pursue an exit strategy after a phase 3 rare disease setback, agreeing to merge with private pulmonary startup Orphai Therapeutics via a reverse merger. The...
FDA litigation setback for brand drugmakers’ Medicare price negotiation challenge
The Supreme Court declined to take up lawsuits challenging Medicare drug price negotiations, dealing another blow to the brand-drug industry’s legal strategy. The decision affects cases filed by...
BIO pushes FDA to refine its Plausible Mechanism Framework
The Biotechnology Innovation Organization (BIO) submitted comments supporting the FDA’s proposed Plausible Mechanism Framework, which is intended to help evaluate safety and efficacy for...
Regeneron’s melanoma LAG-3 combo fails to beat Keytruda in Phase 3
Regeneron’s two-drug regimen combining fianlimab and Libtayo did not significantly outperform pembrolizumab (Keytruda) in a late-stage melanoma trial, adding to pressure on LAG-3-targeted...
Regeneron-led stock volatility highlights DMD gene therapy regulatory uncertainty
Shares of Regenxbio sank sharply despite positive pivotal Phase III data for its Duchenne muscular dystrophy gene therapy candidate RGX-202. Reporting highlighted investor concerns after the...
Neonatal lung disease research links oxygen variability to bronchopulmonary dysplasia risk
New clinical research is sharpening understanding of bronchopulmonary dysplasia (BPD) risk in preterm infants by connecting hypoxic burden—periods of reduced oxygen—with later BPD development. The...
Regulatory action reshapes cell therapy development
The FDA cleared the University of Texas MD Anderson Cancer Center to start a phase I study of JV-394, a CD94-targeted CAR T-cell therapy, for patients with relapsed or refractory CD94-positive...
Late-stage oncology setbacks at Regeneron intensify LAG-3 pressure
Regeneron’s LAG-3 inhibitor fianlimab posted a phase 3 miss in melanoma, failing to outperform pembrolizumab (Keytruda) in a late-stage study. The result adds to recent clinical setbacks across...