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Rezatapopt NEJM: p53 reactivation shows activity in TP53 Y220C tumors
PMV Pharmaceuticals published Phase I results of rezatapopt in the New England Journal of Medicine, reporting objective responses in heavily pretreated patients whose tumors harbored the TP53...
Ginkgo divests biosecurity arm as Q4 revenue drops 24%
Ginkgo Bioworks agreed to sell its biosecurity business to a consortium of investors in exchange for a minority equity stake in the standalone firm, and reported Q4 2025 revenue of $33.0 million—a...
DOJ asks SCOTUS to revive generic pathway: solicitor general backs Hikma
The U.S. Solicitor General filed a brief urging the Supreme Court to reverse an appeals‑court decision that had revived Amarin’s lawsuit against generic maker Hikma over skinny‑labeling for...
Sequencing showdown: Roche’s $150 genome vs Ultima’s UG200 throughput leap
Roche disclosed pricing and performance details for its Axelios 1 sequencing‑by‑expansion system, claiming a $150 list cost to sequence a 30× human genome and positioning the platform for launch...
Ultra‑sensitive CAR‑T (HIT cells): preclinical eradication of multiple solid tumors
Columbia University researchers led by Michel Sadelain reported an engineered HLA‑independent T cell (HIT) receptor with ultra‑sensitivity that detects low levels of CD70 and eradicated kidney,...
ctDNA momentum: Natera eyes Medicare wins as tumor‑informed tests scale
Natera projected that expanded reimbursement for its minimal residual disease (MRD) assays will drive 2026 growth, confirming submissions to CMS MolDx for Latitude in colorectal cancer and...
Mutant p53 reactivation shows clinical responses – NEJM phase I
PMV Pharmaceuticals reported Phase I data showing the p53 reactivator rezatapopt produced objective responses in heavily pretreated patients whose tumors harbor the TP53 Y220C mutation. The New...
Ultra‑sensitive CAR‑T and checkpoint edits push into solid tumors
Two separate preclinical advances aim to overcome solid tumor barriers for cellular immunotherapy. Columbia University researchers reported ultra‑sensitive HLA‑independent T (HIT) receptors that...
Earendil inks $885M deal with WuXi XDC for next‑gen ADC tech
AI‑driven biotech Earendil Labs signed an exclusive license and manufacturing pact with WuXi XDC to use the WuXiTecan‑2 payload‑linker platform for developing next‑generation antibody‑drug...
Novo Nordisk bets up to $2.1B on Vivtex oral biologics push
Novo Nordisk committed up to $2.1 billion to license Vivtex’s gastrointestinal screening and formulation platform as part of a program to develop oral peptide and protein therapeutics for obesity,...
Generate prices $400M IPO – AI drug discovery raises fresh capital
Generate:Biomedicines priced a $400 million Nasdaq IPO, the largest biotech offering since 2024, selling 25 million shares at $16 apiece and retaining an underwriter option that could add $60...
Natera targets expanded MRD reimbursement — MolDx submissions drive 2026 outlook
Natera told investors it has submitted its Latitude tissue‑free minimal residual disease (MRD) test for MolDx assessment in colorectal cancer and has multiple Signatera submissions under review,...
Lex Diagnostics commercializes 10‑minute point‑of‑care qPCR
Lex Diagnostics began commercial ramp‑up for its Velo point‑of‑care molecular platform after securing FDA 510(k) clearance and a CLIA waiver for a flu/COVID assay. The cartridge‑based system...
Roche reveals Axelios details — $150 human genome claim at AGBT
Roche released operational and pricing details for its Axelios 1 sequencing platform at AGBT, claiming the system can deliver a standard 30X human genome for $150 in duplex mode and announcing a...
Astellas and Vir sign up‑to‑$1.7B deal for masked PSMA T‑cell engager
Astellas Pharma and Vir Biotechnology announced a co‑development and co‑commercialization agreement worth up to $1.7 billion for VIR‑5500, a PSMA‑targeted masked T‑cell engager (TCE) derived from...
FDA drafts 'plausible mechanism' fast‑track for ultra‑rare personalized drugs
The US Food and Drug Administration proposed a new 'Plausible Mechanism' framework to accelerate personalized genomic therapies for ultra‑rare diseases where traditional randomized controlled...
Generate prices $400M IPO — Nasdaq debut tops biotech listings
Generate:Biomedicines priced a $400 million Nasdaq initial public offering to bankroll late‑stage development and platform expansion. The Flagship Pioneering‑founded company earmarked roughly $300...
Novo Nordisk bets $2.1B on oral biologics: Vivtex pact
Novo Nordisk struck a strategic collaboration and licensing deal with Vivtex to develop oral formulations of peptide and protein therapeutics for obesity, diabetes and related metabolic diseases,...
Mutant p53 reactivation shows clinical activity — NEJM phase I results
PMV Pharmaceuticals published Phase I results of rezatapopt in the New England Journal of Medicine showing selective reactivation of TP53 Y220C mutant p53 and objective responses across heavily...
FDA uses national‑priority voucher — Boehringer gets first‑line lung label
The FDA expanded the label for Boehringer Ingelheim’s oral drug Hernexeos to include first‑line treatment of HER2‑positive non‑small cell lung cancer under a pilot program that accelerates review...