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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...
Two CAR‑T moves narrow the gap to solid tumors: checkpoint deletion and ultra‑sensitive receptors
Researchers reported two advances aimed at overcoming key barriers to CAR‑T efficacy in solid tumors. One study showed that deletion of the nuclear receptor NR2F6 can reinvigorate exhausted CAR‑T...
Gut microbes reshape cancer therapy — mechanistic link and new microbiome metric
A high‑profile Science report linking the gut microbiome to PD‑1 immunotherapy outcomes received recognition with a Bial Award, while independent work introduced an ecological network balance...
BreezeBio lands $60M to convert delivery tech into internal mRNA pipeline
BreezeBio (formerly Genedit) closed a $60 million financing to shift from an open delivery platform to building an internal pipeline anchored by its Nanogalaxy delivery technology. The round funds...
FDA floats rapid pathways for rare and ultra‑rare therapies
The FDA published draft guidance outlining a 'Plausible Mechanism' framework and a complementary ultra‑rare therapies pathway to accelerate development of highly personalized genomic and...
Sequencing price and throughput battle heats up: Roche’s $150 genome vs Ultima’s UG200
At AGBT, Roche disclosed pricing and performance details for its Axelios 1 sequencing platform, claiming a $150 cost for a 30× human genome and a $750,000 list price for the instrument. The...
Astellas, Vir tie up on masked TCE — up to $1.7B for prostate program
Astellas entered a co‑development and co‑commercialization agreement with Vir Biotechnology for VIR‑5500, a PSMA‑targeted, PRO‑XTEN masked T‑cell engager for prostate cancer, in a deal potentially...
Novo Nordisk Commits $2.1B to Oral Biologics – Vivtex Deal
Novo Nordisk has struck a strategic collaboration with Vivtex to develop oral formulations of peptide and protein therapeutics for obesity, diabetes and related metabolic disorders. The agreement...
Sequencing Price War: Roche’s $150 Genome and Ultima’s UG200 Launch
Two sequencing suppliers unveiled aggressive commercial moves at AGBT that compress cost and expand throughput. Roche disclosed pricing and workflow details for its Axelios 1 sequencing platform,...