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Latest Biotech News

Tempus AI wins $60M ARPA‑H cancer contract for biomarker program

October 14, 2025

The U.S. Department of Health and Human Services awarded Tempus AI a $60 million contract under ARPA‑H to provide testing and contract research services for a project that uses biomarkers to...

FDA delays Denali’s Hunter syndrome review by three months

October 14, 2025

The U.S. Food and Drug Administration extended review of Denali Therapeutics’ biologics license application for tividenofusp (tivi), a transferrin‑receptor‑engineered enzyme replacement therapy...

Tvardi shares plunge after Phase II failure in idiopathic pulmonary fibrosis

October 14, 2025

Tvardi Therapeutics’ stock plunged after its Phase II study of oral STAT3 inhibitor TTI‑101 in idiopathic pulmonary fibrosis (IPF) missed safety and efficacy goals and suffered high dropout rates....

MetaGraph: A search engine for petabases of sequencing data — Nature report

October 14, 2025

MetaGraph, described in Nature, launched as a search engine designed to index and query petabases of raw sequencing reads across public repositories like the Sequence Read Archive. The platform...

Novo Nordisk raises MASH bet – Acquires Akero, faces plant compliance headwind

October 14, 2025

Novo Nordisk announced a planned acquisition of Akero Therapeutics to secure efruxifermin (EFX), an FGF21 analogue showing fibrosis regression in late-stage MASH studies. The deal terms announced...

Bristol Myers buys Orbital for $1.5B – Push into in vivo cell therapy

October 14, 2025

Bristol Myers Squibb completed a $1.5 billion acquisition of Orbital Therapeutics to add an in vivo cell therapy program aimed at autoimmune disease. The deal positions BMS alongside other large...

Excellergy launches with $70M – New effector‑cell strategy for allergy heads to clinic

October 14, 2025

Excellergy Inc. emerged from stealth with a $70 million Series A to advance effector cell response inhibitors (ECRIs), a new class designed to remove IgE from effector cells without triggering...

AI in biotech funds two startups – OutcomesAI $10M; Meta‑Flux $2M seed

October 14, 2025

Two AI‑driven health startups closed seed rounds this week underscoring investor interest in automation across care and discovery. OutcomesAI raised $10 million to commercialize voice‑based AI...

PacBio to sequence Korean pangenome – HiFi selected for national reference effort

October 14, 2025

Pacific Biosciences said its HiFi long‑read sequencing platform was chosen as the primary technology for the Korean Pangenome Reference Project, which plans to generate more than 1,000...

Blacksmith lands QIDP and Fast Track for novel LpxC antibiotic

October 14, 2025

Blacksmith Medicines received FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations for FG‑2101, an LpxC inhibitor targeting Gram‑negative pathogens. The regulatory...

Regeneron to pursue FDA OK for hearing gene therapy – Children regain implant‑free hearing

October 14, 2025

Regeneron reported that nine of 12 children in a trial of its gene therapy for congenital deafness achieved hearing levels that could remove the need for cochlear implants, and the company said it...

Intranasal adenovirus‑subunit vaccine boosts Omicron immunity – New delivery strategy advances

October 14, 2025

Researchers unveiled an intranasal vaccine combining an adenovirus vector and a trimeric subunit protein that enhanced neutralizing immunity against the Omicron variant. Preclinical data described...

Lab‑grown embryo model produces blood stem cells – Hematoids mimic early human development

October 14, 2025

Scientists at the University of Cambridge and collaborators reported creation of three‑dimensional embryo‑like structures—'hematoids'—from human stem cells that recapitulate early developmental...

Trogenix raises $95M – AAV‑driven 'Trojan horse' platform targets aggressive solid tumors

October 14, 2025

Trogenix closed a $95 million Series A to advance an AAV‑based platform (Odysseus) that uses synthetic super enhancers to activate therapeutic payloads selectively in cancer cells. The company...

Novo Nordisk Raises MASH Stake: Up-to-$5.2B Akero Buy and Indiana Plant OAI

October 14, 2025

Novo Nordisk moved to acquire Akero Therapeutics for up to $5.2 billion to add efruxifermin, a Phase III FGF21 analogue that showed fibrosis regression signals in a long Phase IIb SYMMETRY cohort....

Bristol Myers Squibb Pays $1.5B for Orbital—Into in vivo CAR-T

October 14, 2025

Bristol Myers Squibb agreed to acquire Orbital Therapeutics for $1.5 billion to obtain an in vivo cell‑therapy platform intended to make CAR‑T–style approaches accessible for autoimmune disease....

Moderna Teases Melanoma Signals — IDO Move Underpinned by Early Data

October 14, 2025

Moderna previewed early clinical data for its cancer antigen mRNA program (mRNA‑4359) in melanoma patients ahead of ESMO and disclosed that those results informed internal decisions to prioritize...

Excellergy Debuts with $70M—Aims to Reset Allergy Therapeutics

October 14, 2025

Excellergy launched with a $70 million Series A led by Samsara Biocapital to advance a new class of allergy drugs called effector cell response inhibitors (ECRIs). The company says ECRIs work...

Regeneron Seeks Approval After NEJM Hearing Gains in Children

October 14, 2025

Regeneron disclosed NEJM‑published data showing that nine of 12 children treated with its gene therapy for a congenital form of deafness achieved hearing levels where cochlear implants were no...

Lab‑grown Embryo Models Produce Blood Stem Cells: Hematoids Advance

October 14, 2025

Researchers at the University of Cambridge reported creation of three‑dimensional embryo‑like structures—termed hematoids—that recapitulate early human developmental events including the emergence...