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FDA accelerates Tecvayli-Darzalex approval: national priority pathway used
The FDA granted rapid approval to Johnson & Johnson’s Tecvayli paired with Darzalex Faspro for early relapsed/refractory multiple myeloma using the agency’s Commissioner’s National Priority...
Roche-Zealand amylin misses Lilly bar: phase‑2 efficacy disappoints
Roche and Zealand Pharma reported Phase 2 results for petrelintide showing mean weight loss of 10.7% (9.0% placebo‑adjusted) at 42 weeks and a favorable tolerability profile, but the efficacy...
FDA halts PepGen US Phase 2 over preclinical safety questions
The FDA placed a partial clinical hold on PepGen’s Freedom2‑DM1 Phase 2 trial after reviewers flagged preclinical pharmacology and toxicology findings — notably blood-pressure drops in mice —...
Alnylam pays Tenaya for heart‑disease genetics: up to $1.13B pact
Alnylam Pharmaceuticals and Tenaya Therapeutics struck a research collaboration in which Tenaya will deliver up to 15 novel genetic targets for cardiovascular disease discovery. Alnylam committed...
BillionToOne doubles revenue — raises full‑year guidance and inks UHC contract
Molecular diagnostics company BillionToOne reported Q4 revenue of $96.1 million, more than double year‑ago sales, and raised full‑year 2026 guidance to $430–$445 million. The company said it will...
Kestrel clears IND for oral pan‑KRAS inhibitor — first‑in‑human trial due
Kestrel Therapeutics secured FDA clearance to begin clinical testing of KST‑6051, an oral pan‑KRAS small‑molecule inhibitor targeting KRAS‑driven cancers. The company plans to open a...
UCLA engineers CAR‑T to breach solid‑tumor defenses
Researchers at UCLA unveiled a next‑generation CAR‑T platform engineered to overcome the immunosuppressive microenvironment of solid tumors. The preclinical work describes design features intended...
Gene therapy cuts seizures in Dravet: zorevunersen shows large reductions
A clinical program led by University College London and Great Ormond Street Hospital reported that zorevunersen, an investigational gene‑regulation therapy for Dravet syndrome, produced dramatic...
FDA and uniQure clash: agency demands randomized sham control for Huntington’s gene therapy
A senior FDA official publicly rejected uniQure’s characterization of agency actions and defended a request for a randomized, sham‑controlled trial of AMT‑130, the company’s intracranial gene...
FDA converts Tecvayli accelerated approval and greenlights Tec‑Dara combo under priority voucher
The FDA granted full approval to Johnson & Johnson’s Tecvayli as a monotherapy and cleared the Tecvayli plus Darzalex Faspro combination for previously treated relapsed or refractory multiple...
Servier to buy Day One for $2.5B: acquires pediatric brain‑tumor drug Ojemda
Servier agreed to acquire Day One Biopharmaceuticals for roughly $2.5 billion in cash, securing global rights to the marketed pediatric low‑grade glioma drug Ojemda and Day One’s rare oncology...
Tenaya and Alnylam sign $1B‑plus cardio research pact: $10M upfront, big milestones
Tenaya Therapeutics struck a research collaboration with Alnylam Pharmaceuticals to identify up to 15 genetic targets for cardiovascular disease discovery, with $10 million upfront and potential...
Moderna to pay up to $2.25B to settle lipid nanoparticle patent fight
Moderna agreed to pay up to $2.25 billion to Arbutus Biopharma and Genevant Sciences to resolve a longstanding dispute over lipid nanoparticle (LNP) delivery technology used in mRNA vaccines. The...
FDA places partial hold on PepGen’s DM1 trial after reviewers flag preclinical signals
The FDA placed a partial clinical hold on PepGen’s Freedom2‑DM1 Phase II multiple ascending‑dose trial of PGN‑EDODM1 for myotonic dystrophy type 1, citing concerns from previously submitted...
Kestrel clears IND for oral pan‑KRAS KST‑6051, moves toward first‑in‑human trial
Kestrel Therapeutics received FDA clearance of an IND for KST‑6051, an oral small‑molecule pan‑KRAS inhibitor targeting KRAS‑driven cancers, and plans to start a first‑in‑human Phase I FALCON...
Illumina expands pharma research alliance with 50,000 genomes paired to proteomics
Illumina announced it will add 50,000 whole genomes with matched proteomic data to the Alliance for Genomic Discovery (AGD), with DeCode Genetics generating protein data using Illumina’s Protein...
Liquid biopsy moves beyond cancer: cfDNA fragmentomics detects liver fibrosis and chronic disease indicators
Two independent reports detailed advances in fragmentomics‑based liquid biopsy: Johns Hopkins published a prototype cfDNA fragmentomics test that identifies liver fibrosis, cirrhosis, and chronic...
UCB licenses Antengene’s ATG‑201 in $1.1B autoimmune deal: bispecific T‑cell engager pact
UCB struck a global licensing agreement with Antengene for ATG‑201, a CD19/CD3 bispecific T‑cell engager designed to deplete pathogenic B cells in autoimmune diseases, with $60 million upfront...
Moderna to pay up to $2.25B: patent settlement ends LNP fight
Moderna agreed to a multi-hundred-million to multibillion-dollar settlement to resolve a long‑running dispute over lipid nanoparticle (LNP) delivery technology used in its COVID‑19 vaccine. The...
UCB inks $1.1B deal... Antengene’s CD19/CD3 T‑cell engager
UCB secured global rights to ATG‑201, a CD19/CD3 bispecific T‑cell engager (TCE) from Antengene in a deal that could total more than $1.1 billion in milestones plus tiered royalties. Antengene...