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FDA delays Denali decision: three‑month extension on Hunter syndrome BLA
The FDA pushed back its target PDUFA date for Denali Therapeutics’ enzyme replacement therapy tividenofusp alfa (tivi) for Hunter syndrome by three months to April 5, 2026 after classifying an...
Novo Nordisk raises its MASH stake: efruxifermin buyout of Akero
Novo Nordisk moved to acquire Akero Therapeutics in a transaction valued at up to $5.2 billion to add efruxifermin (EFX), an FGF21 analogue now in Phase III for metabolic dysfunction‑associated...
BMS pays $1.5B for Orbital: in vivo cell therapy enters big pharma chase
Bristol Myers Squibb agreed to acquire Orbital Therapeutics for roughly $1.5 billion to secure an in‑vivo cell therapy platform targeting autoimmune disease. Orbital’s technology aims to program...
Lila Sciences ups its war chest: Nvidia joins $350M haul for AI‑driven biology
Lila Sciences expanded its Series A with an additional $115 million — including investment from Nvidia’s venture arm — bringing the startup’s haul to $350 million. Lila, founded by Flagship...
SPT Labtech and 10x Genomics automate single‑cell workflows: plug‑and‑play scale
SPT Labtech and 10x Genomics announced a strategic partnership to integrate SPT’s Firefly liquid‑handling automation with 10x’s Chromium single‑cell platform, with plans to extend to Visium...
BioCryst Pays $700M for Astria to Bulk Up HAE Portfolio
BioCryst Pharmaceuticals agreed to acquire Astria Therapeutics in a roughly $700 million cash-and-stock deal to add a long-acting injectable hereditary angioedema (HAE) candidate to its portfolio....
Kailera Raises $600M to Take Zepbound‑Like Obesity Shot Into Phase 3
Kailera Therapeutics secured $600 million in a Series B financing led by Bain Capital Private Equity to fund global Phase 3 trials of KAI‑9531, a weekly injectable that targets the same pathways...
PacBio Cuts Costs: Reusable Consumables and New Chemistry Aim at $300 Genome
Pacific Biosciences unveiled a plan to let select customers reuse its most expensive SMRT cell consumables and launched a new sequencing chemistry, Sprq‑Nx, to raise throughput and add...
FDA Extends Denali Review: Hunter Syndrome Decision Pushed Three Months
The FDA extended its review of Denali Therapeutics’ biologics license application for tividenofusp (tivi), an enzyme replacement therapy for Hunter syndrome, moving the PDUFA date three months to...
Benchling Adds NVIDIA Tools; Lila Sciences Expands Nvidia‑Backed Funding
Benchling is integrating NVIDIA BioNeMo models and NIM microservices into its Benchling AI platform to let scientists run protein structure prediction (OpenFold2) and other biomolecular AI tools...
Gene Therapy Momentum: Krystal’s FDA Platform Win and AAV PPT1 Results
Krystal Biotech became the second company to secure the FDA’s platform technology designation for a genetically modified, non‑replicating herpes simplex virus type platform, which can streamline...
Sequencing Partnerships Scale Clinical and Consumer Genomics
Bio‑Techne and Oxford Nanopore extended and broadened their partnership through 2032 to develop a portfolio of targeted nanopore sequencing kits for screening and diagnosing heritable genetic...
Automation Push: 10x Genomics and SPT Labtech; Sampled Outsources Extraction
SPT Labtech and 10x Genomics announced a strategic partnership to automate single‑cell workflows by integrating SPT’s Firefly liquid‑handling system with 10x’s Chromium single‑cell chemistry and...
J&J to Spin Out Orthopedics as DePuy Synthes; Strategy Shift for Medtech
Johnson & Johnson announced plans to spin out its orthopedics business into a standalone company that will retain the DePuy Synthes name, aiming to create a focused competitor to Stryker and...
BioCryst buys Astria: $700M play for long‑acting HAE shot
BioCryst announced a cash-and-stock acquisition of Astria Therapeutics that values the buyered company at roughly $700 million and centers on Astria’s long-acting injectable navenibart for...
Kailera nets $600M — launch pad for a Zepbound‑style obesity shot
Kailera Therapeutics closed a $600 million Series B led by Bain Capital to fund global trials of its obesity injectable, following late‑stage success in China. The financing ranks among the...
Benchling integrates NVIDIA BioNeMo: structure prediction in the lab UX
Benchling announced integration of NVIDIA’s BioNeMo models and NIM microservices into its Benchling AI platform, enabling users to run Nvidia OpenFold2 predictions and other biomolecular models...
Lila Sciences bulks up: Nvidia joins an expanded $350M Series A
Lila Sciences expanded its Series A with a new $115 million tranche that included investment from Nvidia’s venture arm, taking the round to about $350 million total. The Flagship Pioneering‑backed...
FDA delays Denali review: Hunter syndrome decision pushed to April 2026
The FDA extended its review of Denali Therapeutics’ application for tividenofusp (tivi), an enzyme replacement therapy for Hunter syndrome, issuing a three‑month delay that moves the PDUFA date to...
Drug pricing talks and manufacturing alarms: AstraZeneca deal; Novo plant OAI
AstraZeneca reportedly struck a U.S. drug‑pricing agreement following the administration’s MFN/onshoring talks, while separate reporting flagged a Novo Nordisk manufacturing site in Bloomington,...