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FDA gene therapy approval
The FDA granted accelerated approval to Regeneron’s Otarmeni (lunsotogene parvec-cwha), described as the first gene therapy intended to restore neurosensory function in OTOF-related sensorineural...
Alzheimer’s drug regulatory setback and pipeline financing
Biogen and Eisai said the FDA delayed its decision on subcutaneous Leqembi, pushing the review date to August 24. The original decision timing was later this month, extending uncertainty for a...
FDA reconsideration of rejected cell therapy (Ebvallo)
Pierre Fabre and Atara Biotherapeutics said the FDA will reconsider Ebvallo (tabelecleucel/tab-cel) after the agency previously rejected the therapy using the same underlying single-arm evidence...
Large pharma digital pathology M&A
Roche agreed to acquire PathAI for up to $1.05 billion, aiming to accelerate use of AI in diagnostic workflows. Roche will pay $750 million upfront and up to $300 million in milestone-linked...
Big pharma rare-disease M&A expansion into US
Angelini Pharma is buying Catalyst Pharmaceuticals for about $4.1 billion in cash, paying $31.50 per share. The all-cash offer represents a premium to Catalyst’s recent trading levels and is...
Virology breakthrough: first human measles antibody panel with dual blockade
Researchers at the La Jolla Institute for Immunology (LJI) identified human monoclonal antibodies that neutralize measles virus by blocking viral entry through two essential surface proteins:...
Cell therapy delivery platform at ASGCT
Vyriad said it will showcase its G-Link modular CAR T delivery platform at the American Society of Gene & Cell Therapy (ASGCT) meeting in Boston. The company described G-Link as a plug-and-play...
Seed funding for programmable durable mRNA
ParcelBio raised $13 million in seed financing led by Breyer Capital, with participation from General Catalyst, Y Combinator, Metaplanet, SurgePoint Capital, and others. The company will use the...
Precision oncology test platform momentum and revenue guidance lift
Natera raised its 2026 revenue guidance after reporting a 39% year-over-year jump in Q1 revenue driven by growth in clinical oncology testing and women’s health volumes. The company reset its...
Sequencing/diagnostic IPO and rapid traction
Alamar Biosciences became newly publicly traded after a $220 million IPO and reported a Q1 2026 revenue surge that nearly doubled year over year. The proteomics company posted $26.0 million in...
FDA overturns rejection pathway for Atara/Pierre Fabre cell therapy
The US FDA agreed to reconsider approval of Atara Biotherapeutics and Pierre Fabre Pharmaceuticals’ off-the-shelf T-cell therapy Ebvallo (tabelecleucel/tab-cel) after a second meeting that walked...
Bayer buys Perfuse to expand ophthalmology pipeline with implantable PER-001
Bayer agreed to acquire Perfuse Therapeutics for up to $2.45 billion, adding PER-001 to its ophthalmology development pipeline. The deal includes a $300 million upfront payment and additional...
Roche to acquire PathAI to scale AI-driven digital pathology
Roche agreed to acquire PathAI for up to $1.05 billion to expand its digital pathology capabilities and accelerate AI adoption in companion diagnostics. The deal structure calls for a $750 million...
Biotech financial guidance: PacBio trims outlook on soft instrument demand
Pacific Biosciences cut the high end of its 2026 revenue guidance by $5 million after reporting flat Q1 revenue tied to softer instrument demand, particularly for its Vega platform, and continued...
Liquid biopsy diagnostics: Guardant boosts guidance on rising oncology and screening volumes
Guardant Health reported Q1 2026 revenue of $301.7 million, up 48% year over year, and increased its full-year guidance to $1.30 billion to $1.32 billion. The ramp was driven by continued growth...
Precision diagnostics: Natera resets 2026 revenue outlook after Q1 growth surge
Natera increased its 2026 guidance after first-quarter 2026 revenue jumped 39% year over year, reflecting strength across its clinical oncology business and women’s health testing. Management said...
Prenatal testing: BillionToOne reports Q1 spike and points to Unity Confirm demand driver
BillionToOne reported Q1 2026 revenue of $108.4 million, up 84% year over year, citing growth across prenatal clinical testing and related services. The company said it accessioned 189,000 tests...
Digital pathology and AI diagnostics funding: Moonlight AI raises seed to expand image-genomic biomarker library
Moonlight AI, a Swiss developer of diagnostic image-analysis software, raised $3.3 million in private financing to expand its dataset linking cytology images to genomic biomarkers. The company...
Biotech IPO: Odyssey upsized $304m offering for autoimmune and inflammatory pipeline
Odyssey Therapeutics priced an upsized initial public offering at $18 per share to raise about $304 million in gross proceeds, following a prior attempt to go public that was paused earlier. The...
Cell therapy access and manufacturing automation: Cellular Origins partners with Immatics
Cellular Origins and Immatics expanded their manufacturing technology collaboration, agreeing to use Cellular Origins’ automated mobile robotic platform, Constellation, for parts of Immatics’ cell...