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What’s in Today’s Brief? (February 7th Preview)
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UniQure pauses higher Fabry gene doses — safety signal emerges
UniQure paused mid‑ and high‑dose cohorts in its AAV gene‑therapy study for Fabry disease after patients developed dose‑limiting liver toxicities. Company filings and trial updates show two patients at the 4×10^13 gc/kg dose experienced grade‑3 elevations in liver enzymes, prompting an immediate dosing suspension and safety review. The firm cited standard toxicity management steps and protocol amendment planning. The pause follows recent industry scrutiny of systemic AAV vectors and dose‑related hepatotoxicity seen across multiple programs. UniQure’s action will drive a re‑examination of dose selection, monitoring schedules and stopping rules in ongoing rare‑disease gene therapy trials. Regulators and investors will be watching amendments and safety data before enrollment or dose escalation resumes.
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Hims launches Wegovy knockoff — regulators take aim
Telehealth company Hims & Hers moved to market a compounded, oral version of semaglutide marketed as a weight‑loss pill, drawing immediate pushback from originator drugmakers and regulators. Novo Nordisk and Eli Lilly flagged legal and safety concerns, arguing the product is an unapproved copy and could mislead patients. Industry statements underscored intellectual property and manufacturing gaps between approved biologics and compounded alternatives. FDA leaders signaled rapid enforcement. FDA Commissioner statements and public comments warned against mass‑marketing of unapproved copycat GLP‑1 products and stressed patient safety risks tied to compounding biologics outside approved manufacturing channels. The episode ramps up legal and regulatory scrutiny at the intersection of telehealth, compounding pharmacies and high‑demand GLP‑1 markets.
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White House rolls out TrumpRx — early reach looks limited
The White House launched TrumpRx, a direct‑to‑consumer drug‑pricing hub built on technology from GoodRx that displays cash prices for a curated list of medicines. Officials rolled the platform out with 43 drugs and a set of announced manufacturer discount deals intended to showcase lower out‑of‑pocket cash prices for uninsured or cash‑paying patients. Policy and market analysts noted the platform’s limited immediate impact on insured patients because most prescriptions are dispensed through insurance benefit designs. The administration framed TrumpRx as a transparency and access tool while critics questioned whether the platform shifts meaningful costs for the broader, insured population.
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Biotech IPO surge returns — Eikon leads big public raises
Biotech markets saw a cluster of sizable public offerings as Eikon Therapeutics priced an upsized IPO to raise $381 million and peers Agomab Therapeutics and SpyGlass Pharma raised a combined $350 million in Nasdaq listings. The companies said proceeds will fund clinical development across oncology, immunology and ocular pipelines. Bankers and analysts framed the activity as a potential turning point after a slow IPO stretch, with multiple later‑stage and platform biotechs testing public demand. The wave of listings will increase near‑term liquidity for clinical programs but places pressure on new issuers to demonstrate clinical readouts and efficient cash burn.
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Illumina leans into clinical sequencing as sales stabilize
Illumina reported modest top‑line growth in Q4 and flat full‑year 2025 revenue while flagging an acceleration in clinical sequencing consumables. CEO Jacob Thaysen said clinical, sequencing‑intense applications — including comprehensive genomic profiling and whole‑genome diagnostics — drove placements of NovaSeq X systems and consumables demand outside China. The firm also disclosed a small strategic purchase of short‑read sequencing‑by‑binding IP from PacBio, positioning Illumina to defend platform leadership and optionality in read chemistry. The results highlight a pivot toward clinical consumables as a revenue stabilizer amid broader market headwinds.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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