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What’s in Today’s Brief? (February 22nd Preview)
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Grail’s Galleri stumbles: NHS trial misses primary endpoint, shares plunge
Grail’s large NHS-Galleri randomized trial failed to show a statistically significant reduction in late-stage (stage III–IV) cancer diagnoses, the company reported in top-line results. The study enrolled 142,000 people in England and compared standard-of-care screening with and without the Galleri multicancer early detection blood test. Grail highlighted pre-specified signals: fewer stage IV diagnoses and an increase in early-stage detections for a group of 12 high‑mortality cancers, and plans to extend follow-up by 6–12 months to see if effects emerge with more time. Investors reacted sharply: shares fell roughly half their value in after‑hours trading. The NHS trial outcome complicates Grail’s regulatory and commercial pathway in the U.K. and U.S.; the data will be presented at ASCO and will be scrutinized for statistical power, endpoint definitions, and how early-stage detection translates into mortality benefit. Multicancer early detection (MCED) tests screen for cancer-specific signals in blood—validation requires demonstrating reduced late-stage incidence or mortality, not just detection rates.
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FDA reverses course on Moderna flu shot – agency sets PDUFA date
The FDA agreed to review Moderna’s mRNA‑1010 seasonal flu vaccine after a Type A meeting, setting an Aug. 5 PDUFA target date and accepting a revised regulatory pathway that seeks full approval in adults 50–64 and accelerated approval in those 65+. Moderna said the agency will evaluate its resubmission and that it expects a decision this summer. Moderna CEO Stéphane Bancel issued a statement praising agency engagement. Reports from Politico and industry coverage noted political pressure and an unusually expedited process around the agency’s reversal. Biocentury commentary examined how the episode may reshape FDA‑industry interactions and the optics of regulatory decision‑making. The development restores a near‑term regulatory runway for an mRNA flu candidate and highlights political and policy risk in vaccine reviews. A PDUFA decision would affect seasonal vaccine supply dynamics and the competitive landscape for mRNA‑based seasonal immunizations.
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Korsana raises $175M to push brain‑penetrant Alzheimer’s antibodies
Korsana Biosciences disclosed a $175 million financing to advance a platform engineered to ferry antibodies across the blood‑brain barrier for Alzheimer’s disease and other neurologic indications. The company’s technology aims to improve central nervous system delivery by leveraging molecular engineering to increase brain exposure. Korsana’s approach tracks several industry efforts—Roche and AbbVie have clinical‑stage programs with similar brain‑delivery strategies—so clinical differentiation will hinge on safety, target engagement, and CNS exposure. The financing positions Korsana to move lead candidates into IND‑enabling studies or early clinical testing.
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Illuminare’s fluorescent nerve agent clears Phase 1 – surgery visualization advances
Illuminare Biotechnologies reported first‑in‑human Phase 1 data showing Illuminare‑1, a fluorescent agent that binds myelin, enables rapid and sustained intraoperative nerve visualization under blue light. Early results indicate the agent can delineate peripheral nerves from surrounding tissue, potentially reducing iatrogenic nerve injury during procedures. The company presented safety and imaging onset data and outlined plans for broader clinical evaluation. Illuminare‑1 is an imaging probe—these agents are administered systemically or locally and fluoresce under specific wavelengths to aid real‑time surgical decisions. If larger trials confirm reduced nerve injury rates, the technology could affect ophthalmic, head‑and‑neck, urology, and general surgical workflows.
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MoonLake posts mid‑stage arthritis win ahead of FDA filing
MoonLake Immunotherapeutics reported Phase 2 results showing its investigational drug produced clinically meaningful benefit in patients with an aggressive inflammatory arthritis subtype, a company source told Endpoints. MoonLake said it has confidence as it prepares an impending FDA submission. The data reportedly supported improvement on key clinical endpoints versus baseline and informed MoonLake’s regulatory strategy. The asset’s Phase 2 signal will determine the scale and timing of a pivotal program; the company’s next steps include finalizing submission materials and engaging with regulatory authorities on trial design and labeling.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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