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What’s in Today’s Brief? (February 19th Preview)
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FDA reconsiders Moderna: flu mRNA shot back on review
The FDA reversed a recent refusal-to-file and agreed to review Moderna’s mRNA seasonal influenza vaccine mRNA-1010, assigning a PDUFA target date of Aug. 5, 2026. Moderna will seek full approval for adults 50–64 and accelerated approval for those 65+, with a required post-marketing study in older adults, the company said. The agency’s change follows a Type A meeting in which Moderna proposed an amended regulatory approach and agreed to additional data commitments. The reversal reduces immediate regulatory risk for Moderna but leaves open patent and broader policy uncertainties as the regulator navigates high-profile vaccine reviews under new leadership.
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Tempus sued over genetic-data transfers: class action filed in Illinois
A class-action complaint in the Northern District of Illinois alleges Tempus AI compelled Ambry Genetics to disclose customer genetic data without consent after acquiring Ambry in a $600 million deal. Plaintiff Jennifer Nash claims disclosures violated Illinois’ Genetic Information Privacy Act, and accuses Tempus of sharing de-identified data with numerous pharma partners — including AstraZeneca, Pfizer, Novartis and Merck — in ways the suit alleges were neither authorized nor truly anonymized. The filing cites Ambry’s 2020 breach affecting over 200,000 customers to argue re-identification risk. Tempus and Ambry have maintained they share only de-identified data; the suit challenges those assurances and could prompt scrutiny of data licensing practices across genomic platform deals.
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Korsana surfaces with $175M — Alzheimer’s antibody push begins
Boston-based Korsana Biosciences emerged from stealth with $175 million in seed and Series A backing to advance KRSA-028, a shuttle-equipped monoclonal antibody targeting amyloid beta, the company announced. Investors include Wellington Management, J.P. Morgan Life Sciences Private Capital and Sanofi Ventures. Korsana expects first-in-human studies in early 2027, with initial safety data midyear and proof-of-concept plaque-reduction readouts by year-end. The financing aims to support development through 2028 and build a broader neurodegeneration pipeline. Korsana’s strategy places it directly in competition with incumbent anti-amyloid approaches and underscores continued investor appetite for high-cost Alzheimer’s antibody programs despite a crowded field.
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Compass posts second Phase III win – psychedelics stocks rally
Compass Pathways reported positive results from a second Phase III trial of its synthetic psilocybin therapy COMP360 for treatment‑resistant depression, with the high-dose arm showing statistically meaningful symptom reductions and acceptable tolerability. The company said it will meet the FDA to discuss a rolling submission and aims to file an approval application between October and December. Market response lifted psych‑drug equities across the sector. Investors and analysts flagged that repeated positive late‑stage data strengthens regulatory discussions and could create the first classical psychedelic approval pathway if regulators concur on benefit–risk.
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Novartis signs big macrocycle pact: up to $1.8B with Unnatural Products
Novartis struck a research and licensing collaboration with Unnatural Products to apply UNP’s AI‑guided macrocyclic peptide platform against cardiovascular targets, a deal that could deliver up to $1.8 billion in milestones. Novartis will handle IND-enabling studies, clinical development and global commercialization while UNP contributes its discovery engine combining AI design, massively parallel synthesis and direct-to-biology screening. UNP received $100 million upfront and near-term milestones under earlier reports; the tie-up highlights pharma’s continued interest in modalities that can address traditionally undruggable targets and shows large-cap companies buying platform‑level access rather than single assets.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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