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What’s in Today’s Brief? (February 13th Preview)
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FDA refusal halts Moderna flu review — mRNA vaccine program in limbo
The FDA issued a refusal-to-file for Moderna’s mRNA influenza vaccine, prompting an immediate public dispute between the company and regulators. Moderna said the agency’s letter cited procedural concerns inconsistent with prior guidance and did not identify safety or efficacy deficiencies. The refusal has reverberated across vaccine developers that relied on established pre-submission interactions with the agency. Moderna responded that earlier FDA discussions had approved its comparator choice and that the RTF caught the company by surprise. The move also highlighted a regulatory bottleneck: senior FDA leadership personally signed the letter, signaling a tougher review stance for complex vaccine programs. The company has already pared R&D spending and reorganized its pipeline away from large late-stage respiratory programs. Moderna’s strategic pivot — shifting resources toward oncology and select vaccine targets — reflects immediate operational impacts from the regulatory setback and raises questions about future investment in U.S.-based respiratory vaccine trials.
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BridgeBio’s oral drug boosts growth in children — Phase 3 win sets up FDA filing
BridgeBio announced positive top-line results from Propel 3: oral infigratinib produced a statistically significant increase in annualized height velocity in children with achondroplasia. The trial met its primary endpoint with an adjusted least‑squares mean treatment difference versus placebo, and the company plans regulatory discussions and submissions later this year. The trial reported both primary and supporting growth endpoints that, according to the company, exceed previous randomized results in the indication and compare favorably with existing injectable therapies. Safety signals were manageable; the firm disclosed transient phosphate elevations in a small number of patients. BridgeBio said it will pursue filing discussions with regulators and accelerate development in related skeletal disorders. The result adds to a recent run of pivotal wins in rare-disease programs and will likely trigger competitive dynamics with approved and near‑launch competitors.
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Ultragenyx cuts 10% as late‑stage failures force restructuring — gene therapy review stalled
Ultragenyx disclosed a strategic restructuring that includes laying off roughly 10% of staff after a year of disappointing late‑stage trial results. The company reported that two brittle bone disease trials of setrusumab missed primary endpoints, prompting a reevaluation of programs and a push to reduce operating expenses. Separately, Ultragenyx’s biologics manufacturing files are under heightened FDA scrutiny: the agency requested additional supportive documentation for the company’s gene therapy application for Sanfilippo syndrome type A, delaying potential regulatory action. The firm resubmitted its application after prior manufacturing-related pushbacks and now faces further review requirements. Ultragenyx framed the moves as necessary to focus resources on high‑value programs and to position the company for profitability goals in the coming years while handling regulatory follow‑up on UX111.
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FDA removes black‑box warnings from six menopausal therapies — labeling overhaul
The FDA removed the most severe 'black box' warnings related to breast cancer, cardiovascular disease and dementia from labeling for six hormone replacement therapies used in menopause. Commissioner Marty Makary led the labeling change after an agency review and input from industry, experts and manufacturers. Twenty‑nine companies submitted proposed label revisions at the FDA's request; the agency convened expert panels and reviewed the broader literature, concluding that prior warnings were discouraging access. The label changes are meant to help clinicians and patients make informed decisions about HRT use for symptomatic relief. The move is likely to affect prescribing patterns and payer coverage for menopausal therapies and signals a willingness by the agency to reevaluate long‑standing safety statements in light of evolving evidence.
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PacBio posts 14% Q4 revenue rise — clinical customers and Europe drive growth
Pacific Biosciences reported a 14% year‑over‑year revenue increase in Q4, attributing gains to expanded adoption by clinical customers and stronger demand in Europe. The company said consumables revenue reached a record and that instrument shipments of Revio and Vega contributed to product revenue growth. CEO Christian Henry noted a shift toward clinical applications such as whole‑genome sequencing for rare disease. PacBio also highlighted an upcoming cost‑focused product, SPRQ‑Nx, intended to lower sequencing costs and broaden market penetration. While instrument revenue softened in some markets due to constrained academic budgets, PacBio’s commercial and clinical traction positions the firm to capitalize on diagnostics and clinical sequencing momentum into 2026.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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