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What’s in Today’s Brief? (February 22nd Preview)
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Moderna wins FDA reprieve — agency agrees to review mRNA‑1010
The FDA reversed an earlier refusal-to-file and agreed to review Moderna’s seasonal mRNA flu vaccine application, setting a PDUFA target date of Aug. 5. The company proposed an age‑stratified regulatory pathway: full approval for adults 50–64 and accelerated approval for those 65+, with post‑marketing study requirements in older adults. Moderna framed the outcome as the result of a productive Type A meeting with CBER; CEO Stéphane Bancel issued a statement thanking the agency. Coverage from Politico cited unnamed sources alleging a White House phone call to FDA leadership preceded the agency’s reversal, a claim the White House denied. For developers and investors, the episode underscores how high‑visibility political and regulatory interactions can reshape the review timeline for novel vaccine platforms and influence competitive dynamics in seasonal vaccine markets.
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DeepMind spin‑off keeps next‑gen drug AI under wraps — scientists stunned
Isomorphic Labs released a technical report touting IsoDDE, a drug‑discovery model its scientists say advances prediction of protein–drug interactions and antibody structures, but the company is keeping the model proprietary. The release drew comparisons to AlphaFold’s earlier leaps; researchers cited in Nature called IsoDDE a potential step on par with an "AlphaFold 4." Academics and open‑source developers flagged the lack of methodological transparency as a barrier to replication and community progress. The technical paper provides performance claims but few implementation details, leaving groups developing open models—such as Boltz‑2—uncertain how to match IsoDDE’s results. The move highlights a growing tension between private AI drug‑discovery commercialization and the open science community’s drive for reproducibility and shared tooling.
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Korsana pulls in $175M to advance BBB‑crossing Alzheimer’s drug
Korsana Biosciences announced a $175 million financing to accelerate its preclinical Alzheimer’s program built on a platform that shuttles antibodies across the blood–brain barrier. The company said the funding will support preclinical development and IND‑enabling work for brain‑penetrant therapeutic antibodies. Korsana’s approach joins other industry efforts—Roche and AbbVie have clinical‑stage programs using similar BBB‑crossing concepts—positioning the startup in a crowded but strategically important area of neurodegenerative drug development. Investors backing Korsana signaled sustained appetite for platform plays that address delivery barriers in CNS disease, a central bottleneck for many neurotherapeutic programs.
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MoonLake reports mid‑stage win — confidence ahead of FDA submission
MoonLake Immunotherapeutics disclosed Phase 2 data showing a clinically meaningful benefit for its sole investigational drug in an aggressive inflammatory arthritis subtype, and said the results give the company confidence as it prepares an FDA submission. The data were shared with Endpoints News and framed as supportive of a regulatory filing pathway. MoonLake characterized the outcome as validation of its program and indicated readiness to engage regulators. Independent details on effect size, endpoints and patient population were limited in the company’s disclosure. The mid‑stage readout will determine whether MoonLake can advance toward a pivotal strategy and whether the benefit is durable and robust enough to support expedited regulatory discussions.
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Disordered lipid nanoparticles deliver better — studies challenge packing dogma
Two recent reports presented new evidence that lipid nanoparticles (LNPs) with internal disorder release therapeutic cargo more effectively than highly organized particles. Researchers at the University of Copenhagen used single‑particle, high‑throughput measurements to reveal two LNP subpopulations—organized and amorphous—and found the amorphous particles achieved superior intracellular release. A related presentation at the Biophysical Society meeting showed that disordered internal arrangements reduce the tight electrostatic binding that can trap RNA, improving endosomal release inside target cells. For mRNA and gene therapies, where only ~1–5% of cargo has historically reached the cytosol, the findings suggest formulation strategies should prioritize functional release over maximal encapsulation. The work offers a technical clarification: while encapsulation efficiency matters for dose, therapeutic efficacy can hinge on nanoparticle architecture that favors unbinding and membrane fusion once inside cells.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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