Tag: clinical trials
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REMODEL’s Primary Kidney-Imaging Endpoints Were Null. The “Mechanism” Story Comes From Secondary and Exploratory Layers Instead
Evidence-first notes on bioscience and deep tech, at the edge of the lab and the market. Information only — not investment advice. This post covers two peer-reviewed randomized trials of incretin-axis drugs, both industry-sponsored. Every number below is attributed to its source tier — peer-reviewed full text, a public trial registry, or a sponsor statistical…
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NHS-Galleri’s Primary Endpoint Was Negative. A Day Later, FDA’s Panel Voted Yes. They Were Answering Different Questions, About Different Devices
Evidence-first notes on bioscience and deep tech, at the edge of the lab and the market. Information only — not investment advice. This post covers a peer-reviewed randomized trial and a public regulatory advisory-committee record for a listed company’s screening test. Every number below is attributed to its source tier — peer-reviewed abstract, FDA public…
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Lp(a)HORIZON: A Missed Primary Endpoint, a Press Release, and the Numbers That Are Still Missing
Evidence-first notes on bioscience and deep tech, at the edge of the lab and the market. Information only — not investment advice. This post covers a corporate topline announcement about a completed cardiovascular outcomes trial in a listed company’s pivotal asset. Every result-layer number below is attributed as a company statement; trial design, population, and…
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Aficamten Met Both Primary Endpoints in Nonobstructive HCM. Its Effect Size Nearly Overlaps With the Trial That Didn’t
Evidence-first notes on bioscience and deep tech, at the edge of the lab and the market. Information only — not investment advice, and not medical advice. Both trials discussed below are peer-reviewed, randomized, double-blind, placebo-controlled phase 3 trials published in the New England Journal of Medicine. The comparison drawn between them is an indirect, cross-trial…
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Does lowering Lp(a) actually cut cardiovascular events? The outcome trials — HORIZON, OCEAN(a) and ACCLAIM — and why the first readout is still not in
Evidence-first notes on bioscience and deep tech, at the edge of the lab and the market. Information only — not investment advice, and not medical advice. The 30-second version What. Earlier parts of this series established that Lp(a) is causal (Mendelian randomization), genetically fixed, and now pharmacologically lowerable by 80–90%+ with siRNA/ASO/oral agents. But biomarker…
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Lowering Lp(a) is a solved problem — the RNA pipeline now competes on durability, not on depth
Evidence-first notes on bioscience and deep tech, at the edge of the lab and the market. Information only — not investment advice, not medical advice. The 30-second version What. Four nucleic-acid drugs that shut down hepatic apo(a) production — one antisense oligonucleotide (pelacarsen) and three siRNAs (olpasiran, lepodisiran, zerlasiran) — have already saturated the depth…
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The clinical cost behind the GLP-1 headline — reading lean-mass loss, discontinuation, rebound, and safety signals by evidence tier
Evidence-first notes on bioscience and deep tech, at the edge of the lab and the market. Information only — not investment advice, and not medical advice. The 30-second version What. The GLP-1/GIP headline of −15 to −20% body weight comes with clinical costs: loss of lean (fat-free) mass, real-world discontinuation (roughly 50%+ within a year),…
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The next-generation obesity pipeline: from “how much you lose” to “at what cost”
Evidence-first notes on bioscience and deep tech, at the edge of the lab and the market. Information only — not investment advice, not medical advice. The 30-second version What. The next-generation obesity drugs push weight-loss efficacy along three vectors: triple agonists (retatrutide), oral small molecules (orforglipron), and amylin combinations (CagriSema). At the top end, retatrutide’s…
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Do incretins move hard outcomes in CKM, not just weight? A close read of SELECT, FLOW and SUMMIT
Evidence-first notes on bioscience and deep tech, at the edge of the lab and the market. Information only — not investment advice, and not medical advice. The 30-second version What. GLP-1 / incretin agents lowered hard cardiovascular (SELECT) and kidney (FLOW) outcomes. In SELECT’s pre-specified analysis, roughly two-thirds of the cardiovascular benefit appeared independent of…
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ATTR-CM Part 3 — gene editing (nex-z): a single, permanent TTR knockout buys durability by genome permanence, but the real bottleneck is the asymmetric safety risk that irreversibility creates
Evidence-first notes on bioscience and deep tech, at the edge of the lab and the market. Information only — not investment advice, not medical advice. All reduction and knockdown figures are attributed to the sponsoring trial or company; nex-z Phase 1 numbers are Intellia investor/conference data (AHA 2025-11), company presentations rather than peer-reviewed data. Safety…
