Articles Tagged: biomarkers

2 articles found

Inside Nvidia and Eli Lilly’s ‘AI Factory’: What a Pharma Supercomputer Means for Nvidia’s Revenue Mix, Data‑Center Demand and $5T Valuation

Nvidia just crossed the unprecedented $5 trillion valuation mark, a watershed moment powered by a global race to build AI infrastructure. The company’s newest marquee win isn’t a hyperscaler or a sovereign lab—it’s a pharma giant. Eli Lilly will own and operate a purpose-built AI supercomputer and “AI factory” based on more than 1,000 of Nvidia’s newest Blackwell Ultra GPUs, tied together on a high-speed unified network. The system goes live in January and underpins a sweeping plan to accelerate discovery, development, imaging, and biomarker work across Lilly and its TuneLab platform. For investors, the Lilly build is more than a logo win. It signals the rise of a new enterprise buyer archetype—a vertical, domain-rich customer building in-house AI data centers not simply to train chatbots but to push the frontiers of a hard-science business. Paired with Nvidia’s asserted $500 billion order visibility for 2025–2026 and a widening web of partnerships spanning telecom, transportation, energy, and government research, the deal expands both the breadth and durability of demand for Nvidia’s data-center stack. This article unpacks the Lilly architecture, the pharma compute thesis, the demand setup for Blackwell, and what it all means for Nvidia’s revenue mix, margins, cyclicality, and a $5 trillion valuation that now bakes in extraordinary execution.

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ONC201 (dordaviprone) in Pediatric Diffuse Midline Glioma (H3K27-altered): Evidence of Benefit, Limitations, and the Path Forward

Diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), is among the most devastating pediatric brain tumors. Most cases harbor the hallmark histone H3 K27-alteration (commonly H3K27M), which rewires epigenetic programs and drives aggressive, infiltrative growth in the brainstem and other midline structures. Historically, focal radiation yields temporary neurologic improvement but nearly universal relapse. Durable disease control with systemic therapy has remained elusive. ONC201 (dordaviprone), the first-in-class imipridone and a pharmacologic activator of the mitochondrial protease ClpP that triggers the integrated stress response, has been extensively explored preclinically and clinically in DMG. As of August 2025, the U.S. FDA has approved dordaviprone (brand name MODEYSO) for adults and pediatric patients aged 1 year and older with H3 K27M-mutant DMG and progressive disease, with Jazz Pharmaceuticals as the NDA holder (NDA 219876), based on safety and efficacy data in this molecularly defined population. Compassionate-use series and translational monitoring studies suggest that a subset of patients experience clinical or radiographic stabilization, often accompanied by favorable biomarker dynamics, though broad, durable remissions remain uncommon in monotherapy settings. This review synthesizes mechanistic and clinical evidence to answer a critical question from families and clinicians: do ONC201 or related ClpP-activating agents materially help children with DMG—or do they mainly add adverse effects? We integrate regulatory developments, observational and translational data, and the current clinical trial landscape to provide a balanced, evidence-based appraisal.

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