Events

SHERIDAN, WYOMING - December 8, 2025 - The U.S. Food and Drug Administration is preparing a fundamental shift in its evidentiary standards for new drugs, with Commissioner Marty Makary signaling that a single pivotal trial could soon be sufficient for approval-a move that has roiled internal leadership, unsettled some regulators and analysts, and triggered immediate recalculations in biopharma portfolio models.

From Two Pivotal Trials to One: A Structural Break

SHERIDAN, WYOMING - December 8, 2025 - Denali Therapeutics is facing another regulatory setback after the U.S. Food and Drug Administration (FDA) placed a clinical hold on DNL952, its enzyme replacement candidate for Pompe disease, citing preclinical hypersensitivity signals and demanding protocol changes before the company can start Phase I studies.

FDA Flags Hypersensitivity Risk Before First Human Dosing

The clinical hold, disclosed in an SEC filing, stems from "hypersensitivity reactions" observed in mouse models. While the agency has not required additional non-clinical studies, it is insisting on a more conservative first-in-human plan. Denali has been asked to lower the proposed starting dose for DNL952 and implement "revised inclusion criteria, adjusted stopping rules and unspecified safety monitoring commitments" before the program can proceed.

SHERIDAN, WYOMING - December 8, 2025 - Praxis Precision Medicines has doubled down on its neurology strategy with back-to-back updates: a Phase II win for its sodium current blocker relutrigine in rare developmental and epileptic encephalopathies (DEE) and a "successful" pre-NDA meeting for its essential tremor candidate ulixacaltamide, positioning the Boston biotech as a potential new commercial player in both ultra-rare epilepsy and movement disorders.

Relutrigine Study Stopped Early for Efficacy in DEE

Praxis has halted its mid-stage EMBOLD trial of relutrigine early, after an independent data monitoring board recommended the study "stop the study early for efficacy." The Phase II EMBOLD study is evaluating relutrigine in patients with DEE linked to SCN8A and SCN2A mutations, a small but highly underserved genetic epilepsy population with limited therapeutic options and high unmet medical need.

SHERIDAN, WYOMING - December 8, 2025 - Days after Johnson & Johnson reported a mid-stage failure for its anti-tau antibody posdinemab, Eisai is using the Clinical Trials on Alzheimer's Disease (CTAD) 2025 conference to argue that tau is still a viable target-if drug designers hit the right part of the protein-while investors and scientists pivot their attention to inflammation and vascular pathways.

Anti-tau Setbacks Raise the Bar for New Entrants

Tau-directed drugs have been among the most high-profile disappointments in Alzheimer's disease (AD) R&D. J&J's recent miss with posdinemab follows last year's Phase II failure of UCB's bepranemab and Eli Lilly's inability to replicate its amyloid success with the anti-tau candidate LY3372689. Collectively, these readouts have fed a narrative that tau may be an intractable or poorly understood target for disease modification.

SHERIDAN, WYOMING - December 8, 2025 - The CDC's Advisory Committee on Immunization Practices (ACIP) has triggered a major shift in U.S. newborn immunization policy, voting 8-3 to delay the hepatitis B vaccine for infants born to hepatitis B-negative mothers from the traditional birth dose to two months of age, despite decades of evidence and CDC messaging that the shot is safe, effective and critical for long-term protection.

A Narrow Vote to Delay the Birth Dose for Some Newborns

Under the new recommendation, only babies born to mothers who test positive for hepatitis B-or whose status is unknown-would still receive the birth dose. For infants of mothers who test negative, the vaccine can be delayed until two months, effectively dismantling the universal birth-dose strategy that has been in place for about 30 years.

SHERIDAN, WYOMING - December 8, 2025 - SprintRay's acquisition of the EnvisionTEC dental product portfolio marks a strategic step in the consolidation of the dental 3D printing market, expanding its materials ecosystem, reinforcing supply resilience and giving both SprintRay and EnvisionTEC users clearer long-term pathways in digital production.

What Changes for SprintRay Customers: More Materials, Same Workflow

For existing SprintRay practices and labs, the immediate impact is about breadth rather than disruption. The EnvisionTEC dental portfolio brings additional validated resin formulations that SprintRay is adapting for its own printers, which means customers gain more material options without having to invest in new hardware.

SHERIDAN, WYOMING - December 8, 2025 - As more practices adopt chairside 3D printing, many clinicians worry quietly about what it means for long-standing dental lab relationships-but rather than replacing labs, in-house production is reshaping them into higher-value, more strategic partnerships built around clearly defined roles and shared digital workflows.

From Full Lab Dependency to Hybrid Production

For years, the dominant model in restorative and appliance production has been full lab dependency: every crown, bridge, model, surgical guide, night guard or retainer went out the door to a third-party provider. In that setup, "Lab controls your timeline. Lab controls your cost per case. Lab capacity limits your capacity. Emergency cases wait on lab availability."

SHERIDAN, WYOMING - December 8, 2025 - Chairside 3D printing has moved from conference buzzword to everyday reality in U.S. dental practices, and SprintRay is positioning its ecosystem as a way for clinics to bring production in-house, compress treatment timelines, and turn same-day crowns into a strategic differentiator rather than a marketing slogan.

From Lab Dependency to In-Practice Production

At its core, "chairside" simply means producing the restoration in your own practice while the patient is still in your care, instead of sending cases to an external lab and waiting one to two weeks. Clinically, the workflow is familiar-examination, preparation, design and cementation remain the same-but the fabrication step moves from a third party you can't control to equipment in your operatory that you can.

SHERIDAN, WYOMING - December 8, 2025 - Heidelberger Druckmaschinen AG (HEIDELBERG) has reached a major milestone with the delivery of its 1,000th Speedmaster CX 104 press, a 14-unit specialty configuration bound for the fast-growing Chinese packaging printer Hoifu Group, underscoring strong demand for high-performance, value-optimized presses in the premium packaging market.

Global Bestseller Targets High-End Packaging Growth in China

The Speedmaster CX 104 has become the bestseller in HEIDELBERG's portfolio thanks to its attractive price-performance ratio and broad suitability for commercial and packaging applications. The landmark 1,000th unit will be installed at Hoifu Group's new site in Yancheng, where it will run as part of an end-to-end, Prinect-based workflow.

SHERIDAN, WYOMING - December 8, 2025 - Heidelberger Druckmaschinen AG (HEIDELBERG) is turning its "Home of Print" into a global showcase for the next generation of printers, using the first Print Technology World Championship to promote the attractiveness of print careers and strengthen the industry's long-term skills pipeline.

World Championship Turns the "Home of Print" into a Live Skills Arena

In November, HEIDELBERG and the Swiss Printing and Media Association jointly hosted the inaugural "Print Technology World Championship" for young printing professionals at the Print Media Center at the Wiesloch-Walldorf site. The competition was explicitly aimed at emerging talent and designed to draw attention to the relevance of print as a modern, technology-driven profession.

SHERIDAN, WYOMING - December 8, 2025 - Kellanova is using its "Cool Soil Critters" campaign in Australia to turn an often invisible topic-soil health-into a mainstream sustainability and supply-chain conversation, linking biodiversity beneath the surface directly to crop resilience, food security and long-term brand value.

From Iconic Foods to the Health of the Soil Behind Them

As a company that depends on crops to make the foods people know and love, Kellanova is positioning soil health as a strategic asset rather than a purely agronomic concern. Through its partnership with the Cool Soil Initiative, Kellanova Australia and New Zealand (ANZ) is supporting programs that help farmers increase organic carbon levels and reduce greenhouse gas emissions on Australian farms.

SHERIDAN, WYOMING - December 5, 2025 - Stellantis Pro One is using Solutrans 2025 in Lyon to underline its leadership in Europe's light commercial vehicle (LCV) market, combining a strong electric line-up, factory-integrated CustomFit conversions, V2G pilots and renewable fuel demonstrations to help craftsmen, SMEs and large fleets decarbonize without compromising capability.

Electric and Custom-Built Vans for Every Professional Use Case

On its Solutrans stand, Stellantis Pro One presents a broad mix of electric and combustion-powered vans configured through its CustomFit program, designed to address different trades and duty cycles from city logistics to specialist services. The display underlines that electrification and tailored conversions are now core to the Stellantis business model rather than niche options.

Key vehicles on show include:

SHERIDAN, WYOMING - December 5, 2025 - Stellantis is preparing a leadership handover at the top of its global motorsport operations, appointing seasoned engineer and team principal Olivier Jansonnie as Head of Stellantis Motorsport from January 31, 2026, as long-time motorsport chief Jean-Marc Finot retires after nearly four decades shaping performance programs across multiple brands.

Leadership transition at Stellantis Motorsport from 2026

From early 2026, Olivier Jansonnie will assume responsibility for Stellantis Motorsport, reporting to Emanuele Cappellano, Head of Enlarged Europe, European Brands and Stellantis Pro One. The transition will be managed jointly with outgoing leader Jean-Marc Finot to ensure continuity across factory programs, customer racing and high-performance road car initiatives.

SHERIDAN, WYOMING - December 5, 2025 - Stellantis is launching the HVO Aurora project as a practical way for European light commercial vehicle (LCV) fleets to certify the real-world use of renewable diesel, turning low-carbon fuel consumption into traceable data that supports decarbonization strategies and day-to-day operations.

HVO Aurora tracks real-world use of renewable diesel

HVO Aurora is built around Hydrotreated Vegetable Oil (HVO), a renewable fuel produced from waste streams such as used cooking oil and animal fats. By design, it targets a key question for fleet operators: how to prove that vehicles are actually running on low-carbon fuel in daily use, not just on paper.

SHERIDAN, WYOMING - December 4, 2025 - Mavsign, a leading provider of secure offsite contracting and fraud prevention solutions for the automotive finance ecosystem, has strengthened its legal and compliance backbone by engaging Hudson Cook LLP to review and enhance its information security, privacy and customer-facing frameworks. The move underscores how digital contracting platforms are investing ahead of regulatory pressure to give lenders, fintechs and dealers greater confidence in remote identity verification and high-value transactions.

Reinforcing a Compliance-First Offsite Contracting Model

SHERIDAN, WYOMING - December 4, 2025 - London-based fashion house self-portrait is stepping deeper into the creator economy with the announcement that Academy Award-winning filmmaker Sean Baker will debut his new short film Sandiwara as part of the brand's Residency programme, starring fellow Oscar winner Michelle Yeoh and slated to premiere in February 2026. For the luxury and culture industries, the move signals how fashion labels are increasingly operating as full-fledged content studios, using film to extend brand equity far beyond the runway.

Residency as a Strategic Content Lab for the Brand

SHERIDAN, WYOMING - December 4, 2025 - MicroCloud Hologram Inc. is pushing deeper into quantum computing and AI with a new quantum-driven 3D intelligent model designed to automate high-precision 3D model and image generation for enterprise customers. Built on a modular, quantum-optimized architecture, the system aims to shrink development timelines, cut manual rework and give industrial users a more scalable backbone for holographic digital twins, LiDAR and advanced visualization workloads.

Quantum Meets 3D Modeling for Enterprise-Grade Workflows

At the core of MicroCloud's new system is a 3D modeling and image-processing stack that fuses quantum deep learning with classical AI. The model ingests massive, heterogeneous datasets-ranging from 3D modeling inputs to complex image streams-and uses quantum-enhanced algorithms to extract key features and automatically generate 3D assets that align with user-defined parameters.

SHERIDAN, WYOMING - December 4, 2025 - TELEO Capital portfolio company Sharpen Technologies, Inc. ("SharpenCX") is expanding its reach in the communications platform market with the acquisition of Ytel, Inc., adding developer-centric CPaaS capabilities to its cloud-native customer engagement stack. The deal positions SharpenCX to serve enterprises that want to unify contact center, telephony and programmable messaging on a single, AI-ready platform rather than relying on multiple point solutions.

Strategic move in a consolidating CX and CPaaS landscape

SHERIDAN, WYOMING - December 4, 2025 - Thumzup Media Corporation is moving quickly to shed its image as a niche social advertising startup and reposition itself as a diversified operator in digital-asset infrastructure, data-center capacity, and next-generation computation. Backed by fresh capital and a pipeline of deals, the Los Angeles-based company is steering toward businesses with more predictable cash flows and scalable hard assets.

From Social Ad Startup to Balance-Sheet Builder

Thumzup's strategic reset rests on a markedly stronger financial base. In August 2025, the company raised $50 million in a public offering, lifting total assets to approximately $52 million. That step-change in scale gives Thumzup, which previously operated with far leaner resources, a genuine platform to pursue acquisitions, infrastructure buildouts, and selective minority stakes across high-growth technology verticals.

SHERIDAN, WYOMING - December 4, 2025 - Life sciences dealmaking is regaining momentum after a period of macroeconomic caution, but new research from West Monroe shows that transaction volume alone will not determine who comes out ahead. Instead, success in the next wave of M&A will hinge on execution speed, AI and digital maturity, and the ability to integrate people and cultures without losing focus on the deal thesis.

Dealmaking Rebounds, but the Rules Have Changed

West Monroe's report, The Next Wave of Life Sciences M&A: Navigating Policy, Power, and Progress, combines practitioner insight with a survey of 250 private equity firms and strategic acquirers in life sciences. The findings point to a clear rebound in activity: 68% of respondents expect more acquisitions in the next two years, while only 7% plan no deals at all.