United States

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 - 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 - 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 4, 2025 - Restaurant operators facing tight margins and rising equipment costs have a new digital sourcing option as CrazyGoodBuy.com officially launches with a combination of deeply discounted commercial kitchen gear and a weekday "one-cent" auction format aimed squarely at independent and multi-unit foodservice businesses across the United States.

Auction-Based Equipment Buying for Cost-Pressed Operators

At the core of the new platform is the CrazyGood Buy Daily Deal Auction, a simple but aggressive model designed to help operators access premium equipment without tying up unnecessary capital. Each weekday at 9:00 a.m. Eastern, the site lists a single piece of brand-new equipment-ranging from refrigeration and prep tables to cooking lines and bar essentials-with bidding starting at just one cent and running until 5:00 p.m.

SHERIDAN, WYOMING - December 4, 2025 - Butler National Corporation's Avcon Industries has secured European Union Aviation Safety Agency (EASA) and UK Civil Aviation Authority (CAA) approvals for its non-halon portable fire extinguisher retrofit on Learjet cabins, giving operators a certified, drop-in path to meet the looming December 31, 2025 halon phase-out deadline. The new approvals extend an earlier FAA Supplemental Type Certificate (STC) and position Avcon as a one-stop regulatory solution provider for Learjet fleets operating across North America, the UK and Europe.

Halon Phase-Out Drives Urgent Retrofit Decisions

SHERIDAN, WYOMING - December 4, 2025 - Cresta Fund Management is expanding its senior leadership team to support the next phase of growth, appointing industry veteran David Altshuler as Partner and Head of Capital Formation and promoting two long-standing team members into expanded roles. The Dallas-based private equity firm, which focuses on energy infrastructure across industrial, logistics and agricultural sectors, is sharpening its institutional capital-raising capabilities as limited partners seek specialist managers with operational depth and clear energy-transition strategies.

Bringing a Capital Formation Heavyweight Into the Partnership

SHERIDAN, WYOMING - December 4, 2025 - Workday has secured its position as a four-time Leader in the 2025 Gartner® Magic Quadrant™ for Financial Planning Software, underscoring how the company's AI-enabled platform is becoming a strategic hub for finance teams navigating volatility, pricing pressure and tighter capital markets. The recognition highlights Workday Adaptive Planning's role in helping financial planning and analysis (FP&A) organizations shift from static budgeting to always-on, scenario-based planning.

Four Years as a Gartner Leader in Financial Planning

SHERIDAN, WYOMING - December 4, 2025 - Ubicquia has unveiled a coordinated next-generation smart streetlighting portfolio built around its new UbiCell® Micro controller, major enhancements to the UbiVu® infrastructure management platform and the launch of UbiScout™, an AI video accessory that turns existing streetlights into multi-purpose urban sensors for safety, mobility and energy efficiency.

Integrated portfolio targets utilities and cities under pressure to modernize

With grid operators and municipalities facing rising energy costs, decarbonization targets and aging infrastructure, Ubicquia's new offering is designed to make large-scale modernization of streetlighting networks faster and more manageable. The company positions the portfolio as a way to deliver asset intelligence, remote control and AI analytics without wholesale replacement of installed luminaires.