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Market Trends & Strategy

Saol Positions Ultrarare PDCD Therapy SL1009 as Test Case for FDA's New Rare Disease Evidence Principles

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Saol Positions Ultrarare PDCD Therapy SL1009 as Test Case for FDA’s New Rare Disease Evidence Principles

SHERIDAN, WYOMING - December 11, 2025 - Saol Therapeutics is turning an FDA rejection into a potential regulatory test case, as the biotech prepares to argue that its pyruvate dehydrogenase complex deficiency (PDCD) drug SL1009 is the ideal "poster child" for the agency's new Rare Disease Evidence Principles (RDEP) framework at a Type A meeting on December 18.

Saol Recasts a Complete Response Letter as a Strategic Opening

On September 8, Saol disclosed that the FDA had issued a complete response letter (CRL) for SL1009, an oral formulation of sodium dichloroacetate for children with PDCD, a genetic disorder affecting fewer than 1,000 people in the U.S. The CRL, according to CEO Dave Penake, "suggested that we would need to do an additional adequate and well controlled clinical trial," and that "and that's not feasible to be done by our company and in this patient population."

Terns' 'Unprecedented' CML Data Puts TERN-701 on Track to Challenge Novartis' Scemblix

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Terns’ ‘Unprecedented’ CML Data Puts TERN-701 on Track to Challenge Novartis’ Scemblix

SHERIDAN, WYOMING - December 11, 2025 - Terns Pharmaceuticals is rapidly emerging as a serious contender in chronic myeloid leukemia (CML), after early clinical data for its allosteric BCR/ABL1 inhibitor TERN-701 more than doubled response rates seen with Novartis' approved STAMP inhibitor Scemblix in comparable settings and sent the biotech's share price sharply higher.

Best-in-Disease Early Efficacy Raises the Bar in CML

At the American Society of Hematology (ASH) annual meeting, Terns reported Phase I data from the CARDINAL trial in previously treated CML patients, with 38 participants evaluable for efficacy. TERN-701 achieved a major molecular response (MMR) rate of 75% at week 24, with 64% of patients reaching MMR overall in the dataset presented. The investigational agent also supported simple once-daily dosing without a food effect, improving convenience relative to many existing tyrosine kinase inhibitor (TKI) regimens.

Pfizer Deepens Cardiometabolic Push with Global YaoPharma Deal for Oral GLP-1 Candidate

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Pfizer Deepens Cardiometabolic Push with Global YaoPharma Deal for Oral GLP-1 Candidate

SHERIDAN, WYOMING - December 10, 2025 - Pfizer Inc. is expanding its cardiometabolic ambitions through an exclusive global collaboration and license agreement with YaoPharma, a subsidiary of Shanghai Fosun Pharmaceutical, to develop, manufacture and commercialize YP05002, an oral GLP-1 receptor agonist currently in Phase 1 for chronic weight management. The deal strengthens Pfizer's position in the fast-moving obesity field and adds a differentiated small-molecule asset to its portfolio of metabolic disease candidates.

Strategic Bet on Small-Molecule GLP-1 in Obesity

Under the agreement, China-based YaoPharma will complete an ongoing Phase 1 study of YP05002 before transferring global development and commercialization rights to Pfizer. For Pfizer, the asset fits neatly into a strategy that aims to pair novel mechanisms with scalable, oral delivery formats for obesity and adjacent cardiometabolic conditions.

Pfizer Schedules Analyst Webcast to Outline Full-Year 2026 Financial Guidance

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Pfizer Schedules Analyst Webcast to Outline Full-Year 2026 Financial Guidance

SHERIDAN, WYOMING - December 10, 2025 - Pfizer Inc. is setting the stage for its next financial chapter with an analyst conference call and webcast on December 16, 2025, where the U.S.-based biopharmaceutical leader will present full-year 2026 financial guidance to investors and the broader market. The event underscores how large pharma companies use structured guidance cycles to frame expectations around revenue, R&D investment, pipeline execution and capital allocation.

Anchoring Investor Expectations with 2026 Guidance

Pfizer will host the live call with investment analysts at 8:00 a.m. EST on Tuesday, December 16, 2025, with a simultaneous webcast for global stakeholders. The primary objective is to provide formal full-year 2026 financial guidance, giving clarity on topline trends, margin expectations, R&D spending and the company's capital deployment priorities.

Implantica's RefluxStop® Gains Momentum as Florence's Careggi University Hospital Joins European Rollout

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Implantica’s RefluxStop® Gains Momentum as Florence’s Careggi University Hospital Joins European Rollout

SHERIDAN, WYOMING - December 10, 2025 - Implantica is strengthening its European market expansion for RefluxStop®, announcing that Florence's renowned Careggi University Hospital has performed its first procedure with the implantable device for gastroesophageal reflux disease (GERD), adding another high-profile reference center to the therapy's growing footprint.

Careggi University Hospital Becomes a Flagship Center for GERD Innovation

The first RefluxStop® implantation at Careggi University Hospital was carried out by Dr. Paolo Prosperi, Chief of Emergency Surgery, assisted by Dr. Alessio Giordano. As part of the University of Florence, Careggi is one of Italy's most respected academic medical centers and a key reference institution for advanced surgical technologies.

Husqvarna Group Uses Capital Markets Day to Map 2030 Strategy for Profitable Growth

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Husqvarna Group Uses Capital Markets Day to Map 2030 Strategy for Profitable Growth

SHERIDAN, WYOMING - December 10, 2025 - Husqvarna Group is sharpening its long-term strategy to deliver profitable growth, unveiling new 2030 financial and sustainability targets and a transformational cost-out program as it positions its global outdoor equipment and robotics portfolio for higher margins and capital efficiency.

New 2030 Strategy Anchored in Portfolio Focus and Operational Excellence

At its Capital Markets Day in Stockholm, Husqvarna Group's leadership team briefed institutional investors, analysts and financial media on the next strategy period to 2030. The company will focus on strategic portfolio management, operational excellence and full leverage of its aftermarket offering across its core manufacturing and industry segments.

VisIC Secures $26 Million to Accelerate GaN Power Semiconductors for Next-Generation EV Platforms

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VisIC Secures $26 Million to Accelerate GaN Power Semiconductors for Next-Generation EV Platforms

SHERIDAN, WYOMING - December 10, 2025 - VisIC Technologies has raised $26 million in a Round B financing that positions its Gallium Nitride (GaN) power devices at the center of the next wave of electric vehicle (EV) drivetrain innovation for global automotive and mobility markets. Led by a global semiconductor leader with Hyundai Motor Company and Kia (HKMC) joining as strategic investor, the funding will help VisIC industrialize its D³GaN™ platform for high-volume traction inverters and adjacent high-voltage applications.

GaN Steps Forward as EV OEMs Push Beyond Silicon and SiC

Fresco Raises €15 Million to Scale AI-Powered Smart Kitchen Platform for Global Appliance Brands

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Fresco Raises €15 Million to Scale AI-Powered Smart Kitchen Platform for Global Appliance Brands

SHERIDAN, WYOMING - December 10, 2025 - Fresco is stepping up its ambition to become the default operating system for the smart kitchen, closing a €15 million Series C round to accelerate its AI-driven cooking platform for appliance manufacturers and their global consumer base. The Dublin-based company is positioning its KitchenOS and AI Cooking Companion as core infrastructure for appliance OEMs that want to deliver personalized, connected cooking experiences at scale.

From Smart Appliances to an AI-Driven Connected Kitchen Ecosystem

The latest funding round brings together mission-aligned investors focused on the future of food and connected living. New backers include Samuel Dennigan of Strong Roots, Barry Napier of Cubic3 and Tyler Hu of Arda, with continued support from existing investors such as Middleby, ACT Venture Capital, AE Ventures, Morpheus Ventures and Alsop Louie Partners.

Hanwha Finance Targets "100-Year Partnership" with UAE as Abu Dhabi Emerges as Digital Capital Hub

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Hanwha Finance CGO Uses Abu Dhabi Stage to Deepen South Korea–UAE “100-Year Partnership”

SHERIDAN, WYOMING - December 10, 2025 - Hanwha Finance is sharpening its Middle East growth agenda as Chief Global Officer Dong-Won Kim used his opening address at Abu Dhabi Finance Week's Global Markets Summit to position South Korea-UAE financial collaboration as a long-term strategic pillar for both economies and a testbed for next-generation digital capital markets.

Strengthening a Korea-UAE "100-Year Partnership" Through Finance

Speaking in Abu Dhabi, Kim framed financial services as the connective tissue that will turn high-level Korea-UAE diplomacy into investable projects and new cross-border capital flows. He noted that "since the establishment of diplomatic relations in 1980, South Korea and the UAE have continuously expanded the scope of cooperation", and stressed that Hanwha Finance intends to help carry forward a "100-year partnership" between the two nations.

European Protected Waveform Demo Marks Strategic Breakthrough for Europe's Secure Satcom

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European Protected Waveform Demo Marks Strategic Breakthrough for Europe’s Secure Satcom

SHERIDAN, WYOMING - December 10, 2025 - Europe has taken a decisive step toward defence communications sovereignty with the successful over-the-air demonstration of the European Protected Waveform (EPW), validating a new generation of secure, resilient, multi-orbit military satellite communications across GEO and LEO.

Milestone trial proves resilience against jamming and cyber threats

Conducted on November 26-27, 2025 at Universität der Bundeswehr München in Germany, the EPW tests confirmed the waveform's ability to protect mission-critical links against jamming, cyber threats and unauthorised access. For defence ministries facing increasingly contested and congested spectrum, the results provide concrete evidence that next-generation protected satcom can be engineered on European soil and operated across both geostationary and non-geostationary constellations.