North America

SHERIDAN, WYOMING - December 15, 2025 - HoldCo Asset Management says Comerica shareholders should vote against the proposed merger with Fifth Third at a special meeting scheduled for January 6, 2026, arguing the transaction undervalues Comerica and that rejecting the deal could improve shareholder outcomes with limited downside.

Activist investor challenges deal process and governance safeguards
HoldCo Asset Management, a Florida-based investment firm managing approximately $2.6 billion in regulatory assets under management, said it holds beneficial ownership of approximately 1.6% of Comerica's outstanding common stock and released a presentation titled "Why We Recommend Voting AGAINST The Proposed Merger and Our Litigation Update." The firm's case centers on how the transaction was negotiated and whether the board's process delivered maximum value for shareholders.

SHERIDAN, WYOMING - December 15, 2025 - TuHURA Biosciences (NASDAQ: HURA) has provided a corporate update following a recent $15.6 million equity financing, detailing near-term milestones across its Phase 3 IFx-2.0 program in Merkel cell carcinoma, its VISTA-inhibiting antibody TBS-2025 in AML, and its Delta Opioid Receptor (DOR)-focused conjugate platform aimed at overcoming resistance to cancer immunotherapy.

SHERIDAN, WYOMING - December 15, 2025 - TuHURA Biosciences, Inc. (NASDAQ:HURA) announced that Kintara's REM-001 clinical trial in ten metastatic cutaneous breast cancer patients met its primary endpoint demonstrating safety, a contractual milestone that is expected to trigger distribution of TuHURA common stock to eligible contingent value right (CVR) holders.

SHERIDAN, WYOMING - December 11, 2025 - The FDA's first use of its new Commissioner's National Priority Voucher (CNPV) has gone not to a cutting-edge biologic, but to a decades-old extended-release antibiotic, Augmentin XR-sending a clear signal that domestic manufacturing and supply resilience are now front-and-center regulatory priorities for the U.S. pharmaceutical industry.

A New Fast-Track Tool Aimed at Supply Chain Security

Launched in June, the CNPV program promises to compress review timelines from the usual 10-12 months to as little as 1-2 months for drugs that align with U.S. "national priorities," such as strengthening domestic production or addressing systemic shortages. The first approval under this framework went to USAntibiotics' Augmentin XR after the FDA completed its review in "just two months," focusing heavily on quality, manufacturing and facility assessments rather than new clinical data.

SHERIDAN, WYOMING - December 11, 2025 - A new convergence of obesity dealmaking, regulatory uncertainty at the U.S. Food and Drug Administration (FDA) and fresh neurology data out of the Clinical Trials on Alzheimer's Disease (CTAD) conference is forcing biopharma executives to recalibrate their 2026 playbooks across R&D, partnering and risk management.

Obesity Dealflow Enters a More Competitive, High-Stakes Phase

Pfizer continues to double down on cardiometabolic disease, following its $10 billion acquisition of obesity startup Metsera with an exclusive collaboration to license YaoPharma's oral GLP-1 receptor agonist YP05002. Together with other emerging oral and peptide GLP-1s, this next wave of assets is pushing obesity beyond a single-product, single-modality market and into a diversified, highly competitive landscape.

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."

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.

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.

SHERIDAN, WYOMING - December 10, 2025 - Koelnmesse Inc. is initiating a carefully planned leadership transition in North America, with long-time President and Managing Director Mette Petersen set to retire on June 30, 2026, and 22-year company veteran Darrin Stern taking over the top role on January 1, 2026. The structured handover is designed to safeguard continuity while positioning the U.S. subsidiary for its next decade of portfolio growth and international expansion.

Structured transition protects continuity and relationships

From 1 January 2026, Stern will assume the role of President and Managing Director, while Petersen will continue through the first half of the year in an advisory capacity. During this period she will mentor key team members and support strategic initiatives with Koelnmesse's headquarters in Cologne, Germany.

SHERIDAN, WYOMING - December 8, 2025 - Canada is moving to tighten the link between immigration policy and health system capacity, with the federal government announcing new measures to accelerate the arrival and integration of internationally trained physicians-and the Canadian Medical Association (CMA) signalling that the real prize will be pairing these policies with faster, more predictable credential recognition.

New Federal Pathways Aim to Bring Doctors into Practice Faster

In Ottawa, Immigration, Refugees and Citizenship Minister Lena Diab unveiled a package of measures to make it easier for international doctors to settle and work in Canada. The initiative includes a new fast-track entry program for foreign physicians currently working in the country on a temporary basis, as well as additional slots dedicated to doctors under the Provincial Nominee Program.