Regulatory Update

European Union – October 29, 2026 -- The Council of the European Union has confirmed Carlo Comporti as the next Chair of the European Securities and Markets Authority (ESMA), effective 1 November 2026. ESMA announced the appointment in the latest edition of its Spotlight on Markets newsletter, which covers September and October 2026.

ESMA sets 2027 work programme around simpler, more integrated capital markets

The regulator's 2027 Annual Work Programme lists priorities for stronger, simpler and more integrated EU capital markets. ESMA also introduced a new Union Strategic Supervisory Priority on digital innovation. The European Supervisory Authorities (ESAs) separately published their joint priorities for 2027.

Berlin – October 29, 2026 -- Germany's pharmacist federation ABDA is lobbying the Bundesrat to retain the pharmacy-only dispensing requirement. It argues that the emergency care reform passed by the Bundestag on October 15 would let physicians dispense medicines directly and weaken drug safety checks.

Reform allows doctors to dispense drugs in emergency centers and out-of-hours services

The Notfallversorgungsreformgesetz would let physicians hand medicines directly to patients, for example in Integrated Emergency Centers and ambulatory emergency services. ABDA President Thomas Preis says this circumvents the pharmacy obligation, which protects patients from medication errors and misuse.

Preis describes the established pharmacist-physician four-eyes principle as a central safeguard. He says pharmacists are the last control point before a drug is dispensed, responsible for correct intake and dosage.

Burlington – October 29, 2026 -- The U.S. Food and Drug Administration has approved an expanded indication for Instylla's Embrace Hydrogel Embolic System (HES), covering embolization of peripheral arterial bleeds in vessels of 6 mm or less. Embrace HES is now the first and only liquid embolic approved for both peripheral arterial bleeds and hypervascular tumors, according to the privately held company. The product is commercially available in the U.S.

HALT trial met both primary endpoints in 130 patients

The approval rests on the HALT study, a prospective, multicenter, single-arm trial that enrolled 130 patients with peripheral arterial bleeds at 22 U.S. sites. Embrace HES delivered 100% freedom from major adverse events and 90.0% clinical success, defined as no rebleeding from the target lesion, through 30 days. Both were prespecified primary endpoints.

EU – October 29, 2026 -- The European Securities and Markets Authority (ESMA) has recommended limiting the mandatory operating expenditure (OpEx) KPI under the EU Taxonomy to non-capitalised research and development expenditure, according to a Final Report submitted to the European Commission.

ESMA narrows the mandatory OpEx KPI to non-capitalised R&D spending

The report contains ESMA's technical advice on simplifying key performance indicators under the Taxonomy Disclosures Delegated Act. The change would cut the scope of the OpEx metric that companies must report.

ESMA proposes removing the weighted-average KPI from group Taxonomy reporting

ESMA also proposes simpler group-level Taxonomy reporting, including removal of the weighted-average KPI. Further targeted measures aim to make disclosures more proportionate, clearer and easier to use.

Prairieville, Louisiana – October 29, 2026 -- Hope Charities is backing H.R. 10549, a House bill that would bar commercial health plans from steering patients toward insurer- or PBM-owned specialty pharmacies, with the rules taking effect for plan years beginning on or after January 1, 2029.

Rep. Neal Dunn (R-FL) introduced the Patients Choice in Specialty Pharmacy Act on September 24, 2026, with Rep. Joe Wilson (R-SC) as an original cosponsor. The bill is with the House Committee on Energy and Commerce. Hope Charities is urging Congress to act and is asking members to cosponsor.

Los Angeles – October 29, 2026 -- Langar Investment Management, LLC will liquidate and close the Langar Global HealthTech ETF (Ticker: LGHT), a series of the Spinnaker ETF Series, after the Trust's Board of Trustees approved a Plan of Liquidation and Termination.

Board cites asset size and demand outlook in liquidation decision

The Adviser recommended the closure after evaluating the Fund's current asset size, historical growth, and ongoing outlook for investor demand, concluding that liquidation serves the best interests of the Fund and its shareholders.

Creation units halt October 28, trading ends October 30

Effective post-close on October 29, 2026, the Fund will stop accepting orders for new creation units from Authorized Participants. October 29, 2026 marks the final day of public trading on the Cboe BZX Exchange, with shares halted prior to market open on October 29, 2026 and subsequently de-listed.

European Union – October 29, 2026 -- The European Securities and Markets Authority (ESMA) has updated its transparency manual with new guidance on identifying over-the-counter (OTC) derivatives subject to transparency requirements and on applying the tick-size regime.

ESMA specifies how OTC derivatives reference data must be supplied

The update clarifies how identifying reference data for OTC derivatives should be provided for transparency purposes. ESMA aims to make the data reported to, and published through, the consolidated tape more consistent.

The guidance on OTC identifying reference data remains a draft until the related technical standards enter into force: RTS 2 and the RTS on CTP input/output data.

Europe – October 29, 2026 -- The European Securities and Markets Authority (ESMA) has named geopolitical risks and uncertainties, and restructuring provisions and debt restructuring, as enforcement focus areas for listed issuers' 2026 annual financial reports under its European Common Enforcement Priorities (ECEP).

ESMA sets three reporting areas for 2026 annual reports

The ECEP cover IFRS financial statements, sustainability statements under the European Sustainability Reporting Standards (ESRS) and European Single Electronic Format (ESEF) digital reporting.

For IFRS financial statements, the two priorities are geopolitical risks and uncertainties, and restructuring provisions and debt restructuring.

EU – October 29, 2026 -- The European Banking Authority (EBA), an independent EU authority, describes its core remit as safeguarding the integrity and robustness of the EU banking sector to support financial stability.

EBA develops harmonised rules and promotes supervisory convergence

The authority writes harmonised rules for financial institutions and promotes convergence of supervisory practices. It also monitors and advises on the impact of financial innovation and the transition to sustainable finance.

EBA monitors risks for banks and investment firms through reporting and disclosure

To keep the EU financial system orderly and stable, the EBA monitors and analyses risks and vulnerabilities relevant to the regulation of banks and investment firms. It facilitates information sharing among authorities and institutions through supervisory reporting and data disclosure.

European Union – October 29, 2026 -- The number of retail clients receiving cross-border investment services in the EU/EEA rose 47% in 2025 from 2024 to about 15.5 million, according to the European Securities and Markets Authority (ESMA).

That is almost twice the 2023 level. ESMA compiled the annual analysis with national competent authorities (NCAs), using data from investment firms across 30 jurisdictions.

Firm numbers rise 2% while client numbers surge

A total of 379 financial firms provided cross-border services to retail clients. That is 2% more than in 2024, so the client increase far outpaced firm growth.

Complaints stayed stable, down 0.2% from 2024.

Cyprus hosts 20% of passporting firms

Cyprus remained the main base for firms providing cross-border investment services in the EU/EEA, with 20% of passporting firms. Luxembourg followed with 14% and Germany with 12%.