Regulatory Compliance

ESMA adds five grounds to delay inside information disclosure

European Union – October 27, 2026 -- The European Securities and Markets Authority (ESMA) has finalised its revised Market Abuse Regulation (MAR) guidelines on delaying the disclosure of inside information, adding five legitimate interests that issuers can cite to justify a delay.

Under MAR, issuers must disclose inside information concerning them as soon as possible, so that investors are informed and insider dealing is prevented. Issuers may delay disclosure in specific circumstances to avoid prejudicing their legitimate interests. The guidelines give issuers a non-exhaustive list of such interests. The update completes the revised regulatory framework.

Five new legitimate interests follow public consultation

After a public consultation, ESMA added five situations in which a delay may be justified:

ESMA Sets Conditions for Clearing Exemption on Post-Trade Risk Reduction

EU – October 27, 2026 -- The European Securities and Markets Authority (ESMA) has defined the conditions that providers and users of post-trade risk reduction (PTRR) services must meet for certain OTC derivative transactions to be exempt from the clearing obligation under EMIR 3.

ESMA's final report sets requirements for PTRR providers and the exemption

The final report specifies the elements and requirements of PTRR services. It covers the information provided to participants, how exercises are carried out, the controls providers must have in place, record-keeping, and how use of the exemption will be monitored.

ESMA says the rules are meant to facilitate use of PTRR services. They also aim to prevent the exemption from being used to circumvent the clearing obligation, keeping its use within the conditions laid down in EMIR 3.

ESMA Withdraws Outdated MiFID II, MAR and SSR Q&As in Cleanup

European Union – October 27, 2026 -- The European Securities and Markets Authority (ESMA) has withdrawn or amended several Questions and Answers (Q&As) covering market structure under MiFID II, the Market Abuse Regulation (MAR) and the Short Selling Regulation (SSR), removing guidance it considers outdated, duplicative or no longer relevant.

ESMA targets Q&As overtaken by legislative amendments and established practice

The review is part of ESMA's Simplification and Burden Reduction (SBR) initiative. It focused on Q&As made redundant by legislative amendments already reflected in market practice, and on those covered by other ESMA guidance.

Cadrenal Wins FDA Alignment on Phase 3 Endpoint for CAD-1005

PONTE VEDRA, Fla. – October 27, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) reached agreement with the FDA on the primary endpoint and placebo-controlled design of its Phase 3 registration study of CAD-1005, a first-in-class 12-lipoxygenase (12-LOX) inhibitor for heparin-induced thrombocytopenia (HIT). The agreement came at a Type D meeting held July 28, 2026.

FDA accepts thrombus-extension definition of worsening HIT

The agency agreed to define worsening HIT as progression of thrombotic events through Day 14 of treatment or hospital discharge. Worsening will also include extension of an existing thrombus into a new vascular segment or bed. Cadrenal said this avoids site-to-site variability from manual size measurements.

The composite primary endpoint will measure the proportion of Serotonin Release Assay-positive (SRA+) participants with adjudicated new or worsening composite thromboembolic events through Day 14 or hospital discharge.

EBA Calls for Papers on Banking Regulation Boundaries by 5 July

Europe – October 27, 2026 -- The European Banking Authority (EBA) has opened a call for papers for its 13th Annual Research Workshop, "Boundaries of Banking Regulation", with a submission deadline of Friday 5 July 2024.

EBA targets policy-oriented, preferably empirical, research

The 2024 EBA Policy Research Workshop will examine policies that can ensure innovation and sustainability amid competition and risk arbitrage, while preserving financial stability. The EBA says the boundaries of banking regulation raise questions about whether the present regulatory regime is adequate.

Researchers from supervisory authorities and central banks are especially encouraged to submit papers for presentation.

Five topics focus on non-bank finance and digital technology

The EBA lists five priority areas for submissions:

GlobalFoundries Names Vermont GaN Hub in $16B US Expansion

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GlobalFoundries Names Vermont GaN Hub in $16B US Expansion

New York – October 26, 2026 -- GlobalFoundries (GF) has committed $16 billion to expand manufacturing and advanced packaging in New York and Vermont, and has designated its Vermont site as the core hub for gallium nitride (GaN) technology development. The October 26, 2026 announcement is backed by Apple, SpaceX, AMD, Qualcomm, NXP and General Motors.

The plan also covers silicon photonics for data centers and FDX processes for edge AI. One month after the announcement, TSMC confirmed it will exit the GaN foundry business by 2027, which leaves a gap in the market for a domestic alternative.

OBSI Appoints CRKhoury to Lead 2026 Independent Ombudsman Review

Toronto – October 25, 2026 -- The Ombudsman for Banking Services and Investments (OBSI) has appointed CRKhoury (CRK) to conduct its 2026 independent external review of banking and investment complaint operations, with the final report due on OBSI's website later this year.

The review will test whether OBSI has met its regulatory obligations and operates effectively under recognized best practices for financial services ombudsmen. CRK has set up a dedicated review website and is running a public consultation as the process advances.

Loss-calculation consultation traces back to the 2021 evaluation

On October 25, 2026, OBSI opened a public consultation on how it calculates investor losses in complaints over unsuitably sold illiquid exempt market securities. The consultation examines the current process and whether better alternatives exist. OBSI said the 2021 independent expert external review recommended it.

CMS Moves to Quarterly HCPCS Drug Code Cycles, Semi-Annual for Devices

United States – October 25, 2026 -- The Centers for Medicare & Medicaid Services (CMS) will replace its single annual window for HCPCS Level II code applications with quarterly cycles for drugs and semi-annual cycles for devices, Administrator Seema Verma said at the Medical Device Manufacturers Association (MDMA) Annual Meeting.

CMS expects faster adoption for new technologies under the revised coding calendar

Until now, applicants for new HCPCS Level II codes had one opportunity per year. CMS anticipates the more frequent windows will greatly improve how technologies move through the adoption curve. The agency said additional details on the updated process will follow.

SeekrFlow Named to Fast Company's 2026 Next Big Things in Tech

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SeekrFlow Named to Fast Company's 2026 Next Big Things in Tech

Reston – October 24, 2026 -- Fast Company has named Seekr's SeekrFlow platform to its 2026 Next Big Things in Tech list in the Established Excellence category, citing its ability to make AI explainable and defensible for enterprises and government agencies.

SeekrFlow targets the gap between AI outputs and regulatory defense

Organizations are moving AI into loan approvals, supply chains, critical infrastructure and national security, according to Seekr. Most still cannot show which data drove an output or defend it to a regulator, auditor or oversight body.

AI-Ready Data Engine and verification tools anchor the platform

The SeekrFlow AI-Ready Data Engine converts raw enterprise data into high-quality datasets. Its verification tools trace data influence, score accuracy and let teams contest and correct errors.

MIND Automates Fixes for Exposed Data at Rest

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MIND Automates Fixes for Exposed Data at Rest

Global – October 24, 2026 -- MIND can automatically apply a company's remediation policies when it detects an exposure issue in data at rest, or it can route the fix to a human reviewer first.

MIND targets three gaps that leave sensitive data exposed

The vendor says manual labeling of sensitive data is burdensome, error-prone and creates security gaps. Sensitive elements often go undetected, so compliance and security risks persist unnoticed. "Anyone with a link" sharing can bypass controls and give unauthorized users access to sensitive files without detection or restriction.

MIND classifies data using company-specific business context

The platform maintains a catalog of resources, users, authorizations, file activities and metadata. MIND says this catalog is meant to keep at-rest security policies effective over time.