Month: February 2026

The strategic allure of the U.S. Healthcare and Life Sciences (HCLS) market—as detailed in our previous installments—is undeniable. However, for a European acquirer, the transition from “Strategic Intent” to “Value Realization” requires successfully navigating a regulatory landscape that is currently undergoing its most significant shift in decades. In 2026, the complexity of this “maze” has intensified, driven by a post-shutdown FDA backlog, a new era of “relative” data privacy standards, and aggressive national security oversight.

To preserve deal value, European buyers must move beyond traditional check-the-box compliance and adopt a multidisciplinary approach to regulatory due diligence.

The “Regulatory Velocity” Hurdle: Navigating the Post-Shutdown FDA

The 43-day U.S. federal government shutdown from October 1 to November 12, 2025, created a significant “bow wave” of administrative delays that continues to impact 2026 product launch timelines. While the FDA has resumed full operations, the “review clock” for many pending 510(k) and PMA submissions was effectively frozen for over a month, as the agency lacked the legal authority to accept new user-fee-bearing applications during the lapse.

For an investment  banker or operational expert, this isn’t just a compliance issue—it’s a valuation variable. European buyers must now conduct “Regulatory Velocity Diligence.” It is no longer enough to confirm that a target has a clean filing; you must assess where that filing sits in the current backlog. It is critical to differentiate between submissions funded by “Carryover User Fees”—which may have continued to move—and those reliant on “New Appropriations” that stalled. A delayed 510(k) or PMA approval can shift a valuation model by six to twelve months, fundamentally altering the deal’s ROI.

Data Governance: The New “Relative” Standard (GDPR vs. HIPAA)

Transatlantic data transfers have long been the “third rail” of HCLS M&A. However, a landmark September 4, 2025, ruling by the Court of Justice of the European Union (CJEU) in EDPS v. SRB has introduced a strategic “middle path” for European acquirers.

The court confirmed the concept of “Relative Personal Data.” In practice, this means that sufficiently pseudonymized data may be considered “personal data” for the U.S. seller (who holds the key) but not for the European recipient, provided the recipient cannot reasonably re-identify the individuals.

This is a massive win for M&A efficiency. European firms can now conduct more granular R&D and clinical trial diligence on U.S. assets without immediately triggering full GDPR liability, provided that strict technical and contractual “anti-identification” measures are in place. This “Privacy by Design” approach allows for faster integration of R&D pipelines while remaining compliant with both the EU’s strict privacy mandates and the U.S. HIPAA framework.

Beyond HIPAA: The State-Level Patchwork

While HIPAA provides a federal floor for data protection, European buyers often underestimate the complexity of state-level privacy laws. States like Texas have increasingly utilized their own statutory frameworks—such as the Texas Data Privacy and Security Act—to enforce standards that can overlap or even conflict with federal guidance.

For an Attorney, the risk lies in the “most restrictive” standard. If a target operates in multiple states, the integration team must ensure that data governance policies satisfy the most aggressive state regulator, not just the federal baseline. In the current 2026 climate, state-level enforcement is a primary driver of post-close litigation risk.

Safeguarding the Pipeline: The “Small Biotech” Exception

The 2026 Medicare drug price negotiations represent a seismic shift in U.S. reimbursement. However, the Inflation Reduction Act (IRA) includes a critical “Safe Harbor” for mid-market innovators: the Small Biotech Exception.

For European firms acquiring U.S. targets, verifying this status is paramount. If a drug’s Medicare Part D expenditure is less than or equal to 1% of total Part D expenditures, and the drug accounts for at least 80% of the manufacturer’s total sales, it may be exempt from negotiations until 2029. This provides a vital “valuation shield” for R&D pipelines, ensuring that the expected “Maximum Fair Price” (MFP) does not erode the deal’s long-term ROI.

The New CFIUS: National Security in Healthcare

The Committee on Foreign Investment in the United States (CFIUS) has significantly expanded its footprint throughout 2025 and 2026. While European allies often benefit from “excepted investor” status, HCLS deals involving large-scale U.S. patient data, biotech IP, or critical medical supply chain manufacturing are increasingly being flagged for national security reviews.

The strategy for 2026 is “Pre-emptive Transparency.” Buyers should evaluate whether a voluntary “Declaration” is safer than a full “Notice” to achieve deal-close certainty. In an era of heightened geopolitical sensitivity, the “health” of the target’s IP is as much a matter of national security as it is of clinical success.

Conclusion

Navigating the U.S. regulatory maze in 2026 requires a shift from defensive compliance to offensive strategy. By mastering the nuances of “Relative Data,” factoring in “Regulatory Velocity,” and identifying “Small Biotech” safe harbors, European acquirers can turn regulatory complexity into a competitive advantage.

In our next installment, we move from the ‘Legal Maze’ to the ‘Financial Truth,’ exploring the unique hurdles of U.S. GAAP vs. IFRS reconciliation and the art of the HCLS Quality of Earnings report.

About the Authors:

Nathan Cali is a Managing Partner at Noble Capital Markets with more than 18 years of Capital Markets experience. He has been a lead Managing Director/Head of the Healthcare and Life Sciences Investment Banking and Advisory franchise at NOBLE since 2017 and was previously a sell-side equity analyst for 9 years. Nathan is a Board Member of Precise Bio, a tissue engineering, biomaterials, and cell technologies company, including cardiology, orthopedics, and dermatology. He was previously a board observer of Eledon Pharmaceuticals (ELDN:NASDAQ, f.k.n.a. Anelixis Therapeutics, Inc.), a phase II biotechnology company. Prior to joining NOBLE, Nathan gained investment experience as a portfolio account analyst/manager at Franklin Templeton Investments. Nathan also currently holds series 7, 79, 86, and 87 FINRA designations.

Hinesh Patel, MCMI ChMC is a Partner in CNM LLP’s Los Angeles Office with over 20 years of experience in accounting. He leads and oversees the firm’s Accounting and Transaction Advisory practice. He brings a vast knowledge of US GAAP, technical accounting, and International Financial Reporting Standards (IFRS) reporting requirements to his role at CNM. Hinesh primarily focuses on technical accounting, IPO readiness, SEC reporting, and mergers and acquisitions. Prior to joining CNM, Hinesh worked as a Senior Manager at Deloitte with a primary focus in the technology, manufacturing, consumer business and entertainment industries for both public and private companies. He has assisted various companies through the IPO process and advised on a range of accounting services including technical accounting, financial reporting, and new business processes requirements.

Matthew (Matt) Podowitz is the founder and Principal Consultant of Pathfinder Advisors LLC, bringing experience on 400+ global M&A engagements to his clients. He specializes in the critical operational and technology aspects of M&A transactions, providing due diligence, carve-out, integration, and value creation services. Known for practical, actionable advice derived from extensive hands-on experience with healthcare and life sciences transactions, Matt helps companies, investment banks, and private equity firms navigate complex cross-border HCLS M&A through every step of the transaction lifecycle. Leveraging his perspective as a dual US/EU citizen, he provides seamless support for transactions in both markets. His background includes leadership roles at firms like Ernst & Young, Grant Thornton, and CFGI.

Chris Raphaely is the Co-Chair of Cozen O’Connor’s Health Care & Life Sciences Practice where he provides sophisticated transactional and regulatory counsel to an array of health care providers and investors in the health care industry. His practice focuses on mergers, acquisitions, and divestiture transactions for health care clients and the comprehensive regulatory schemes requisite to doing business in the health care space. Chris routinely handles matters involving payer negotiations, payment disputes and contract enforcement, accountable care organizations, management services organization, clinically integrated networks, value based payment arrangements, pharmacy benefit management and third party administrator contracts for self-insured employers, digital health, organizational and governance structures, HIPAA, information privacy and security, tax exemption, Stark Law, fraud and abuse matters, clinical integration, medical staff relations, facility and professional licensing, Pennsylvania’s Medical Marijuana Act, and general compliance. Prior to joining the firm, Chris served as the deputy general counsel to Jefferson Health System and general counsel to the system’s accountable care organization and captive professional liability insurance companies.

Federal Reserve officials are increasingly signaling that interest rates may remain unchanged for an extended period as policymakers evaluate whether inflation is cooling enough to justify further adjustments. Cleveland Federal Reserve President Beth Hammack said this week that the central bank’s current policy stance is well positioned to remain steady while officials analyze incoming economic data and the lingering effects of prior rate cuts.

Hammack indicated that monetary policy is close to neutral, meaning it is no longer significantly restraining economic activity. After cutting rates three times last fall, the Federal Reserve has shifted into a wait-and-see mode, focused on determining whether those moves are sufficient to guide inflation back toward its long-term target without risking renewed price pressures.

Inflation remains the central concern. While price growth has slowed from its post-pandemic highs, Hammack noted that inflation has largely moved sideways for more than two years and could remain near 3% throughout 2026. That level is still well above the Fed’s 2% goal, raising the risk that inflation could become more entrenched if policymakers ease too quickly. As a result, she emphasized the need for clear and sustained evidence that inflation is decisively trending lower before considering further rate cuts.

Rather than attempting to fine-tune policy in response to short-term data fluctuations, Hammack expressed a preference for patience. She highlighted the importance of fully assessing the economic impact of last year’s rate reductions, as well as broader trends in growth, consumer demand, and financial conditions. At present, she views the risks of rates needing to move higher or lower as roughly balanced.

Cost pressures facing businesses remain a key area of focus. Hammack said tariffs have increased input costs for many companies, with some already passing those expenses on to consumers and others signaling additional price increases ahead. She also pointed to rising electricity and health insurance costs as factors that could keep inflation elevated. Taken together, these pressures make it difficult to determine whether inflation has fully peaked.

The labor market, however, appears to be on more stable footing. With the unemployment rate at 4.4%, conditions have changed little since last fall. Indicators suggest that job openings and job seekers are largely in balance, while initial claims for unemployment insurance remain low. Although some firms have announced layoffs, overall levels of job cuts remain in line with historical norms.

Looking ahead, Hammack expects economic growth to strengthen over the course of the year. She cited the delayed effects of last year’s rate cuts and ongoing fiscal support as factors that could encourage businesses to resume investment and expansion plans. Stronger growth, in turn, could support hiring and gradually push unemployment lower.

The Federal Reserve held its benchmark interest rate steady last month in a range of 3.5% to 3.75%. Hammack’s comments reinforce the view that policymakers are in no rush to alter policy, signaling that interest rates could remain on hold well into the year as the Fed waits for inflation to show more convincing signs of easing.

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Strengthens Global IP Portfolio for PrimeC Through 2042

CAMBRIDGE, Mass., Feb. 9, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense”), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the Australian Patent Office (IP Australia) has granted Australian Patent No. 2022370513, entitled “Compositions Comprising Ciprofloxacin and Celecoxib,” representing another strategic step in the continued expansion of the Company’s global intellectual property protection for PrimeC.

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The granted Australian patent, following prior approval of the corresponding U.S. patent (12,097,185), further expands NeuroSense’s patent  protection across key global markets and reinforces the Company’s exclusivity strategy for PrimeC, with patent coverage extending through October 2042. NeuroSense continues to strengthen the company’s global intellectual property estate and to support the long-term development and potential commercialization of PrimeC in ALS, Alzheimer’s disease and other neurodegenerative indications.

 “Securing patent protection in Australia, in addition to the already granted patent in the US, is an important step in executing our global IP protection strategy for PrimeC,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “As we advance PrimeC toward pivotal development and potential commercialization, building a broad, durable IP estate across major jurisdictions is central to supporting long-term value creation.”

PrimeC is a proprietary fixed-dose oral therapy combining ciprofloxacin and celecoxib in a synchronized, extended-release formulation specifically engineered to deliver both agents in a coordinated manner – a key differentiator versus simple co-administration. The formulation enables consistent exposure across multiple disease pathways implicated in ALS, including neuroinflammation, iron dysregulation, and miRNA dysregulation, supporting a multi-target disease-modifying approach.

PrimeC is Phase 3-ready in ALS, following positive Phase 2b PARADIGM results and FDA clearance of the pivotal Phase 3 protocol.

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

About PrimeC

PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

About Alzheimer’s Disease
Alzheimer’s disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. AD is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression. Given the complexity of AD, approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families.

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding the length of patent coverage, are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

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SOURCE NeuroSense

For further information: For further information: Email: info@neurosense-tx.com, Tel: +972 (0)9 799 6183