Release – Tonix Pharmaceuticals Announces Uplisting from Nasdaq Capital Market to Nasdaq Global Select Market

Research News and Market Data on TNXP

March 03, 2026 6:00am EST Download as PDF

BERKELEY HEIGHTS, N.J., March 03, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced that it has received approval from Nasdaq to transfer the listing of its common stock from the Nasdaq Capital Market to the Nasdaq Global Select Market. Trading on the Nasdaq Global Select Market is expected to commence at the open of market on March 3, 2026, under the Company’s existing ticker symbol “TNXP.”

The uplisting to the Nasdaq Global Select Market reflects the Company’s compliance with the Nasdaq Global Select Market’s higher financial and corporate governance standards. The transition to this higher tier of the Nasdaq market may enhance the Company’s visibility among institutional investors, improve liquidity and broaden market recognition.

“Uplisting to the Nasdaq Global Select Market is an important milestone for Tonix,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We look forward to leveraging this enhanced platform to drive growth and create value for our shareholders. We’re grateful for the support that has brought us here and excited about what’s ahead.”

The Nasdaq Global Select Market is the highest of the three Nasdaq market tiers and is designed for companies that meet higher financial, liquidity and corporate governance requirements than those of the Nasdaq Capital Market and the Nasdaq Global Market. The Company believes that trading on this tier will further enhance its reputation with customers, partners and investors. Companies at this level may experience increased trading volumes and greater access to institutional investors. Meeting the Global Select Market’s higher financial and corporate governance standards may also signal to the market that a company has achieved financial and operational growth.

Tonix Pharmaceuticals Holding Corp.*
Tonix Pharmaceuticals is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA™ (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s recently approved flagship medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® and Tosymra®. Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, the company’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection.

* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially as a result of a number of factors, including the ability of the Company to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals 
investor.relations@tonixpharma.com 
(862) 799-8599 

Brian Korb 
astr partners 
(917) 653-5122 
brian.korb@astrpartners.com 

Media Contacts
Ray Jordan 
Putnam Insights 
ray@putnaminsights.com 

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released March 3, 2026

Markets in Shock: What History Says About Oil, Gold, and Stocks After Global Conflict

The US and Israeli strikes on Iran have rattled global markets, triggering sharp swings in oil, gold, and equities. Brent crude surged, gold climbed, and the S&P 500 whipsawed as investors grappled with the possibility of a prolonged conflict.

Whenever geopolitical tensions erupt, the first market reaction is often dramatic. Energy prices spike on supply fears. Gold rallies as investors seek safety. Stocks wobble amid uncertainty.

But history suggests that the first move is rarely the lasting one.

A review of past geopolitical shocks — including Iraq’s invasion of Kuwait in 1990, the Sept. 11 attacks, the 2003 Iraq War, US intervention in Libya, and Russia’s invasion of Ukraine — shows a consistent pattern. Markets tend to react sharply in the opening days, only to moderate or reverse course within weeks.

Consider the 12-day conflict between Israel and Iran in June 2025. When hostilities began on June 13, oil and gold jumped immediately while stocks fell.

Brent crude rose roughly 7% in the first trading session following the outbreak of fighting. Yet 30 trading days later, oil prices were slightly below where they had started.

Gold followed a similar trajectory. An initial pop of about 1.5% gave way to a modest decline over the next month.

Equities moved in the opposite direction. The S&P 500 fell just over 1% on the first day of trading after the conflict began but was up nearly 6% a month later.

The lesson: initial fear-driven moves do not necessarily define the medium-term trend.

The same dynamic appeared after other major events. Gold surged nearly 7% in the first trading session after the Sept. 11, 2001 attacks, reflecting a rush into safe-haven assets. But over the subsequent 30 trading days, gains were far more moderate.

Oil’s reaction to Russia’s invasion of Ukraine in 2022 was even more dramatic. Prices spiked more than 30% in the early days of the conflict amid fears of supply disruptions. Yet a month later, oil’s net gain had narrowed significantly.

Across multiple episodes, the direction of prices after the first day matched the direction one month later only slightly more than half the time. In other words, a sharp spike — or drop — offers limited predictive power.

There is, however, at least one important exception.

When Iraq invaded Kuwait in August 1990, oil prices jumped more than 11% on the first day and continued climbing, rising nearly 57% over the following month. Stocks also continued their downward trajectory, with the S&P 500 falling more than 10% over 30 trading days.

Even in that case, however, markets eventually recovered after allied forces expelled Iraqi troops from Kuwait.

The current conflict may ultimately chart its own course. The scale of military action, potential energy supply disruptions, and broader geopolitical consequences all remain fluid. Analysts have cautioned that it is simply too early to project where prices will settle in the weeks ahead.

Still, history offers a measured perspective. Markets often overshoot in moments of crisis, pricing in worst-case scenarios before recalibrating as new information emerges.

For investors, that pattern underscores a familiar reality: volatility may dominate the headlines in the first days of a global shock, but longer-term outcomes are rarely determined by the opening move alone.

1-800-Flowers.com (FLWS) – Sets The Table For Investors


Thursday, February 26, 2026

For more than 45 years, 1-800-Flowers.com has offered truly original floral arrangements, plants and unique gifts to celebrate birthdays, anniversaries, everyday occasions, and seasonal holidays, and to deliver comfort during times of grief. Backed by a caring team obsessed with service, 1-800-Flowers.com provides customers thoughtful ways to express themselves and connect with the most important people in their lives. 1-800-Flowers.com is part of the 1-800-FLOWERS.COM, Inc. family of brands. Shares in 1-800-FLOWERS.COM, Inc. are traded on the NASDAQ Global Select Market, ticker symbol: FLWS.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Updates it corporate presentation. Management recently updated its corporate presentation to provide more detail around the company’s four pillar initiative to transform it toward a more profitable, scalable, growth oriented company. The four key pillars: achieving cost savings and operational efficiency, strengthening customer focus, expanding reach beyond e-commerce, and enhancing talent alignment and accountability. 

Omnichannel Expansion. The company is expanding distribution channels beyond its owned e-commerce platforms. The Company is meeting customers where they already shop by leveraging leading third-party marketplaces to lower acquisition friction and expand reach. These marketplace channels are intended to complement owned platforms, while selective physical retail testing will occur under strict ROI thresholds. 


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Gilead to Acquire Arcellx in $7.8B Bet on Next-Gen CAR-T Leadership

Gilead Sciences (Nasdaq: GILD) is doubling down on cell therapy. The Foster City–based biopharma announced it will acquire Arcellx (Nasdaq: ACLX) in a transaction valued at approximately $7.8 billion in equity value, giving Gilead full control of anitocabtagene autoleucel (anito-cel), an investigational BCMA-directed CAR T-cell therapy for multiple myeloma.

Kite, a Gilead company, has partnered with Arcellx since 2022 to co-develop and co-commercialize anito-cel. Under the new agreement, Gilead will acquire all outstanding shares of Arcellx it does not already own for $115 per share in cash, plus one non-transferable contingent value right (CVR) worth $5 per share if cumulative global net sales of anito-cel reach $6.0 billion from launch through year-end 2029.

The $115 cash component represents a 68% premium to Arcellx’s 30-day volume-weighted average share price as of February 20, 2026. Gilead already owns approximately 11.5% of Arcellx’s outstanding common stock. The transaction, approved by both companies’ boards, is expected to close in the second quarter of 2026, subject to customary conditions including the tender of a majority of outstanding shares, regulatory approvals and other standard closing requirements.

If completed, the acquisition would eliminate profit-sharing, milestone payments and royalty obligations tied to the existing collaboration, streamlining economics as Gilead prepares for potential commercialization.

The timing is notable. The U.S. Food and Drug Administration has accepted the Biologics License Application (BLA) for anito-cel as a fourth-line treatment for adult patients with relapsed or refractory multiple myeloma. The application is supported by results from a Phase 1 study and the pivotal Phase 2 iMMagine1 trial. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of December 23, 2026.

In clinical studies to date, anito-cel has demonstrated deep and durable responses with a predictable and manageable safety profile, according to company disclosures. Multiple myeloma remains an area of high unmet need, particularly among heavily pretreated patients who often face diminishing responses, increasing toxicity and fewer therapeutic options over time.

Full ownership provides Gilead with greater flexibility to align development strategy, scale manufacturing through Kite, and potentially explore expansion into earlier lines of therapy, subject to clinical outcomes and regulatory review.

Beyond anito-cel, Gilead is also acquiring Arcellx’s D-Domain CAR platform, which has generated proprietary target-binding domains designed to improve specificity and binding affinity. The platform may support future CAR T-cell programs, bispecific constructs and in vivo cell therapy approaches, further strengthening Gilead’s oncology pipeline.

Management indicated that, upon FDA approval of anito-cel, the proposed transaction is expected to be accretive to earnings per share in 2028 and thereafter.

For investors, the acquisition highlights a broader trend in large-cap biotech capital deployment. Established companies are increasingly seeking full ownership of late-stage oncology assets to simplify economics, reduce long-term partnership obligations and consolidate strategic control ahead of potential commercialization milestones.

Cell therapy remains one of the most capital-intensive areas of oncology, requiring specialized manufacturing, logistics and commercial infrastructure. Gilead’s move signals confidence in both the asset and its ability to integrate development and commercialization within its existing cell therapy platform.

The next key inflection point will be the FDA’s review decision later this year, which will shape the commercial trajectory of anito-cel and the long-term impact of the acquisition.

GDP Stumbles to 1.4% as Shutdown Slams Q4 Growth

The US economy ended 2025 on a weaker-than-expected note.

New data from the Bureau of Economic Analysis showed GDP grew at an annualized rate of just 1.4% in the fourth quarter, well below economist expectations for 2.9% growth. The miss marks a notable slowdown from earlier in the year and caps full-year 2025 growth at 2.2%, down from 2.8% in 2024.

A key culprit: government spending.

Federal outlays fell sharply during the quarter, reflecting the impact of the 43-day government shutdown that spanned October and November. Overall government spending declined at a 5.1% annualized rate, subtracting 0.9 percentage points from headline GDP. Federal spending alone plunged 16.6%, shaving 1.15 percentage points off growth.

President Trump, posting on Truth Social ahead of the release, argued the shutdown cost the economy “at least two points in GDP” and renewed calls for lower interest rates.

Under the Surface: Not All Weakness

Despite the headline disappointment, underlying private-sector demand remained more resilient.

Real final sales to private domestic purchasers — a key gauge of core demand — rose 2.4%, only slightly below the prior quarter’s 2.9% pace. Private fixed investment increased 2.6%, supported by continued spending on intellectual property and information processing equipment.

The AI build-out remains a meaningful contributor to growth. Spending on information processing equipment added 0.65 percentage points to GDP in the quarter, while investment in intellectual property products rose at a 7.4% pace.

However, consumer behavior showed signs of divergence. Services spending grew 3.4%, while goods spending fell 0.1%, underscoring a continued rotation away from physical goods.

What This Means for Small-Cap Stocks

For small- and micro-cap investors, the implications are layered.

First, government spending volatility tends to disproportionately impact smaller companies with federal exposure. Contractors, niche defense suppliers, and specialized service providers may have felt the brunt of delayed payments or paused contracts during the shutdown.

Second, slower headline GDP growth can pressure investor sentiment toward riskier asset classes — and small caps often sit at the front of that risk spectrum. The Russell 2000 historically reacts more sharply to growth scares than large-cap indices.

But there’s another side.

If economists are correct that shutdown-related drag reverses in the first quarter — with some forecasts calling for 3% growth in early 2026 — small caps could benefit from a rebound narrative. Lower rates, which the administration continues to push for, would also ease capital constraints for smaller companies that rely more heavily on credit markets.

And the ongoing AI investment cycle may continue to support smaller industrial, semiconductor-adjacent, and specialty tech names tied to infrastructure build-outs.

Bottom Line

The Q4 GDP miss highlights how policy disruptions can ripple through the broader economy. While headline growth slowed, core private demand and investment remain intact.

For small-cap investors, volatility may persist in the near term — but a rebound in government activity and continued capital investment could shift the narrative quickly in early 2026.

Conduent (CNDT) – New CEO Unveils Action Plan


Tuesday, February 17, 2026

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Q4 results. Q4 revenue of $770 million was modestly below our estimate of $778 million, driven by ongoing softness in the Commercial segment, while adj. EBITDA of $50 million exceeded our estimate of $41 million as cost performance improved, resulting in a 6.5% adj. EBITDA margin.

New CEO outlines action plan. CEO Harsha V. Agadi outlined a framework centered on faster decision-making, reduced organizational complexity, and a “fix, sell, or grow” review of every business unit, with emphasis on financial discipline, cost reduction, and converting the pipeline into sustainable organic revenue and EBITDA growth.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Kelly Services (KELYA) – Reports 4Q25 Results


Tuesday, February 17, 2026

Kelly (Nasdaq: KELYA, KELYB) connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. We’re always thinking about what’s next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 350,000 people around the world and connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice. Revenue in 2021 was $4.9 billion. Visit kellyservices.com and let us help with what’s next for you.

Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Overview. Kelly’s fourth quarter continued to be impacted by many of the same trends evident in previous quarters, most notably discrete impacts associated with reduced demand for U.S. federal government contractors and from three large commercial customers.  Employers continue to take a cautious approach to hiring amid a mixed labor market. However, the Company was able to capitalize on positive trends in each of the segments.

4Q25 Results. Revenue was $1.05 billion, down 11.9% y-o-y, but down only 3.9% excluding the discrete impacts associated with reduced demand for U.S. federal government contractors and from three large commercial customers. Gross margin declined 150 bps to 18.8%. Adjusted EBITDA totaled $12 million, or a 2.0% margin, compared to $43.5 million, or 3.7% margin, last year. Adjusted EPS was $0.16 versus $0.79 in 4Q24.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Inflation Cools to 2.4% in January, Beating Expectations as 2026 Begins

American consumers received welcome news to start 2026 as inflation slowed more than anticipated in January, offering fresh optimism about the economy’s trajectory and easing concerns about rising prices that have plagued households for years.

The Bureau of Labor Statistics reported Friday that the Consumer Price Index rose just 0.2% in January from the previous month, with annual inflation declining to 2.4% from December’s 2.7%. The figures came in below economist expectations of a 0.3% monthly increase and 2.5% annual rise, marking encouraging progress in the ongoing battle against elevated prices.

Core Inflation Hits Multi-Year Low

Perhaps most significantly, core inflation—which strips out volatile food and energy costs to reveal underlying price trends—registered its slowest annual increase since March 2021. Core prices climbed 2.5% over the past year while rising 0.3% month-over-month, both meeting expectations but signaling sustained moderation in inflationary pressures.

The positive inflation data represented the second encouraging economic report this week. Wednesday’s employment figures showed unemployment ticking downward while payrolls expanded at double the anticipated pace, suggesting the economy remains resilient even as price pressures ease.

Economic analysts noted that the softer-than-expected reading was particularly noteworthy given historical patterns. Recent years have typically seen inflation spike unexpectedly in January due to residual seasonal factors and delayed price adjustments stemming from pandemic-era disruptions. The absence of these typical January surprises suggests that tariff-induced price increases on goods may be largely complete, offering hope for more stable pricing ahead.

Despite the overall positive trends, certain categories continue challenging household budgets. Food prices climbed 2.9% annually, with cereals and bakery products jumping 1.2% in January alone. Coffee and beef prices remained especially elevated throughout the past year, though beef and veal saw a modest 0.4% monthly decline. Egg prices, another closely watched staple, dropped 7% after surging in recent months.

Energy costs provided significant relief, falling 1.5% in January as fuel oil plunged 5.7% and gasoline decreased 3.2%. The national average for regular gasoline now sits at $2.94, down from $3.16 a year ago, according to AAA data.

Housing costs, the largest component of most household budgets, rose 0.2% monthly and 3% annually. While still elevated, the shelter index increased at half December’s pace, potentially signaling improvement ahead for renters and homeowners alike.

Analysts had closely watched January’s data for signs of tariff-related price increases following President Trump’s sweeping levies implemented last year. While some tariff-sensitive categories showed increases—apparel rose 0.3%, video and audio products jumped 2.2%, and computers climbed 3.1%—the overall impact appeared muted.

Economic forecasters had anticipated that core goods prices would accelerate from December levels due to increased tariff pass-through effects and typical seasonal patterns that push January inflation higher. However, the fact that core goods prices remained unchanged in January suggests that tariffs and unseasonably large price hikes were not significant drivers of the monthly inflation reading.

One notable exception: airline fares surged 6.5% monthly, meaning travelers may want to consider road trips over flights in the near term. Used car prices, meanwhile, slid 1.8%, offering potential savings for vehicle shoppers.

The cooler-than-expected inflation data strengthens the case for continued economic stability as 2026 unfolds, though Federal Reserve policymakers will carefully monitor upcoming reports before making decisions about interest rates.

US Budget Deficit Narrows in January as Revenue Growth Outpaces Spending

The US government posted a $95 billion budget deficit in January, marking a sharp improvement from the same month a year earlier as revenue gains — including a surge in customs duties — outpaced modest growth in federal spending.

According to data released by the Treasury Department, January’s deficit was $34 billion lower than in January 2025, a decline of 26%. After adjusting for routine calendar-related payment shifts, including benefit disbursements affected by weekends and holidays, the deficit would have been just $30 billion — a 63% drop from the comparable period last year.

Government receipts totaled $560 billion in January, an increase of $47 billion, or 9%, compared with a year earlier. Meanwhile, federal outlays reached $655 billion, up $13 billion, or 2%. Both receipts and spending set records for the month of January, reflecting the continued expansion of the federal government’s revenue base and spending obligations. Despite the record figures, the deficit itself was not a record for the month.

The narrowing gap reflects stronger revenue performance relative to spending growth, a dynamic that has also carried into the broader fiscal year. Through the first four months of fiscal 2026, which began October 1, the deficit totaled $697 billion — down $143 billion, or 17%, from the same period in fiscal 2025.

Year-to-date receipts have climbed to $1.785 trillion, up 12% from the prior year period, while outlays have increased more modestly, rising 2% to $2.482 trillion. Both figures represent records for the first four months of a fiscal year, though the cumulative deficit is not historically unprecedented.

A significant driver of the revenue increase has been a surge in customs duties tied to tariffs implemented under President Donald Trump. Net customs receipts totaled $27.7 billion in January, roughly in line with December levels and only slightly below the approximately $30 billion monthly pace recorded late last year. By comparison, customs duties in January 2025 — before the administration’s tariff measures were announced — stood at just $7.3 billion.

On a fiscal year-to-date basis, net customs duties have reached $117.7 billion, a dramatic rise from $28.2 billion during the same period last year. The sharp increase underscores the growing role tariffs are playing in federal revenue collection.

Another factor contributing to January’s improved deficit figure was a rare decline in Treasury interest payments. Interest outlays on the public debt fell by $12 billion to $72 billion for the month. Treasury officials attributed the drop to technical adjustments related to inflation-linked securities, with some payments affected by last year’s government shutdown and delayed consumer price index data.

However, despite the January dip, interest costs remain elevated overall. Through the first four months of fiscal 2026, interest payments on the national debt have totaled $426 billion — a record for that period and up 9% from a year earlier.

While January’s improved deficit provides a measure of fiscal relief, the broader picture remains complex. Revenues are rising at a healthy pace, aided in part by tariffs, but interest costs continue to consume a growing share of federal spending. Whether the current trend of revenue outpacing spending can be sustained will depend on economic growth, inflation trends, and future policy decisions in Washington.

Navigating the U.S. Regulatory & Legal Maze – Key Considerations for European Buyers

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 Signals Extended Pause as Policymakers Assess Inflation Path

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.

Release – NeuroSense Expands Global IP Protection Strategy With Granted Australian Patent Covering PrimeC Composition

Research News and Market Data on NRSN

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.

Continue Reading

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 LinkedInYouTube 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.

Logo – https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg

SOURCE NeuroSense

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

Elon Musk’s Boldest Bet Yet: How SpaceX Became the Lifeline That Turned xAI Into a $1.25 Trillion Giant

Elon Musk has never been shy about bending corporate structure to his will, but his latest move may be the most audacious of his career. By merging SpaceX with xAI, Musk has created a $1.25 trillion private colossus, instantly making it the most valuable private company in history — and rescuing a cash-hungry AI venture in the process.

The deal folds Musk’s dominant rocket maker, his lossmaking artificial intelligence startup xAI, and the social media platform X into a single vertically integrated entity. Musk framed the merger as a necessary step toward launching data centers into orbit, building factories on the Moon, and ultimately colonizing Mars. Supporters see visionary logic. Critics see financial engineering on a historic scale.

At the heart of the transaction is SpaceX’s balance sheet. The company, now marked up to a $1 trillion valuation, generates roughly $16 billion in annual revenue, driven by its near-monopoly on commercial rocket launches and the rapid expansion of its Starlink satellite broadband business. That steady cash flow and investor confidence gave Musk the leverage to absorb xAI, which reportedly burns around $1 billion per month as it races to build advanced AI models and massive data centers.

Under the terms of the deal, SpaceX will acquire xAI for $250 billion, matching the valuation implied by a recent funding round. xAI shareholders will receive SpaceX stock at roughly a seven-to-one exchange ratio, with the combined entity priced at $527 per share. Investors were briefed on hurried calls, with many reportedly blindsided by both the speed and the scale of the merger.

The strategic rationale is straightforward: AI’s biggest bottlenecks are energy, compute, and data — areas where Musk already has deep assets. SpaceX provides launch capability and satellite infrastructure, Starlink delivers global connectivity, X contributes a vast real-time data stream, and xAI supplies the models. In theory, the combination creates a self-reinforcing ecosystem few competitors can match.

Yet the risks are just as real. xAI’s revenues remain in the low hundreds of millions, far behind rivals like OpenAI, Google, and Anthropic. Folding such a capital-intensive, lossmaking business into SpaceX complicates a planned June IPO, which could raise as much as $50 billion. Existing SpaceX shareholders will be diluted as the company issues new shares to fund the acquisition — a move that has unsettled some long-term investors.

Still, Musk has a long track record of forcing through controversial deals. His 2016 acquisition of SolarCity using Tesla stock faced years of litigation, yet ultimately rewarded shareholders who stayed the course. Many investors believe this is another example of Musk using his control, credibility, and cult-like investor loyalty to move faster than governance norms would typically allow.

The broader market implication is clear: Musk is racing to position his empire at the center of the AI arms race, even if it means rewriting the rules of valuation along the way. Whether this $1.25 trillion gamble proves visionary or reckless will depend on whether xAI can convert ambition into revenue — before investor patience runs out.