Great Lakes Dredge & Dock Corporation is the largest provider of dredging services in the United States. In addition, Great Lakes is fully engaged in expanding its core business into the rapidly developing offshore wind energy industry. The Company has a long history of performing significant international projects. The Company employs experienced civil, ocean and mechanical engineering staff in its estimating, production and project management functions. In its over 131-year history, the Company has never failed to complete a marine project. Great Lakes owns and operates the largest and most diverse fleet in the U.S. dredging industry, comprised of approximately 200 specialized vessels. Great Lakes has a disciplined training program for engineers that ensures experienced-based performance as they advance through Company operations. The Company’s Incident-and Injury-Free® (IIF®) safety management program is integrated into all aspects of the Company’s culture. The Company’s commitment to the IIF® culture promotes a work environment where employee safety is paramount.
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.
Another Pause. The Trump Administration is pausing leases for five offshore wind projects, including the Sunrise Wind and Empire Wind 1 projects, both of which Great Lakes’ soon to be delivered Acadia vessel is contracted to provide subsea rock services. Described as due to national security risks identified by the Pentagon, the pause is currently not expected to exceed 90 days. If accurate, the pause should not have a significant impact on Great Lakes, in our opinion.
Details. The administration said the pause will give the Interior Department, which oversees offshore wind, time to work with the Department of War and other agencies to assess the possible ways to mitigate any security risks posed by the projects. In past research, the U.S. government has found that the movement of turbine blades and the highly reflective towers can create radar interference called “clutter.” The clutter caused by offshore wind projects obscures legitimate moving targets and generates false targets in the vicinity of wind projects. However, these risks were already considered in the permitting process.
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*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.
MILAN & FLORHAM PARK, N.J. — Conduent Transportation, a global provider of smart mobility technology solutions and business unit of Conduent Incorporated (Nasdaq: CNDT), today announced the launch of Italy’s first integrated transit EMV (Europay, Mastercard, and Visa) contactless payment system, developed in partnership with transit operators Brescia Mobilità and Arriva Italia. Conduent previously collaborated with both operators to implement their individual EMV systems, and this new integration marks a significant step forward in digitalizing ticketing systems.
The integrated system allows passengers traveling on Brescia Mobilità’s urban network and Arriva Italia’s extra-urban network to purchase a single ticket that is valid across both systems using contactless debit or credit cards, as well as NFC enabled digital wallets. The solution automatically calculates the correct fare based on the journey taken. In addition, the system enables a multi-passenger ticket, allowing one traveler to purchase multiple fares in a single transaction with the same card.
This represents the first EMV system integration between two public transport operators in Italy, and it serves as a pioneering example of a multi-operator EMV platform functioning as a shared service hub across public transport companies.
To support this innovation, Conduent enhanced its EMV solution with two new modules.
A Tokenizer protects sensitive data by generating a unique identifier, or token, for each card used.
An Orchestrator manages the end-to-end payment process, ensuring transactions are secure and efficient, including the reconciliation of payments.
“We are proud to have been the first in Lombardy to introduce EMV contactless payment technology,” said Marco Medeghini, General Manager at Brescia Mobilità Group. “By working with Conduent and Arriva Italia, we have taken a major step toward digitalizing public transportation and advancing our shared vision of a modern, sustainable system.”
“This collaboration represents a decisive step forward for public transport in the city of Brescia and its province – a first-of-its kind integrated payment system connecting two major operators,” said Angelo Costa, Managing Director of Arriva Italia. “Building off the success of EMV technology, we invested in this joint solution to offer an innovative and easy-to-use service to our passengers.”
“Brescia Mobilità and Arriva Italia recognize that adopting innovative technologies enhances the passenger experience. Conduent’s EMV solution laid the foundation for a scalable, multi-operator system that can be expanded to a wider geographical area,” said Jean-Charles Zaia, President, Transit Solutions at Conduent. “We are proud to support Brescia Mobilità and Arriva Italia with this first-of-its-kind implementation in Italy, made possible by Conduent’s innovation and our partners’ commitment to progress.”
Conduent fare collection systems are in use on more than 400 public transit networks of all sizes around the world. In addition to Brescia, Conduent has deployed contactless payment systems in more than 10 cities in Italy including Bergamo, Venice, and Verona.
About Conduent Conduent delivers digital business solutions and services spanning the commercial, government and transportation spectrum – creating valuable outcomes for its clients and the millions of people who count on them. The Company leverages cloud computing, artificial intelligence, machine learning, automation and advanced analytics to deliver mission-critical solutions. Through a dedicated global team of approximately 53,000 associates, process expertise and advanced technologies, Conduent’s solutions and services digitally transform its clients’ operations to enhance customer experiences, improve performance, increase efficiencies and reduce costs. Conduent adds momentum to its clients’ missions in many ways including disbursing approximately $85 billion in government payments annually, enabling 2.3 billion customer service interactions annually, empowering millions of employees through HR services every year and processing nearly 13 million tolling transactions every day. Learn more at www.conduent.com.
Trademarks Conduent is a trademark of Conduent Incorporated in the United States and/or other countries. Other names may be trademarks of their respective owners.
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced it has entered into a definitive agreement to acquire Amicus Therapeutics (Nasdaq: FOLD) in an all-cash transaction valued at approximately $4.8 billion. Under the terms of the deal, BioMarin will acquire Amicus for $14.50 per share, representing a significant premium to Amicus’ recent trading levels. The transaction is expected to close in the second quarter of 2026, subject to regulatory approvals and Amicus shareholder approval.
The acquisition significantly expands BioMarin’s presence in the rare disease market by adding two marketed, high-growth therapies to its commercial portfolio. Amicus brings Galafold® (migalastat), an oral therapy for Fabry disease, and Pombiliti® (cipaglucosidase alfa-atga) in combination with Opfolda® (miglustat), a next-generation treatment for Pompe disease. Together, these products generated $599 million in revenue over the past four quarters, immediately strengthening BioMarin’s top-line growth profile.
From a strategic standpoint, the transaction deepens BioMarin’s focus on lysosomal storage disorders, an area where the company already has established expertise and commercial infrastructure. The addition of Amicus’ therapies is expected to accelerate BioMarin’s long-term revenue growth rate through 2030 and beyond, while diversifying its enzyme therapies business unit. BioMarin also plans to leverage its global commercial footprint to expand access to Galafold and Pombiliti + Opfolda in additional international markets.
The deal carries favorable financial implications for BioMarin shareholders. Management expects the acquisition to be accretive to non-GAAP diluted earnings per share within the first 12 months following closing and substantially accretive beginning in 2027. BioMarin intends to finance the transaction using a combination of existing cash and approximately $3.7 billion in new debt financing, with no equity issuance required. The company has stated that it remains committed to deleveraging, targeting gross leverage below 2.5x within two years after closing.
Importantly, a key overhang related to Galafold’s U.S. intellectual property has been resolved ahead of the acquisition. Amicus has settled ongoing patent litigation with generic challengers, securing U.S. exclusivity for Galafold until January 2037, barring limited customary exceptions. This resolution enhances revenue visibility and strengthens the long-term value of the Fabry franchise within BioMarin’s portfolio.
Beyond marketed products, Amicus also contributes pipeline optionality. The company holds U.S. rights to DMX-200, a Phase 3 investigational therapy for focal segmental glomerulosclerosis (FSGS), a rare and often fatal kidney disease. While not central to the acquisition thesis, the asset provides additional upside potential.
Overall, the acquisition underscores BioMarin’s capital allocation strategy of deploying its strong balance sheet to acquire de-risked, revenue-generating assets that align with its core rare disease focus. With immediate revenue contribution, improved earnings power, and expanded global reach, the Amicus transaction positions BioMarin to strengthen its leadership in rare diseases while delivering long-term shareholder value.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Hans Baldau, Associate Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Initiating coverage with an Outperform rating. We are initiating coverage of Summit Midstream Corporation with an Outperform rating and a price target of $47 per share. Summit is a diversified midstream operator headquartered in Houston, Texas, focused on developing, owning, and operating strategically located natural gas, crude oil, and produced water infrastructure across several key U.S. unconventional resource basins.
Strategically positioned. Summit owns and operates midstream infrastructure in major U.S. unconventional resource basins, including: 1) the Williston Basin in North Dakota, 2) the Denver-Julesburg (DJ) Basin in Colorado and Wyoming, 3) the Fort Worth Basin in Texas, 4) the Piceance Basin in Colorado, and 5) the Arkoma Basin in Oklahoma. The company also holds a 70% majority interest in and operates the Double E Pipeline, a natural gas transmission system connecting the Delaware Basin to the Waha Hub in Texas. The diversified footprint provides Summit with exposure to multiple producing regions.
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This 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.
U.S. inflation is expected to remain above the Federal Reserve’s 2% target in November, reinforcing the central bank’s cautious stance as the economic data calendar finally returns to normal following this year’s prolonged government shutdown. The upcoming Consumer Price Index (CPI) report, scheduled for release Thursday morning, will be the final major inflation update published on a disrupted schedule, marking a key moment for markets assessing the trajectory of monetary policy into 2026.
Consensus estimates suggest headline CPI rose 3.1% year over year in November, while core inflation—which excludes food and energy—is also expected to come in at 3.1%. That would represent a modest increase from the 3.0% readings recorded in September, the most recent inflation data available after October’s report was canceled during the shutdown. With no October data to provide a month-to-month comparison, investors will be forced to rely on broader trend signals rather than short-term momentum.
Despite inflation remaining elevated, economists generally view current price pressures as part of a gradual cooling process rather than a renewed acceleration. Demand across the economy has shown signs of moderation, particularly as higher borrowing costs continue to weigh on discretionary spending and business investment. However, progress toward the Fed’s target remains uneven, and several factors continue to complicate the inflation outlook.
One key source of persistence is goods inflation, which analysts say remains sticky due to tariffs and supply chain adjustments. While global logistics have improved compared to prior years, trade policy and cost pressures continue to filter through consumer prices. At the same time, services inflation—long viewed as a more stubborn component—has shown tentative signs of easing, helped in part by softer health insurance costs and slower wage growth in some sectors.
Recent labor market data adds another layer of complexity. The November jobs report, released earlier this week, showed stronger-than-expected job creation alongside an unemployment rate that rose to a four-year high. This combination suggests a labor market that is cooling, but not collapsing—an outcome that supports the Fed’s view that inflation can ease without triggering a sharp economic downturn.
As a result, markets increasingly expect the Federal Reserve to remain on hold at its January meeting. Futures pricing currently implies a relatively low probability of a rate cut in the near term, as policymakers wait for clearer evidence that inflation is moving sustainably toward target. The Fed’s most recent projections point to only one additional rate cut in 2026, following a series of quarter-point reductions late in 2025.
For investors, the message is one of patience rather than panic. Inflation remains above target, but the direction of travel appears constructive. As economic data resumes its regular cadence in the months ahead, policymakers and markets alike will gain a clearer picture of whether pricing pressures are continuing to fade or becoming entrenched once again. Until then, the Fed is likely to err on the side of caution, prioritizing long-term stability over short-term market expectations.
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.
Strategic Committee. On Friday, NN announced the Board of Directors has formed a Strategic Committee to oversee a review of strategic and financial alternatives to further enhance shareholder value. Given the success to date of management’s transformation plan, the Board feels now is the time to take a fresh comprehensive look at additional ways to unlock value for shareholders.
Committee Details. The Strategic Committee is comprised of three independent directors, Raynard Benvenuti, Jeri Harman, and Thomas Wilson. All have been tasked with evaluating a broad spectrum of strategic, financial and business configuration options for the Company. The Board has engaged Houlihan Lokey, as the Company’s financial advisor.
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.
The U.S. cannabis sector is heading into a potentially transformative moment as reports surface that President Donald Trump is preparing to push for a reclassification of marijuana from a Schedule I drug to Schedule III. While no final decision has been made, the conversations happening between top administration officials and industry leaders signal a serious shift in federal posture—one that could reshape the economics, legal landscape, and competitive structure of the cannabis industry. For small-cap companies operating in or around this space, the impact could be particularly significant.
Cannabis has long been stuck at the federal level in a category reserved for substances with no accepted medical use, a classification that has held back the industry for decades. Reclassifying it to Schedule III would not legalize cannabis federally, but it would meaningfully reduce the restrictions companies face. The most immediate change would be relief from Section 280E of the tax code, which currently prevents cannabis operators from deducting ordinary business expenses. Larger players with substantial revenues would feel this impact first—but small-cap companies stand to benefit disproportionately because the tax burden has historically crushed their margins and limited their ability to reinvest.
A shift to Schedule III could also open the door to greater access to banking services, institutional capital, insurance products, and credit facilities. These are areas where small-cap operators—cultivators, distributors, multi-state operators, ancillary service providers, and biotech firms researching cannabinoids—have been at a disadvantage compared with more capitalized competitors. If traditional lenders and investors begin viewing cannabis as a legitimate medical or commercial sector rather than a high-risk legal minefield, the funding gap could narrow. That alone could reshape the competitive landscape, giving innovative but undercapitalized players a fighting chance to scale.
Public small-cap cannabis stocks are already reacting. Shares across the sector surged following the news, reflecting expectations that regulatory reform would unlock new revenue opportunities and ease long-standing financial pressures. But beyond the rally, the structural implications matter more. With reclassification, companies may finally be able to reduce compliance costs, expand into new states, and invest more aggressively in product development. Small-cap players focused on medical cannabis, CBD therapeutics, agricultural technology, and retail operations could all find themselves in a stronger position.
Of course, the path forward is not guaranteed. The reclassification process requires regulatory rulemaking and could face legal challenges, political resistance, and bureaucratic delays. The mixed landscape of state laws adds another layer of complexity that will not immediately disappear. And federal rescheduling alone does not address interstate commerce restrictions or full legalization—two changes that would unlock the broadest economic benefits.
Still, even a modest shift at the federal level can materially change market dynamics. The cannabis industry has operated for years under a patchwork of conflicting rules that increase costs and protect incumbents. Any move that reduces uncertainty—even if incremental—creates an environment where smaller, nimble companies can innovate, expand, and compete more effectively.
For small-cap investors, this moment is worth watching closely. Policy changes of this scale tend to create inefficiencies and valuation gaps, especially in sectors where regulation has held back growth. While volatility is likely as the political process unfolds, the prospect of lower taxes, reduced compliance friction, and increased access to capital could mark the beginning of a new cycle for cannabis-related equities.
The Federal Reserve’s December policy meeting delivered a third consecutive quarter-point rate cut, bringing the federal funds rate down to a 3.5%–3.75% range. But the decision was far from unanimous. In fact, the meeting produced the highest number of dissents in more than six years, with Chicago Fed President Austan Goolsbee, Kansas City Fed President Jeff Schmid, and Fed Governor Stephen Miran all breaking from the majority. Their reasons shed light on why the central bank remains cautious—and why some policymakers believe the Fed should have waited before easing further.
At the core of the dissent is a simple theme: uncertainty. Goolsbee and Schmid both argued that the Fed lacks enough recent data to justify another cut. With government reporting disrupted and key inflation releases delayed, the policymakers said they were uncomfortable lowering rates again without a clearer picture of how prices and demand are evolving. Goolsbee stressed that waiting until early 2026 for updated data would not have introduced meaningful economic risk, but it would have allowed the Fed to make a more informed call. In his view, patience was the more prudent option.
Both Goolsbee and Schmid pointed to inflation as the most compelling reason to pause. After moving sharply lower in 2023, progress on inflation has stalled for several months. Businesses across multiple sectors continue to cite rising input costs, and consumer surveys show persistent unease about prices. Schmid went further, warning that inflation is still “too hot” and that the economy’s ongoing momentum suggests current policy may not be restrictive enough. He raised the concern that households and firms could begin incorporating inflation into their everyday decision-making—a trend that historically makes inflation harder to bring down.
Goolsbee acknowledged that some price pressures appear tied to tariffs and may prove temporary, but he also highlighted risks that inflation in services could remain sticky. With the labor market cooling gradually rather than sharply, he argued there is no urgent economic threat that requires cutting rates before more evidence arrives. Hiring and firing activity has slowed into what he described as a “low hiring/low firing” environment—typical of businesses navigating uncertainty rather than signaling any dramatic downturn.
Fed Governor Stephen Miran dissented for a different reason, preferring a larger 0.50% cut. His stance reflects the broader tension within the central bank: some officials fear easing too slowly risks stalling momentum, while others worry easing too quickly risks reigniting inflation. The result is a policy landscape where the Fed is attempting to balance growth risks against inflation risks in real time, with incomplete information.
Still, the majority of the committee moved forward with the cut, signaling confidence that inflation will eventually resume its downward trend. But the dissents highlight that key voices inside the central bank are urging caution. For investors, the takeaway is straightforward: the Fed is not unanimously convinced that the inflation battle is over, and future rate moves may be more contested than markets expect.
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.
NobleCon21. On December 3rd, the company presented at NobleCon21 at Florida Atlantic University (FAU) in Boca Raton, Florida. The presentation was conducted by Mark Goldston, Executive Chairman, Carl Daikeler, Co-founder and CEO, and Brad Ramberg, CFO. The team highlighted its favorable digital fitness and nutrition businesses and the successful completion of a multi-year operational turnaround. A replay of the presentation can be viewed here.
Digital. The digital fitness segment is supported by 900,000 subscribers and roughly 140 programs, with over 10,000 hours of content. This segment provides predictable recurring revenue, with gross margins in the high 80% range, efficient customer acquisition, and cross-selling leverage as the company expands into retail distribution and repositions its nutrition business.
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.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Hans Baldau, Associate Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Exploration Licenses Granted in Brittany. Aurania, through a wholly owned French subsidiary, has been granted three new exploration licenses for polymetallic metals, including gold, in the Brittany Peninsula of northwestern France. It represents a new opportunity for Aurania in a stable mining jurisdiction with developed infrastructure. Initial mining inventory studies conducted by the French Geological Survey (BRGM) confirmed the presence of gold associated with strategic metals over more than 150 kilometers along a shear zone.
Precious and Strategic Metals. The permits allow Aurania to explore the South American Shear Zone, a major crustal fault where mineralization, including antimony, tungsten, tin, zinc, and copper, accompanied by gold and other metals, have been deposited. The Brittany Peninsula is a highly prospective area that can be considered a greenfield district. Aurania will proceed with stakeholder engagement, while advancing preparations for an airborne geophysical survey and subsequent field activities.
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.
SpaceX’s potential IPO is shaping up to be one of the most pivotal market events of the decade, with implications that reach far beyond the company itself. Analysts estimate that a SpaceX listing could help unlock nearly $3 trillion worth of value tied up in large private companies that have avoided the public markets for years. The anticipation surrounding this single event is already pushing investors, bankers, and late-stage startups to rethink the divide between private and public valuations.
After the blockbuster IPO wave of 2021, the market grew unusually quiet. Many of the world’s most valuable private companies, including SpaceX, Stripe, and ByteDance, chose to continue raising funds privately. This allowed them to grow far larger than the typical public-market debutant while sidestepping the scrutiny of quarterly reporting. SpaceX sits at the top of this group, with private valuations ranging from $800 billion to a possible $1.5 trillion. A listing of that size would instantly become the largest in history and would test the limits of both investor appetite and market infrastructure.
Despite the concerns, the demand appears strong. SpaceX is viewed as a company that combines scale, technological leadership, and global relevance. Its advancements in reusable rockets, crewed orbital launches, and satellite internet have created capabilities unmatched in the private sector. Starlink alone now provides high-speed connectivity to millions of users, and the company’s planned direct-to-cell network has gained additional momentum through strategic spectrum acquisitions.
The company’s revenue trajectory adds to the optimism. Estimates place 2025 revenue at roughly $15 billion, with expectations of reaching more than $22 billion the following year. These figures put SpaceX among the highest-earning private firms in the world, though some observers argue that such revenue still leaves questions about trillion-dollar valuations. For many investors, the financials need to support not only growth but also profitability and scale under the discipline of the public markets.
Governance is another area under scrutiny. SpaceX operates in a unique position, driven by an aggressive engineering culture and long-term missions that include the development of Starship and eventual human flights to Mars. These projects are capital-intensive and often involve timelines that do not align naturally with short-term shareholder expectations. Going public would introduce new oversight, regulatory obligations, and investor influence, potentially altering the company’s traditionally independent operating style.
Another open question is what path SpaceX might take to enter the public markets. A traditional IPO would require raising tens of billions of dollars if even a small percentage of the company were sold. Some market participants believe a direct listing could be more practical, especially for a company that does not need to raise fresh capital and already has a large institutional shareholder base.
Regardless of the route, a SpaceX listing in 2026 would represent a watershed moment. It could reopen the window for many large private firms that have delayed going public and force a reevaluation of how extreme private-market valuations translate to public markets. If successful, it may trigger a wave of mega-IPOs that reshape market dynamics for years to come.
Ms. Ishak brings more than 25 years of corporate legal and strategic leadership experience in the life sciences industry
CHATHAM, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated commercial-stage biotechnology company today announced the appointment of Irina Ishak as General Counsel, effective December 8, 2025. Ms. Ishak will lead Tonix’s legal, corporate governance, and compliance functions.
“Irina is a highly accomplished corporate and commercial attorney whose experience spans public and private life sciences companies, as well as advising life sciences investors,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “Her deep background in complex transactions, public company matters, and governance will be a significant asset as we commercialize our marketed products, advance our pipeline, manage our partnerships, and continue to execute on Tonix’s long-term strategy.”
Ms. Ishak joins Tonix from Lowenstein Sandler LLP, where she served since 2013 as Senior Counsel, and has advised Tonix since 2017 in structuring and negotiating financings, licensing and other strategic transactions, key commercial agreements, and employment-related contracts, and advising senior management and the Board of Directors on corporate strategy, governance, risk, and securities offerings and filings. In addition to Tonix, Ms. Ishak acted as outside general counsel, corporate secretary, and advisor to certain other public and private life sciences companies, as well as to investors. Previously, she was Senior Director, Legal and Assistant Corporate Secretary at Savient Pharmaceuticals, Inc., which developed, won US Food and Drug Administration (FDA) approval for, and launched KRYSTEXXA® (pegloticase), a biologic treatment for chronic gout in adults. Earlier in her career Ms. Ishak was a corporate associate at Fried, Frank, Harris, Shriver & Jacobson LLP. She received her J.D. from New York University School of Law and her B.A., with highest honors, from Rutgers College in New Brunswick, N.J.
“I am honored to join Tonix as General Counsel at such a pivotal moment in the Company’s evolution,” said Ms. Ishak. “Tonix has just launched the first therapy approved by the FDA for treating fibromyalgia in more than 15 years. Now the company is maximizing that science to expand into other conditions. It’s an exciting time at Tonix and there is immense opportunity to make a valuable contribution. I look forward to working closely with Seth, the leadership team, and the Board to support the Company’s next phase of growth.”
Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix markets FDA-approved TONMYA™, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. Tonix also markets two treatments for acute migraine in adults: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray). Tonix’s development portfolio* is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2- ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a Phase 2- ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.
* 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 under development.
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. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. 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.
INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS
MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information.
To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem. Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Michael Burry, the famed investor known for predicting the 2008 housing market crash, is once again at the center of attention — this time for a surprisingly bullish stance on Fannie Mae and Freddie Mac. In a lengthy blog post published Monday, Burry revealed he holds sizable positions in both government-sponsored enterprises and believes their long-awaited return to public markets may be close. The disclosure has fueled excitement among investors who have followed the Fannie and Freddie saga for more than a decade.
According to Burry, a relisting of the mortgage-finance giants is “nearly upon us.” His detailed post explored the political, regulatory, and financial steps that must occur before the companies can be fully released from government control. Both Fannie Mae and Freddie Mac were placed into conservatorship during the 2008 crisis, and since then, multiple administrations have debated how to reform or privatize them. Burry argues that conditions are finally shifting toward a path back to Wall Street.
Michael Burry’s renewed interest in the housing-finance sector is significant given his historical role in identifying weaknesses in the mortgage market before the financial collapse. He reminded readers of this history by including excerpts from an older note in which he criticized the agencies and described his earlier investments in credit-default swaps tied to their debt. This time, however, Burry says he did not become bullish on their common stock until after Donald Trump’s presidential win last year, which he believes increased the likelihood of policy changes that benefit shareholders.
In the post, Burry stated that he owns both Fannie Mae and Freddie Mac common stock “in good size,” and suggested that the offering price in any IPO will play a major role in determining their true intrinsic value. He highlighted three major changes regulators would need to make before a public offering could occur: easing capital requirements, converting certain preferred shares into common stock, and reducing the government’s senior claims on future profits. Without addressing the last issue, Burry warned that common shares could be “worthless.”
Despite the optimism, he also cautioned that the path to an IPO remains “steep, windy, and rocky,” noting that the political process could still slow progress. Shares of Fannie Mae and Freddie Mac reacted positively to his commentary, rising more than 3% on Tuesday and gaining over 15% so far this month. The stocks, which trade over-the-counter, remain highly volatile as investors digest shifting expectations.
Burry’s views arrive shortly after longtime shareholder Bill Ackman proposed a plan on social media to relist the companies on the New York Stock Exchange. Meanwhile, analysts such as Bose George at Keefe Bruyette & Woods remain cautious, arguing that common shareholders still face significant downside risks if reforms stall or if the government opts to convert preferred shares in a way that dilutes existing holders.
Whether Michael Burry’s thesis proves correct remains to be seen, but his involvement has injected new momentum into one of the most closely watched restructuring stories in U.S. finance.
