TOI is an oncology practice management company that provides administrative services to oncology clinics. These clinics provide cancer care to a population of approximately 1.9 million patients. Services include cancer care, pharmacy and dispensary services, clinical trials, and services associated with oncology care. The company employs nearly 120 clinicians and over 700 teammates at over 70 clinic locations.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
TOI Is Addressing The Unsustainable Cost Trend In Oncology. The Oncology Institute manages medical clinics that have improved outcomes and patient satisfaction while reducing the cost of cancer treatment. Dr. Daniel Virnich, CEO, and Rob Carter, CFO, highlighted the benefits of the company’s hybrid model of employed physicians and contracted independent community oncologists. The video of the company’s presentation may be viewed here.
Differentiated Competitive Advantage. TOI distinguishes itself from competitors in the value-based oncology field through its ownership of clinical assets (employed physicians and clinics). This provides greater control over care delivery compared to pure utilization management firms (such as Evolent’s New Century Health) or care navigation models (such as Thyme Care). This control enables higher compliance with value-based prescribing pathways, better integration of ancillary services, and more predictable and significant cost savings for payers.
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.
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.
Q3 Preview. We expect that there will be some impact on the third quarter from the “pull forward” in Branded Product revenue into the second quarter as consumers reacted ahead of possible trade policy changes. As such, we are modestly lowering our Q3 revenue and earnings expectations, highlighted in Figure #1 Q3 Revisions.
Largest variance. The largest adjustment to our Q3 revenue estimate is in Branded Products, revised from $89.8 million to $85.0 million. In our view, this segment offers one of the largest upside surprise potential in Q4, which could benefit from an improving macro economy.
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.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Nutriband Is Developing Transdermal Abuse-Deterrent Technologies. Nutriband has developed abuse-deterrent technology for dermal patch drug delivery. Serguei Melnik, Interim CEO, and Irina Gram, Director, highlighted the company’s platform, known as AVERSA, and its focus on patches containing FDA-approved drugs. The presentation may be viewed here.
Lead Product & Market Opportunity. The lead product, AVERSA Fentanyl, is an abuse-deterrent fentanyl patch. Upon approval, the FDA could mandate such technology for all fentanyl patches, the same way it required opioid pills to have abuse-deterrents. Market analysis by Advanced Health projects annual sales of $200 million for the branded AVERSA Fentanyl. If the abuse-resistant patch were mandated and replaced generic patches, sales could reach $800 million. A patch with improved safety and abuse-deterrence could reverse the decline in fentanyl prescriptions caused by reluctance to prescribe a drug with known abuse potential.
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.
Third quarter estimate update. We have trimmed our third-quarter revenue and net income estimates to C$21.6 million and C$6.9 million, respectively, from C$23.5 million and C$7.5 million. Additionally, we have lowered our adjusted funds flow (AFF) and AFF per share estimates to C$10.0 million and C$0.10, respectively, from C$10.7 million and C$0.11.
Full-year estimate changes. For the full year 2025, we project revenues and net income of C$93.7 million and C$27.4 million, respectively, compared to our previous estimates of C$97.7 million and C$29.6 million. Moreover, we have lowered our AFF and AFF per share estimates to C$41.0 million and C$0.41, respectively, from C$43.3 million and C$0.43.
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.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Proprietary Technology & Drug Design. James Martin, Chief Financial Officer and Co-CEO, participated in Noble’s Virtual Emerging Growth Conference on October 8th & 9th. The discussion focused on the company’s core technology to design antiviral compounds that bind to highly conserved, essential areas of the viral replication machinery, as well as progress updates on the product pipeline.The full video may be viewed here.
Lead Program & Near-Term Catalyst In Norovirus. The company’s most advanced program is CDI-988, an oral drug for norovirus. This lead indication was chosen strategically because there are no approved vaccines or therapeutics for norovirus. The market is significant, with a stated $60 billion annual market opportunity.
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.
Gold and Bitcoin, two assets long seen as safe havens in times of economic uncertainty, suffered steep declines this week, signaling a setback for the so-called “debasement trade.” On Wednesday, gold futures dropped more than five percent—the steepest single-day fall in over a decade—and extended losses by another one percent to around $4,060 per troy ounce. Bitcoin mirrored this weakness, plunging over three percent to trade just above $108,000 after staging a short-lived rebound earlier in the week.
The “debasement trade” refers to a strategy in which investors move money out of fiat currencies and government bonds and into “hard assets” such as gold, silver, and digital currencies. The concept hinges on fears that excessive fiscal spending, rising global debt, and accommodative central bank policies will erode the long-term purchasing power of major currencies—analogous to historic “debasement” when rulers diluted precious-metal coins to stretch resources. Essentially, it reflects investors’ desire to preserve value amid the perception that monetary and fiscal policy are inflating away real wealth.
For much of 2025, this trade propelled gold and Bitcoin to record highs as investors sought shelter from currency risk and persistent inflation. Gold rose over 65% year-to-date before this week’s sharp pullback, its rally supported by central bank buying and investor skepticism over government debt levels. Bitcoin, which climbed about 15% in the same period, benefited from similar narratives linking decentralized assets to long-term protection from currency erosion.
This week’s reversal, however, underscores shifting market sentiment. A stronger U.S. dollar, stabilizing geopolitical conditions, and profit-taking from heavily leveraged positions triggered a broad liquidation across both asset classes. The retreat in gold prices also weighed on mining equities and exchange-traded funds, signaling that speculative capital had overextended itself following months of relentless inflows.
Despite the sell-off, some strategists maintain that the underlying argument for the debasement trade endures. Inflation remains elevated, and major economies—including the United States and members of the eurozone—continue to operate under large fiscal deficits. These structural conditions sustain long-term concerns over fiat currency stability, though near-term volatility may temper enthusiasm. Analysts expect gold to find support in the $3,900–$4,000 range, while Bitcoin’s next key psychological level remains near $100,000.
What distinguishes this moment is the synchronized correction across both traditional and digital safe-haven assets. Their decline highlights the limitations of purely inflation-hedge strategies in an environment where tighter liquidity and the resurgence of the dollar can erase months of speculative gains almost overnight.
While the “debasement trade” is far from over, its stumble this week serves as a reminder that no hedge is immune to sentiment swings in global markets. In the evolving battle between inflation anxiety and monetary tightening, investors are being forced to reassess what truly qualifies as a reliable store of value in the modern economy.
On October 22, 2025, Alkermes plc (Nasdaq: ALKS) and Avadel Pharmaceuticals plc (Nasdaq: AVDL) announced a definitive merger agreement reflecting a major shift in the sleep medicine sector and the broader biopharmaceutical industry. The all-cash transaction, valued at up to $20 per Avadel share, comprises an $18.50 cash payment plus a contingent value right (CVR) for an additional $1.50 per share linked to final FDA approval of LUMRYZ™ for idiopathic hypersomnia. This structure represents a transaction value of approximately $2.1 billion and a 38% premium to Avadel’s three-month average share price, indicating strong confidence in Avadel’s commercial prospects.
The acquisition marks Alkermes’ strategic expansion into the sleep medicine market—a key area of growth for the company. With this move, Alkermes augments its existing neuroscience and rare disease franchise by adding Avadel’s FDA-approved LUMRYZ™ (sodium oxybate), a once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in narcoleptic patients aged seven and older. LUMRYZ™ distinguishes itself as the market’s only once-nightly oxybate, offering significant convenience and competitive advantage over the twice-nightly alternative. Since its 2023 launch, LUMRYZ™ has experienced rapid adoption, with over 3,100 patients on therapy as of June 2025 and new patient starts outpacing competitors more than two-to-one. Net revenues are projected between $265–275 million for 2025, backed by a U.S. narcolepsy market of over 50,000 eligible patients.
Alkermes’ acquisition is expected to be immediately accretive to earnings and profit margins, providing the scale and financial strength to accelerate both commercial and clinical development programs. For Alkermes, the deal offers a robust foundation to support its late-stage developmental pipeline, specifically its orexin 2 receptor agonist candidates—alixorexton, ALKS 4510 and ALKS 7290—for narcolepsy and idiopathic hypersomnia. The combined company harnesses both organizations’ commercial expertise and operational infrastructure, streamlining R&D and driving cost synergies.
Leadership at both Alkermes and Avadel have expressed optimism about the transaction. Alkermes’ CEO Richard Pops described the acquisition as “a pivotal step” in the company’s evolution—a move that bolsters Alkermes’ entry into sleep medicine as it prepares to advance alixorexton into phase 3 trials. Avadel’s CEO, Greg Divis, characterized the merger as a validation of Avadel’s strategy, highlighting the differentiated value of LUMRYZ™ and the company’s dedication to sleep disorder patients.
Under the transaction’s terms, Alkermes will fund the acquisition with cash on hand and new debt, subject to regulatory and shareholder approvals. Both boards have unanimously approved the deal, targeting a closing date in the first quarter of 2026. Financial and legal advising teams include J.P. Morgan, Morgan Stanley, Goldman Sachs, Paul Weiss, and Cleary Gottlieb.
With this acquisition, Alkermes solidifies its position as a leader in neurological and sleep disorder treatments, accelerating the pace of innovation in a space with significant unmet patient needs. The combined organization is set to pursue further label expansions for LUMRYZ™, bring new therapies to market, and deliver increased value to shareholders and patients alike.
The landmark agreement between Alkermes and Avadel Pharmaceuticals underscores the accelerating consolidation trend within the life sciences sector, where innovative therapies and commercial scale are driving strategic acquisitions. The addition of LUMRYZ™ to Alkermes’ portfolio not only diversifies its product base but strengthens its market position in a segment characterized by high unmet medical need and strong growth potential.
Alkermes’ entry into the sleep medicine market will leverage Avadel’s proven commercial infrastructure and rare disease expertise, enabling more efficient launches and access for future products. The transaction also sets the stage for Alkermes to explore global expansion opportunities for LUMRYZ™ and other pipeline assets, while supporting additional indications such as idiopathic hypersomnia and leveraging Avadel’s salt-free, once-at-bedtime oxybate candidate.
As the two organizations integrate, operational synergies are expected to improve profitability and streamline R&D processes for advancing both existing therapies and new clinical programs. The merger, backed by reputable financial advisors and committed financing, represents a pivotal moment for stakeholders, positioning Alkermes as an emerging leader in neurology and sleep disorder therapeutics with a stronger foundation for future innovation and patient impact.
NEW YORK, Oct. 22, 2025 /PRNewswire/ — Travelzoo® (NASDAQ: TZOO):
WHAT:
Travelzoo, the club for travel enthusiasts, will host a conference call to discuss the Company’s financial results for the third quarter ended September 30, 2025. Travelzoo will issue a press release reporting its results before the market opens on October 28, 2025.
WHEN:
October 28, 2025 at 11:00 AM ET
HOW:
A live webcast of Travelzoo’s Q3 2025 earnings conference call can be accessed at http://ir.travelzoo.com/events-presentations. The webcast will be archived within 2 hours of the end of the call and will be available through the same link.
CONTACT:
Travelzoo Investor Relations
ir@travelzoo.com
About Travelzoo We, Travelzoo®, are the club for travel enthusiasts. We reach 30 million travelers. Club Members receive Club Offers personally reviewed by our deal experts around the globe. We have our finger on the pulse of outstanding travel, entertainment, and lifestyle experiences. We work in partnership with thousands of top travel suppliers—our long-standing relationships give us access to irresistible deals.
ATLANTA, Oct. 22, 2025 (GLOBE NEWSWIRE) — DLH Holdings Corp. (NASDAQ: DLHC) (“DLH” or the “Company”), a leading provider of digital transformation and cybersecurity, systems engineering and integration, and science research and development, today announced that it has achieved Cybersecurity Maturity Model Certification (CMMC) Level 2.
The CMMC Program is designed to enforce the protection of sensitive unclassified information shared by the Department of Defense (DoD) with its contracting base.
To achieve Level 2 certification, DLH was required to complete a rigorous audit which verified compliance with over one hundred security requirements outlined by the National Institute of Standards and Technology (NIST), to confirm the Company’s ability to secure national defense data.
“This achievement validates DLH’s ability to carry out national security missions with efficiency, security, and agility,” said Zach Parker, DLH President & CEO. “Customers know that DLH leverages its core capabilities and commercial best practices to deploy resilient systems which are built to withstand the rigors of the modern threat environment.”
CMMC 2.0 requirements are expected to begin appearing in new DoD solicitations as early as November 2025. Achieving this certification positions DLH to compete for new business across the federal contracting landscape.
About DLH
DLH (NASDAQ: DLHC) enhances technology, public health, and cyber security readiness missions through science, technology, cyber, and engineering solutions and services. Our experts solve some of the most complex and critical missions faced by customers today, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With a world-class workforce dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of technology, innovation, and world-class expertise, to improve lives across the globe. For more information, visit www.DLHcorp.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or DLH`s future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that the Company or its management “believes”, “expects”, “anticipates”, “plans”, “intends” and similar expressions) should be considered forward looking statements that involve risks and uncertainties which could cause actual events or DLH’s actual results to differ materially from those indicated by the forward-looking statements. Forward-looking statements in this release include, among others, statements regarding estimates of future revenues, operating income, earnings and cash flow. These statements reflect our belief and assumptions as to future events that may not prove to be accurate. Our actual results may differ materially from such forward-looking statements made in this release due to a variety of factors, including: the risk that we will not realize the anticipated benefits of acquisitions (including anticipated future financial performance and results); the diversion of management’s attention from normal daily operations of the business and the challenges of managing larger and more widespread operations; the inability to retain employees and customers; contract awards in connection with re-competes for present business and/or competition for new business; our ability to manage our debt obligations; compliance with bank financial and other covenants; changes in client budgetary priorities; government contract procurement (such as bid and award protests, small business set asides, loss of work due to organizational conflicts of interest, etc.) and termination risks; the impact of inflation and higher interest rates; and other risks described in our SEC filings. For a discussion of such risks and uncertainties which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the Company’s periodic reports filed with the SEC, including our Annual Report on Form 10-K for the fiscal year ended September 30, 2024 as well as subsequent reports filed thereafter. The forward-looking statements contained herein are not historical facts, but rather are based on current expectations, estimates, assumptions and projections about our industry and business.
Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company does not assume any responsibility for updating forward-looking statements, except as may be required by law.
FOCUS is a randomized, double-blind, placebo-controlled crossover pilot study evaluating Tonix’s investigational intranasal potentiated oxytocin products in patients with Arginine-Vasopressin Deficiency (AVP-D)
The trial is intended to generate preliminary data to inform future potential clinical studies of oxytocin replacement therapy in AVP-D
CHATHAM, N.J., Oct. 22, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated biotechnology company with marketed products and a pipeline of development candidates, today announced that the first patient has been dosed in the investigator-initiated FOCUS study (NCT04789148) at Massachusetts General Hospital (MGH) in adult patients with arginine-vasopressin deficiency (AVP-D), a rare endocrine disorder associated with oxytocin deficiency and adverse mental health outcomes, formerly known as central diabetes insipidus.
“Patients with AVP-D often experience mental health and quality-of-life challenges that are not adequately addressed by current interventions,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Oxytocin plays an important role in regulating mood and socioemotional functioning, and evidence suggests that AVP-D is associated with oxytocin deficiency. We are pleased to support the FOCUS study at MGH, which will evaluate our investigational intranasal potentiated oxytocin products (TNX-1900/TNX-2900) in this population and may help lay the groundwork for future studies of oxytocin replacement therapy.”
“The FOCUS study uses a randomized, placebo-controlled crossover design that enables within-patient comparisons of placebo and investigational intranasal potentiated oxytocin product at different doses,” said Elizabeth Lawson, M.D., M.M.Sc., principal investigator of the study and Director, Interdisciplinary Oxytocin Research Program in the Neuroendocrine Unit, Department of Medicine at MGH. “This approach will provide critical first data to inform future larger-scale clinical trials for patients with AVP-D. Ultimately, our goal is to generate insights that can lead to better treatments and improved quality of life for patients living with this condition.”
The FOCUS study (Feasibility of Oxytocin for Clinical Use and Socioemotional wellbeing) is a randomized, double-blind, placebo-controlled crossover pilot study that will evaluate single-dose investigational intranasal potentiated oxytocin product at two different doses (6 IU, TNX-2900 and 24 IU, TNX-1900) on markers of anxiety, depression, and socioemotional functioning in patients with AVP-D, formerly known as central diabetes insipidus. An exploratory analysis will assess the effects of two weeks of the investigational products replacement on mental health outcomes.
About Tonix’s Potentiated Oxytocin Platform (TNX-1900 and TNX-2900) TNX-1900 and TNX-2900 are based on Tonix’s patented intranasal Mg2+-potentiated oxytocin formulations. Both are drug-device combination products, each with an intranasal actuator device that delivers oxytocin into the nasal cavity. TNX-1900 is a proprietary formulation of oxytocin in development as a candidate for prevention of chronic migraine and other conditions. TNX-2900 is in development for use by children and adolescents with Prader-Willi syndrome. The formulations will also be developed for craniofacial pain conditions. Tonix has a license with the University of Geneva for the use of the intranasal potentiated oxytocin products in the treatment of insulin resistance and related conditions. The addition of magnesium to the oxytocin formulation enhances oxytocin receptor binding1,2 as well as oxytocin’s inhibitory effects on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models3. Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children3. Targeted nasal delivery results in low systemic exposure4,5 and lower risk of non-CNS, off-target effects. Oxytocin is a naturally occurring human peptide hormone that also acts as a neurotransmitter within the central nervous system (CNS). It is believed to be more than 600 million years old and is present in vertebrates including mammals, birds, reptiles, amphibians, and fish. Oxytocin also has no recognized addiction potential. It was initially approved by the U.S. Food and Drug Administration as Pitocin®, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor and control postpartum bleeding or hemorrhage. An intranasal formulation of oxytocin is marketed in some European countries to assist in breast milk production as Syntocinon® (oxytocin nasal 40 international units/ml).
1Meyerowitz JG, et al. Nat Struct Mol Biol. 2022. 29(3):274-281. 2Bharadwaj VN, et al. Pharmaceutics. 2022 14(5):1105. 3Bharadwaj VN, et al. Pharmaceutics. 2021. Jul 16;13(7):1088. 4Yeomans, DC et al. 2017. US patent US2017368095 5Shafer SL, et al. Br J Anaesth. 2025. 134(5):1513-1522.
Investigator-Initiated Studies Using TNX-1900 at Mass General Hospital (MGH) In addition to the recently initiated FOCUS study, Dr. Lawson has three other ongoing investigator-initiated trials using TNX-1900.
The STROBE (STRategy of Oxytocin for Binge Eating) study is a Phase 2 randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of TNX-1900 for the treatment of binge-eating disorder in adults. The 8-week trial has a target enrollment of at least 60 participants 18-70 years old with binge-eating. Subjects are randomized to receive TNX-1900 or placebo and are studied at MGH. Subjects self-administer TNX-1900 or placebo as two sprays total (one spray in each nostril) up to four times per day for 8 weeks. The primary endpoint is 8-week change from baseline in binge frequency. For more information, see ClinicalTrials.gov Identifier: NCT05664516.
The POWER (Pediatric Oxytocin Weight and Energy Research) study is a Phase 2 randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of TNX-1900 for the treatment of pediatric obesity. The 12-week trial has a target enrollment of 75 participants 12-18 years old with obesity (BMI ≥95th percentile for age and gender). Subjects are randomized to receive TNX-1900 or placebo. Subjects self-administer TNX-1900 or placebo as two sprays total (one spray in each nostril) before meals and at bedtime for 12 weeks. The primary endpoint is 12-week change in body mass index standard deviation score (BMI-SDS) versus placebo. For more information, see ClinicalTrials.gov Identifier: NCT04551482.
The BOX (Bone Oxytocin) study is a Phase 2, randomized, placebo-controlled study to evaluate the effects of twice daily administration of TNX-1900 on bone measures in children with autism spectrum disorder. Study subjects, ages six to 18 years old, are randomized 1:1 to receive TNX-1900 twice per day or placebo for 12 months in the double-blind phase, followed by a six-month open label phase during which all study subjects receive TNX-1900 twice daily. The primary endpoint is the difference between TNX-1900 compared to placebo groups in 12-month change in whole body (less head bone) mineral density Z-scores. A Z-score compares one’s bone density to the average bone density of age and sex matched controls. For more information, see ClinicalTrials.gov Identifier: NCT05754073.
Tonix Pharmaceuticals Holding Corp.* Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix has received FDA approval for Tonmya™, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. 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 a Physician-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 an 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. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a 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 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.
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.
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.
DALLAS, Oct. 22, 2025 (GLOBE NEWSWIRE) — Twin Hospitality Group Inc. (“Twin Hospitality”) (Nasdaq: TWNP), the parent company of Twin Peaks Restaurant and Smokey Bones, is pleased to announce that Noble Capital Markets has initiated company-sponsored equity research coverage on the Company. The full report by Noble Capital Markets Senior Research Analyst, Joe Gomes, as well as news and advanced market data on Twin Hospitality, is available on Channelchek.
FAT Brands Inc. (NASDAQ: FAT) served as the parent company that executed the strategic spin-out of Twin Hospitality Group earlier this year, separating its Twin Peaks and Smokey Bones restaurant brands into Twin Hospitality Group Inc.
About Twin Hospitality Group Inc.:
Twin Hospitality Group Inc. (NASDAQ: TWNP) is a restaurant company that strategically develops, operates, and franchises specialty casual dining restaurant concepts with a goal of redefining the casual dining category with its experiential-driven brands, Twin Peaks and Smokey Bones. Twin Peaks, known as the ultimate sports lodge, is an award-winning restaurant and sports bar brand with 114 locations across 27 states and Mexico and is known for its made-from-scratch food, 29-degree draft beer, innovative cocktail program and sports on wall-to-wall televisions. Smokey Bones is a full-service, meat-centric restaurant brand and concept with 45 locations, across 15 states specializing in ribs and a variety of other slow-smoked, fire-grilled and seared meats, along with a full bar. For more information, please visit www.twinpeaksrestaurant.com.
About Noble Capital Markets:
Established in 1984, Noble Capital Markets is an SEC / FINRA registered full-service investment bank and advisory firm with an award-winning research team and proprietary investor distribution platform. We deliver middle market expertise to entrepreneurs, corporations, financial sponsors, and investors. Over the past 40 years, Noble has raised billions of dollars for companies and published more than 45,000 equity research reports.
About Channelchek:
Noble launched www.channelchek.com in 2018 – an investor community dedicated exclusively to public emerging growth and their industries. Channelchek is the first service to offer institutional-quality research to the public, for FREE at every level without a subscription. More than 7,000 public emerging growth companies are listed on the site, and content including equity research, webcasts, and industry articles.
WEST HARRISON, N.Y.–(BUSINESS WIRE)– Sky Harbour Group Corporation (NYSE: SKYH, SKYH WS) (“SHG” or the “Company”), an aviation infrastructure company building the first nationwide Home Base Operator (HBO) network of campuses for business aircraft, announced the release of its unaudited financial results for the three months ended June 30, 2025 on Form 10-Q. The Company also announced the filing of its unaudited financial results for the three months ended June 30, 2025 for Sky Harbour Capital (Obligated Group) with MSRB/EMMA. Please see the following links to access the filings:
Financial Highlights on a Consolidated Basis include:
Constructed assets and construction in progress reached over $295 million at quarter end, an increase of $125 million year-over-year and $18 million as compared to the prior quarter.
Q2 2025 consolidated revenues increased 82% as compared to Q2 2024 and 18% as compared to the prior quarter.
Net cash used in operating activities was approximately $0.9 million for the quarter, a significant improvement from the $5 million used in prior quarter.
Strong liquidity and capital resources as of June 30th, 2025, with consolidated cash and US Treasuries totaling nearly $75 million.
Reiterating our guidance of reaching operating cash-flow breakeven on a consolidated run-rate basis by year-end 2025, supported by the commencement of revenues from campuses in Phoenix, Denver, Dallas and Seattle.
Financial Highlights at Sky Harbour Capital (Obligated Group) include:
Q2 2025 Obligated Group Revenues increased approximately 20% as compared to the prior quarter.
Net cash from operating activities (positive) reached approximately $2.2 million in Q2 2025, a 117% increase from the prior quarter.
Cash and US Treasuries at the Obligated Group totaled $37 million as of June 30th, 2025.
Update on Site Acquisition
Sky Harbour currently has campuses operating at Houston’s Sugar Land Regional Airport (SGR), Nashville International Airport (BNA), Miami Opa-Locka Executive Airport (OPF), San Jose Mineta International Airport (SJC), Camarillo Airport (CMA), Phoenix Deer Valley Airport (DVT), Dallas’s Addison Airport (ADS), Seattle’s King County International Airport – Boeing Field (BFI); one campus nearing construction completion at Denver’s Centennial Airport (APA); campuses in pre-development at Chicago Executive Airport (PWK), Sky Harbour’s first four New-York-metro area airports – Bradley International Airport (BDL), Hudson Valley Regional Airport (POU), Trenton-Mercer Airport (TTN), and Stewart International Airport (SWF); Orlando Executive Airport (ORL), Dulles International Airport (IAD), Salt Lake City International Airport (SLC), and Portland-Hillsboro Airport (HIO).
We reiterate our prior guidance of five additional airport ground leases to be announced by the end of 2025, for a total portfolio of 23 airports by year end.
Update on Construction and Development Activities, Change in Development Leadership
As reported on our monthly activity reports filed with MSRB/EMMA, and available on our website, Dallas Addison (ADS) achieved its first Certificates of Occupancy in Q2 and has commenced resident flight operations. Denver Centennial (APA) achieved its first Certificates of Occupancy last month and will commence resident flight operations in the coming weeks. Please see the following link for the last monthly construction report:
Miami Opa Locka (OPF) Phase 2 commenced construction in Q2 and is expected to be completed by Q2 2026.
Outgoing COO, Will Whitesell, who led the Company’s construction division, has entered an amicable separation agreement with the Company and has assisted in an orderly transfer of his responsibilities. The Company is grateful for Will’s commitment and his contributions and wishes him much success in his future endeavors.
Phil Amos, a 40-year veteran of the Pre-Engineered Metal Building (PEMB) industry, and co-founder of A&F Contractors, has joined Sky Harbour as Head of Construction and President of Sky Harbour’s newly-formed, wholly-owned development subsidiary, Ascend Aviation Services (“Ascend”). Ascend brings specialized airport construction-management and in-house General Contracting capabilities to Sky Harbour. Ascend is headquartered in Houston, TX, and staffed by veterans of the airport construction industry around the United States, including legacy members of the Sky Harbour development team. In addition to its construction management and general contracting functions, Ascend oversees the operations of Stratus Building Systems, Sky Harbour’s wholly-owned PEMB manufacturing subsidiary. Ascend and Stratus together constitute a vertically-integrated, specialized airport infrastructure developer. Mr. Amos, while at A&F, served as the general contractor for Sky Harbour’s first hangar campus at Sugar Land Regional Airport, which was delivered on time and under budget.
Update on Leasing Activities
Stabilized campuses: The Company continues to enjoy higher-than-forecast revenue per square foot at its stabilized campuses. Revenue per square foot continues to grow as legacy hangar leases turn or are renewed.
New campuses: The Company has executed the first six hangar leases at its new Denver, Dallas and Phoenix campuses, and is under LOI for additional leases. The Company expects to meet its revenue run-rate targets at the new campuses within six months.
Pre-leasing: The Company has initiated a pilot project at two airports – Bradley International Airport (BDL) and Dulles International Airport (IAD) to pre-lease hangar space prior to construction commencement. The objective is to take advantage of growing awareness of the Sky Harbour HBO value proposition within the US Business Aviation industry to a) reduce lease-up times, b) better curate resident communities, and c) integrate customized resident improvements during construction (as opposed to retrofitting). Hangar leases have been executed at both airports at revenue rates that present an introductory pricing advantage to pre-lease residents while still delivering above-target per-square-foot revenue to the Company. Additional pre-leases are under LOI.
Update on Airport Operations
As of Q3, the Company is conducting flight operations at nine airports.
Under the leadership of Marty Kretchman, Senior Vice President of Airports, the company has transitioned to a centralized operating model, featuring National Directors of Line Training; Facilities; and Ground Support Equipment (GSE).
Surveys of current residents indicate that Sky Harbour’s HBO service offering has become a key differentiating component of the Sky Harbour value proposition. The Company plans to continue to invest in constant improvement in airfield operations, through selective recruiting, rigorous training, detailed and thoughtful operating procedures, and constant innovation in collaboration with Sky Harbour residents.
Update on Capital Formation
After several quarters of “dual tracking” the review of various debt funding alternatives and proposals, the Company has decided to pursue a tax-exempt bank debt facility in lieu of a bond issue.
We are currently in advanced discussions with a major US financial institution for an expected five (5) year drawdown construction facility of $200 million, with an expected indicative interest rate of 80% of 3-month SOFR plus 200 basis points (~5.47% in the current market).
Our debt financing plan is to fund the next 5-6 airport projects using this facility and internal equity. The Company expects to replace this facility with permanent tax-exempt bonds in the next 3-4 years. We expect to close the facility on or about August 28th. However, we can provide no assurance on exact terms or the timing of this facility.
Tal Keinan commented: “As Sky Harbour navigates the transition from a tactical team, emphasizing agility, innovation and flexibility, to a high-growth organization, increasingly embracing process, discipline and specialization, five constants will continue to guide our leadership: 1) Obsessive focus on the Resident, 2) Commitment to building long-term shareholder value, 3) Uncompromising pursuit of professional excellence, 4) Cost-efficiency, and 5) Individual ownership of results. We value the reputation we are building in business aviation and intend to continue building it for years to come.”
About Sky Harbour
Sky Harbour Group Corporation is an aviation infrastructure company developing the first nationwide network of Home-Basing campuses for business aircraft. The company develops, leases, and manages general aviation hangar campuses across the United States. Sky Harbour’s Home-Basing offering aims to provide private and corporate residents with the best physical infrastructure in business aviation, coupled with dedicated service, tailored specifically to based aircraft, offering the shortest time to wheels-up in business aviation. To learn more, visit www.skyharbour.group.
Forward Looking Statements
Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements about the financial condition, results of operations, earnings outlook and prospects of SHG, including statements regarding our expectations for future results, our expectations for future ground leases, our expectations on future construction and development activities and lease renewals, and our plans for future financings. When used in this press release, the words “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “would” and other similar words and expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements are based on the current expectations of the management of Sky Harbour Group Corporation (the “Company”) as applicable and are inherently subject to uncertainties and changes in circumstances. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. For more information about risks facing the Company, see the Company’s annual report on Form 10-K for the year ended December 31, 2024 and other filings the Company makes with the SEC from time to time. The Company’s statements herein speak only as of the date hereof, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Key Performance Indicators
We use a number of metrics, including annualized revenue run rate per leased rentable square foot, to help us evaluate our business, measure our performance, identify trends affecting our business, formulate business plans, and make strategic decisions. Our key performance indicators may be calculated in a manner different than similar key performance indicators used by other issuers. These metrics are estimated operating metrics and not projections, nor actual financial results, and are not indicative of current or future performance.
Will Commemorate Milestone by Ringing the Nasdaq Closing Bell on October 23, 2025
NEW YORK–(BUSINESS WIRE)– Vince Holding Corp., (Nasdaq: VNCE) (“VNCE” or the “Company”), a global contemporary retailer, will begin trading today on The Nasdaq Stock Market LLC (“Nasdaq”) following its voluntary transfer from the New York Stock Exchange under the ticker symbol “VNCE”. To celebrate this milestone, the Company will ring the Nasdaq Closing Bell on October 23, 2025.
“We are thrilled to begin this exciting new chapter on Nasdaq—a milestone that celebrates both our incredible team and our company’s distinguished legacy of delivering understated luxury and timeless quality to customers,” said Brendan Hoffman, Chief Executive Officer of VNCE. “This transition reflects our continued growth trajectory as we remain on track with our objectives and continue to see nice momentum across the business today as we execute on our strategic vision. We couldn’t be more proud to ring the Nasdaq Closing Bell and showcase the remarkable transformation and the bright future we have ahead.”
The Nasdaq Closing Bell ceremony will be broadcast live starting at approximately 3:45 p.m. Eastern Time from the Nasdaq MarketSite Tower in New York City. A live stream of the Nasdaq Closing Bell will be available at: https://www.nasdaq.com/marketsite/bell-ringing-ceremony under Bell Ceremony Events at the bottom of the page.
ABOUT VINCE HOLDING CORP. Vince Holding Corp. is a global retail company that operates the Vince brand women’s and men’s ready to wear business. Vince, established in 2002, is a leading global luxury apparel and accessories brand best known for creating elevated yet understated pieces for every day effortless style. Vince Holding Corp. operates 46 full-price retail stores, 14 outlet stores, and its e-commerce site, vince.com, as well as through premium wholesale channels globally. Please visit www.vince.com for more information.
This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identifiable by use of the words “may,” “believe,” “expect,” “intend,” “plan to,” “estimate,” “project” or similar expressions. Investors are cautioned that such forward-looking statements are not guarantees of future performance and involve risk and uncertainties. Though we believe that expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectation will prove to be correct. Actual results may differ materially from the forward-looking statements as a result of various factors. These and other risk factors are discussed in the Company’s filings with the Securities and Exchange Commission, including those set forth under “Risk Factors” and “Disclosures Regarding Forward-Looking Statements” in our Annual Report on Form 10-K for the year ended February 1, 2025 and, if applicable, our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. All forward-looking statements included in this press release are expressly qualified in their entirety by such cautionary statements. We expressly disclaim any obligation to update, amend or clarify any forward-looking statement to reflect events, new information or circumstances occurring after the date of this press release except as required by applicable law.
