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.
Phase 3 Data To Be Presented At A Medical Meeting. Presentation of data from the Hydronidone Phase 3 trial is scheduled for Friday, November 7,2025 at the The Liver Meeting, the annual conference of the American Association for the Study of Liver Disease (AASLD). This presentation is expected to give detailed clinical data on the actions Hydronidone in liver fibrosis associated with chronic hepatitis B infection. We see this indication as proof of concept as well as a revenue opportunity.
We Expect Additional Clinical Trial Details To Be Presented. The Phase 3 trial met its primary endpoint of regression of liver fibrosis, with treated patients showing a regression rate of 52.85% compared with a placebo patient rate of 29.84% (p=0.0002). This reduction compared with placebo is both statistically significant and clinically meaningful. An important secondary endpoint, reduction in inflammation, also showed meaningful improvement.
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.
Unicycive Expects To Resubmit Its Application Before YE2025. Unicycive announced plans to resubmit its application for OLC (oxylanthanum carbonate) approval before the end of 2025. This follows a meeting with the FDA to identify and resolve issues that resulted in the Complete Response Letter (CRL) in June 2025. This timeframe is consistent with our expectations for resubmission. We continue to expect OLC to be approved by mid-2026.
Resubmission Announcement Follows An FDA Meeting. In early June 2025, Unicycive announced that a manufacturing inspection found deficiencies at a contract manufacturer’s facility. These inspections were one of the last steps toward approval of the New Drug Application (NDA), but the findings stopped the review process. Following the announcement, the company received a CRL on its PDUFA date of June 30, 2025.
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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.
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.
Initiating with an Outperform rating. After years of revenue declines, we believe that the company is on the cusp of a swing toward revenue growth, offering a breakout opportunity for a stock that has been range-bound. We are initiating coverage with an Outperform rating and a $12 price target.
Well-recognized brands with growth potential. The company has established brands in workout videos, such as Insanity and P90x, and nutritional supplements, including Shakeology, Beachbar, and Beachbody Performance. Such strong brands are expected to support the company’s revenue growth initiatives as it expands distribution of its products into mass merchants.
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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.
Swiss pharmaceutical giant Novartis AG announced plans to acquire Avidity Biosciences for approximately $12 billion in cash, a move aimed at deepening its focus on rare and neuromuscular diseases while navigating an increasingly complex U.S. trade and regulatory landscape.
Under the terms of the agreement, Avidity shareholders will receive $72 per share, representing a 46% premium to the company’s most recent closing price. The acquisition, expected to close later this year pending regulatory approval, underscores Novartis’ aggressive strategy to expand its biotech capabilities and offset upcoming patent expirations on several of its blockbuster therapies.
The deal also includes the formation of a new spin-off company, Spinco, which will house Avidity’s early-stage precision cardiology programs. Spinco is expected to operate as an independent, publicly traded firm, led by Avidity’s current Chief Program Officer, Kathleen Gallagher.
Headquartered in San Diego, Avidity Biosciences has gained attention for pioneering a new class of RNA-based therapeutics that directly target muscle tissue. Its lead candidate, Del-zota, is being developed to treat a rare subtype of Duchenne muscular dystrophy (DMD), a debilitating genetic disorder that leads to progressive muscle weakness. Avidity is also advancing two other promising treatments for serious neuromuscular diseases, all of which leverage its proprietary antibody oligonucleotide conjugate (AOC) platform.
For Novartis, this acquisition offers a timely expansion into rare disease treatments — a sector experiencing growing investor interest due to high unmet medical needs and favorable regulatory incentives. The move is consistent with Novartis’ 2024 acquisition of Kate Therapeutics, another biotech developing gene therapies for muscle diseases, as well as its 2025 deals with Anthos Therapeutics and Regulus Therapeutics, collectively strengthening its position in genetic and cardiovascular medicine.
The rare disease market has become an increasingly competitive frontier for pharmaceutical innovation. Analysts note that Novartis’ acquisition spree is partly driven by its looming patent cliff, as flagship drugs such as Entresto, Xolair, and Cosentyx approach the end of their exclusivity periods. By acquiring companies like Avidity, Novartis not only diversifies its revenue base but also positions itself at the forefront of next-generation therapeutics that could define the next decade of biotech innovation.
The acquisition also carries strategic geopolitical undertones. With the Trump administration imposing 39% tariffs on Switzerland earlier this year, Swiss-based pharmaceutical companies face heightened uncertainty over U.S. trade policy. Expanding operations through American biotech acquisitions helps Novartis maintain a strong U.S. presence and mitigate risks tied to international tariffs.
For small-cap investors, the transaction reinforces an ongoing trend in the life sciences sector: large-cap pharma companies are increasingly looking to buy innovation rather than build it in-house. Early-stage biotech firms with validated technologies, particularly in RNA, gene therapy, and rare disease research, continue to attract premium valuations in acquisition deals.
Ultimately, Novartis’ acquisition of Avidity Biosciences is more than just a growth strategy — it’s a signal of where the pharmaceutical industry is heading. With advances in RNA therapeutics and genetic medicine accelerating, investors can expect more high-value takeovers in the months ahead as established players race to secure the next generation of life-changing treatments.
OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT), a leading distributor of Medicare insurance policies and owner of a rapidly growing Healthcare Services platform, today announced it will release its first quarter 2026 financial results before market open on Thursday, November 6, 2025. Chief Executive Officer, Tim Danker, and Chief Financial Officer, Ryan Clement, will host a conference call on the day of the release (November 6, 2025) at 8:30 am ET to discuss the results.
After registering, a confirmation will be sent via email, including dial in details and unique conference call codes for entry. Registration is open through the live call, but to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of the call. The event will also be webcasted live via our investor relations website https://ir.selectquote.com/investor-home/default.aspx or via this link.
About SelectQuote:
Founded in 1985, SelectQuote (NYSE: SLQT) pioneered the model of providing unbiased comparisons from multiple, highly rated insurance companies, allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads. Today, the Company operates an ecosystem offering high touchpoints for consumers across insurance, pharmacy, and virtual care.
With an ecosystem offering engagement points for consumers across insurance, Medicare, pharmacy, and value-based care, the company now has three core business lines: SelectQuote Senior, SelectQuote Healthcare Services, and SelectQuote Life. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, SelectPatient Management, a provider of chronic care management services, and Healthcare Select, which proactively connects consumers with a wide breadth of healthcare services supporting their needs.
CERRITOS, Calif., Oct. 22, 2025 (GLOBE NEWSWIRE) — The Oncology Institute, Inc. (“TOI”) (NASDAQ: TOI), a pioneer in value-based community oncology care, today announced that the company will release its third quarter 2025 financial results after the market close on Thursday, November 13, 2025, to be followed by a conference call the same day at 5:00 p.m. (Eastern Time).
The conference call can be accessed live over the phone by dialing 1-877-407-0789 or for international callers, 1-201-689-8562. A replay will be available two hours after the call and can be accessed by dialing 1-844-512-2921, or for international callers, 1-412-317-6671. The passcode for the live call and the replay is 13756737. The replay will be available until Thursday, November 20, 2025.
Interested investors and other parties may also listen to a simultaneous webcast of the conference call by logging onto the Investor Relations section of the Company’s website at https://investors.theoncologyinstitute.com/.
About The Oncology Institute
Founded in 2007, The Oncology Institute (NASDAQ: TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.9 million patients, including clinical trials, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With over 180 employed and affiliate clinicians and over 100 clinics and affiliate locations of care across five states and growing, TOI is changing oncology for the better.
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.
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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.
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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.
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.
The evolving relationship between the Trump administration and major pharmaceutical giants like Pfizer and Eli Lilly is reshaping the U.S. biotech and pharmaceutical sectors in unexpected ways. As President Trump’s approach to drug pricing and distribution intensifies, investors are watching closely to see whether these changes will threaten Big Pharma’s profit margins—or set the stage for a new era of growth for smaller, more innovative companies.
One of the most notable policy shifts has been the Trump administration’s overt encouragement—or at least acceptance—of large pharmaceutical firms selling directly to consumers. This “TrumpRx” strategy is a radical departure from the conventional system involving intermediaries and pharmacy benefit managers. On one hand, such a model could potentially drive efficiency and lower costs for some patients. On the other hand, it stirs up considerable uncertainty about how much profit large firms like Pfizer and Eli Lilly can preserve in an environment where pricing pressure and regulatory scrutiny are rising.
For investors focused on the biotech sector, the uncertain impact on Big Pharma profits is neither an all-out negative nor a clear positive. Recent developments, including public negotiations between the Trump administration and pharmaceutical leaders, have left markets feeling neutral in their outlook. There’s a sense that the sector may finally be heading into a period of relative stability after years of headlines about aggressive price controls and disruptive policy threats.
But questions linger: If legislative and regulatory changes ultimately compress profit margins for giants like Pfizer and Eli Lilly, how much will these incumbents be willing to invest in breakthrough innovation? Big Pharma’s research budgets have long been a cornerstone of biotech progress, underwriting everything from gene therapies to next-generation cancer drugs. If these resources dwindle, will smaller players have to pick up the slack—or could this shift clear the runway for young, ambitious biotech companies to rise?
Some analysts argue that a direct-to-consumer environment and tighter financial discipline for industry leaders could empower small and mid-cap biotech firms. Unlike their larger rivals, these companies are often leaner, faster-moving, and more reliant on outside partnerships and licensing deals to bring new therapies to market. With Big Pharma potentially becoming more selective in its investments, nimble startups may find themselves with new opportunities to innovate, collaborate, and even become acquisition targets.
Ultimately, the Trump administration’s evolving stance toward pharmaceutical profits and the direct selling model may serve as a stabilizing force in the sector—at least in the short term. Investors will need to monitor how major policy decisions translate to bottom-line impacts, R&D spending, and future innovation. While uncertainty remains, the potential for small-cap biotech firms to thrive in the coming years has rarely looked more compelling. For patient investors, this environment could prove fertile ground for discovering the next generation of biotech trailblazers.
Minerva Neurosciences (Nasdaq: NERV) has put itself firmly back in the spotlight, announcing one of the largest small-cap biotech financings of 2025. The Massachusetts-based clinical-stage company will receive up to $200 million to fund a confirmatory Phase 3 trial and commercial launch preparation for roluperidone, a promising therapy targeting the often-overlooked negative symptoms in schizophrenia patients. The initial $80 million arrives up front, with further tranches contingent on study milestones, offering NERV investors rare clinical and regulatory visibility at a critical inflection point.
This private placement, due to close October 23, includes $80 million upfront through Series A Convertible Preferred Stock and up to $80 million more if Tranche A warrants are fully exercised, plus a potential $40 million linked to subsequent milestone events. The offering is led by Vivo Capital with support from several prominent healthcare investors, suggesting the market sees real value in roluperidone’s regulatory progress.
But unlike many small caps, which struggle with dilutive equity raises or uncertain funding, Minerva’s staged, milestone-driven deal structure means investors can track clinical and regulatory progress directly to additional capital inflows. Warrants are only unlocked if the trial meets its statistically significant 12-week endpoint, keeping capital efficiently aligned to risk.
Minerva has achieved a notable alignment with the FDA on its confirmatory trial protocol for roluperidone, targeting negative symptoms—a significant unmet need in schizophrenia treatment. Negative symptoms, such as social withdrawal or loss of motivation, often persist even with current antipsychotics, representing a billion-dollar market where no competitor is FDA-approved. Minerva’s confirmatory Phase 3 design will use a randomized double-blind, placebo-controlled format, tracking the PANSS Marder negative symptoms factor score as a primary endpoint over 12 weeks.
This clarity on regulatory requirements and a defined path for NDA resubmission is crucial for investors, lowering typical clinical-stage risk and increasing confidence in eventual market entry. The company has committed resources for trial expansion and is already preparing for a U.S. commercial launch, signaling an advanced state of readiness pending approval.
In addition to the funding, Minerva plans to strengthen its board with up to three new directors experienced in schizophrenia trials, further supporting robust clinical execution. Investors will also appoint a Scientific Advisory Board dedicated to trial oversight, ensuring best practices and direct accountability to stakeholders.
With shares already up over 150% for the year, Minerva now stakes its future on one pivotal readout. For small cap-focused investors, NERV offers rare transparency on trial financing, regulatory alignment, and near-term commercial prospects—key ingredients for outsized returns but also heightened binary risk typical of biotech.
As Minerva initiates its confirmatory Phase 3 trial and prepares for NDA resubmission, sector watchers will track not just headline efficacy results, but also enrollment metrics, board appointments, and potential warrant triggers. For investors tolerant of volatility and seeking direct exposure to major clinical milestones, Minerva’s fully funded path towards solving negative symptoms in schizophrenia could prove a defining bet in the 2025 biotech landscape.
NX-801 is a live virus vaccine investigational candidate, designed to provide durable protection against mpox and smallpox
TNX-801 demonstrated favorable safety, immunogenicity, and long-term protection in multiple preclinical models
Data support advancement of TNX-801 toward clinical development
CHATHAM, N.J., Oct. 17, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”) presented data in an oral presentation at the World Vaccine Congress–Europe 2025, held October 14–16, 2025, in Amsterdam, the Netherlands. A copy of the Company’s presentation, titled “Safety, Durability and Protection of a Single-Dose TNX-801 Mpox Vaccine,” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.
“Vaccines remain a cornerstone of pandemic preparedness and biodefense,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The data presented in Amsterdam support the potential of TNX-801 as a next-generation orthopoxvirus vaccine candidate with the ability to confer durable protection. We believe TNX-801 has the potential to strengthen global readiness for emerging and re-emerging poxvirus threats.”
TNX-801 is a live, attenuated, minimally replicative investigational vaccine candidate based on horsepox virus and is being developed to protect against mpox (monkeypox) and smallpox. Preclinical data presented by Sina Bavari, Ph.D., Executive Vice President, Infectious Disease Research at Tonix Pharmaceuticals, demonstrated that TNX-801 produced durable immune protection following a single dose and was well tolerated across multiple routes of administration, including percutaneous, subcutaneous, and intramuscular delivery. TNX-801 elicited strong neutralizing antibody responses and protected animals from clinical disease and mortality following mpox challenge in non-human primate, rabbit, and murine models. Immunogenicity and durability were observed for at least 14 months post-vaccination.
“We are encouraged by the consistency and durability of the TNX-801 data across multiple preclinical models,” said Dr. Sina Bavari. “We are also excited by the opportunity to evaluate microneedle patch technology as a novel delivery platform to simplify administration and expand vaccine accessibility in future development stages.”
About TNX-801* TNX-801 (recombinant horsepox virus) is an, attenuated, minimally replicative, live virus vaccine based on horsepox in pre-clinical development to prevent mpox and smallpox. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with monkeypox. After a single dose vaccination, TNX-801 prevented clinical disease and lesions and decreased shedding in the mouth and lungs of non-human primates. The findings are consistent with mucosal immunity and suggest the ability to block forward transmission, similar to Dr. Edward Jenner’s vaccine, which eradicated smallpox and kept mpox out of the human population. TNX-801 is based on synthesized horsepox which is believed to be more closely related to Dr. Jenner’s vaccine than 20th century vaccinia viruses. Smallpox vaccines descended from Jenner’s vaccine used prior to 1900 would be called horsepox by modern nomenclature.. Tonix has received official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-801 as a potential vaccine to protect against mpox disease and smallpox. Tonix has announced a collaboration with the Kenya Medical Research Institute (KEMRI) to design, plan and seek regulatory approval for a Phase I clinical study of TNX-801 in Kenya. The Company believes TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines. The FDA-approved non-replicating mpox vaccine Jynneos® requires two doses and provides a relatively short duration of protection. FDA also recently approved ACAM2000, a live, replicating vaccinia vaccine for prevention of mpox. ACAM200 is a clone from DryVax®, a 20th century vaccinia vaccine derived from the NYCBH strain. Pre-clinical results from an mRNA vaccine recently showed some protection from a Clade I monkeypox challenge, but with multiple break-through lesions in vaccinated animals.
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 TonmyaTM, 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.
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.
