MALVERN, Pa., June 16, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies). The FDA previously granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19, and cone-rod dystrophy 3.
“We have had a highly productive and collaborative engagement with the FDA’s Center for Biologics Evaluation and Research (CBER) in establishing the pivotal confirmatory trial for OCU410ST,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen. “It’s evident that there is a real sense of urgency by the agency in providing treatment options for patients who currently have nothing available to them. As we initiate the Phase 2/3 registration trial, we are expediting the clinical development of OCU410ST by two to three years and potentially providing an innovative gene therapy to patients desperate for a treatment option.”
Positive data from the Phase 1 GARDian trial for OCU410ST demonstrated:
A favorable safety and tolerability profile with no serious adverse events related to OCU410ST, including no cases of ischemic optic neuropathy, vasculitis, intraocular inflammation, endophthalmitis or choroidal neovascularization and no adverse events of special interest
Considerably slower lesion growth—48% at 12-month follow up in evaluable treated eyes when compared to untreated eyes
Statistically significant (p=0.031) improvement with clinically meaningful, nearly 2-line gain in visual function (BCVA) at 12-month follow-up in evaluable treated eyes when compared to untreated eyes
The Phase 2/3 clinical trial for OCU410ST will enroll 51 participants diagnosed with Stargardt disease. Of these, 34 will receive a one-time subretinal injection of OCU410ST (200 μL at a concentration of 1.5 × 10¹¹ vector genomes/mL) in the eye with poorer visual acuity, while 17 will be assigned to an untreated control group. The primary objective of the trial is to evaluate the reduction in atrophic lesion size. Key secondary endpoints include improvements in best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA), compared to controls. Data from the one-year follow-up will be used to support the company’s Biologics License Application (BLA).
“The initiation of this pivotal Phase 2/3 study represents a significant milestone in our commitment to bringing transformative genetic therapies to individuals affected by Stargardt disease—a progressive and debilitating condition,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “The recent RPDD granted by the FDA for this program further underscores the urgent need for innovative treatment options for children living with Stargardt disease. OCU410ST, developed through our proprietary modifier gene therapy platform, is designed to target the underlying biological mechanisms of the disease.”
Approximately 100,000 patients in U.S. and Europe combined and 1 million patients globally live with Stargardt disease. Stargardt and ABCA4-associated retinopathies are genetically complex, involving more than 1,200 known mutations and addressing this condition with traditional gene therapy or gene editing approaches remains highly challenging.
“Stargardt disease represents a significant unmet medical need, particularly among children and young adults,” said Lejla Vajzovic, MD, FASRS, Director of the Duke Surgical Vitreoretinal Fellowship Program and Professor of Ophthalmology, Pediatrics, and Biomedical Engineering with Tenure at Duke University Eye Center. “The Phase 2/3 study of OCU410ST is thoughtfully designed with scientific rigor and a patient-centered focus to evaluate both structural and functional outcomes. We are optimistic that this approach will move us closer to a meaningful therapeutic solution for affected families.”
The OCU410ST Phase 2/3 pivotal confirmatory trial represents a major advancement as Ocugen’s second late-stage clinical program. Ocugen plans to submit a BLA for OCU410ST in 2027 in alignment with its strategic goal of filing three BLAs over the next three years.
About OCU410ST OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR-Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathophysiological pathways linked to Stargardt disease, such as lipofuscin formation, oxidative stress, complement formation, inflammation, and cell survival networks.
About Stargardt Disease Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.
Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Cautionary Note on Forward-Looking Statements Thispressreleasecontainsforward-lookingstatementswithinthemeaningofThePrivateSecuritiesLitigationReformActof1995,including,butnot limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,whicharesubjecttorisksanduncertainties.Wemay,insomecases,usetermssuchas “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including,butnotlimitedto,therisksthatpreliminary,interimandtop-lineclinicaltrialresultsmaynotbeindicativeof,andmaydifferfrom,finalclinical data;the ability of OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data;thatunfavorablenewclinicaltrialdatamayemergeinongoingclinicaltrialsorthroughfurtheranalysesofexistingclinicaltrialdata;thatearlier non-clinicalandclinicaldataandtestingofmaynotbepredictiveoftheresultsorsuccessoflaterclinicaltrials;andthatthatclinicaltrialdataare subject to differing interpretations and assessments, including by regulatory authorities.Theseandotherrisksanduncertaintiesaremorefully describedinourperiodicfilingswiththeSecuritiesandExchangeCommission(SEC),includingtheriskfactorsdescribedinthesectionentitled“Risk Factors”inthequarterlyandannualreportsthatwefilewiththeSEC.Anyforward-lookingstatementsthatwemakeinthispressreleasespeakonlyas ofthedateofthispressrelease.Exceptasrequiredbylaw,weassumenoobligationtoupdateforward-lookingstatementscontainedinthispress release whether as a result of new information, future events, or otherwise, after the date of this press release.
TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia: FDA PDUFA goal date of August 15, 2025
TNX-102 SL demonstrated statistically significant improvement in the primary endpoint of reduction in fibromyalgia pain in two double-blind randomized placebo-controlled Phase 3 studies
If approved by FDA, TNX-102 SL would become the first member of a new class of non-opioid analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years
CHATHAM, N.J., June 16, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company) presented data in a poster presentation at the Annual European Congress of Rheumatology (EULAR) 2025, held June 11-14, 2025, in Barcelona, Spain. A copy of the Company’s poster, titled “Advancing Fibromyalgia Treatment: Transmucosal Sublingual Cyclobenzaprine (TNX-102 SL) Targets Non-restorative Sleep and Provides Sustained Pain Reduction” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com. TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is a non-opioid analgesic designed for daily bedtime dosing with an FDA Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025.
“Fibromyalgia is a complex and invisible chronic pain condition which drives many patients to be prescribed chronic opioids which are associated with addiction and overdose,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “To address the chronic symptoms of fibromyalgia, potential therapeutic options must provide durable benefits. TNX-102 SL has shown statistically significant, durable activity (14 weeks) in reducing fibromyalgia pain in two Phase 3 studies. Designed to target the sleep disturbance of fibromyalgia, TNX-102 SL harnesses the therapeutic activity of cyclobenzaprine in part by reducing in the level of the active metabolite norcyclobenzaprine relative to oral cyclobenzaprine. Norcyclobenzaprine is believed to interfere with the durability of oral cyclobenzaprine’s treatment effect in off-label chronic dosing regimens and in a failed double-blind randomized placebo-controlled trial.1 TNX-102 SL now has the potential to be the first new treatment option for fibromyalgia patients in 15 years.”
TNX-102 SL is designed for transmucosal absorption to bypass first-pass hepatic metabolism. The poster presentation shows the day 20 steady state blood levels from a study of nightly TNX-102 SL dosing in which the peak level of cyclobenzaprine exceeds the level of the active metabolite norcyclobenzaprine during sleep time. In contrast, with nightly oral cyclobenzaprine dosing, pharmacokinetic simulations show that norcyclobenzaprine accumulates to higher levels, and the cyclobenzaprine peak level does not exceed the norcyclobenzaprine level during sleep time.
The poster includes data from the RESILIENT Phase 3 study evaluating the efficacy and safety of TNX-102 SL with a primary endpoint of reducing daily pain numeric rating scale scores after 14 weeks of treatment. TNX-102 SL significantly reduced pain and improved clinical outcomes in fibromyalgia patients while demonstrating a favorable tolerability profile. TNX-102 SL employs a novel mechanism targeting the sleep disturbance in fibromyalgia by acting as a potent antagonist at four post-synaptic receptors, each of which is known to regulate sleep.
About Fibromyalgia
Fibromyalgia is a common chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system, called central sensitization. Brain imaging studies have localized the functional disorder to the brain’s insula and anterior cingulate cortex. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including depression, anxiety, headaches and abdominal pain or cramps. Individuals suffering from fibromyalgia often struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. Fibromyalgia is now recognized as the prototypic nociplastic syndrome. Nociplastic pain is the third primary type of pain in addition to nociceptive pain and neuropathic pain. Many patients present with pain syndromes that are mixtures of the three primary types of pain. Nociplastic syndromes are associated with central and peripheral sensitization. Fibromyalgia can occur without any identifiable precipitating event. However, many fibromyalgia cases follow one or more precipitating event(s) including: post-operative pain, acute or chronic nociceptive or neuropathic pain states; recovery from an infectious illness; a cancer diagnosis or cancer treatment; a metabolic or endocrine stress; or a traumatic event. In the cases of recovery from an infectious illness, fibromyalgia is considered an Infection-Associated Chronic Condition. In addition to fibromyalgia cases associated with other conditions or stressors, the U.S. National Academies of Sciences, Engineering, and Medicine, has concluded that fibromyalgia is a diagnosable condition that can occur after recovery from COVID-19 in the context of Long COVID.
About TNX-102 SL
TNX-102 SL is a centrally acting, non-opioid investigational drug, designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for bedtime dosing for the management of fibromyalgia. Cyclobenzaprine potently binds and acts as an antagonist at four different post-synaptic neuroreceptor subtypes: serotonergic-5-HT2A, adrenergic-α1, histaminergic-H1, and muscarinic-M1-cholinergic receptors. Together, these interactions are believed to target the non-restorative sleep characteristic of fibromyalgia identified by Professor Harvey Moldofsky in 1975. Cyclobenzaprine is not associated with risk of addiction or dependence. The TNX-102 SL tablet is based on a eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. Patents based on TNX-102 SL’s eutectic composition and its properties have issued in the U.S., E.U., Japan, China and many other jurisdictions around the world and provide market protection into 2034. The European Patent Office’s Opposition Division maintained Tonix’s European Patent EP 2 968 992 in unamended form after an Opposition was filed against it by a Sandoz subsidiary, Hexal AG. Hexal AG did not appeal that decision. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, while reducing the risk of daytime somnolence. Clinical pharmacokinetic studies indicated that relative to oral cyclobenzaprine, TNX-102 SL results in higher levels of exposure during the first 2 hours after dosing and in deceased levels of the long-lived active metabolite, norcyclobenzaprine in both single dose and multiple dose studies, consistent with bypassing first pass hepatic metabolism. Cyclobenzaprine is a tertiary amine tricyclic and its active metabolite norcyclobenzaprine is a secondary amine tricyclic. At steady state after 20 days of dosing TNX-102 SL, the dynamic peak level of cyclobenzaprine is higher than the background level of norcyclobenzaprine during sleep time. In contrast, after 20 days of dosing oral cyclobenzaprine, the simulated peak level of cyclobenzaprine is lower than the simulated background level of norcyclobenzaprine.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also 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). 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 infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as 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. TNX-4200 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 Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* 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.
1Carette S, et al. Arthritis Rheum. 1994;37(1):32-40.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
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 obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; 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.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
BOCA RATON, Fla.–(BUSINESS WIRE)–Jun. 16, 2025– The GEO Group, Inc. (NYSE: GEO) (“GEO” or the “Company”) announced today that its wholly-owned subsidiary, GEO Transport, Inc. has entered into a new five-year contract, inclusive of option periods, with the U.S. Marshals Service for the provision of secure transportation and contract detention officer services across three service regions covering 26 federal judicial districts and spanning 14 states.
The new contract is expected to generate up to approximately $147 million over the five-year period, or up to approximately $29 million in annualized revenues per full-year of operations, with margins consistent with GEO’s Managed-Only services contracts which average approximately 15 percent.
George C. Zoley, Executive Chairman of GEO, said, “We believe that this important new contract is a testament to the high-quality services GEO delivers on behalf of the U.S. Marshals Service, and it underscores the strength of our diversified services platform which provides our company multiple avenues to pursue quality growth opportunities. We are proud of our long-standing partnership with the U.S. Marshals Service, and we stand ready to continue to help the federal government meet its law enforcement priorities.”
About The GEO Group
The GEO Group, Inc. (NYSE: GEO) is a leading diversified government service provider, specializing in design, financing, development, and support services for secure facilities, processing centers, and community reentry centers in the United States, Australia, South Africa, and the United Kingdom. GEO’s diversified services include enhanced in-custody rehabilitation and post-release support through the award-winning GEO Continuum of Care®, secure transportation, electronic monitoring, community-based programs, and correctional health and mental health care. GEO’s worldwide operations include the ownership and/or delivery of support services for 98 facilities totaling approximately 77,000 beds, including idle facilities and projects under development, with a workforce of up to approximately 18,000 employees.
Use of forward-looking statements
This news release may contain “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements and any such forward-looking statements are qualified in their entirety by reference to the cautionary statements and risk factors contained in GEO’s filings with the U.S. Securities and Exchange Commission including its Form 10-K, 10-Q and 8-K reports. All forward-looking statements speak only as of the date of this news release and are based on current expectations and involve a number of assumptions, risks and uncertainties that could cause the actual results to differ materially from such forward-looking statements. Readers are strongly encouraged to read the full cautionary statements and risk factors contained in GEO’s filings with the U.S. Securities and Exchange Commission, including those referenced above. GEO disclaims any obligation to update or revise any forward-looking statements, except as required by law.
New 50,000-Square-Foot Facility, Located on 20 acres, is Expected to Expand to 100,000 Square Feet and House up to Five GEK Engine Production Lines
PARIS, June 16, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a Technology Company in the Defense, National Security and Global Markets, today announced plans to open a new advanced manufacturing facility in Bristow, Oklahoma to produce its GEK (GE Aerospace-Kratos) family of turbojet engines, with an initial focus on the GEK800.
The announcement was made during the Oklahoma Breakfast in Paris ahead of the 2025 Paris Air Show, with Kratos CEO Eric DeMarco, Kratos Turbine Technologies (KTT) President Stacey Rock, and Oklahoma Governor Kevin Stitt in attendance.
The 50,000-square-foot facility, located on 20 acres, is expected to expand to 100,000 square feet and house up to five GEK engine production lines and initial output of 500 engines annually, supporting thrust classes from 600 to 6000 pounds. Occupancy is expected in mid-2026, with operations fully ramped by Q4 2026.
The facility will include three small engine (200-2000 lbf thrust) test cells, which are expected to be operational in 2027, thanks to approved grant funding from the State of Oklahoma.
The initial engine line is expected to create 60 high-quality jobs at the site, with key positions beginning recruitment in late 2025 and general hiring in Q1 2026. Each additional production line is expected to add approximately 45 new jobs.
“This facility underscores Kratos’ strategy of delivering affordable, high-performance, made-in-America propulsion systems at scale,” said Stacey Rock, President of Kratos Turbine Technologies. “Bristow will be a critical site for delivering mass to the mission and meeting the growing propulsion needs of our defense customers.”
Governor Kevin Stitt of Oklahoma, said, “This is a big win for American workers, for our military, and for every Oklahoman who believes in freedom, innovation, and strength. Kratos could’ve gone anywhere in the world, but they choose to continue investing in Oklahoma because it is the best place to build, grow, and do business. Oklahoma is proud to be a hub for national defense that is leading the way in rebuilding America’s industrial base and powering the technologies that keep our country safe.”
Eric DeMarco, President and CEO of Kratos Defense & Security Solutions, said, “Kratos is truly honored to expand our presence in Oklahoma with this new, state-of-the-art propulsion production facility in Bristow. This new Kratos investment reflects our continued commitment to delivering high-performance, affordable jet engine technology to support the Department of Defense and our allies and answers the rising demand for propulsion systems for cruise missiles and CCA-type aircraft, while being targeted and optimized for cost reduction. The Bristow facility will play a critical role in accelerating production of the GEK family of engines, including the GEK800, and strengthening America’s industrial base in this decisive era. We thank Governor Stitt and the State of Oklahoma for their partnership in helping us build the future of high-performance propulsion right here in the heartland.”
“Oklahoma is proud to be home to Kratos and all they do to provide cutting-edge defense technologies to our warfighters from target drones and unmanned combat aircraft to state-of-the-art turbine engines. Their investment in our state is an investment in our workforce, our warfighters, and our national security.” – Senator Markwayne Mullin
“Kratos’ expansion in Oklahoma is further proof that Oklahoma is a hub for innovative defense technology and high-quality manufacturing jobs. I am proud of all Kratos does day-to-day, providing our servicemembers with the best technology in the world, and ensuring our national security.” – Congressman Kevin Hern
“Kratos’ decision to grow in Oklahoma highlights Oklahoma’s strong workforce and unwavering support for our nation’s defense mission. Kratos continues to excel and I look forward to seeing the positive impact this facility will have on our state and national security.” – Congressman Frank Lucas
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading-edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.
Notice Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 29, 2024, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
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Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Joining the Russell. On June 10, the company announced that it is expected to join the Russell 3000 Index at market open on June 27. Notably, membership in the Russell 3000 Index, which remains active for one year, provides the company with automatic inclusion in the Russell 2000 Index.
Improved share visibility. In our view, joining the Russell Indices could provide a meaningful impact for the TZOO shares. Notably, we believe the inclusion in the Russell indices is likely to enhance the company’s share visibility among institutional investors and has the potential to increase trading volume, improve share liquidity, and introduce new investors to the company. As such, we view the development favorably.
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.
Highlights its investment merits. On June 5, the company presented at the Noble Virtual Conference to the investment community. The presentation conducted by Michael Benstock, CEO, and Mike Koempel, CFO, highlighted the company’s diverse business segments, favorable history of growth, and solid financial position. A replay of the presentation is available for viewing here.
Diverse business segments. The company operates three distinct business segments: Healthcare Apparel, Branded Products, and Contact Centers. Importantly, all three of the company’s segments have favorable organic growth opportunities, are profitable, and have compelling acquisition target opportunities. Furthermore, the company has a solid history of growth, with consolidated revenue growing at an 8% CAGR from 2019 through 2024.
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.
Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Highlights from Noble’s Emerging Growth Virtual Conference. Tim Herr, Senior Vice President of Finance, presented at Noble’s Virtual Equity conference June 4 & 5th. Mr. Herr highlighted the company’s high-margin leasing model, market opportunity, and strategic initiatives. A rebroadcast is available here.
Attractive unit economics driven by high-margin lease model. Sky Harbour secures long-term airport ground leases at highly favorable rates, often below $1 per square foot annually. Although only 25–33% of each site is convertible into revenue-generating hangar space, that portion can lease for $40 or more per square foot, creating a substantial economic spread.
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.
Key Points: – Supernus to acquire Sage for up to $12.00 per share, combining upfront cash and milestone-based CVRs. – Deal adds FDA-approved ZURZUVAE® for postpartum depression to Supernus’ growing CNS portfolio. – Transaction expected to be accretive by 2026, with $200M in annual cost synergies forecast.
Supernus Pharmaceuticals (NASDAQ: SUPN) has announced a strategic acquisition of Sage Therapeutics (NASDAQ: SAGE) in a deal worth up to $795 million, signaling a bold expansion into the neuropsychiatric space. This all-cash transaction, set to close in Q3 2025, brings to Supernus a key commercial asset—ZURZUVAE® (zuranolone)—as well as access to Sage’s central nervous system (CNS) discovery platform.
The proposed deal includes an upfront payment of $8.50 per share in cash, representing approximately $561 million, and a non-tradable contingent value right (CVR) worth up to an additional $3.50 per share. The CVR milestones are tied to commercial performance of ZURZUVAE in the U.S. and its future launch in Japan.
This acquisition is a transformative step for Supernus, best known for CNS products such as Qelbree®, GOCOVRI®, and ONAPGO™. With the addition of ZURZUVAE—the first and only FDA-approved oral treatment for postpartum depression—the company further solidifies its footprint in the growing neuropsychiatry market. Supernus CEO Jack Khattar stated that the move “adds a fourth growth product” and “diversifies our sources of future growth.”
ZURZUVAE was developed by Sage and commercialized in partnership with Biogen. Under the collaboration, Supernus will recognize revenue equal to 50% of U.S. net sales. In 2024, that share amounted to $36.1 million, with $13.8 million already reported in Q1 2025—indicating an accelerating ramp that Supernus is now positioned to capitalize on.
From a financial perspective, the deal is expected to be significantly accretive starting in 2026, supported by estimated annual cost synergies of up to $200 million. Supernus will fund the transaction entirely through its existing cash reserves, avoiding equity dilution or new debt issuance. For investors, this adds a layer of financial discipline and long-term earnings potential.
Sage’s leadership, including CEO Barry Greene, called the deal the result of a comprehensive strategic review aimed at maximizing shareholder value. Greene highlighted the company’s mission in brain health and praised the Sage team’s work in delivering two first-in-class therapies for postpartum depression.
In terms of integration, Sage’s R&D pipeline and commercial operations will fold into Supernus’ existing infrastructure—a move expected to streamline costs and accelerate product development. The combined entity will also benefit from a strengthened CNS platform and expanded market reach.
While the deal is subject to customary closing conditions, including regulatory approvals and a majority tender of Sage’s outstanding shares, both companies anticipate a smooth closing process. Supernus plans to provide revised financial guidance following deal completion in Q3.
This acquisition reflects a strategic shift in mid-cap biopharma, where clinical differentiation and near-term revenue growth are prioritized. For small- and micro-cap investors, it also signals continued consolidation in the CNS space—where innovation, reimbursement potential, and strong commercialization strategy drive M&A activity.
Company Now Holds Over 100 BTC as Part of Long-Term Growth Strategy
ATLANTA, June 13, 2025 (GLOBE NEWSWIRE) — Bitcoin Depot (NASDAQ: BTM), a U.S.-based Bitcoin ATM (“BTM”) operator and leading fintech company, today announced it has purchased additional Bitcoin (BTC) as part of its treasury strategy first initiated in June 2024.
The move follows the Company’s earlier purchases of 51 and 11 BTC in February 2025. With this latest addition, Bitcoin Depot now holds over 100 BTC in its treasury, further reinforcing its belief in Bitcoin’s long-term potential as both a strategic asset and a store of value.
“As the digital asset landscape continues to evolve during a period of strong industry momentum and innovation, we view Bitcoin as a foundational piece of our long-term growth strategy, and this purchase is a continuation of that conviction,” said Brandon Mintz, CEO and founder of Bitcoin Depot. “As we expand our treasury and our footprint, we remain committed to enabling access to Bitcoin and aligning with its future.”
This announcement comes as Bitcoin continues to experience significant momentum in 2025, marked by policy and regulatory clarity, growing institutional demand, increased adoption, and the recent all-time price high of over $111,000.
Bitcoin Depot’s latest BTC purchase also follows a wave of strong business growth for the Company, including the recent strategic acquisition of regional operator Pelicoin’s assets to further strengthen its market leadership. Today, Bitcoin Depot operates the largest Bitcoin ATM network in North America, with more than 8,500 locations and a growing international footprint.
The financial terms of the transaction were not disclosed. For more information, visit www.bitcoindepot.com.
About Bitcoin Depot Bitcoin Depot Inc. (Nasdaq: BTM) was founded in 2016 with the mission to connect those who prefer to use cash to the broader, digital financial system. Bitcoin Depot provides its users with simple, efficient and intuitive means of converting cash into Bitcoin, which users can deploy in the payments, spending and investing space. Users can convert cash to bitcoin at Bitcoin Depot kiosks in 47 states and at thousands of name-brand retail locations in 31 states through its BDCheckout product. The Company has the largest market share in North America with over 8,500 kiosk locations as of June 2025. Learn more at www.bitcoindepot.com.
Cautionary Note Regarding Forward-Looking Statements This press release and any oral statements made in connection herewith include “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. Forward-looking statements are any statements other than statements of historical fact, and include, but are not limited to, statements regarding the expectations of plans, business strategies, objectives and growth and anticipated financial and operational performance, including our growth strategy and ability to increase deployment of our products and services, the anticipated effects of the Amendment, and the closing of the Preferred Sale. These forward-looking statements are based on management’s current beliefs, based on currently available information, as to the outcome and timing of future events. Forward-looking statements are often identified by words such as “anticipate,” “appears,” “approximately,” “believe,” “continue,” “could,” “designed,” “effect,” “estimate,” “evaluate,” “expect,” “forecast,” “goal,” “initiative,” “intend,” “may,” “objective,” “outlook,” “plan,” “potential,” “priorities,” “project,” “pursue,” “seek,” “should,” “target,” “when,” “will,” “would,” or the negative of any of those words or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. In making these statements, we rely upon assumptions and analysis based on our experience and perception of historical trends, current conditions, and expected future developments, as well as other factors we consider appropriate under the circumstances. We believe these judgments are reasonable, but these statements are not guarantees of any future events or financial results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond our control.
These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political and legal conditions; failure to realize the anticipated benefits of the business combination; future global, regional or local economic and market conditions; the development, effects and enforcement of laws and regulations; our ability to manage future growth; our ability to develop new products and services, bring them to market in a timely manner and make enhancements to our platform; the effects of competition on our future business; our ability to issue equity or equity-linked securities; the outcome of any potential litigation, government and regulatory proceedings, investigations and inquiries; and those factors described or referenced in filings with the Securities and Exchange Commission. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that we do not presently know or that we currently believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect our expectations, plans or forecasts of future events and views as of the date of this press release. We anticipate that subsequent events and developments will cause our assessments to change.
We caution readers not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, future events, or other factors that affect the subject of these statements, except where we are expressly required to do so by law. All written and oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary statement.
Toronto, Ontario–(Newsfile Corp. – June 13, 2025) – Aurania Resources Ltd. (TSXV: ARU) (OTCQB: AUIAF) (FSE: 20Q) (“Aurania” or the “Company”) announces that its shareholders approved all resolutions at the Company’s Annual and Special Meeting of Shareholders (the “Meeting”) which was held on Thursday, June 12, 2025. The formal part of the Meeting was followed by an update from Aurania’s President & CEO, Dr. Keith Barron. To access the replay of Dr. Barron’s update on YouTube, click this link: https://youtu.be/m0SIk501QtY
At the Meeting, shareholders approved the financial statements for the year-ended December 31, 2024, and the report of the auditors thereon, the appointment of auditors, election of directors, and the Company’s incentive stock option plan for the upcoming year. Details of these matters are disclosed in the Management Information Circular for the Meeting dated April 30, 2025, and posted under the Company’s profile on www.sedarplus.ca and on the Company’s corporate website http://www.aurania.com/investors/annual-general-meeting/.
Clarification to Press Release Dated June 11, 2025
Further to the Company’s press release dated June 11, 2025, the Company wishes to clarify the terms of the proposed fee that the Company would be required to pay as presented by ARCOM. As currently contemplated, half of this fee is expected to be due by July 31, 2025, and the remaining 50% is expected to be due by January 31, 2026.
About Aurania
Aurania is a mineral exploration company engaged in the identification, evaluation, acquisition, and exploration of mineral property interests, with a focus on precious metals and copper in South America. Its flagship asset, The Lost Cities – Cutucu Project, is located in the Jurassic Metallogenic Belt in the eastern foothills of the Andes mountain range of southeastern Ecuador.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Mr. Hunter brings more than 40 years of experience building and leading commercial organizations in the biopharmaceutical industry, including leadership roles at Validus Pharmaceuticals, Relialab and Novartis
Led launch of Tonix Medicines, acquisition of migraine assets Zembrace® SymTouch® and Tosymra®, and recruitment of commercial leadership team
Appointment strengthens commercial strategy and governance as Tonix prepares for potential launch of TNX-102 SL for fibromyalgia this year
CHATHAM, N.J., June 13, 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 the appointment of James “Jim” Hunter to its Board of Directors, effective June 12, 2025. Mr. Hunter most recently served as Executive Vice President, Commercial at Tonix, where he was responsible for building the Company’s commercial subsidiary, Tonix Medicines, and successfully executing its entry into the migraine market.
“Jim’s appointment to our Board comes at a pivotal moment as we continue to expand our commercial footprint and intensify our pre-commercial efforts for the potential launch of TNX-102 SL for fibromyalgia later this year,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Having successfully built Tonix Medicines from the ground up, Jim brings a unique operational perspective and deep commercial expertise that will be invaluable as we advance our commercial strategy and long-term growth.”
In his role as Executive Vice President of Commercial Operations at Tonix Pharmaceuticals and President of Tonix Medicines from June 2023 to December 2024, Mr. Hunter was responsible for managing all aspects of Tonix’s commercial efforts, including sales, marketing, market access and other operational and strategic initiatives. In addition to its ongoing commercial activities with respect Tosymra and Zembrace, Tonix Medicines is actively involved in TNX-SL 102 pre-launch activities including launch strategy, market analysis, product positioning, and market access initiatives.
Previously, Mr. Hunter was CEO and Co-founder of Validus Pharmaceuticals from 2007 to 2018, where he was responsible for more than two dozen successful product acquisitions from companies such as Shire, Roche, Novartis and Sanofi. Jim was also Co-Founder of Relialab, a diagnostics company focused on CLIA-waived, point-of-care psychiatric testing. Prior to these ventures, Mr. Hunter was Executive Director of Neuroscience Sales at Novartis Pharmaceuticals, where he launched and supported products in schizophrenia, epilepsy, migraine, Parkinson’s and Alzheimer’s. Mr. Hunter also served as Executive Director of the Northeast Business Unit at Ciba Geigy Pharmaceuticals, where he was responsible for the General Practice and hospital sales force and Regional Managed Care. Mr. Hunter received his B.S. at Seton Hall University and earned his M.B.A at Fairleigh Dickinson University.
“I’m honored to join Tonix’s Board at such an exciting juncture,” said Mr. Hunter. “It’s been a privilege to help build Tonix Medicines and launch the Company’s commercial capabilities. I look forward to continuing to support Tonix’s mission as a member of the Board and contributing to its next phase of growth.”
“I’m grateful to Jim for creating and building our commercial department which has positioned us well to launch TNX-102 SL for the management of fibromyalgia,” said Thomas Englese, EVP of Commercial Operations and leader of Tonix Medicines. “Jim’s continued strategic involvement as we prepare for the launch and continue to build our commercial infrastructure will be incredibly valuable.”
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also 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). 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 infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as 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. TNX-4200 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 Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* 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.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
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 obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; 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.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Key Points: – Small-cap defense companies operate in specialized sectors with higher agility and acquisition potential compared to mega-cap contractors – Cybersecurity, drone systems, and advanced materials offer the strongest growth opportunities in current geopolitical climate – Market volatility creates entry opportunities before institutional recognition drives valuations higher
While major defense contractors like Lockheed Martin and Northrop Grumman capture headlines during geopolitical tensions, astute small-cap investors should turn their attention to the lesser-known defense players positioned to benefit from increased military spending and technological innovation. Small-cap defense companies often operate in specialized niches that make them indispensable to larger prime contractors and government agencies, and unlike their mega-cap counterparts, these firms can pivot quickly to emerging threats and technologies, making them attractive acquisition targets or compelling long-term growth stories.
The current geopolitical climate, highlighted by recent Middle East tensions and ongoing global conflicts, has created a sustained tailwind for defense spending. President Trump’s pledge of a $1 trillion defense budget, while potentially falling short in fiscal 2026, signals a multi-year commitment to military modernization that extends far beyond traditional weapons systems. This environment particularly benefits small-cap companies specializing in cybersecurity and electronic warfare, where firms focusing on cyber defense, electronic countermeasures, and signal intelligence are experiencing unprecedented demand. These companies often possess proprietary technologies that are difficult to replicate and command premium margins, creating substantial competitive advantages.
The drone revolution presents another compelling opportunity, extending beyond consumer applications into military reconnaissance, logistics, and combat operations. Small-cap manufacturers of specialized UAV components, software, and support systems are capturing market share from traditional aerospace giants, while companies developing next-generation materials for armor, stealth applications, and extreme environment operations often fly under the radar while generating substantial returns for early investors.
When evaluating small-cap defense opportunities, successful investors focus on companies with government contract diversification across multiple agencies and international allies to reduce single-customer risk. The most attractive investments typically feature proprietary technology through patents and specialized expertise that create competitive moats justifying premium valuations. Experienced management teams with deep defense industry connections and security clearances consistently accelerate contract wins, while financial discipline demonstrated through strong balance sheets and consistent cash flow generation proves crucial despite the lumpy nature of contract timing.
Small-cap defense investing requires careful risk assessment, as government budget cycles, security clearance requirements, and regulatory compliance create unique challenges. However, companies that successfully navigate these hurdles often enjoy sustained competitive advantages and multi-year revenue visibility that reward patient investors. The current environment of elevated geopolitical tensions, combined with technological disruption in warfare, creates an ideal backdrop for small-cap defense investments. While large-cap names grab immediate attention during crisis periods, the real long-term value creation often occurs in the innovative small companies that power the next generation of military capabilities. Smart investors should use market volatility as an opportunity to build positions in quality small-cap defense names before institutional recognition drives valuations higher.
Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.
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.
Noble Virtual Conference. On June 4, the company presented at the Noble Virtual Conference to the investment community. The presentation conducted by Heidy Chow, CFO, and Peter Lin, Sr. Manager, FP&A, highlighted the company’s release roadmap, unique product offerings, and portfolio diversification. A replay of the presentation can be viewed here.
Favorable release roadmap. The company has a busy release roadmap for 2025, which includes a 10th-anniversary expansion pack for ARK: Survival Evolved, a new expansion pack for ARK: Survival Ascended, and the release of Bellwright on Xbox in Q4. Additionally, nine new gaming titles are slated for 2025, including Robots at Midnight, Honeycomb, and Echoes of Elysium, which could have breakout potential. Additionally, the company recently expanded into new entertainment categories to further expand its portfolio.
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.
