PDF VersionManaged Complex Ground Integration Program of Critical Systems with Diverse Partners
SAN DIEGO, Sept. 29, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a technology company in Defense, National Security and Global Markets, has successfully completed the Preliminary Design Review (PDR) for the Space Development Agency’s Advanced Fire Control Ground Integration (AFCGI) system. Kratos’ successful completion of the PDR with zero liens allows the program to advance on an accelerated timeline, aligning with projected launch milestones.
As previously announced, in 2024 Kratos secured a $116.7 million prime contract for the AFCGI program. AFCGI integrates advanced software, resilient ground systems and secure networks into a unified architecture for real-time fire control. It is a complex capability providing the warfighter with immediate, mission-relevant advantages. Achieving zero liens signifies that all design challenges, risks and outstanding items identified during the review for this program were thoroughly addressed and resolved, ensuring no lingering issues remain that could impede the project’s progress. Kratos completed the PDR in April of 2025, only five months from the award date.
Greg Caicedo, Senior Vice President of Kratos Space, said, “Kratos is leading this strategic and complex program with our industry partners to meet SDA’s demand for speed. An advanced software-enabled approach delivered on aggressive timelines enables rapid adaptation and readiness far beyond what legacy hardware-centric systems can achieve.”
Kratos, along with its diverse team, will deliver and manage ground segment resources, operate a government-owned, contractor-operated (GOCO) demonstration center and run a secure cloud environment for mission software and partner system integration. Kratos will also provide program management, engineering, integration, testing and operations for the entire ground structure. Through its OpenSpace® platform, Kratos is integrating virtualized ground functions with advanced orchestration and automation, allowing software-defined scalability to support the complex demands of the program.
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.
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.
BRENTWOOD, Tenn., Sept. 29, 2025 (GLOBE NEWSWIRE) — CoreCivic, Inc. (NYSE: CXW) (“CoreCivic”) announced today that it has been awarded two new contracts with U.S. Immigration and Customs Enforcement (“ICE”) to utilize 3,593 beds at two facilities we own in core enforcement areas of the United States. Once fully activated, we expect to generate total annual revenue at the two facilities combined of nearly $200 million.
California City Immigration Processing Center – 2,560 beds
New contract with ICE to utilize our 2,560-bed California City Immigration Processing Center. We have been preparing to accept detainees at this facility since April 1, 2025, when we entered into a six-month Letter Contract with ICE to resume operations at the facility while we worked to negotiate and execute a longer-term contract.
We began receiving detainees at the facility on August 27, 2025 under terms of the Letter Contract. Transitioning from a Letter Contract to the definitive contract effective September 1, 2025 will result in variability in revenue and cash flow as we continue to successfully hire staff and receive additional detainees during the activation period. We currently expect the activation to be complete in the first quarter of 2026, achieving a normalized run-rate in the second quarter of 2026. Total annual revenue once the activation is complete is expected to be approximately $130 million. The new contract expires in August 2027.
Midwest Regional Reception Center – 1,033 beds
New contract with ICE at our 1,033-bed Midwest Regional Reception Center in Leavenworth, Kansas. We entered into a six-month Letter Contract with ICE on March 7, 2025 to begin activation efforts at the facility while we worked to negotiate and execute a longer-term contract. Although we have been successful in hiring staff and have prepared the facility to accept detainees during this term, the intake process has been delayed by legal challenges.
The new contract commenced on September 7, 2025, and is for a term of 24 months. The agreement provides for a fixed monthly payment plus an incremental per diem payment based on detainee populations, both of which commence once the temporary injunction currently prohibiting the intake of detainees is no longer enforceable. Total annual revenue once the facility is fully activated is expected to be approximately $60 million. However, we cannot predict if or when the legal challenges will be successfully resolved.
Damon T. Hininger, CoreCivic’s Chief Executive Officer, commented, “We are pleased to announce the finalization of contracts for these two facilities, both of which were idle at the beginning of the year. The geographic locations of each of these facilities will enhance our ability to support our government partner in its effort to enforce immigration laws in areas of need across the United States. Looking forward, we anticipate additional contracting activity that will help satisfy ICE’s growing needs.”
Patrick D. Swindle, CoreCivic’s President and Chief Operating Officer, added, “Once fully activated, these two facilities are expected to generate combined annual revenue of nearly $200 million. While the intake process has been delayed at the Midwest Regional Reception Center, we will offer newly hired employees opportunities to be redeployed at our other activations until the legal challenges are resolved. Our team continues to work hard on activating our idle facilities, which helps lay the foundation for continued earnings growth into 2026 and beyond.”
About CoreCivic
CoreCivic is a diversified, government-solutions company with the scale and experience needed to solve tough government challenges in flexible, cost-effective ways. We provide a broad range of solutions to government partners that serve the public good through high-quality corrections and detention management, a network of residential and non-residential alternatives to incarceration to help address America’s recidivism crisis, and government real estate solutions. We are the nation’s largest owner of partnership correctional, detention and residential reentry facilities, and one of the largest operators of such facilities in the United States. We have been a flexible and dependable partner for government for more than 40 years. Our employees are driven by a deep sense of service, high standards of professionalism and a responsibility to help government better the public good. Learn more at www.corecivic.com.
This press release includes statements as to our beliefs and expectations of the outcome of future events that are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements may include such words as “anticipate,” “estimate,” “expect,” “project,” “plan,” “intend,” “believe,” “may,” “will,” “should,” “can have,” “likely,” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. Such forward-looking statements may be affected by risks and uncertainties in CoreCivic’s business and market conditions. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements made. Important factors that could cause actual results to differ are described in the filings made from time to time by CoreCivic with the Securities and Exchange Commission (“SEC”) and include the risk factors described in CoreCivic’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 21, 2025. Except as required by applicable law, CoreCivic undertakes no obligation to update forward-looking statements made by it to reflect events or circumstances occurring after the date hereof or the occurrence of unanticipated events.
CERRITOS, Calif., Sept. 29, 2025 (GLOBE NEWSWIRE) — The Oncology Institute (NASDAQ: TOI), a pioneer in value-based community oncology care, is pleased to announce a new partnership with Protocol Behavioral Health, a leading provider of evidence-based mental health care for cancer patients. This collaboration underscores TOI’s commitment to delivering whole-person care by integrating behavioral health services directly into the cancer care journey.
Research shows that approximately 30% of cancer patients experience significant depression or anxiety, and oncologists widely agree that behavioral health support can benefit nearly every patient. Through this partnership, TOI patients will gain timely access to mental health services that are tailored specifically to the emotional and psychological challenges of cancer, with no waitlists and full integration into the patient’s care team, and the added benefit of services offered in multiple languages to support our diverse patient population.
“Anxiety and depression can greatly threaten a patient’s outcome by affecting their ability to complete treatment in the recommended time,” said Yale Podnos, MD, Chief Medical Officer at The Oncology Institute. “By embedding behavioral health services directly into our care model, we’re closing a critical gap in oncology and ensuring our patients have access to the support they need, exactly when they need it.”
Key Benefits of the Partnership:
Integrated Care Delivery: Protocol clinicians collaborate with TOI providers using the Collaborative Care Model (CoCM), an evidence-based framework proven to improve outcomes through team-based care.
Improved Access: Patients receive behavioral health support without delays, removing a major barrier to care in traditional mental health systems.
Specialized Expertise: Protocol’s behavioral health care managers and psychiatric providers are trained specifically to support oncology patients through diagnosis, treatment, survivorship, and beyond.
Improved Patient Outcomes: Studies link integrated behavioral health care to better treatment adherence, quality of life, and patient satisfaction.
“We founded Protocol to meet a clear need in oncology,” said Cara Bohon, PhD, Chief Clinical Officer of Protocol Behavioral Health. “Through this partnership, we’re ensuring that mental health care is not a luxury or an afterthought; it’s a core part of the patient’s treatment plan from day one.”
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.
Protocol Behavioral Health provides timely, evidence-based mental health care tailored to the unique needs of cancer patients. Using the Collaborative Care Model, Protocol integrates behavioral health managers and psychiatric providers directly into oncology care teams. This model ensures seamless coordination, personalized support, and better outcomes for patients experiencing depression, anxiety, and other behavioral health challenges.
NORWOOD, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed” or the “Company”) (CSE: MRMD) (OTCQX: MRMD), a leading cannabis consumer packaged goods company and retailer, announced today it will report its third quarter 2025 financial results on November 5, 2025 after the markets close. Management will host a conference call on November 6, 2025 at 8:00 a.m. EDT to discuss financial results.
A webcast will be available and can be accessed via MariMed’s Investor Relations website at MariMed Q325 Earnings Webcast. A playback of the call will also be made available on MariMed’s Investor Relations website.
About MariMed MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, InHouse™, Nature’s Heritage™, and Vibations™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.
Company Contact: Howard Schacter Chief Communications Officer Email: hschacter@marimedinc.com Phone: (781) 277-0007
Phase 2 randomized, double-blind, placebo-controlled trial planned to evaluate TNX-2900 in children and adolescents (ages 8 to 17.5 years) with Prader-Willi Syndrome under a cleared IND
TNX-2900 granted Orphan Drug and Rare Pediatric Disease Designations by the FDA, providing the potential for a Priority Review Voucher upon approval
Magnesium-potentiated intranasal oxytocin formulation designed to reduce dose-related inconsistencies in receptor activity
CHATHAM, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated commercial-stage biotechnology company with innovative marketed products and a pipeline of development candidates, today announced plans to progress its TNX-2900 program for the treatment of Prader-Willi syndrome (PWS) into a Phase 2 clinical trial. TNX-2900 is a proprietary magnesium-potentiated intranasal oxytocin formulation designed to improve receptor binding and decrease dose-related inconsistencies in receptor activity. The program has received both Orphan Drug and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA), which would make Tonix eligible for a transferable Priority Review Voucher, upon approval. The FDA has cleared the Investigational New Drug (IND) application for TNX-2900 to progress into Phase 2 development.
“We are pleased to advance TNX-2900 into a Phase 2 trial for PWS, a condition with unmet needs for new medicines with activity and tolerability,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Families caring for children with PWS face significant challenges and burdens. Among them is hyperphagia which drives persistent food-seeking behaviors that require constant supervision and often result in obesity and serious medical complications. With an average life expectancy of less than 30 years, treatment of PWS remains an urgent and unmet need. By addressing limitations of traditional oxytocin delivery, we believe TNX-2900 has the potential to become an FDA-approved therapy targeting the oxytocin receptor in PWS and provide meaningful benefit for patients and families living with this rare disorder.”
Tonix plans to conduct a Phase 2 randomized, double-blind, placebo-controlled, parallel-design study to evaluate the safety, tolerability, and efficacy of TNX-2900 in male and female participants with PWS, ages 8 to 17.5 years. Eligible participants will be randomized to receive 12-weeks of treatment with TNX-2900 at one of three dose levels, or placebo, in a 1:1:1:1 ratio. The primary efficacy endpoint will be the change from baseline in the validated Hyperphagia Questionnaire for Clinical Trials (HQ-CT), a widely used measure of hyperphagia severity in PWS. Secondary objectives will include assessments of behavior, caregiver burden, and quality of life measures, as well as safety and tolerability outcomes.
Prader-Willi syndrome (PWS) is a rare genetic disorder and the leading cause of life-threatening childhood obesity, affecting about 1 in 10,000 to 1 in 30,000 births. Infants often present with poor muscle tone and feeding difficulties, while children and adolescents develop hyperphagia, behavioral challenges, and severe obesity and metabolic disease. Current interventions are difficult to sustain and often inadequate.
Research suggests PWS is associated with a functional deficiency of oxytocin, a neuropeptide that regulates satiety and feeding behaviors through the oxytocin receptor. Oxytocin treatment addresses several key features of PWS expressed in the MAGEL2 (MAGE-like 2) knock-out mouse.1 Intranasal oxytocin therapy has shown benefits in infants with PWS.2 Carbetocin has a different spectrum of activity on oxytocin and vasopressin receptors than oxytocin and carbetocin has not been tested to our knowledge in the MAGEL2 knock-out mouse.3 Oxytocin has dose-related inconsistencies in receptor activity that have been described as “high-dose suppression” or an “inverted “U” dose response.4 TNX-2900 is formulated with magnesium to further enhance oxytocin receptor binding and signaling, with the goal of providing more consistent and selective receptor activation while minimizing off-target vasopressin effects. In vitro and in vivo in animals Mg++– containing formulations reduce these inconsistencies.4
About Prader-Willi Syndrome (PWS)
PWS is recognized as the most common genetic cause of life-threatening childhood obesity and affects males and females with equal frequency and all races and ethnicities. PWS results from the absence of expression of a group of genes, specifically related to the MAGE (melanoma antigen) gene family on the Prader–Willi critical region (15q11–q13) on the paternally acquired chromosome. The hallmarks of PWS are lack of suckling in newborns and, in children and adolescents, severe hyperphagia – an overriding physiological drive to eat, leading to severe obesity and other complications associated with significant mortality. A systematic review of the morbidity and mortality as a consequence of hyperphagia in PWS found that the average age of death in PWS was 22.1 years.5 Given the serious or life-threatening manifestations of these conditions, there is a critical need for effective treatments to decrease morbidity and mortality, improve quality of life, and increase life expectancy in people with PWS. Oxytocin has potent effects in correcting behavioral characteristics of the MAGEL2 knock-out mouse model for PWS and autism. 1,6,7 Six clinical trials have investigated intranasal oxytocin as a treatment in pediatric patients with PWS. Four clinical studies showed evidence for improvement in PWS-related behaviors/symptoms/2,810 Three of these clinical studies reported evidence for improvement in hyperphagia8-10 and one showed an improvement in sucking in infants.2
Schaller F, et al. Hum Mol Genet. 2010. 19:4895-4905.
Tauber M, et al. Pediatrics. 2017. 139(2):e20162976.
Meyerowitz JG, et al. Nat Struct Mol Biol. 2022 29(3):274-281.
Bharadwaj VN, et al. Pharmaceutics. 2022 14(5):1105.
Bellis SA, et al. Eur J Med Genet. 2022. 65(1):104379.
Bertoni A, et al. Mol Psychiatry. 2021. 26(12):7582-7595.
Meziane H, et al. Biol Psychiatry. 2015. 78: 85-94.
Kuppens RJ, et al. Clin Endocrinol. 2016. 85:979-987.
Miller JL et al. Am J Med Genet A. 2017. 173:1243-1250.
Damen L, et al. Clin Endocrinol. 2020. 94:774-785.
About TNX-2900 and Tonix’s Potentiated Oxytocin Platform
TNX-2900 is based on Tonix’s patented intranasal Mg2+-potentiated oxytocin formulation intended for use by children and adolescents. This formulation is believed to enhance the potency of oxytocin as well as increase specificity for oxytocin receptors relative to vasopressin receptors, potentially reducing unwanted side effects from activating vasopressin receptors. In collaboration with academic investigators, Tonix is also testing a different intranasal formulation, designated TNX-1900 for adolescent obesity, binge eating disorder, bone health in autism, and social anxiety disorder. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin is believed to be more than 600 million years old and is present in vertebrates including mammals, birds, reptiles, amphibians, and fish. It was initially approved by the U.S. Food and Drug Administration as Pitocin®, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor and control postpartum bleeding or hemorrhage. An intranasal formulation of oxytocin is marketed in some European countries to assist in breast milk production as Syntocinon® (oxytocin nasal 40 international units/ml).
Tonix Pharmaceuticals Holding Corp.*
Tonix Pharmaceuticals is a commercial-stage, fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix recently 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 and infectious diseases. 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). 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’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS
TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS
Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
DRUG INTERACTIONS
MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information.
To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Danish biotechnology company Genmab (Nasdaq: GMAB) has agreed to acquire Dutch oncology firm Merus (Nasdaq: MRUS) in an all-cash transaction valued at roughly $8 billion, a move that significantly expands Genmab’s late-stage pipeline and accelerates its push toward a fully owned operating model.
Under the terms of the deal, Genmab will pay $97.00 per share for all outstanding common shares of Merus, representing a premium of more than 40% over Merus’ most recent closing price. The boards of both companies have unanimously approved the transaction, which is expected to close by the first quarter of 2026 pending regulatory and shareholder approvals.
The acquisition brings Merus’ lead asset, petosemtamab, into Genmab’s pipeline. The bispecific antibody therapy, currently in Phase 3 clinical trials, has received two Breakthrough Therapy Designations from the U.S. Food and Drug Administration for treatment of head and neck cancers. Recent Phase 2 data presented at the 2025 ASCO meeting indicated promising efficacy, with outcomes surpassing standard of care benchmarks.
The addition of petosemtamab is expected to bolster Genmab’s transition to a fully owned model, reducing reliance on partnerships and collaborations. By 2027, Genmab anticipates four proprietary programs reaching the commercial stage, positioning the company for multiple new product launches within oncology.
Petosemtamab’s potential launch as early as 2027 could deliver significant commercial impact, with projections suggesting annual sales of $1 billion by 2029 and the possibility of multi-billion-dollar revenues in the longer term. Genmab expects the acquisition to become accretive to EBITDA before the end of the decade.
The $8 billion consideration will be financed through a combination of cash on hand and approximately $5.5 billion in debt, backed by commitments from Morgan Stanley Senior Funding. Genmab stated it remains committed to deleveraging, with a target of reducing gross leverage below three times within two years of closing.
A tender offer for Merus shares will launch in the coming weeks. If successful, the transaction will result in Merus becoming a wholly owned subsidiary of Genmab. Shareholders who do not tender their shares are expected to receive equivalent value through statutory buy-out proceedings in the Netherlands.
The deal highlights the intense competition among biotech companies to secure late-stage oncology assets with strong regulatory momentum. By integrating Merus’ multispecific antibody expertise, Genmab gains not only a promising drug candidate but also a platform that complements its own antibody development technologies.
For Merus, the acquisition provides the scale and resources of a global biotechnology leader to advance petosemtamab through late-stage development, regulatory review, and potential commercialization.
With a strong balance sheet, an expanded pipeline, and an emphasis on proprietary innovation, Genmab is positioning itself to compete more directly with larger global oncology players in the second half of the decade.
SASKATOON, Saskatchewan, Canada, September 26, 2025 – MustGrow Biologics Corp. (TSXV: MGRO) (OTC: MGROF) (FRA: 0C0) (the “Company” or “MustGrow”) today announced that the board of directors of the Company authorized and approved the grant of a total of1,660,315 deferred share units (“DSUs”) and restricted share units (“RSUs”) to certain directors, officers, and consultants of the Company, effective September 25, 2025. This grants of DSUs and RSUs are made pursuant to the Company’s Omnibus Equity Incentive Plan (the “Plan”).
The DSUs will vest when the holder ceases to be a director, officer or employee of the Company or any of its affiliates, as applicable. On settlement, each DSU will entitle the holder to recive to receive one common share in the capital of the Company or a cash payment equivalent thereof at the discretion of the Company.
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About MustGrow
MustGrow Biologics Corp. is a fully-integrated provider of innovative biological and regenerative agriculture solutions designed to support sustainable farming. The Company’s proprietary and third-party product lines offer eco-friendly alternatives to restricted or banned synthetic chemicals and fertilizers. In North America, MustGrow offers a portfolio of third-party crop nutrition solutions, including micronutrients, nitrogen stabilizers, biostimulants, adjuvants and foliar products. These products are synergistically distributed alongside MustGrow’s wholly-owned proprietary products and technologies that are derived from mustard and developed into organic biocontrol and biofertility products to help replace banned or restricted synthetic chemicals and fertilizers. Outside of North America, MustGrow is focused on collaborating with agriculture companies, such as Bayer AG in Europe, the Middle East and Africa, to commercialize MustGrow’s wholly-owned proprietary products and technologies. The Company is dedicated to driving shareholder value through the commercialization and expansion of its intellectual property portfolio of approximately 109 patents that are currently issued and pending, and the sales and distribution of its proprietary and third-party product lines through NexusBioAg. MustGrow is a publicly traded company (TSXV-MGRO) and has approximately 58.9 million common shares issued and outstanding and 69.1 million shares fully diluted. For further details, please visit www.mustgrow.ca.
This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.
Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.
CULVER CITY, Calif., Sept. 26, 2025 (GLOBE NEWSWIRE) — Snail, Inc. (Nasdaq: SNAL) (“Snail Games” or the “Company”), a leading global independent developer and publisher of interactive digital entertainment, announced its participation in this year’s Steam Autumn Sale, starting from September 29, 2025 through October 6, 2025. By featuring flagship titles, early access projects, and indie publishing partnerships, Snail aims to leverage this event as an opportunity to showcase portfolio depth, increase visibility, and potentially broaden its player base across multiple market segments.
Featured Discounts and Content Highlights:
ARK: Survival Ascended – 50% Off – Jump into the ultimate dinosaur survival adventure at 50% off and experience ARK like never before.
Bellwright – 20% Off – With over 1 million Steam wishlists, Bellwright remains in early access and may benefit from the visibility generated through seasonal events during its path to 1.0.
West Hunt – 50% Off – A social deduction party game that has developed its audience through visibility among multiplayer and streaming communities.
Survivor Mercs – 38% Off – An early access roguelite extraction shooter, where Snail anticipates that additional exposure during the sale may support community growth in advance of its 1.0 release.
Robots at Midnight – 30% Off – Designed as an accessible entry point into soulslike gameplay, the title combines immersive exploration, fast-paced combat, and a striking retro-futuristic setting.
Zombie Rollerz: The Last Ship – 19% Off – Stands out in the crowded roguelite and bullet heaven space by fusing tower defense strategy with bullet-dodging chaos, bringing a fresh twist to genre conventions through hybrid innovation.
Snail views seasonal promotions as a key element of its broader publishing strategy. During the recent Annual Steam Publisher Sale Event in June, significant discounts on many of its titles helped drive in-game engagement and sustained momentum throughout the month. Following the sale, ARK: Survival Evolved experienced a notable resurgence in both player engagement and sales, with over 3.8x total units sold, average daily sales increasing by 3,022% compared to prior months in 2025 and concurrent players peaking at 65,885 during the recent Steam Publisher Sale. These seasonal promotional events are designed to lower barriers to entry, making it easier for new players to explore established franchises while also drawing attention to early access projects still in active development. By participating in the Steam Autumn Sale, the Company aims to continue driving engagement for its established games while increasing exposure for indie and up-and-coming titles. This multifaceted approach has the potential to both diversify Snail’s player base and strengthen long-term engagement across its portfolio.
For creators interested in collaborative opportunities please reach out to creatordirect@noiz.gg
About Snail, Inc. Snail, Inc. (Nasdaq: SNAL) 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. For more information, please visit: https://snail.com/.
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this press release can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “may,” “predict,” “continue,” “estimate” and “potential,” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places in this press release and in our public filings with the SEC and include, but are not limited to, statements regarding the possibility that these seasonal promotions will reduce barriers to entry and our multifaceted approach has the potential to both diversify Snail’s player base and strengthen long-term engagement across out portfolio. You should carefully consider the risks and uncertainties described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed by the Company with the SEC on March 26, 2025 and other documents filed by the Company from time to time with the SEC, including the Company’s Forms 10-Q filed with the SEC. The Company does not undertake or accept any obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based.
Investor Contact: John Yi and Steven Shinmachi Gateway Group, Inc. 949-574-3860 SNAL@gateway-grp.com
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
2Q26. In what is likely the Company’s final quarterly report as a public company, Steelcase reported better than expected results. Results benefitted from continued strengthening of demand from large corporate customers and International growth driven by India, China, and the United Kingdom. Improved International volume drove a $5 million reduction in y-o-y adjusted operating loss in the International segment. These were Steelcase’s highest quarterly results over the past five years.
Financials. Revenue of $897.1 million rose 4.8% y-o-y and exceeded the $890 million high end of management’s guidance. We were at $875 million. Gross margin of 34.4% was flat y-o-y and exceeded the 33.5% high end of guidance. Adjusted EBITDA totaled $99.6 million, or 11.1% of revenue, up from $89.5 million and 10.5% in 2Q25. Adjusted EPS was $0.45, versus $0.39 last year and above management’s $0.40 high end guide. We were at $0.36.
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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.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Hans Baldau, Associate Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Updating estimates. We are lowering our second-quarter revenue, adjusted EBITDA, and adjusted EPS estimates to $428.3 million, $93.4 million, and $1.54, respectively, from $433.5 million, $101.1 million, and $1.59. While we have increased our revenue estimate for the Metal Coatings segment, we lowered expectations for Precoat Metals due to anticipated weakness in building construction. Our FY 2026 revenue, adjusted EBITDA, and adjusted EPS estimates are $1.660 billion, $374.9 million, and $6.00, respectively, compared to our prior estimates of $1.680 billion, $388.3 million, and $6.00. Our revised estimates reflect lower interest expense, along with modestly lower depreciation and amortization expense.
Organic and acquired growth. AZZ’s three-year goals include generating sales of two billion dollars or more in fiscal year 2028, compared to its trailing twelve-month sales of $1.6 billion. Organic growth is expected to exceed GDP growth, and AZZ is targeting acquisitions that strengthen both of its business segments. While we do not forecast sales of $2.0 billion until 2031, our model does not reflect acquisitions until they are announced.
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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.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Second quarter financial results. As an exploration company, Aurania does not generate revenue and has expenses to advance its projects. During the second quarter of 2025, the company generated a net loss of C$1,610,843 or C$0.01 per share. We had projected a loss of C$1,432,419 or C$0.01 per share. The variance to our estimate was mostly due to higher exploration expenditures, along with higher stock-based compensation. We project a full-year 2025 net loss of C$11.1 million, or C$(0.10) per share, compared to our prior loss estimate of C$10.5 million, or C$(0.09) per share.
Mining service fee. Ecuador recently implemented a new mining service fee on the resource sector (refer to our note dated July 29, 2025). The Ecuadorian Control and Regulation Agency (ARCOM) requested payment from Aurania of US$2,012,618 by July 31, 2025, representing one month of the total annual fee of US$24,151,420. While the penalty for non-payment is unclear, we think Aurania is withholding payment until it becomes clear whether TASA will stand in its current form due to multiple constitutional challenges.
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.
U.S. consumer spending rose more than expected in August, reinforcing the strength of the economy even as inflation continued to edge higher. The Commerce Department reported that household expenditures advanced 0.6% last month, surpassing forecasts of a 0.5% gain and extending July’s 0.5% increase. The results suggest that the economy maintained much of its momentum from the second quarter, when growth hit its fastest pace in nearly two years.
Households increased spending across both services and goods. Travel and leisure categories saw notable gains, with more Americans booking airline tickets, staying in hotels, and dining out. Spending at restaurants and bars remained elevated, while recreational services also benefited from strong demand.
Goods purchases rose 0.8% in August, driven by sales of recreational equipment, clothing, and gasoline. Services spending, which accounts for the bulk of household consumption, advanced 0.5%, in line with the previous month.
This broad-based spending has been supported by wealth gains among higher-income households. Rising stock prices and elevated home values have bolstered balance sheets, allowing affluent consumers to maintain strong levels of discretionary spending. By contrast, lower-income families continue to face challenges from higher food and energy costs, as well as upcoming reductions in federal nutrition assistance programs.
The Personal Consumption Expenditures (PCE) Price Index, the Federal Reserve’s preferred inflation gauge, climbed 0.3% in August following a 0.2% gain in July. On a year-over-year basis, prices rose 2.7%, the largest annual increase since February. Core PCE, which excludes volatile food and energy categories, remained elevated at 2.9%.
The acceleration in prices reflects the lingering impact of tariffs and supply constraints. Many businesses have so far absorbed part of the higher costs rather than pass them directly to consumers, but economists caution that this trend is unlikely to continue indefinitely. As inventories accumulated before tariffs are depleted, broader price pressures could emerge.
Personal income rose 0.4% in August, with a significant portion of the gain stemming from government transfer payments. Wage growth was comparatively modest at 0.3%, highlighting persistent weakness in the labor market. Job creation has slowed considerably in recent months due to policy uncertainty and tighter immigration rules, which have limited labor supply.
This divergence between resilient spending and softer hiring raises questions about the durability of consumption in the months ahead. While households are still fueling growth today, slower income gains could eventually restrain demand, especially if inflation remains elevated.
The Atlanta Fed currently projects third-quarter GDP growth of 3.3%, down slightly from the 3.8% expansion recorded in the second quarter. Analysts expect consumer spending to cool toward the end of the year as higher prices weigh on purchasing power and government support programs wind down.
For now, household consumption remains the key driver of U.S. economic expansion. Whether this momentum can continue in the face of rising inflation and labor market challenges will be a central focus for policymakers and investors heading into the final quarter of 2025.
President Donald Trump unveiled a sweeping new round of tariffs on Thursday, targeting industries from pharmaceuticals to heavy trucks and furniture in what marks one of the most aggressive expansions of his trade agenda to date. The tariffs will range from 30% to 100%, with the heaviest duties falling on patented prescription drugs unless their producers establish manufacturing facilities within the United States.
The pharmaceutical sector sits at the center of the new policy. Under the plan, companies that are not actively building domestic plants face tariffs as high as 100% on patented drugs imported into the U.S. The administration has framed the move as a way to push drugmakers to “reshore” production after years of relying on overseas supply chains.
The measures add new layers to Trump’s already extensive tariff program, which has been rolled out in waves since 2018. While the pharmaceutical duties were previewed earlier this year, the inclusion of industries such as furniture and heavy trucks represents a new front in the administration’s trade efforts.
The White House is also signaling plans to reshape semiconductor supply chains. According to administration officials, chipmakers will be asked to manufacture in the U.S. at least as many chips as they sell domestically, with tariffs applied to firms that fail to meet a 1:1 production-to-import ratio. The move comes amid concerns about the nation’s reliance on foreign-made semiconductors, a vulnerability highlighted by recent supply disruptions.
Trump has suggested using tariff revenue to support U.S. farmers who may be squeezed by the new trade measures. He has argued that while agricultural producers could feel pain in the short term, tariff-driven policy shifts would ultimately benefit them. Still, it remains unclear how relief would be delivered. Any bailout plan could run into legal hurdles, with the Supreme Court preparing to weigh in on challenges to the tariff program. Lower courts have previously ruled against aspects of the administration’s trade authority, raising the possibility that billions in tariff collections could be subject to refund.
The tariff announcement arrives as the U.S. and China move toward broader trade negotiations. Reports indicate the two nations are finalizing a large aircraft purchase by Beijing, potentially involving Boeing, which could serve as a centerpiece of a wider agreement. Trump has described the discussions with Chinese President Xi Jinping as “productive,” noting that the two leaders have agreed to continue talks in the coming months.
The administration has also linked progress in trade talks with other economic and political issues. Earlier this month, the White House confirmed that Oracle would participate in a U.S.-based consortium to manage TikTok operations, part of a wider effort to reshape the economic relationship between the world’s two largest economies.
Investors remain divided on the long-term effects of the new tariffs. While supporters argue the measures will bring manufacturing jobs back to U.S. soil and strengthen domestic industries, critics warn that higher costs could be passed on to consumers and businesses, dampening growth. The pharmaceutical sector, in particular, could face significant disruption as companies weigh the high costs of reshoring production against the risk of steep import penalties.
With the 2024–2025 trade agenda expanding rapidly, the coming months will test whether the administration can balance its protectionist push with the need to maintain global supply chains and avoid further economic strain.
