ORLANDO, Fla., Sept. 10, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB) (NASDAQ:NTRBW) reported its financial results for the six months ended July 31, 2025. The company reported a strong cash position at quarter end, reinforcing its ability to advance the development of its lead product, AVERSA™ Fentanyl which has been granted a Type C meeting on September 18th.
Nutriband is continuing to expand its kinesiology tape contract manufacturing services through its Pocono Pharma subsidiary. The company produced a record six months, reporting revenue of $1,289,884, up 50.87% YOY.
Progress continues on the development of AVERSA Fentanyl, Nutriband is reminding exiting shareholders and updating new shareholders on its development pathway, emphasizing that the NDA will primarily rely on data from a single phase 1 Human Abuse Potential study. Importantly, no Phase 2 or Phase 3 clinical trials will be required before submission.
If approved, AVERSA Fentanyl could become the first and only abuse-deterrent transdermal patch available globally. AVERSA Fentanyl is estimated to have the potential to reach peak annual sales of $80-$200 million, according to a market analysis report from Health Advances.
AVERSA Buprenorphine, which is the company’s second application for AVERSA, is projected to reach peak annual sales of up to $130 million.
As of July 31, 2025, Nutriband’s cash reserves stand at $6.9 million, supporting the company’s ongoing development and commercialization efforts for AVERSA Fentanyl. The company’s total assets are valued at $10.17 million, with stockholders’ equity amounting to $8.5 million.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company’s website is www.nutriband.com. Any material contained in or derived from Company’s websites or any other website if not part of this press release.
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Form 10-K for the year ended January, 2025, filed April 28, 2025, the Forms 10-Q’s filed subsequent to the Form 10-K in 2025, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
For more information, contact:
Nutriband Inc. Phone: 407-377-6695 Email: info@nutriband.com
STAFFORD, Texas, Sept. 10, 2025 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that FDA has granted Fast Track designation for GLSI-100 in the HLA-A*02 patient population.
The designation specifically states that “GLSI-100 for the treatment of patients with HLA-A*02 genotype and HER2-positive breast cancer who have completed treatment with standard of care HER2/neu targeted therapy to improve invasive breast cancer free survival meets the criteria for Fast Track designation.”
The Fast Track designation for GLSI-100 may lead to earlier drug approval as the Company and the FDA can communicate more frequently to expedite the Biologic License Application (BLA) filing of the clinical and manufacturing data from FLAMINGO-01. The Company may be able to utilize a rolling review process, where completed parts of the BLA can be submitted for review, even though other parts of the application are still being completed.
Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, “Greenwich is pleased that the FDA sees the potential of GLSI-100 to change important clinical outcomes in this population of breast cancer patients. We continue to work earnestly to collect data to support a BLA filing demonstrating this benefit.”
CEO Snehal Patel commented, “We are excited to have received Fast Track designation. The FDA review of our Fast Track application included a review of the potential of GLSI-100 as a new drug to treat serious conditions and to fill unmet medical need. By showing the potential of GLSI-100 to prevent metastatic breast cancer recurrence in the patient population that we are studying, we were able to estimate the potential lives that could be saved. The Company plans to continue discussions with the FDA, and potentially the European regulatory authorities, to explore additional ways to make GP2 and GLSI-100 available to larger populations.”
“Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions…Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy…Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.”
The FDA website further states:
“Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:
Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
Avoiding serious side effects of an available therapy
Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
Ability to address emerging or anticipated public health need
A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA”
Previously Published Phase IIb Data
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:
80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up compared to 20-50% reduction in recurrence rate by other approved products
Peak immune response at 6 months
No reported serious adverse events attributable to treatment
Well-tolerated safety profile
Full immunization was received in the Primary Immunization Series (PIS), which included the first 6 GLSI-100 injections over the first 6 months. The PIS elicited a potent immune response as measured by local skin tests and immunological assays. Further, booster injections given every 6 months prolonged the immune response, thereby providing longer-term protection. In the Phase IIb and three Phase I clinical trials, where 146 patients were treated, the GP2 immunotherapy was well tolerated, and there were no reported serious adverse events related to GLSI-100.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Investor & Public Relations Contact for Greenwich LifeSciences Dave Gentry RedChip Companies Inc. Office: 1-800-RED CHIP (733 2447) Email: dave@redchip.com
SASKATOON, Saskatchewan, Canada, September 10, 2025 – MustGrow Biologics Corp. (TSXV: MGRO; OTC: MGROF; FRA: 0C0) (the “Company” or “MustGrow”), is pleased to announce it has secured a $2.0 million line of credit with Canadian Imperial Bank of Commerce, guaranteed by Canada’s Export Development Canada (“EDC”) (the “LOC”).
Access to funds will allow MustGrow to produce its organic mustard-derived biofertility product TerraSanteTM to meet growing demand from U.S. commercial farming operations. In addition, the LOC will help support working capital requirements for its Canadian sales and distribution division, NexusBioAg.
The LOC carries a interest rate linked to Canada’s prime rate plus 1.00%, per annum. The current Canadian prime rate is 4.95%. EDC has guaranteed the LOC on MustGrow’s behalf. MustGrow will endeavour to increase the LOC size to support accelerating TerraSanteTM product demand in the U.S.
“We are seeing significant uptake from large U.S. commercial farming operations which further validates the effectivess, efficiency, and economics of our organic biofertility product TerraSanteTM,” asserted Corey Giasson, President and CEO of MustGrow. “Utilizing our LOC on such favourable terms will enable us to build inventory to meet increasing U.S. demand for TerraSanteTM and support NexusBioAg’s growing operations here in Canada.”
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 67.5 million shares fully diluted. For further details, please visit www.mustgrow.ca.
Contact Information
Corey Giasson Director & CEO Phone: +1-306-668-2652 info@mustgrow.ca
MustGrow Forward-Looking Statements
Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.
Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include: the receipt of final approval by the TSXV and those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2024 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available on SEDAR+ at www.sedarplus.ca. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.
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.
FORT HOOD, Texas, Sept. 9, 2025 /PRNewswire/ — This month marks the 11th anniversary of the Shifting Gears Automotive Technician Training Program, a collaborative initiative between V2X Inc. (NYSE: VVX), General Motors (GM), and the U.S. Army at Fort Hood. For more than a decade, this innovative program has provided transitioning service members with valuable hands-on training and career pathways as certified GM service technicians.
Since its inception, more than 50 graduating cohorts have completed the eight-week program, that’s about 1,000 students, equipping veterans with in-demand technical skills and preparing them for careers at GM dealerships nationwide. Every graduate has been successfully placed at a GM dealership, with many advancing to achieve World Class Technician status, the highest certification level available to GM technicians.
“Celebrating 11 years of Shifting Gears is more than just recognizing a program, it’s honoring the service members whose dedication continues beyond the uniform,” said Jeremy C. Wensinger, President and Chief Executive Officer at V2X. “Through this partnership, we’re ensuring that our nation’s veterans have the skills, stability, and opportunity they deserve as they transition into civilian careers.”
The program represents a cornerstone of V2X’s commitment to supporting warfighters throughout their journey, from delivering world-class training under the Army’s largest training contract (W-TRS), to preparing them for civilian success.
“This program not only builds financial stability for veterans but also ensures dealerships across the country benefit from the discipline, technical expertise, and problem-solving skills of those who have served,” said Wensinger.
The Shifting Gears Automotive Technician Training Program stands as a model of public-private collaboration, providing enduring value for veterans, industry, and communities nationwide.
About V2X V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations IR@goV2X.com 719-637-5773
Media Contact Angelica Spanos Deoudes Director, Corporate Communications Angelica.Deoudes@goV2X.com 571-338-5195
VANCOUVER, BC, September 8, 2025 – Nicola Mining Inc. (the “Company” or “Nicola”) (TSX: NIM) (OTCQB: HUSIF) (FSE: HLIA) announces that it has commenced shipping of gold concentrate via a partnership with Talisker Resources Ltd. (TSX: TSK) (OTCQX: TSKFF) (“Talisker”). Under a Mining, Milling and Smelting Agreement, the parties sold 707 ounces of gold in August, generating gross proceeds of approximately US$2.3 million.
Production benefited from extensive upgrades that included automation of several aspects of concentrate production, for the purpose of flotation recovery. In addition, the Company’s installation of a large concentrator optimized free gold recovery, which is important for ore from Talisker and the Company’s Dominion Gold Project. The Company confluence of numerous upgrades clearly impacted recovery and highlights Nicola’s ability to ramp up future production.
Pre-Processed Ore and Bagged Flotation Concentrate
Mr. Peter Espig, CEO of the Company, commented: “The culmination of our continuous multiple mill facility upgrades is the solidification of Nicola becoming a producer that is poised to benefit from gold and silver prices. The Company continues to conduct work at its 100% of Treasure Mountain, a high-grade silver mine for which the mill was originally constructed. The permitting and production of our partners highlights BC’s Ministry of Mining and Critical Minerals active support of smaller projects, for which we believe Nicola will become a hub.
Bagged Gravity Concentrate and Gravity Concentrate Close Up
About Nicola Mining
Nicola Mining Inc. is a junior mining company listed on the Exchange and Frankfurt Exchange that maintains a 100% owned mill and tailings facility, located near Merritt, British Columbia It has signed Mining and Milling Profit Share Agreements with high grade gold projects. Nicola’s fully permitted mill can process both gold and silver mill feed via gravity and flotation processes.
The Company owns 100% of the New Craigmont Project, a high-grade copper property, which covers an area of over 10,800 hectares along the southern end of the Guichon Batholith and is adjacent to Highland Valley Copper, Canada’s largest copper mine. The Company also owns 100% of the Treasure Mountain Property, which includes 30 mineral claims and a mineral lease, spanning an area exceeding 2,200 hectares.
On behalf of the Board of Directors
“Peter Espig” Peter Espig CEO & Director
For additional information Contact: Bill Cawker Phone: (604) 649 0080 Email: info@nicolamining.com
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.
CHICAGO, Sept. 08, 2025 (GLOBE NEWSWIRE) — FreightCar America, Inc. (NASDAQ: RAIL) (the “Company” or “FreightCar”) announced today that its Board of Directors (the “Board”) has adopted a limited duration stockholder rights plan (the “Rights Plan”) to protect the best interests of all FreightCar America, Inc. stockholders. The Rights Plan is effective immediately and will expire on August 5, 2026, unless terminated earlier by the Board.
The plan is intended to enable all stockholders to realize the long-term value of their investment and protect against any potential efforts to obtain control of the Company that are inconsistent with the best interests of its stockholders.
“Over the past several years, we have fully re-engineered our business and are now actively executing on a strategic plan to deliver substantial growth and long-term value creation. Following an analysis of our current position, the Board determined it was appropriate to adopt a rights plan to promote the fair and equal treatment of all the Company’s stockholders,” said Jim Meyer, Chairman of FreightCar America.
“We believe that there is significant upside ahead as we drive execution across our business, particularly given our leading margin profile and continued growth in market share,” said Nick Randall, President and Chief Executive Officer of FreightCar America. “Our management team is focused on advancing our commercial strategy with the inclusion of tank car conversions and other value-add solutions, while also continuing to support our flexible manufacturing model, which has proved itself to be a key competitive advantage for us and a hallmark of our approach.”
The Board adopted the Rights Plan following a review of the Company’s current ownership structure. The Rights Plan is intended to reduce the likelihood that any person or group gains control of the Company through open-market accumulation or other tactics without paying an appropriate control premium or providing the Board sufficient time to make informed decisions that are in the best interests of the Company and all FreightCar America stockholders. The Rights Plan is not intended to deter offers or preclude the Board from considering offers that are in the best interest of the stockholders.
About the Rights Plan The Rights Plan is similar to plans adopted by other publicly-traded companies. In connection with the adoption of the Rights Plan, the Board of Directors declared a non-cash dividend distribution of one preferred share purchase right for each share of the Company’s common stock outstanding as of September 2, 2025, the record date. In general terms, the rights will become exercisable only if a person or group acquires 15% or more of the outstanding common stock of the Company without the approval of the Board (or 20% or more in the case of passive investors who are eligible to, and do, report their holdings on Schedule 13G). In the event that the rights become exercisable, each right will entitle stockholders (other than the acquiring person or group) to buy shares of FreightCar’s common stock at a 50% discount. The rights of the acquiring person or group in that event will become void and not exercisable.
This announcement is a summary only and is qualified by reference to the full text of the Rights Plan. Additional details regarding the Rights Plan will be contained in a Form 8-K to be filed by the Company with the U.S. Securities and Exchange Commission.
About FreightCar America
FreightCar America, headquartered in Chicago, Illinois, is a leading designer, producer and supplier of railroad freight cars, railcar parts and components. We also specialize in railcar repairs, complete railcar rebody services and railcar conversions that repurpose idled rail assets back into revenue service. Since 1901, our customers have trusted us to build quality railcars that are critical to economic growth and instrumental to the North American supply chain. To learn more about FreightCar America, visit www.freightcaramerica.com.
Forward-Looking Statements
This press release contains statements relating to our expected financial performance, financial condition, and/or future business prospects, events and/or plans that are “forward-looking statements” as defined under the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our estimates and assumptions only as of the date of this press release. Our actual results may differ materially from the results described in or anticipated by our forward-looking statements due to certain risks and uncertainties. These risks and uncertainties relate to, among other things, the cyclical nature of our business; adverse geopolitical, economic and market conditions, including inflation; material disruption in the movement of rail traffic for deliveries; fluctuating costs of raw materials, including steel and aluminum; delays in the delivery of raw materials; our ability to maintain relationships with our suppliers of railcar components; our reliance upon a small number of customers that represent a large percentage of our sales; the variable purchase patterns of our customers and the timing of completion; delivery and customer acceptance of orders; the highly competitive nature of our industry; the risk of lack of acceptance of our new railcar offerings; potential unexpected changes in laws, rules, and regulatory requirements, including tariffs and trade barriers (including recent United States tariffs imposed or threatened to be imposed on China, Canada, Mexico and other countries and any retaliatory actions taken by such countries); and other competitive factors. The factors listed above are not exhaustive. New factors emerge from time to time that may cause our business not to develop as we expect, and it is not possible for us to predict all of them. We expressly disclaim any duty to provide updates to any forward-looking statements made in this press release, whether as a result of new information, future events or otherwise.
Seven-Year Benihana CFO to Lead Accounting and Finance Organization
DENVER–(BUSINESS WIRE)– The ONE Group Hospitality, Inc. (“The ONE Group” or the “Company”) (Nasdaq: STKS) today announced the appointment of Nicole Thaung as Chief Financial Officer effective, September 8, 2025. Ms. Thaung will succeed Tyler Loy, who is departing the Company to pursue other opportunities.
“Nicole’s extensive financial knowledge and deep understanding of our business make her the ideal leader for our finance organization,” said Emanuel “Manny” Hilario, Chief Executive Officer. “Her leadership has been instrumental in the seamless integration of the Benihana acquisition. Nicole’s expertise will be invaluable as we continue realizing the $20 million in expected synergies from this transformative acquisition, which now represents over 55% of our total revenues. We remain on track to capture the full value of these synergies by the end of 2026.”
Ms. Thaung has over 15 years of experience with Benihana, where she has served as CFO since August 2018. Prior to her CFO role, Ms. Thaung held progressive leadership positions at Benihana including Vice President of Finance and Controller. Before joining Benihana in 2009, she spent nearly eight years at Ernst & Young LLP, with her last role being that of Audit Manager. Ms. Thaung holds bachelor’s and master’s degrees in accounting from the University of Florida.
“We thank Tyler for his contributions over the years with The ONE Group,” added Hilario. “We wish him success in his future endeavors.”
About The ONE Group
The ONE Group Hospitality, Inc. (Nasdaq: STKS) is an international restaurant company that develops and operates upscale and polished casual, high-energy restaurants and lounges and provides hospitality management services for hotels, casinos and other high-end venues both in the U.S. and internationally. The ONE Group’s focus is to be the global leader in Vibe Dining, and its primary restaurant brands and operations are:
STK, a modern twist on the American steakhouse concept with restaurants in major metropolitan cities in the U.S., Europe and the Middle East, featuring premium steaks, seafood and specialty cocktails in an energetic upscale atmosphere.
Benihana, an interactive dining destination with highly skilled chefs preparing food right in front of guests and served in an energetic atmosphere alongside fresh sushi and innovative cocktails. The Company franchises Benihanas in the U.S., Caribbean, Central America, and South America.
Benihana Express, a small footprint casual concept showcasing the best of Benihana but without teppanyaki tables or bar.
Kona Grill, a polished casual, bar-centric grill concept with restaurants in the U.S., featuring American favorites, award-winning sushi, and specialty cocktails in an upscale casual atmosphere.
RA Sushi, a Japanese cuisine concept that offers a fun-filled, bar-forward, upbeat, and vibrant dining atmosphere with restaurants in the U.S. anchored by creative sushi, inventive drinks, and outstanding service.
Salt Water Social is your gateway to the seven seas, featuring an array of signature and unique fresh seafood items, complemented by the highest quality beef dishes and elegant, delicious cocktails.
Samurai, an interactive dining experience located in sunny Miami, FL, provides a distinctive dining experience where skilled personal chefs masterfully perform the ancient art of teppanyaki right before your eyes.
ONE Hospitality, The ONE Group’s food and beverage hospitality services business develops, manages and operates premier restaurants and turnkey food and beverage services within high-end hotels and casinos currently operating venues in the U.S. and Europe.
Additional information about The ONE Group can be found at www.togrp.com.
Cautionary Statement on Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including with respect to the impact of the Benihana Inc. acquisition, restaurant openings and 2025 financial targets. Forward-looking statements may be identified by the use of words such as “target,” “intend,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. A number of factors could cause actual results or outcomes to differ materially from those indicated by such forward-looking statements, including but not limited to: (1) our ability to integrate the new or acquired restaurants into our operations without disruptions to operations; (2) our ability to capture anticipated synergies; (3) our ability to open new restaurants and food and beverage locations in current and additional markets, grow and manage growth profitably, maintain relationships with suppliers and obtain adequate supply of products and retain employees; (4) factors beyond our control that affect the number and timing of new restaurant openings, including weather conditions and factors under the control of landlords, contractors and regulatory and/or licensing authorities; (5) our ability to successfully improve performance and cost, realize the benefits of our marketing efforts and achieve improved results as we focus on developing new management and license deals; (6) changes in applicable laws or regulations; (7) the possibility that The ONE Group may be adversely affected by other economic, business, and/or competitive factors, including economic downturns; (8) the impact of actual and potential changes in immigration policies, including potential labor shortages; (9) the potential impact of the imposition of tariffs, including increases in food prices and inflation and any resulting negative impacts on the macro-economic environment; and (10) other risks and uncertainties indicated from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K filed for the year ended December 31, 2024 and Quarterly Reports on Form 10-Q.
Investors are referred to the most recent reports filed with the Securities and Exchange Commission by The ONE Group Hospitality, Inc. Investors are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made, and we undertake no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Gyre Has Made Strong YTD Progress. Gyre has made significant progress during the first three quarters of FY2025 that we believe positions the company for a strong year-end. These developments include continued sales growth from two products introduced in 1H25, an application for Hydronidone approval in China, and the start of a Phase 2 clinical trial for Hydronidone in the US. The company also announced the appointment of Dr. Han Ying as the new CEO, a member of the Board of Directors since January 2025.
Hydronidone Data Showed Efficacy and Proof of Concept. The pivotal Phase 3 trial testing Hydronidone in Chronic Hepatitis B-associated fibrosis has met its primary endpoint of fibrosis regression. The study was conducted in China, and an application for approval by the NMPA (the Chinese regulatory authority) is planned for 3Q2025. Hydronidone has received Breakthrough Therapy Designation, allowing for accelerated review. We expect approval in 2H2026, followed by launch in FY2027.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
The U.S. labor market just got a reality check — and it’s a sobering one. A government revision revealed that the economy employed 911,000 fewer people as of March 2025 than initially reported, exposing a far weaker job market than policymakers and the public had believed. The new data, released by the Bureau of Labor Statistics (BLS), shows the slowdown began months before the summer headlines of weakening payrolls and rising unemployment.
The revision, covering the 12 months between March 2024 and March 2025, slashes average monthly job gains from an already modest 147,000 to just 71,000. For context, that’s less than half the pace originally reported and a figure that suggests the labor market was cooling long before the recent downturn. Economists had anticipated downward revisions, but the scale was startling — many expected about 700,000 fewer jobs, while the actual figure exceeded even the most pessimistic forecasts.
Industries that once looked like pillars of resilience proved more fragile under scrutiny. Leisure and hospitality was revised down by 176,000 jobs, erasing gains that had been touted as proof of post-pandemic recovery strength. Professional and business services followed with a downward revision of 158,000 jobs, signaling weakness in white-collar employment as well. Overall, the private sector absorbed the brunt, losing 880,000 jobs in the revision, while government payrolls were adjusted down by 31,000.
These annual revisions are routine, as the BLS incorporates more accurate data like unemployment insurance filings. But the magnitude of recent adjustments has been unusually large, feeding political tensions and raising questions about the reliability of initial reporting. Last year’s revision cut 818,000 jobs, landing right in the middle of the presidential campaign and fueling criticism from then-candidate Donald Trump.
Now, President Trump is in office and once again pointing to the BLS, accusing it of producing “phony” numbers. He has already dismissed the agency’s former commissioner and nominated E.J. Antoni, a vocal critic from the Heritage Foundation, to lead the bureau. Antoni’s confirmation battle will likely intensify after this revision, as the administration pushes for overhauls in how labor data is collected and reported.
Beyond politics, the numbers matter for the Federal Reserve, which is under pressure to respond to slowing job growth and signs of economic fragility. Trump and his allies argue Fed Chair Jerome Powell has been “too late” in cutting rates, claiming the central bank clung too rigidly to its 2% inflation target at the expense of growth. The White House could now use these revisions as further evidence to press its case.
For millions of Americans, though, the revisions underscore a more personal reality. A job market once presented as resilient is now revealed to have been much shakier. With fewer jobs than thought, weaker household income growth, and rising uncertainty, the labor market is entering a precarious phase. The debate in Washington may revolve around statistics, but the impact is being felt in homes and businesses across the country.
In our previous article, we explored the strategic imperative behind European healthcare and life sciences (HCLS) companies and investors targeting the U.S. middle market. We highlighted the compelling valuations and the U.S.’s enduring role as a global growth and innovation engine. This time, we turn to the “WHAT” and “HOW”—the concrete strategic opportunities that await European acquirers in the dynamic U.S. HCLS landscape. Join us as we delve into the specific avenues through which European firms can unlock substantial value, from accessing the world’s deepest HCLS market to leveraging its unparalleled innovation ecosystems and diverse patient populations.
Accessing the World’s Deepest Market & Robust Growth
The sheer scale of the U.S. HCLS market remains a potent magnet for international capital. Representing over 40% of total global health spending and nearly 50% of global biopharma sales, the U.S. presents an immense operational footprint and growth trajectory rarely matched. For European companies, an acquisition here is more than just an expansion; it’s an immediate leap into the largest, most commercially mature healthcare arena. This article explores the specific, high-value opportunities that may result from European HCLS companies developing the US presence and how they can drive value going forward.
Despite some fluctuations in utilization rates, segments like Medicare Advantage continue to demonstrate robust growth, projected to expand by 5% annually through 2028. This provides a stable, expanding patient base for acquired entities, offering clear pathways for revenue generation and market penetration.
Tap into Dominant Biotech & Biopharma Innovation
The U.S. stands as the undeniable epicenter of biotech and biopharma innovation. Its vibrant ecosystems—think Boston/Cambridge, the San Francisco Bay Area, and the Research Triangle—are veritable hotbeds for pioneering clinical research, robust academic partnerships, and dynamic venture-backed startups. The biotech market alone is projected to grow from $1.74 trillion in 2025 to over $5 trillion by 2034, underscoring its explosive potential.
European acquirers can directly plug into these advanced networks, gaining access to cutting-edge R&D, intellectual property, and a pipeline of groundbreaking therapies. U.S.-based biopharmaceutical companies contribute 55% of global R&D investment, leading advancements in gene editing, mRNA vaccines, and precision medicine. Acquisitions provide a fast-track to these innovations, complementing Europe’s own scientific strengths. Budget related changes to government funding of HCLS research, will only increase the demand for private capital and keep downward pressure on valuations for earlier stage companies in the short term.
Leverage Advanced Digital & AI Integration
The rapid adoption of digital health technologies and artificial intelligence (AI) across the U.S. healthcare system presents another transformative opportunity. The global AI healthcare market is forecast to reach $110.61 billion by 2030, with North America holding the largest share and a high growth rate of 38.6% CAGR from 2025. This momentum translates into practical applications that European companies can acquire.
Over two-thirds of U.S. physicians utilized health AI in 2024, and 79% of healthcare organizations are actively integrating AI into their operations. This widespread adoption, from workflow optimization to predictive analytics and advanced diagnostics (with over 340 FDA-approved AI tools by 2025), offers European buyers a chance to acquire sophisticated digital capabilities, accelerating their own technological evolution and improving efficiency.
Access to Diverse Patient Populations for Clinical Advantage
The United States, with its highly diverse population, serves as an invaluable asset for clinical research and real-world data (RWD) generation. Acquiring a U.S. entity provides immediate access to a broad and varied patient base, crucial for conducting comprehensive clinical trials that reflect real world demographic variations. This diversity is vital for ensuring the safety and efficacy of new treatments across different genetic backgrounds, ages, and ethnicities.
Beyond traditional trials, the U.S. market’s extensive data infrastructure and growing emphasis on RWD allow for more robust post-market surveillance and the development of personalized medicine approaches. European firms can leverage this to refine therapies, expand indications, and accelerate market access.
Gaining A Foothold in a Mature, High-Value Commercial Landscape
An acquisition in the U.S. offers European HCLS companies more than just innovation; it provides immediate entry into a mature, high-value commercial landscape. This includes established distribution networks, robust sales infrastructures, and direct access to a complex yet lucrative multi-payer reimbursement system. While navigating the distinct U.S. market access landscape can be challenging compared to European models, a well-executed acquisition provides a foundational platform from which to optimize commercial strategies and capture significant revenue streams. FDA has served as a quasi-Global Benchmark. U.S. FDA approvals often set the standard for global market entry. Acquisitions and licensing U.S. assets can streamline regulatory pathways in other regions and offer faster times to market utilizing the FDA’s relatively agile regulatory frameworks (e.g., accelerated approval, breakthrough therapy designation).
This integration allows European acquirers to bypass years of organic market development, capitalizing on existing brand recognition, patient relationships, and regulatory approvals. U.S. biotech attracts over 60% of global biotech VC funding, providing acquired firms with greater access to follow-on capital. The U.S. has a mature biotech capital market and companies are acquisition-ready or near IPO-stage, offering clear exit strategies. Companies with US based assets advancing under the FFDA regulatory process are more likely to obtain access to US based biotech VC funding. US VC’s may have a propensity to rely on FDA standards as a benchmark for clinical success globally and access to a robust US commercial market.
Connecting Opportunities: How These Elements Combine for European Buyers
The strategic opportunities in U.S. HCLS are synergistic. For instance, a European biopharma firm might acquire a U.S. biotech startup not only for its innovative pipeline but also for its access to a major U.S. innovation cluster, a diverse patient cohort for future trials, and an existing network for commercialization. This “string-of-pearls” approach—acquiring smaller, specialized companies to build a larger presence—has been a major driver of several recent major deals involving targeted acquisitions that fill specific capability gaps and accelerate growth.
Recent examples, such as Denmark’s Novo Holdings acquiring U.S. CDMO giant Catalent and Swiss Alcon’s acquisition of U.S. medtech firm Lensar, underscore this trend. These deals provide examples of European companies strategically investing in the US to gain manufacturing capabilities, innovative product lines, and direct market access.
Conclusion
The U.S. HCLS market presents unparalleled strategic opportunities for European companies and investors. Beyond the attractive valuations discussed in Article 1, the ability to directly access its vast market scale, dominant innovation ecosystems, advanced digital integration, and diverse patient populations offers a compelling “WHAT” for transatlantic M&A. This is not merely about expansion but about transformative growth and competitive advantage.
In our next article, we will delve into the “HOW” of successful transatlantic M&A, focusing on the critical talent edge and operational synergies necessary for seamless integration and long-term value creation.
About the Authors:
Nathan Caliis a Managing Partner atNoble Capital Marketswith more than 18 years of Capital Markets experience. He has been a lead Managing Director/Head of the Healthcare and Life Sciences Investment Banking and Advisory franchise at NOBLE since 2017 and was previously a sell-side equity analyst for 9 years. Nathan is a Board Member of Precise Bio, a tissue engineering, biomaterials, and cell technologies company, including cardiology, orthopedics, and dermatology. He was previously a board observer of Eledon Pharmaceuticals (ELDN:NASDAQ, f.k.n.a. Anelixis Therapeutics, Inc.), a phase II biotechnology company. Prior to joining NOBLE, Nathan gained investment experience as a portfolio account analyst/manager at Franklin Templeton Investments. Nathan also currently holds series 7, 79, 86, and 87 FINRA designations.
Hinesh Patel, MCMI ChMCis a Partner in CNM LLP’sLos Angeles Office with over 20 years of experience in accounting. He leads and oversees the firm’s Accounting and Transaction Advisory practice. He brings a vast knowledge of US GAAP, technical accounting, and International Financial Reporting Standards (IFRS) reporting requirements to his role at CNM. Hinesh primarily focuses on technical accounting, IPO readiness, SEC reporting, and mergers and acquisitions. Prior to joining CNM, Hinesh worked as a Senior Manager at Deloitte with a primary focus in the technology, manufacturing, consumer business and entertainment industries for both public and private companies. He has assisted various companies through the IPO process and advised on a range of accounting services including technical accounting, financial reporting, and new business processes requirements.
Matthew (Matt) Podowitzis the founder and Principal Consultant ofPathfinder Advisors LLC, bringing experience on 400+ global M&A engagements to his clients. He specializes in the critical operational and technology aspects of M&A transactions, providing due diligence, carve-out, integration, and value creation services. Known for practical, actionable advice derived from extensive hands-on experience with healthcare and life sciences transactions, Matt helps companies, investment banks, and private equity firms navigate complex cross-border HCLS M&A through every step of the transaction lifecycle. Leveraging his perspective as a dual US/EU citizen, he provides seamless support for transactions in both markets. His background includes leadership roles at firms like Ernst & Young, Grant Thornton, and CFGI.
Chris Raphaelyis the Co-Chair ofCozen O’Connor’sHealth Care & Life Sciences Practice where he provides sophisticated transactional and regulatory counsel to an array of health care providers and investors in the health care industry. His practice focuses on mergers, acquisitions, and divestiture transactions for health care clients and the comprehensive regulatory schemes requisite to doing business in the health care space. Chris routinely handles matters involving payer negotiations, payment disputes and contract enforcement, accountable care organizations, management services organization, clinically integrated networks, value based payment arrangements, pharmacy benefit management and third party administrator contracts for self-insured employers, digital health, organizational and governance structures, HIPAA, information privacy and security, tax exemption, Stark Law, fraud and abuse matters, clinical integration, medical staff relations, facility and professional licensing, Pennsylvania’s Medical Marijuana Act, and general compliance. Prior to joining the firm, Chris served as the deputy general counsel to Jefferson Health System and general counsel to the system’s accountable care organization and captive professional liability insurance companies.
Nebius Group’s stock price skyrocketed this week after the Amsterdam-based artificial intelligence infrastructure firm announced a multi-year partnership with Microsoft worth up to $19.4 billion. The deal highlights the surging demand for GPU-powered cloud computing capacity and underscores the critical role infrastructure providers play in supporting the global AI boom.
Shares of Nebius, which was spun out of Russian internet company Yandex in 2023, surged more than 40% on Tuesday following the announcement. The rally came on top of a 60% spike in extended trading Monday, marking one of the steepest short-term gains for an AI-related stock in 2025. Under the agreement, Nebius will supply Microsoft with graphics processing units (GPUs) and computing power valued at $17.4 billion through 2031. Microsoft may also secure additional capacity, potentially bringing the total value of the contract to $19.4 billion.
The Nebius-Microsoft deal instantly positions the European company as a top-tier supplier of AI cloud infrastructure. GPUs are essential for training and scaling large language models, generative AI platforms, robotics, and other advanced artificial intelligence applications. As enterprises race to deploy AI, demand for this specialized hardware has grown far faster than traditional cloud services. For Microsoft, the agreement ensures Azure customers, OpenAI projects, and its own AI-powered products have the computing resources required to expand.
This partnership also shows that while Nvidia remains the leader in AI chips, competition is opening up. Nebius joins a growing roster of infrastructure providers—including CoreWeave, which saw its shares climb 8% on the news—benefiting from hyperscalers’ urgent need to lock in GPU supply. Investors see this as a sign that AI infrastructure spending could remain strong despite market concerns about inflated valuations.
Analysts note that the deal comes amid broader predictions of enormous long-term spending on AI hardware. Nvidia executives recently forecast that between $3 trillion and $4 trillion will flow into AI infrastructure globally by 2030. At the same time, some experts, including OpenAI CEO Sam Altman, have warned of a possible AI bubble as valuations for startups like Anthropic and OpenAI itself reach record highs. Nebius’s surge reflects the optimism that demand will outweigh bubble risks, at least for infrastructure suppliers.
For Nebius, the Microsoft partnership provides not only revenue security through 2031 but also credibility as a global player in the AI race. By aligning with one of the world’s largest technology companies, Nebius strengthens its position in a market where trust, scale, and performance are paramount.
The stock market response suggests investors believe infrastructure will be one of the most resilient segments of the artificial intelligence economy. While software companies may face volatile valuations, firms that deliver the backbone of AI workloads—GPUs, cloud data centers, and compute resources—are emerging as long-term winners. With its $19 billion deal, Nebius has firmly secured its spot in the spotlight.
The U.S. oil industry is facing a sharp slowdown, with layoffs and spending cuts rippling across the sector as lower crude prices and industry consolidation squeeze margins. The wave of belt-tightening could mark the end of the rapid production growth that helped the United States overtake other producers to become the world’s top oil supplier in recent years.
International crude prices have fallen roughly 12% this year, dragged lower in part by rising output from OPEC and its allies, who have been steadily ramping up supply to reclaim market share lost to U.S. shale producers. Prices are now hovering just above $62 a barrel, uncomfortably close to breakeven levels for many U.S. operators. For companies already grappling with higher costs and trade-related tariffs, the weaker pricing environment is forcing tough decisions.
ConocoPhillips, the nation’s third-largest oil producer, recently announced plans to cut up to a quarter of its workforce. The move follows Chevron’s decision earlier this year to trim about 20% of its staff, amounting to roughly 8,000 jobs. Oilfield service providers such as SLB and Halliburton have also been cutting jobs, underscoring how the slowdown is spreading beyond producers to the broader energy ecosystem.
The cuts aren’t limited to people. According to a Reuters review of second-quarter results, 22 publicly traded U.S. producers—including ConocoPhillips, Diamondback Energy, and Occidental Petroleum—have reduced their combined capital spending by about $2 billion. Industry insiders say those pullbacks, along with falling rig counts, are early warning signs that production growth is set to level off. Baker Hughes data shows that the U.S. oil rig count has dropped by nearly 70 so far this year, down to just over 400.
In the Permian Basin, the heart of America’s shale boom, the tone has shifted from aggressive expansion to cautious retrenchment. “We’ve gone from ‘drill, baby, drill’ to ‘wait, baby, wait,’” said one Texas producer, pointing out that prices need to stabilize closer to $70–$75 a barrel before rig activity rebounds. Without that, analysts warn that U.S. output will plateau and could even begin to decline, with OPEC quickly stepping in to fill the gap.
Research firms are already forecasting slower momentum. Energy Aspects expects U.S. onshore production to drop by 300,000 barrels per day in 2025, while Wood Mackenzie projects only modest growth of 200,000 barrels per day—far below the record-setting pace of recent years.
Adding to the pressure are rising costs, much of it tied to tariffs on steel and other inputs. Diamondback Energy expects the price of steel casing for wells to climb by nearly 25% this year, inflating breakeven costs across the industry. For ConocoPhillips, controllable costs have already risen by $2 per barrel since 2021, making profitability harder to sustain.
The impact on employment is significant. Texas labor data shows U.S. oil and gas production jobs fell by nearly 5,000 in the first half of 2025, while energy services jobs have dropped by about 23,000 since January. Even with gains in drilling efficiency, industry analysts caution that technology alone won’t be enough to offset the slowdown.
For now, the U.S. oil industry remains a global leader. But with lower prices, higher costs, and fewer rigs in action, the sector’s once-rapid growth story appears to be entering a more uncertain chapter.
Tonmya was approved by FDA on August 15, 2025 for the treatment of fibromyalgia and is the first new FDA approved treatment for fibromyalgia in over 15 years
Two pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo
Tonmya showed consistent improvements across core fibromyalgia symptoms, including widespread pain, sleep disturbance and fatigue
Tonmya was well tolerated, supporting its potential as a long-term treatment option for fibromyalgia
Tonmya is expected to be commercially available in the fourth quarter
CHATHAM, N.J., Sept. 08, 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, presented four posters at the PAINWEEK conference 2025, held September 2-5, 2025, in Las Vegas, Nevada entitled:
“TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets, Demonstrates Pain Reduction and Favorable Tolerability in Participants With Fibromyalgia”
“Sublingual Cyclobenzaprine (TNX-102 SL) for Fibromyalgia: Efficacy and Safety in Two Randomized, Placebo-Controlled Trials”
“Steady-state Pharmacokinetic Properties of a Sublingual Formulation of Cyclobenzaprine (CBP) HCl (TNX-102 SL): Comparison to Simulations of Oral immediate-release CBP”
“Randomized, Double-Blind, Placebo-Controlled Confirmatory Phase 3 Trial of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Fibromyalgia”
“Fibromyalgia is a chronic and debilitating condition marked by widespread pain, poor sleep, and fatigue and cognitive dysfunction,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The data presented at PAINWEEK show that Tonmya significantly improved pain with a favorable tolerability profile, offering patients and physicians a new, non-opioid treatment option. Now that Tonmya has been approved by FDA, we believe we are well-positioned to execute the launch and remain on track to deliver this drug to patients next quarter.”
The posters included data from two pivotal Phase 3 trials: RELIEF, a 14-week randomized, double-blind, placebo-controlled study of TNX-102 SL 5.6 mg (now Tonmya™), and RESILIENT, a confirmatory trial evaluating efficacy and safety. Across both studies, Tonmya significantly reduced fibromyalgia pain and demonstrated a favorable tolerability profile. By pharmacologically targeting nonrestorative sleep through antagonism of receptors that regulate sleep architecture, Tonmya engages a central mechanism believed to drive the persistence of fibromyalgia symptoms. The availability of a safe and well-tolerated treatment may also support earlier diagnosis and intervention, ultimately improving patient outcomes. Together, these findings suggest Tonmya has the potential to improve a broad spectrum of fibromyalgia symptoms.
About Fibromyalgia Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 10 million adults in the U.S., approximately 80% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep (waking up tired and unrefreshed), fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Patients with fibromyalgia have double the medical costs compared to the general population in the U.S.
About Tonmya™ (cyclobenzaprine HCl sublingual tablets) Tonmya, which was investigated as TNX-102 SL, is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride, which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a tertiary amine tricyclic (TAT) and multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, Tonmya is now approved as a once-daily bedtime treatment for fibromyalgia in adults. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10357465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary composition. These patents are expected to provide Tonmya with U.S. market exclusivity until 2034. Pending patent applications related to method of use could extend exclusivity until 2044.
About the Phase 3 Clinical Trials: RELIEF, RALLY and RESILIENT The RELIEF and RESILIENT studies were double-blind, randomized, placebo-controlled trials designed to evaluate the efficacy and safety of Tonmya™ (cyclobenzaprine hydrochloride sublingual tablets) for the treatment of fibromyalgia. RELIEF and RESILIENT were two-arm trials that enrolled 503 and 457 adults with fibromyalgia across 40 and 33 United States sites, respectively. In both trials, the first two weeks of treatment consisted of a run-in period in which participants started on Tonmya 2.8 mg (1 tablet) or placebo. Thereafter, all participants increased their dose to Tonmya 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint across both trials was the daily diary pain intensity score change (Tonmya 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores). Additional details on RELIEF (NCT04172831) and RESILIENT (NCT05273749) are available on clinicaltrials.gov.
RALLY was a replicate Phase 3 trial to RELIEF and RESILIENT that demonstrated greater but non-significant treatment effect with Tonmya compared to placebo and demonstrated consistent safety. Results of this trial may not have been generalizable due to the presence of factors outside the conduct of the study. Additional details are available on clinicaltrials.gov (NCT04508621).
Tonix Pharmaceuticals Holding Corp.*
Tonix Pharmaceuticals is a 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 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.
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.
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