SK pharmteco Announces Successful FDA Inspection of Small Molecule Manufacturing Facility in La Porte, Texas

SK pharmteco Announces Successful FDA Inspection of Small Molecule Manufacturing Facility in La Porte, Texas




SK pharmteco Announces Successful FDA Inspection of Small Molecule Manufacturing Facility in La Porte, Texas

RANCHO CORDOVA, Calif., March 17, 2026 (GLOBE NEWSWIRE) — SK pharmteco today announced the successful conclusion of a regulatory inspection of its small molecule North America facility in La Porte, Texas.

The U.S. Food and Drug Administration (FDA) carried out a general inspection of the site from February 9 to February 12, 2026. After a thorough review of the facility’s quality systems and manufacturing operations, the FDA completed the inspection without issuing a Form 483. This “No Action Indicated” (NAI) status confirms that the site complies with the highest regulatory standards.

“The successful completion of this FDA inspection directly reflects the commitment to excellence and strong quality culture of our La Porte team,” said Kalen Minvielle, Head of Small Molecule, North America. “Maintaining an NAI status is a significant achievement that continues to highlight the strength of our systems and disciplined approach to building quality into every step of the process. It ensures our customers can continue to rely on SK pharmteco for secure, compliant, and uninterrupted manufacturing of life-enhancing medicines.”

The general inspection included thorough tours of the warehouse, manufacturing plant, and analytical laboratories. Inspectors conducted an in-depth review of the site’s procedural rigor, assessing batch records, Corrective and Preventive Actions (CAPAs), deviation and Out-of-Specification (OOS) investigations, and change controls. The agency also confirmed the integrity of the site’s equipment qualifications, purified water systems, and process and cleaning validations.

SK pharmteco actively partners with the FDA in the pursuit of excellence and continuous improvement. For example, the company recently participated in the FDA Quality Management Maturity (QMM) program, an initiative that recognizes drug manufacturers with advances beyond compliance and a culture of continuous improvement and reliability.

This successful inspection reinforces SK pharmteco’s global reputation for operational excellence in both small molecules and viral vectors, as well as its dedication to meeting the stringent requirements of regulatory agencies worldwide.

About SK pharmteco
SK pharmteco is a global contract development and manufacturing organization (CDMO) with production sites, research & development facilities, and analytical laboratories across the U.S., Europe, and South Korea. The company’s core capabilities center on small molecules, peptides, and viral vectors, providing the specialized expertise needed to bring complex therapies to market. Through these pillars, SK pharmteco supports biopharmaceutical partners of all sizes with comprehensive development and manufacturing solutions worldwide. SK pharmteco is a subsidiary of SK Inc. (KRX: 034730) (SK), the strategic investment company for SK Group, South Korea’s second-largest conglomerate.

Contact:
Keith Bowermaster, APR, CCMP
Communications Consultant
keith.bowermaster@skpt.com

SK pharmteco Announces Successful FDA Inspection of Small Molecule Manufacturing Facility in La Porte, Texas

SK pharmteco Announces Successful FDA Inspection of Small Molecule Manufacturing Facility in La Porte, Texas




SK pharmteco Announces Successful FDA Inspection of Small Molecule Manufacturing Facility in La Porte, Texas

RANCHO CORDOVA, Calif., March 17, 2026 (GLOBE NEWSWIRE) — SK pharmteco today announced the successful conclusion of a regulatory inspection of its small molecule North America facility in La Porte, Texas.

The U.S. Food and Drug Administration (FDA) carried out a general inspection of the site from February 9 to February 12, 2026. After a thorough review of the facility’s quality systems and manufacturing operations, the FDA completed the inspection without issuing a Form 483. This “No Action Indicated” (NAI) status confirms that the site complies with the highest regulatory standards.

“The successful completion of this FDA inspection directly reflects the commitment to excellence and strong quality culture of our La Porte team,” said Kalen Minvielle, Head of Small Molecule, North America. “Maintaining an NAI status is a significant achievement that continues to highlight the strength of our systems and disciplined approach to building quality into every step of the process. It ensures our customers can continue to rely on SK pharmteco for secure, compliant, and uninterrupted manufacturing of life-enhancing medicines.”

The general inspection included thorough tours of the warehouse, manufacturing plant, and analytical laboratories. Inspectors conducted an in-depth review of the site’s procedural rigor, assessing batch records, Corrective and Preventive Actions (CAPAs), deviation and Out-of-Specification (OOS) investigations, and change controls. The agency also confirmed the integrity of the site’s equipment qualifications, purified water systems, and process and cleaning validations.

SK pharmteco actively partners with the FDA in the pursuit of excellence and continuous improvement. For example, the company recently participated in the FDA Quality Management Maturity (QMM) program, an initiative that recognizes drug manufacturers with advances beyond compliance and a culture of continuous improvement and reliability.

This successful inspection reinforces SK pharmteco’s global reputation for operational excellence in both small molecules and viral vectors, as well as its dedication to meeting the stringent requirements of regulatory agencies worldwide.

About SK pharmteco
SK pharmteco is a global contract development and manufacturing organization (CDMO) with production sites, research & development facilities, and analytical laboratories across the U.S., Europe, and South Korea. The company’s core capabilities center on small molecules, peptides, and viral vectors, providing the specialized expertise needed to bring complex therapies to market. Through these pillars, SK pharmteco supports biopharmaceutical partners of all sizes with comprehensive development and manufacturing solutions worldwide. SK pharmteco is a subsidiary of SK Inc. (KRX: 034730) (SK), the strategic investment company for SK Group, South Korea’s second-largest conglomerate.

Contact:
Keith Bowermaster, APR, CCMP
Communications Consultant
keith.bowermaster@skpt.com

Standard Process Launches SP Children’s® ProSynbiotic

Standard Process Launches SP Children’s® ProSynbiotic




Standard Process Launches SP Children’s® ProSynbiotic

A Whole Food-Based Synbiotic Designed to Support Digestive Regularity, Gut Balance, and Immune Health in Children

Standard Process SP Children's ProSynbiotic

PALMYRA, Wis., March 17, 2026 (GLOBE NEWSWIRE) — Standard Process, a leader in whole food-based nutritional solutions, today announced the launch of SP Children’s® ProSynbiotic. The gentle, clinically-backed, whole food-based synbiotic is formulated to support digestive comfort, microbiome balance, and immune health in children three years of age and up as a daily supplement or when needs arise for gastrointestinal (GI) support.

“Most children aren’t consuming adequate amounts of fiber, prebiotics, and beneficial microbes, and it’s an increasingly difficult feat for parents to get what they need in the modern diet landscape,” says Weston Bussler, Nutrition Science PhD and Product Development Manager, Standard Process. “Our ProSynbiotic makes it easy to deliver fiber-packed whole foods, and in a kid-approved format designed and tested at our Nutrition Innovation Center, to provide the nutritional components critical for GI and immune health.”

Standard Process developed SP Children’s® ProSynbiotic to directly meet these needs with a carefully selected blend of probiotics, prebiotics, and whole food-based fiber without added sugars, artificial flavors, or sweeteners. The flavorless powder comes in convenient single-serve sticks, making it easy to mix into food or beverages without altering taste, an important consideration for picky eaters.

Why Now? Children’s Health and The Standard American Diet

Children face health implications of the Standard American Diet (SAD). NCHS data reports approximately 60% of children’s daily calories come from ultra-processed foods (UPF), contributing to widespread nutrient inadequacy. 95% of Americans, for example, don’t come close to consuming 25 grams of recommended daily fiber, which can contribute to digestive issues like constipation and poor gut health.

Numerous factors influence children’s dietary habits, including social determinants, access, convenience, marketing tactics, and autonomy to choose their own foods- contributing to health implications taking root early. Standard Process aims to close the gap through nutrition education and equipping health care practitioners, including chiropractors, nutritionists, nurse practitioners, among others, with science-backed supplement solutions.

Ingredients You Can Trust

  • SP Children’s® ProSynbiotic delivers clinically studied probiotic strains, including Lactobacillus acidophilus DDS-1™ and Bifidobacterium lactis UABla-12™, alongside the yeast Saccharomyces boulardii, to help support microbial balance and healthy bowel movements.
  • The formula is complemented by whole food-based fibers from ingredients such as Royal Ancient Oats™, green banana flour, chicory root, apple pectin, and organic beets to nourish beneficial bacteria and promote digestive regularity.
  • Gluten-free, vegan and contains no stevia, xylitol, silica, citric acid, or added sugars.

Where To Find

ABOUT STANDARD PROCESS

Founded in 1929, Standard Process is a fourth-generation, family-owned company committed to transforming lives through whole food nutrition. Partnering with health care practitioners, we provide science-based nutritional solutions grounded in certified organic agriculture and a systems-based approach to whole-person health.

Standard Process Contact:
Nicole McSwain, Marketing Communications Specialist
nmcswain@standardprocess.com

Media Contact:
Laura Bastardi, MWW Health
Standardprocess@MWW.com

*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent disease.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9938bebc-a267-4be5-8fbb-3cff7394f730

Standard Process Launches SP Children’s® ProSynbiotic

Standard Process Launches SP Children’s® ProSynbiotic




Standard Process Launches SP Children’s® ProSynbiotic

A Whole Food-Based Synbiotic Designed to Support Digestive Regularity, Gut Balance, and Immune Health in Children

Standard Process SP Children's ProSynbiotic

PALMYRA, Wis., March 17, 2026 (GLOBE NEWSWIRE) — Standard Process, a leader in whole food-based nutritional solutions, today announced the launch of SP Children’s® ProSynbiotic. The gentle, clinically-backed, whole food-based synbiotic is formulated to support digestive comfort, microbiome balance, and immune health in children three years of age and up as a daily supplement or when needs arise for gastrointestinal (GI) support.

“Most children aren’t consuming adequate amounts of fiber, prebiotics, and beneficial microbes, and it’s an increasingly difficult feat for parents to get what they need in the modern diet landscape,” says Weston Bussler, Nutrition Science PhD and Product Development Manager, Standard Process. “Our ProSynbiotic makes it easy to deliver fiber-packed whole foods, and in a kid-approved format designed and tested at our Nutrition Innovation Center, to provide the nutritional components critical for GI and immune health.”

Standard Process developed SP Children’s® ProSynbiotic to directly meet these needs with a carefully selected blend of probiotics, prebiotics, and whole food-based fiber without added sugars, artificial flavors, or sweeteners. The flavorless powder comes in convenient single-serve sticks, making it easy to mix into food or beverages without altering taste, an important consideration for picky eaters.

Why Now? Children’s Health and The Standard American Diet

Children face health implications of the Standard American Diet (SAD). NCHS data reports approximately 60% of children’s daily calories come from ultra-processed foods (UPF), contributing to widespread nutrient inadequacy. 95% of Americans, for example, don’t come close to consuming 25 grams of recommended daily fiber, which can contribute to digestive issues like constipation and poor gut health.

Numerous factors influence children’s dietary habits, including social determinants, access, convenience, marketing tactics, and autonomy to choose their own foods- contributing to health implications taking root early. Standard Process aims to close the gap through nutrition education and equipping health care practitioners, including chiropractors, nutritionists, nurse practitioners, among others, with science-backed supplement solutions.

Ingredients You Can Trust

  • SP Children’s® ProSynbiotic delivers clinically studied probiotic strains, including Lactobacillus acidophilus DDS-1™ and Bifidobacterium lactis UABla-12™, alongside the yeast Saccharomyces boulardii, to help support microbial balance and healthy bowel movements.
  • The formula is complemented by whole food-based fibers from ingredients such as Royal Ancient Oats™, green banana flour, chicory root, apple pectin, and organic beets to nourish beneficial bacteria and promote digestive regularity.
  • Gluten-free, vegan and contains no stevia, xylitol, silica, citric acid, or added sugars.

Where To Find

ABOUT STANDARD PROCESS

Founded in 1929, Standard Process is a fourth-generation, family-owned company committed to transforming lives through whole food nutrition. Partnering with health care practitioners, we provide science-based nutritional solutions grounded in certified organic agriculture and a systems-based approach to whole-person health.

Standard Process Contact:
Nicole McSwain, Marketing Communications Specialist
nmcswain@standardprocess.com

Media Contact:
Laura Bastardi, MWW Health
Standardprocess@MWW.com

*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent disease.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9938bebc-a267-4be5-8fbb-3cff7394f730

Hyperion DeFi Schedules Fourth Quarter and Full Year 2025 Earnings Call for Thursday, March 26 at 8:00 a.m. ET

Hyperion DeFi Schedules Fourth Quarter and Full Year 2025 Earnings Call for Thursday, March 26 at 8:00 a.m. ET




Hyperion DeFi Schedules Fourth Quarter and Full Year 2025 Earnings Call for Thursday, March 26 at 8:00 a.m. ET

LAGUNA HILLS, Calif., March 17, 2026 (GLOBE NEWSWIRE) — Hyperion DeFi, Inc. (NASDAQ: HYPD) (“Hyperion DeFi” or the “Company”), the first U.S. publicly listed company building a long-term strategic treasury of Hyperliquid’s native token, HYPE, today announced that it will hold its earnings conference call and webcast for the fourth quarter and full year ended December 31, 2025, on Thursday, March 26, 2026 at 8:00 a.m. Eastern Time.

A press release detailing these results will be issued prior to the call on the same day.

Conference Call Information

To participate in this event, please log on or dial in approximately 5 minutes before the beginning of the call.

Date: March 26, 2026
Time: 8:00 a.m. ET
Access ID: 13758512
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1751342&tp_key=ef0e483a89
Dial in: 1-877-407-9039 or 1-201-689-8470
Call me™: https://callme.viavid.com/viavid/?callme=true&passcode=13754799&h=true&info=company-email&r=true&B=6

Participants can use the dial-in numbers listed above or click the Call me™ link for instant telephone access to the event. The Call me™ link will be available 15 minutes prior to the scheduled start time.

Replay Information

Dial-In: 1-844-512-2921 or 1-412-317-6671
Replay Expiration: Thursday, April 9, 2026
Access ID: 13758512

About the Hyperliquid Platform and the HYPE Token

Hyperliquid is a next-generation layer one blockchain optimized for high frequency, transparent trading. The blockchain includes fully on-chain perpetual futures and spot order books, with every order, cancel, trade, and liquidation occurring within 70 millisecond block times. It also hosts the HyperEVM, a general-purpose smart contract platform that supports permissionless decentralized financial applications akin to Ethereum.

HYPE is the native token of Hyperliquid. Staked HYPE provides utility for users via reduced trading fees and increased referral bonuses. As of March 2026, more than 41 million HYPE have been autonomously purchased and sequestered by the blockchain with the trading fees generated on the network’s central limit order books.

About Hyperion DeFi, Inc.

Hyperion DeFi, Inc. is the first U.S. publicly listed DeFi company building on Hyperliquid. The Company provides investors with streamlined access to the Hyperliquid ecosystem, one of the fastest growing, highest revenue-generating blockchains in the world. Shareholders benefit from compounding exposure to HYPE, both from its native staking yield and additional revenues generated from its unique on-chain utility.

Hyperion DeFi is also developing its proprietary Optejet User Filled Device that is designed to work with a variety of topical ophthalmic liquids, including artificial tears and lens rewetting products. The Optejet is especially useful in chronic front-of-the-eye diseases due to its ease of use, enhanced safety and tolerability, and potential for superior compliance versus standard eye drops. Together, these benefits may result in higher treatment compliance and better outcomes for patients and providers.

For more information, please visit Hyperiondefi.com or follow @hyperiondefi on X.

Forward Looking Statements

Except for historical information, all the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements, our future activities or other future events or conditions, including the viability of, and risks associated with, our cryptocurrency treasury strategy, the growth and revenue potential of the Hyperliquid ecosystem and the growth prospects of the Company. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission.

Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Hyperion DeFi does not undertake any obligation to update any forward-looking statements.

Certain information contained in this press release relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Hyperion DeFi’s own internal estimates and research. While Hyperion DeFi believes these third-party studies, publications, surveys and other data to be reliable as of the date of this press release, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of Hyperion DeFi’s internal estimates or research and no reliance should be made on any information or statements made in this press release relating to or based on such internal estimates and research. You should conduct your own investigation and analysis of Hyperion DeFi, its business, prospects, results of operations and financial condition. In furnishing this information, Hyperion DeFi does not undertake any obligation to provide you with access to any additional information (including forward-looking information and any projections contained herein) or to update or correct the information.

Hyperion DeFi, Inc. Investor Contact:
Jason Assad
Hyperion DeFi, Inc.
IR@hyperiondefi.com
(678) 570-6791

Axe Compute Appoints Two Technology and Telecom Luminaries to Board of Directors as Company Accelerates AI Infrastructure Strategy

Axe Compute Appoints Two Technology and Telecom Luminaries to Board of Directors as Company Accelerates AI Infrastructure Strategy




Axe Compute Appoints Two Technology and Telecom Luminaries to Board of Directors as Company Accelerates AI Infrastructure Strategy

Theodore Zhu, Ph.D. and Thorsten Dirks Bring Deep Semiconductor, Telecom, and International Transformation Expertise

NEW YORK, March 17, 2026 (GLOBE NEWSWIRE) — Axe Compute (NASDAQ: AGPU), the enterprise GPU infrastructure company giving enterprises and entrepreneurs unparalleled choice and access to AI compute, today announced the appointment of Theodore Zhu, Ph.D. and Thorsten Dirks to its Board of Directors, effective March 12, 2026. The appointments mark a significant step in Axe Compute’s strategic pivot to become the definitive enterprise GPU-as-a-Service platform for the global AI era.

Together, Zhu and Dirks bring more than four decades of combined experience spanning semiconductor innovation, large-scale telecommunications transformation, international M&A, and enterprise digitalization — precisely the depth required as Axe Compute scales GPU networks to serve the growing demands of enterprise AI workloads worldwide.

“We’re excited to add these industry experts to our board as Axe Compute grows our compute business. Theodore and Thorsten don’t just bring credentials — they bring the judgment that comes from building technology businesses through real market disruption. Both are an addition to the board that matches our ambition to be the leader in the GPU Infrastructure space.”
— Chris Miglino, Chief Executive Officer, Axe Compute

Theodore Zhu, Ph.D. — Board Director

Theodore Zhu, Ph.D. is a seasoned semiconductor innovator and technology executive whose career sits at the intersection of advanced hardware design and enterprise commercialisation. He is the Founder and Chairman of Iotelligent Technology, which he established in 2011, and previously served as President and Chief Operating Officer of Celestial Semiconductor. He is also co-founder of Jazz Semiconductor. Zhu holds a Ph.D. in Solid State Physics and is the author and holder of more than 85 U.S. patents — a record that speaks to both the depth of his technical expertise and his ability to translate research into commercially viable technology.

“Axe Compute has a structural advantage that is rare in this market — global reach, minimal CapEx, and enterprise-grade reliability. I’m delighted to join the board at this pivotal moment.”
— Theodore Zhu, Ph.D., Board Director, Axe Compute

Thorsten Dirks — Board Director

Thorsten Dirks is one of Europe’s most accomplished technology executives, with approximately 19 years of board experience and 15 years as a chief executive officer across some of the continent’s largest and most complex technology and telecommunications organisations. He has served as CEO of E-Plus Group, Telefónica Deutschland, and Deutsche Glasfaser, and has served as an Executive Board Member at both Deutsche Lufthansa and KPN. His expertise in large-scale transformation, M&A, post-merger integration, and enterprise digitalization is a direct asset as Axe Compute expands its global footprint and deepens its enterprise client relationships.

“The companies that win are the ones that remove friction before their competitors admit it’s a problem. Axe Compute has identified a real friction point in enterprise AI infrastructure and built a sound model to solve it. The global opportunity here is significant.”
— Thorsten Dirks, Board Director, Axe Compute

Strategic Context

The board additions come as Axe Compute sharpens its focus on the enterprise AI infrastructure market — a sector facing acute supply constraints, geographic gaps in hyperscaler coverage, and a structural mismatch between enterprise AI demand and available compute capacity. Axe Compute’s model — delivering GPU access across 200+ global locations through its partnership with Aethir’s distributed network, with zero capital expenditure per revenue dollar and 48-hour deployment timelines — is designed to address these constraints directly.

Zhu’s semiconductor expertise reinforces Axe Compute’s technical credibility with enterprise buyers and investors evaluating the company’s GPU infrastructure capabilities. Dirks’ international operating experience positions the company to accelerate expansion into EMEA and APAC markets — regions where hyperscaler coverage remains limited and enterprise AI demand is growing rapidly.

About Axe Compute

Axe Compute (NASDAQ: AGPU) is redefining AI compute infrastructure by giving enterprises and entrepreneurs greater choice in GPU infrastructure. Through a globally distributed network spanning more than 200 locations, Axe Compute’s platform is designed to enable enterprise-grade AI compute deployments in as little as 48 hours, with no data egress or bandwidth charges and infrastructure that gives customers the option to avoid vendor lock-in — all at competitive market rates. Axe Compute is among the first U.S. publicly traded companies focused on building globally distributed AI compute infrastructure.

Media Contact

Axe Compute Communications
erin@axecompute.com
axecompute.com | NASDAQ: AGPU

Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed or implied. Axe Compute undertakes no obligation to update these statements.

Recent Study Confirms Fundamental Correlation Between Severity of Obstructive Sleep Apnea and Oral Anatomy

Recent Study Confirms Fundamental Correlation Between Severity of Obstructive Sleep Apnea and Oral Anatomy




Recent Study Confirms Fundamental Correlation Between Severity of Obstructive Sleep Apnea and Oral Anatomy

Vivos CARE Oral Medical Devices Proven to Enhance Airways by Redeveloping Dental Arch Forms and Jaws

LITTLETON, Colo., March 17, 2026 (GLOBE NEWSWIRE) — Vivos Therapeutics, Inc. (“Vivos” or the “Company’’) (NASDAQ: VVOS), a leading medical device and healthcare services company focused on the treatment of breathing related sleep disorders and associated chronic health conditions, today announced that an a recent study published in the Journal of Clinical Medicine supports Vivos’ long maintained belief that dental and facial morphology characterized by narrow palatal (upper) dental arches, high peaked palates, and recessed lower jaws were directly correlated to the prevalence and severity of obstructive sleep apnea (OSA) in adults and children.

Over the past decade, Vivos-trained providers have successfully treated tens of thousands of OSA patients using Vivos CARE devices to redevelop and enhance airways.   Vivos CARE devices have been cleared by the U.S. Food and Drug Administration (FDA) for adult patients diagnosed with mild, moderate and severe OSA and moderate-to-severe OSA in children ages 6 to 17. Many Vivos patients finish treatment in less than 12 months with little or no remaining OSA symptoms. Thus, in the majority of such Vivos patients, there is no need for nightly lifetime intervention with CPAP, traditional oral appliances, or neurostimulation implants.

The recent study, the “Correlation Between Severity of Obstructive Sleep Apnea and Dental Arch Form in Adults,” first published in October 2025, affirms what the over 2,000 Vivos-trained providers see every day in clinical practice—that very small changes in the size, shape, and position of the dentition and jaws evoke significant changes in the form, function and patency of the human airway. The study conclusions indicate that maxillary morphology is associated with OSA severity, narrower intermolar distance (IMD) and greater palatal height (PH) linked to higher Apnea-Hypopnea Index (AHI). Larger airways are less prone to collapse (apnea / hypopnea events) during sleep. Fewer apnea / hypopnea events often means less sleep disruption, less blood oxygen desaturation (hypoxia) and better overall sleep architecture.

One hundred patients participated in the study, with 50 OSA patients and 50 controls. The OSA group exhibited significantly narrower transverse intermolar distance and higher palatal height compared to the control group. Linear regression analysis demonstrated a strong association (p<0.001) between these two key craniofacial parameters and OSA severity, as measured by the industry standard measure AHI. These results held true across all demographics. The figure below reflects the strong anatomical correlations in the study.

Matrix plot AHI vs. IMD and PH.

After years of research and product development, in November 2024 the FDA granted Vivos CARE devices an unprecedented 510(k) clearance to treat severe OSA patients. No other oral appliance had ever received such a clearance, nor has any similar clearance been granted since. Moreover, the mechanism of action in Vivos CARE devices is unique and capable of creating what are believed to be lasting results by gradually redeveloping and repositioning the dental arches and jaws.     

Kirk Huntsman, CEO of Vivos Therapeutics, said, “This study reaffirms our longstanding view that cranial and oral morphology is directly correlated to not only the presence of OSA, but also its severity. Traditional treatments such as CPAP, mandibular advancement oral appliances, and neurostimulation implants, all act to temporarily manage symptoms, but require repeated nightly use over a lifetime to remain effective. Vivos CARE devices rehabilitate and restore optimal airway size and shape, allowing patients to breathe more fully and sleep more deeply. After nearly 50 years of limited and undesirable treatment options, patients now have a real choice that is both safe and effective.”

“This year, we estimate that several million Americans will undergo a sleep test. In our experience, nearly half of them will test positive for OSA. Those patients will need to make a serious and life-changing decision—what they will do about their serious medical condition. OSA doesn’t go away on its own, and it will likely get worse with time. If left untreated, it will affect their cardiovascular system, their neurocognitive abilities, their risk of diabetes, chronic fatigue, mental health and more. Yet over 90% will still receive a medical prescription for CPAP, the “Gold Standard” treatment that, statistically, will soon be abandoned by over half of those patients. Then what? That’s why we’re seeing more and more such OSA patients turning to Vivos devices for OSA treatment,” concluded Mr. Huntsman.

About Vivos Therapeutics, Inc.

Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as obstructive sleep apnea (OSA) and snoring in adults. Vivos’ devices have been cleared by the U.S. Food and Drug Administration (FDA) for adult patients diagnosed with all severity levels of OSA and moderate-to-severe OSA in children ages 6 to 17. Vivos’ groundbreaking Complete Airway Repositioning and Expansion (CARE) devices are the only FDA 510(k) cleared technology for treating severe OSA in adults and the first to receive clearance for treating moderate to severe OSA in children. 

OSA affects over 1 billion people worldwide, yet 80% or more remain undiagnosed and unaware of their condition. This chronic disorder is not just a sleep issue—it is closely linked to many serious chronic health conditions. While the medical community has made strides in treating sleep disorders, breathing and sleep health remain areas that are still not fully understood. As a result, legacy OSA treatments like CPAP are often mechanistic and fail to address the root causes of OSA. 

Founded in 2016 and based in Littleton, Colorado, Vivos is working to change this. Through innovative technology, education, and acquisitions of, or commercial collaborations with, sleep healthcare providers, Vivos is empowering healthcare providers to address the complex needs of OSA patients more thoroughly.

Vivos calls the use of its appliances and protocols to treat OSA The Vivos Method, which offers a proprietary, clinically effective solution that is nonsurgical, noninvasive, and nonpharmaceutical, providing hope to allow patients to Breathe New Life.

For more information, visit www.vivos.com. 

Cautionary Note Regarding Forward-Looking Statements

This press release, including statements of the Company’s management and other parties made in connection therewith, contain “forward-looking statements” (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events. Words such as “may”, “would”, “should”, “expects”, “projects,” “potential,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates”, “goal”. “aim” and variations of such words and similar expressions are intended to identify forward-looking statements. In this press release, forward-looking statements include, without limitation, those relating to the actual future impact on Vivos’ revenue and profitability from its operations or the benefits to Vivos of the study as described herein. These statements involve significant known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Actual results (including the actual results from the study and individual results of OSA treatment) may differ materially and adversely from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to: (i) the risk that Vivos may be unable to effectively market or continue to integrate business from the acquisition and alliance model into its own or otherwise implement sales, marketing and other strategies that increase revenues, (ii) the risk that some patients may not achieve the desired results from using Vivos’ products, (iii) risks associated with regulatory scrutiny of and adverse publicity in the sleep apnea diagnosis and treatment sector; (iv) the risk that Vivos may be unable to secure additional financing to continue operations, acquire additional sleep centers practices on reasonable terms, or maintain its Nasdaq listing when needed, if at all, (v) market and other conditions that could impact Vivos’ business or ability to obtain financing, and (vi) other risk factors described in Vivos’ filings with the Securities and Exchange Commission (“SEC”). Vivos’ filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, Vivos expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Vivos’ expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based.

Media Inquiries: 

Jennifer Hauser, Executive Assistant to the CEO

Investor Relations Contact
investors@vivoslife.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2bbc6139-7151-4edd-89dd-5253307b498b

Imprivata Introduces New Advanced Access Management and Passwordless Authentication Capabilities to Address Evolving NHS Cyber Security and Compliance Challenges

Imprivata Introduces New Advanced Access Management and Passwordless Authentication Capabilities to Address Evolving NHS Cyber Security and Compliance Challenges




Imprivata Introduces New Advanced Access Management and Passwordless Authentication Capabilities to Address Evolving NHS Cyber Security and Compliance Challenges

Imprivata Enterprise Access Management now offers facial recognition, AI-powered behavioral analytics, and high-assurance identity verification to further streamline access to personal and shared-use devices, increase operational efficiency, and strengthen security and compliance posture

LONDON, March 17, 2026 (GLOBE NEWSWIRE) — Imprivata, a leading provider of access management solutions for healthcare and other mission-critical industries, today introduced comprehensive new capabilities designed to help NHS organisations and UK healthcare providers meet the unique demands of the UK’s evolving compliance, cybersecurity, data protection landscape, including the Cyber Assessment Framework (CAF)-aligned Data Security and Protection Toolkit (DSPT) and Care Identity Service (Spine) Authentication.

Imprivata Enterprise Access Management (EAM) now offers context-aware passwordless authentication, high-assurance identity verification, and AI-powered behavioral analytics, expanding the company’s leading solutions for improving workflow productivity while meeting the unique demands of the UK’s evolving compliance, cybersecurity, and data protection landscape.

“Providers and Trusts across the NHS system continue to rely on Imprivata to deliver solutions that remove workflow friction while bolstering security. As UK healthcare organisations face evolving compliance and operational challenges, our expanded EAM platform will help them meet these new requirements while ensuring clinicians have fast, seamless access to the resources they need to care for patients,” said Fran Rosch, CEO of Imprivata. “Imprivata EAM delivers these workflow, security, and compliance benefits from a single, comprehensive platform, which also helps reduce cost and drive meaningful return on technology investment, which is critical as budgets continue to tighten.”

Addressing UK-Specific Identity and Access Challenges

UK health and care systems are under increasing pressure to adopt modern, standards-based approaches to identity, authentication, and access control, while demonstrating compliance to national assurance frameworks such as the CAF-aligned DSPT and NHS England Spine Authentication, a modern, standards-based identity authentication service. These and other initiatives underscore the need for strong authentication and access management practices across NHS organisations.

The new EAM functionality delivers tailored capabilities that support NHS identity and cyber security priorities:

  • CAF-Aligned DSPT & Identity Assurance: Advanced access management and passwordless authentication help NHS organisations strengthen identity assurance, reduce reliance on shared credentials, and demonstrate multi-factor authentication (MFA) controls required under regional requirements such as the CAF-aligned DSPT. This includes detailed reporting and audit trails to support toolkit submission and independent assessment evidence.
  • Seamless Passwordless Experience: Clinicians and care staff benefit from friction-free, secure login methods that reduce login fatigue, increase productivity, and align with NHS workforce needs. These options support the wide range of authenticators and help drive adoption of secure access without compromising user experience.
  • Role-Based Access and Audit-Ready Controls: Built-in role and attribute-aware policies ensure that authenticated users are granted precisely the access they need, helping NHS organisations demonstrate cyber framework compliant access control and accountability while reducing the surface for misuse or lateral movement.

Imprivata EAM addresses these challenges by delivering a unified access management platform to support all enterprise users and workflows while also enabling a seamless, consistent user experience. The platform supports a wide variety of authenticator options and combinations to give users the flexibility to meet their specific requirements and preferences. Platform capabilities include:

  • Advanced passwordless authentication, including support for integrated face authentication technology to improve security while simplifying access for users
  • High-assurance identity verification to enable secure onboarding, help desk authentication, and self-service password reset
  • Risk signaling and behavioral analytics to determine and respond to potential security threats associated with users accessing corporate resources
  • Secure access for VPN-less remote access built on Zero Trust principles to provide a seamless experience for users outside the network
  • Operational analytics that provide near real-time workflow and access data to drive more informed, strategic decisions

Interested in learning more?
Imprivata offers several different ways to learn more about Imprivata EAM and the expanded functionality:

  • Imprivata will demonstrate the new functionality of EAM during Digital Health Rewired 2026 (24-25 March, 2026, The NEC, Birmingham) in Hall 4. To book a demo at Digital Health Rewired, visit here.
  • Watch our on-demand webinar for a first look at the new features
  • Register Now to attend our live webinar “Next generation of Imprivata Enterprise Access Management for the NHS” on Thursday, April 30, 2026 at 11a.m. GMT.
  • Request a demo here.

About Imprivata 
Imprivata delivers simple and secure access management solutions for healthcare and other mission-critical industries to ensure every second of crucial work is both frictionless and secure. Imprivata’s platform of innovative, interoperable access management and privileged access security solutions enable organisations to fully manage and secure all enterprise and third-party identities to facilitate seamless user access, protect against internal and external security threats, and reduce total cost of ownership. For more information, visit www.imprivata.com.
 
Media Contact
press@imprivata.com

Pennant Group to Participate in the 2026 Oppenheimer Annual Healthcare Conference

Pennant Group to Participate in the 2026 Oppenheimer Annual Healthcare Conference




Pennant Group to Participate in the 2026 Oppenheimer Annual Healthcare Conference

EAGLE, Idaho, March 16, 2026 (GLOBE NEWSWIRE) — The Pennant Group, Inc. (NASDAQ: PNTG), the parent company of the Pennant group of affiliated home health, hospice and senior living companies, announced today that it will participate in the upcoming 2026 Oppenheimer Co. Annual Healthcare MedTech & Services Conference on March 18, 2026.

Brent Guerisoli, Chief Executive Officer, and Lynette Walbom, Chief Financial Officer will participate in a fireside chat on March 18, 2026 at 9:40 a.m. Eastern Time. A live webcast of the event will be accessible at the following address:
investor.pennantgroup.com/events-and-presentations.

About Pennant

The Pennant Group, Inc. is a holding company of independent operating subsidiaries that provide healthcare services throughout the United States. Each of these businesses is operated by a separate, independent operating subsidiary that has its own management, employees and assets. References herein to the consolidated “company” and “its” assets and activities, as well as the use of the terms “we,” “us,” “its” and similar verbiage, are not meant to imply that The Pennant Group, Inc. has direct operating assets, employees or revenue, or that any of the home health and hospice businesses, senior living communities or the Service Center are operated by the same entity. More information about Pennant is available at www.pennantgroup.com.

Contact Information

The Pennant Group, Inc.
(208) 506-6100
ir@pennantgroup.com

SOURCE: The Pennant Group, Inc.

Zenas BioPharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Zenas BioPharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




Zenas BioPharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

WALTHAM, Mass., March 16, 2026 (GLOBE NEWSWIRE) — Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today announced that on March 16, 2026 (the “Grant Date”), the Compensation Committee of the Company’s Board of Directors granted non-qualified stock options to purchase an aggregate of 235,700 shares of the Company’s common stock (“Stock Options”) and an aggregate of 33,450 restricted stock units of the Company’s common stock (“RSUs”) to newly hired employees of the Company as an inducement material to such employees’ entry into employment with the Company, in accordance with Nasdaq Listing Rule 5635(c)(4) (the “Inducement Grant”).

The Stock Options have a ten-year term and an exercise price per share of $23.23, which is equal to the closing price of Zenas’ common stock on the Grant Date. The Stock Options will vest over a four-year period, with 25% of the shares vesting on the one-year anniversary of each of the employees’ first day of employment with the Company, and thereafter the remainder of the option will vest in 36 equal monthly installments. The RSUs will vest in four (4) equal installments over a four-year period, with vesting as to twenty-five percent (25%) of the RSUs subject to the award on each of March 15, 2027, March 15, 2028 March 15, 2029 and March 15, 2030. Inducement Grants are subject to the employees’ continued service with Zenas through the applicable vesting dates. The Inducement Grants were granted pursuant to, and are subject to, the terms and conditions of the Company’s 2026 Inducement Plan and the applicable award agreement.

About Zenas BioPharma, Inc.

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule BTK inhibitor. Orelabrutinib’s mechanism of action targets pathogenic B cells not only in the periphery but also within the CNS. Additionally, it directly modulates macrophages and microglial cells in the CNS, with the potential to address compartmentalized inflammation and disease progression in MS. Zenas’ earlier stage programs include ZB021, a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor. For more information about Zenas BioPharma, please visit https://zenasbio.com/ and follow us on LinkedIn.

The Zenas BioPharma word mark, logo mark, and the “lightning bolt” design are trademarks of Zenas BioPharma, Inc. or its affiliated companies. All rights reserved.

Investor and Media Contact:

Argot Partners
Zenas@argotpartners.com