First Rate Infusion & Wellness Launches Mobile “Vitamins in a Bag” Program to Support Employee Wellness Across Dallas–Fort Worth




First Rate Infusion & Wellness Launches Mobile “Vitamins in a Bag” Program to Support Employee Wellness Across Dallas–Fort Worth

First Rate Infusion & Wellness Expands Services With Mobile IV Hydration Offering for Employers in the Dallas–Fort Worth Region

Mesquite, Texas, Nov. 26, 2025 (GLOBE NEWSWIRE) — First Rate Infusion & Wellness, a Texas-based wellness clinic specializing in IV hydration and advanced wellness services, announced the launch of its new mobile IV hydration program designed to support workforce health across the Dallas–Fort Worth region. The service, known as Mobile Vitamins in a Bag, delivers hydration, energy blends, vitamin infusions, and recovery treatments directly to job sites for employee teams experiencing high fatigue and workplace stress.

Teria Mullin leading an educational wellness session, breaking down the benefits of IV vitamin therapy and personalized health solutions offered at First Rate Infusion & Wellness.

The mobile program was developed in response to growing concerns about physical and mental exhaustion among American workers, including airline crews, corporate teams, warehouse employees, frontline personnel, educators, and municipal staff. By offering on-site wellness support, the new service enables organizations to provide health benefits to employees without disrupting workflow or productivity.

“Employee fatigue continues to affect multiple industries,” said Teria Mullin, CRNA, FNP-C, clinical lead at First Rate Infusion & Wellness. “This initiative gives companies a practical way to address dehydration, stress, and burnout while helping employees maintain energy, mental clarity, and physical recovery during demanding work schedules.”

IV hydration is known for its rapid absorption and effectiveness in restoring fluids, vitamins, and electrolytes. The Mobile Vitamins in a Bag program aims to help reduce workplace downtime, support immune health, and improve overall employee well-being.

Industries Served by the Mobile Program

The service is available to organizations across the Dallas–Fort Worth area, including:

• Airline crews
• Corporate offices
• Educators and school districts
• Warehouse operations
• Transportation and logistics teams
• Municipal and utility departments
• First responders
• Event and hospitality groups

Corporate Wellness Service Options

Organizations can schedule:

• On-site employee wellness days
• Hydration and vitamin recovery sessions
• Recurring monthly wellness support
• Custom corporate wellness plans tailored to workforce needs

Teria Mullin, CRNA, FNP-C, clinical lead of First Rate Infusion & Wellness, showcasing her signature “Vitamins in a Bag” IV hydration therapy designed to boost energy, recovery, and overall wellness.

About First Rate Infusion & Wellness

First Rate Infusion & Wellness is a Texas-based wellness clinic offering IV hydration, ketamine therapy, vitamin therapy, weight management services, and mobile wellness services throughout the Dallas–Fort Worth area. The clinic focuses on delivering evidence-based treatments that support recovery, energy, mental well-being, and overall health for diverse workforce and community populations.

Media Contact

First Rate Infusion & Wellness
Email: info@firstrateinfusionandwellness.com
Website: www.firstrateinfusionandwellness.com

A video accompanying this announcement is available at https://www.youtube.com/embed/g2s89rHD9go

Wake Radiology Moves its Chapel Hill Office to the Timberlyne Neighborhood




Wake Radiology Moves its Chapel Hill Office to the Timberlyne Neighborhood

New footprint offers a modern, conveniently accessible facility primed for continued office growth

RALEIGH, N.C., Nov. 26, 2025 (GLOBE NEWSWIRE) — Wake Radiology UNC Health Rex, the largest outpatient imaging provider in the Triangle, today announced plans to move its Chapel Hill office from its current location on S. Estes Drive to 120 Banks Drive, Suite 110, in the Timberlyne neighborhood of Chapel Hill. The move, made possible through the purchase of an existing suite previously owned by Raleigh Radiology, minimizes the threat of future service disruption due to flooding, enabling greater continuity of care for the Chapel Hill community.

“Following the flooding of our S. Estes facility due to Tropical Storm Chantal, we have been evaluating opportunities to safeguard our service offerings so patients can continue to receive the essential imaging they need,” said Dr. Brent Townsend, President and Managing Partner, Wake Radiology. “This new location on Banks Drive offers full-service care, the potential for expanded service capabilities, and a state-of-the-art location that is convenient and accessible to the Chapel Hill community.”

Situated on the first floor of 120 Banks Drive, Wake Radiology’s new facility features EV charging stations and a bicycle storage room, as well as easy access from the I-40 corridor. The office will offer similar services to its current offerings, including 3D screening mammography, 3D diagnostic mammography, ultrasound, breast ultrasound, bone density (DXA), MRI, and walk-in X-ray. Additional service offerings will be shared as they become available.

“We are excited to offer our patients the same excellent radiology services they have come to know and trust in a new, modern facility,” said Parul Galloway, Chief Operating Officer, Wake Radiology. “We are thankful to Raleigh Radiology for working with our team on this solution, allowing us to re-establish key imaging services that benefit the patient and provider community in Chapel Hill.” 

Wake Radiology’s new location is set to open in January 2026. The existing location on S. Estes Drive will continue to operate until the transition to the new facility is completed, ensuring no disruption to scheduled patient exams.

About Wake Radiology UNC Health Rex

Wake Radiology UNC Health Rex has set the standard for medical imaging excellence and innovation since 1953. Physician-owned and led, our results-driven team of sub-specialized radiologists delivers an unparalleled patient experience rooted in accessible, compassionate and actionable care. As the Triangle’s first and largest outpatient imaging provider, Wake Radiology relies on world-class technology to deliver faster and more accurate imaging services, allowing physicians to elevate patient care and help our communities thrive. Specialties include MRI, CT, X-ray, Ultrasound, Interventional Radiology, Nuclear Medicine, Bone Density and Mammography across 13 area locations. Learn more at WakeRad.com

CONTACT: Rivers Agency:
publicrelations@riversagency.com
919-932-9985

Moleculin to Participate in the Virtual Investor Closing Bell Series




Moleculin to Participate in the Virtual Investor Closing Bell Series

Live video webcast with Walter Klemp, Chairman and Chief Executive Officer, on Tuesday, December 2^nd at 4:00 PM ET

HOUSTON, Nov. 26, 2025 (GLOBE NEWSWIRE) — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that Walter Klemp, Chairman and Chief Executive Officer of Moleculin will participate in the Virtual Investor Closing Bell Series on Tuesday, December 2, 2025 at 4:00 PM ET.

As part of the event, Mr. Klemp will provide a corporate overview and business outlook. In addition to the prepared remarks, interested parties will have the opportunity to submit questions live during the event. Mr. Klemp will answer as many questions as possible in the time allowed.

A live video webcast of the event will be available on the Events page under the Investors section of the Company’s website (moleculin.com). A webcast replay will be available two hours following the live event and will be accessible for 90 days.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin, is a next-generation highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

The Company has begun the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.

For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook.

Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
MBRX@jtcir.com

Krystal Biotech to Present at 8th Annual Evercore Healthcare Conference




Krystal Biotech to Present at 8th Annual Evercore Healthcare Conference

PITTSBURGH, Nov. 26, 2025 (GLOBE NEWSWIRE) — Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that the Company will participate in the 8^th Annual Evercore Healthcare Conference on December 3, 2025, in Miami. Krish S. Krishnan, Chairman and Chief Executive Officer, will take part in a fireside chat scheduled at 10:00 am ET and host investor meetings throughout the day.

A webcast of the presentation will be available here beginning at 10:00 am ET on Wednesday, December 3, 2025 and will be posted on the Investors section of the Company’s website.

About Krystal Biotech, Inc.

Krystal Biotech, Inc. (NASDAQ: KRYS) is a fully integrated, commercial-stage, global biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK^®, the Company’s first commercial product, is the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. For more information, please visit http://www.krystalbio.com, and follow @KrystalBiotech on LinkedIn and X (formerly Twitter).

CONTACT
Investors and Media:
Stéphane Paquette
Krystal Biotech
spaquette@krystalbio.com

Design Therapeutics to Participate in Upcoming Investor Conferences




Design Therapeutics to Participate in Upcoming Investor Conferences

CARLSBAD, Calif., Nov. 26, 2025 (GLOBE NEWSWIRE) — Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today announced that management will participate in fireside chats at the following upcoming investor conferences:

• Piper Sandler 37^th Annual Healthcare Conference on Wednesday, December 3, 2025, at 3:30 p.m. ET in New York, NY
• Evercore 8^th Annual Healthcare Conference on Thursday, December 4, 2025, at 10:00 a.m. ET in Coral Gables, FL

Live webcasts of each fireside chat will be available here and in the investors section of the company’s website at www.designtx.com. The webcasts will be archived for at least 30 days following each presentation.

About Design Therapeutics
Design Therapeutics is a clinical-stage biotechnology company developing a new class of therapies based on its platform of GeneTAC^® gene targeted chimera small molecules. The company’s GeneTAC^® molecules are designed to either dial up or dial down the expression of a specific disease-causing gene to address the underlying cause of disease. In addition to its clinical-stage GeneTAC^® programs, DT-216P2, in development for patients with Friedreich ataxia, and DT-168, for Fuchs endothelial corneal dystrophy, the company is advancing DT-818 for myotonic dystrophy type-1, and a program in Huntington’s disease. Discovery efforts are underway for multiple genomic medicines. For more information, please visit designtx.com.

Contact:
Renee Leck
THRUST Strategic Communications
renee@thrustsc.com

ARS Pharmaceuticals to Participate in Piper Sandler 37th Annual Healthcare Conference




ARS Pharmaceuticals to Participate in Piper Sandler 37th Annual Healthcare Conference

SAN DIEGO, Nov. 26, 2025 (GLOBE NEWSWIRE) — ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, today announced its participation at the Piper Sandler 37^th Annual Healthcare Conference, December 2-4, 2025, in New York.

Richard Lowenthal, Co-Founder, President and CEO and Eric Karas, Chief Commercial Officer will participate in a fireside chat on Wednesday, December 3 at 2:30 pm ET with Piper Sandler analyst David Amsellem. Company management will also participate in one-on-one meetings with investors.

A live webcast of the fireside chat will be available here, and in the Investors & Media section of the Company’s website. A replay of the webcast will be archived on the Company’s website for 90 days.

About ARS Pharmaceuticals, Inc.
ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializing neffy® (trade name EURneffy® in the EU), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult patients and pediatric patients 4 years of age and older who weigh 33 lbs. or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visit www.ars-pharma.com.

Investor Contact:
Justin Chakma, ARS Pharma
justinc@ars-pharma.com

Media Contact:
Christy Curran, Sam Brown Inc.
christycurran@sambrown.com
615.414.8668

Adial Pharmaceuticals Announces a Warrant Inducement Transaction for Approximately $2.86 Million in Gross Proceeds




Adial Pharmaceuticals Announces a Warrant Inducement Transaction for Approximately $2.86 Million in Gross Proceeds

GLEN ALLEN, Va., Nov. 26, 2025 (GLOBE NEWSWIRE) — Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced its entry into a warrant inducement agreement with an existing healthcare-focused institutional investor of the Company for the immediate exercise of existing Series C-1 Warrants (the “Series C-1 Warrants“) to purchase up to 4,025,000 shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”), and Series E Warrants (the “Series E Warrants”, and together with the Series C-1 Warrants the “Existing Warrants”) to purchase up to 5,190,675 shares of Common Stock at a reduced exercise price of $0.31 for gross cash proceeds of approximately $2.86 million, before deducting financial advisor fees and other transaction expenses. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

A.G.P./Alliance Global Partners is acting as the exclusive financial advisor in this warrant inducement transaction.

In consideration for the immediate exercise in full of the Existing Warrants, the investor will receive, in a private placement, new unregistered Series F Warrants to purchase up to 13,823,512 shares of Common Stock (the “New Warrants”). The New Warrants will have an exercise price of $0.31, will be initially exercisable on the date that shareholder approval of the issuance of the New Warrants is obtained (the “Approval Date”), and will expire 24 months following the Approval Date. The closing of the warrant inducement transaction is expected to occur on or about December 1, 2025, subject to satisfaction of customary closing conditions.

The private placement of the New Warrants and the shares of Common Stock underlying the New Warrants offered to the institutional investor will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and Regulation D promulgated thereunder. Accordingly, the securities issued in the private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Adial Pharmaceuticals, Inc.

Adial is a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com.

Forward-Looking Statements

This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include without limitation, statements regarding the closing of the private placement, the satisfaction of the closing conditions of the private placement, and the use of net proceeds from the private placement as well as the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, market and other conditions, our ability to pursue our regulatory strategy, our ability to maintain our listing on The Nasdaq Capital Market (“Nasdaq”), our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to retain our key employees or maintain our Nasdaq listing, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.

Investor Contact

Crescendo Communications, LLC
David Waldman / Alexandra Schilt
Tel: 212-671-1020
Email: adil@crescendo-ir.com

Genelux Corporation to Participate in a Fireside Chat at Piper Sandler 37th Annual Healthcare Conference




Genelux Corporation to Participate in a Fireside Chat at Piper Sandler 37th Annual Healthcare Conference

WESTLAKE VILLAGE, Calif., Nov. 26, 2025 (GLOBE NEWSWIRE) — Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced that Thomas Zindrick, President, CEO and Chairman of the Board and Matt Pulisic, Chief Financial Officer, will participate in a fireside chat at the Piper Sandler 37^th Annual Healthcare Conference on Wednesday, December 3, 2025 at 12:00 p.m. ET in New York, NY.

A live webcast of the fireside chat can be found here. Following the live webcast, an archived replay will be available on the Company’s website https://investors.genelux.com/.

About Genelux Corporation

Genelux is a late clinical-stage biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. Olvi-Vec currently is being evaluated in two U.S.-based clinical trials: OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination platinum-doublet + bevacizumab compared with physician’s choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer; and, VIRO-25, a multi-center, randomized, open-label Phase 2 trial evaluating the efficacy and safety of Olvi-Vec & platinum-doublet + physician’s choice of immune checkpoint inhibitor compared to docetaxel in non-small-cell lung cancer. Additionally, Olvi-Vec currently is being evaluated for dose selection in Olvi-Vec-SCLC-202, a China-based, multi-center, open label Phase 1b trial evaluating the efficacy and safety of Olvi-Vec & platinum-doublet in recurrent small-cell lung cancer. The core of Genelux’s discovery and development efforts revolves around its proprietary CHOICE™ platform from which the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec. For more information, please visit www.genelux.com and follow us on X @Genelux_Corp and on LinkedIn.

Investor Contact

Austin Murtagh
Precision AQ
austin.murtagh@precisionaq.com

Media Contact

Ashley Murphy
Precision AQ
ashley.murphy@precisionaq.com

Source: Genelux Corporation

Tangram Therapeutics Submits Clinical Trial Application for Phase 1/2 Study of TGM-312, a Novel Investigational RNAi MASH Candidate




Tangram Therapeutics Submits Clinical Trial Application for Phase 1/2 Study of TGM-312, a Novel Investigational RNAi MASH Candidate

The Company expects to initiate first-in-human study in early 2026, with initial data anticipated H2 2026

Clinical Trial Application (CTA) submission marks the advancement of Tangram’s GalOmic RNAi platform into clinical development

LONDON, Nov. 26, 2025 (GLOBE NEWSWIRE) — Tangram Therapeutics (‘Tangram’), a company committed to uniting computation and RNAi to make better medicines faster, today announced the submission of a Clinical Trial Application (CTA) to the Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 1/2 clinical trial of its lead pipeline program TGM-312. TGM-312 is an investigational GalOmic siRNA designed to specifically silence a novel gene in hepatocytes to treat metabolic dysfunction-associated steatohepatitis (MASH).

“The submission of our first CTA is a significant milestone for Tangram. It is a testament to the power of combining AI and RNAi to discover novel medicines and the passion of our lean team,” commented CEO Ali Mortazavi. “TGM-312 has the potential to offer a differentiated and patient-friendly therapeutic option for people living with MASH, where substantial unmet need remains. With this submission, we are proud to advance our first GalOmic medicine into the clinic and become a clinical-stage company.”

The proposed Phase 1/2 study will evaluate TGM-312 in healthy adult volunteers and patients with MASH, assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of the candidate. The trial will also include liver biopsies and exploratory imaging and biomarker endpoints in MASH patients. Pending regulatory clearance, the study is expected to commence in early 2026 in the United Kingdom, with initial data anticipated in H2 2026.

About TGM-312

TGM-312 is a novel GalOmic GalNAc-conjugated small interfering RNA (GalNAc-siRNA) therapeutic candidate in development as a safe and effective treatment for metabolic dysfunction-associated steatohepatitis (MASH). TGM-312 has potential for a patient-friendly quarterly subcutaneous dosing regimen. In preclinical studies in the highly translational Gubra-Amylin NASH diet-induced obese (GAN-DIO) mouse model, administration of TGM-312 led to dramatic reductions in NAFLD Activity Score (NAS), decreased hepatic inflammation and slowed fibrosis progression, both as monotherapy and in combination with approved and emerging MASH therapies.

About Tangram Therapeutics 

Tangram Therapeutics is a biotech company committed to uniting computation, RNAi, and unconventional thinking to make better medicines faster. We are advancing a pipeline of GalOmic RNAi medicines for a broad range of diseases with high unmet need.

Tangram’s innovative medicines are enabled by GalOmic, our proprietary RNAi chemistry platform designed to selectively silence disease-driving genes in hepatocytes. Discovery is powered by LLibra OS, our next-generation AI platform with an agentic infrastructure. The unique combination of these platforms is the foundation of our Relentless Medicine Discovery. Faster, smarter development of RNAi medicines designed for real-world impact.

Learn more at www.tangramtx.com.

Media Contact
press@tangramtx.com

Investor Relations Contact
IR@tangramtx.com

Nyxoah’s Genio® Therapy Receives Significant 2026 Medicare Reimbursement Increases Under Final CMS Rule




Nyxoah’s Genio® Therapy Receives Significant 2026 Medicare Reimbursement Increases Under Final CMS Rule

Nyxoah’s Genio® Therapy Receives Significant 2026 Medicare Reimbursement Increases Under Final CMS Rule

Assignment to New Technology APC 1580 is positive news for Nyxoah’s U.S. commercial rollout by strengthening hospital and ASC economics

Mont-Saint-Guibert, Belgium – November 26, 2025, 7:45 am CET / 1:45 am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has finalized its CY2026 Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgery Center (ASC) Rule. Within the final rule, CMS assigned CPT Code 64568, the code used for all Genio hypoglossal nerve stimulation (HGNS) implants, to New Technology Ambulatory Payment Classification (APC) 1580.

Effective January 1, 2026, Hospital Outpatient Department (HOPD) reimbursement for CPT 64568 will increase to approximately $45,000, a 48% rise compared to 2025. In addition, Ambulatory Surgery Centers (ASC) facility reimbursement will increase to $42,373, reflecting a 58% increase compared to 2025.

These updates apply uniformly to all procedures billed under CPT 64568, including Genio®, and strengthen the economic foundation supporting therapy adoption across U.S. hospital outpatient departments and ambulatory surgical centers. With CMS’ decision, Genio® enters 2026 with a stronger reimbursement framework that is expected to support broader adoption, increased procedural throughput, and expansion across Medicare-heavy institutions.

Genio®’s single-incision procedure is well suited for the ASC environment, and the significant increase in ASC facility payment creates new opportunities for therapy expansion and site-of-service diversification.

“CMS’ decision to significantly increase reimbursement for CPT 64568 reinforces the growing recognition of hypoglossal nerve stimulation as a high-value therapy for obstructive sleep apnea,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer.“ The new rates create a more favorable environment for expanding access to our Genio therapy across both outpatient hospitals and ASCs.”

About Nyxoah

Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65.

For more information, please visit http://www.nyxoah.com/.

Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device.

Forward-looking statements

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the Company’s commercialization strategy and entrance to the U.S. market; and the Company’s results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:

Nyxoah
John Landry, CFO
IR@nyxoah.com

Rémi Renard
Chief Investor Relations & Corporate Communication Officer
IR@nyxoah.com

Attachment

• ENGLISH_2026 CMS Final Payment Rule_FINAL