Medicenna Therapeutics to Host a Live Webinar with Q&A to Discuss Updated MDNA11 Clinical Data

Medicenna Therapeutics to Host a Live Webinar with Q&A to Discuss Updated MDNA11 Clinical Data




Medicenna Therapeutics to Host a Live Webinar with Q&A to Discuss Updated MDNA11 Clinical Data

TORONTO and HOUSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) — Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines for the treatment of cancer as well as autoimmune and inflammatory diseases is pleased to announce that it will host a live webinar on December 10, 2025 at 08:30 AM Eastern Time.

As previously announced, Medicenna will present updated clinical data from the ABILITY-1 Phase 1/2 Study, evaluating MDNA11 as a monotherapy and in combination with pembrolizumab, on December 10th at the ESMO Immuno-Oncology Congress 2025. The webinar will have Medicenna’s management team and the presenting Principal Investigator along with commentary from key opinion leaders to discuss the updated data.

Medicenna Therapeutics – KOL Webinar | Live Event Details:

  • Date: December 10, 2025
  • Time: 08:30 – 09:30 AM ET
  • Format: Live Webinar with Q&A
  • Registration: Participants can register for the webinar through the link: [Registration]. A replay of the webinar will be available on Medicenna’s website following the event.

The webinar will feature presentations from Medicenna’s executive and scientific advisory team, including Dr. Fahar Merchant, President and CEO, Dr. Arash Yavari, Director of Clinical Strategy, and the presenting Principal Investigator Dr. André Mansinho, Assistant Professor, Faculty of Medicine, University of Lisbon. Additional commentary from key opinion leaders and live Q&A will follow the presentation.

About Medicenna Therapeutics

Medicenna is a clinical-stage immunotherapy company focused on developing novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first-in-class Empowered Superkines. Medicenna’s long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior affinity toward CD122 (IL-2 receptor beta) and no CD25 (IL-2 receptor alpha) binding, thereby preferentially stimulating cancer-killing effector T cells and NK cells. Medicenna’s first-in-class targeted PD-1 x IL-2 bispecific, MDNA113, is in development for solid tumors and was designed using the Company’s proprietary BiSKITs™ (Bifunctional SuperKine ImmunoTherapies) and T-MASK™ (Targeted Metalloprotease Activated SuperKine) platforms. Medicenna’s IL-4 Empowered Superkine, bizaxofusp (formerly MDNA55), has been studied in 5 clinical trials enrolling over 130 patients, including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. Bizaxofusp has obtained FastTrack and Orphan Drug status from the FDA and FDA/EMA, respectively.

For more information, please visit www.medicenna.com, and follow us on X and LinkedIn.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, express or implied statements regarding the future operations of the Company, estimates, plans, strategic ambitions, partnership activities and opportunities, objectives, expectations, opinions, forecasts, projections, guidance, outlook or other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expect”, “believe”, “seek”, “potentially” and similar expressions. and are subject to risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the risks detailed in the latest annual information form of the Company and in other filings made by the Company with the applicable securities regulators from time to time in Canada.

The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date hereof and except as required by law, we do not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements.

This news release contains hyperlinks to information that is not deemed to be incorporated by reference in this new release.

Investor/Media Contact:

Shushu Feng
Investor Relations, Medicenna Therapeutics
(416) 964-5442
ir@medicenna.com

Picard Celebrates Patient Living a World-Record of Over Eight Years with the SynCardia Total Artificial Heart

Picard Celebrates Patient Living a World-Record of Over Eight Years with the SynCardia Total Artificial Heart




Picard Celebrates Patient Living a World-Record of Over Eight Years with the SynCardia Total Artificial Heart

-Picard Medical / SynCardia Systems LLC mark historic milestone as a patient reaches 2,900 days of continuous support with the SynCardia Total Artificial Heart — the longest timeframe in the world ever recorded-

TUCSON, Ariz., Dec. 09, 2025 (GLOBE NEWSWIRE) — Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and Health Canada, proudly marks a new milestone in the field of mechanical circulatory support with a patient living over eight years or 2,900 days with a SynCardia™ Total Artificial Heart (STAH), the longest timeframe that a patient has ever lived on an artificial heart.

“This achievement shows the life-changing impact of the SynCardia Total Artificial Heart, offering not only a bridge to transplant but also durable long-term support, to support life far beyond the typical time span for patients waiting for a donor heart,” said Patrick NJ Schnegelsberg, Chief Executive Officer of Picard Medical. “In this case, the STAH demonstrates long-term durability and reliability as well as fills a life-saving gap for patients who would otherwise have no viable options. Building on this foundation of long-term success, Picard Medical is now developing the Emperor, its next generation of fully implantable, artificial heart systems to broaden access and provide greater flexibility for long-term support worldwide.”

About the Patient

A 46-year-old patient, facing end-stage heart failure, received the SynCardia Total Artificial Heart on December 9, 2017 at the Institute for Cardiovascular Diseases, Dedinje hospital (also known as “IVDK Dedinje Hospital”) in Belgrade, Serbia. Today, eight years later, this patient continues to live supported by the SynCardia Total Artificial Heart, reaching more than 2,900 days of extended life, with most of those days spent at home with family and loved ones. The dedication of the medical team at IVDK Dedinje Hospital, combined with SynCardia’s technology, continues to make a profound difference in this patient’s journey.

Long-term Success Concentrated in Serbia

Serbia continues to lead the world in long-duration support with the SynCardia Total Artificial Heart. The five longest supported patients globally are all from IVDK Dedinje Hospital in Belgrade, with one patient supported for about eight years, another for more than four years, a third for more than three years, and two additional patients each supported for just under three years. These extraordinary cases reflect the strength of the clinical program in the region and the dedication of Serbian cardiac surgeons and transplant teams at IVDK Dedinje Hospital, who have advanced the SynCardia Total Artificial Heart at an exceptional level.

About Picard Medical and SynCardia

Picard Medical, Inc. is the parent company of SynCardia Systems, LLC (“SynCardia”), the Tucson, Arizona–based leader with the only commercially available total artificial heart technology for patients with end-stage heart failure. SynCardia develops, manufactures, and commercializes the SynCardia Total Artificial Heart (“STAH”), an implantable system that assumes the full functions of a failing or failed human heart. It is the first artificial heart approved by both the FDA and Health Canada, and it remains the only commercially available artificial heart in the United States and Canada. With more than 2,100 implants performed at hospitals across 27 countries, the SynCardia Total Artificial Heart is the most widely used and extensively studied artificial heart in the world.

For additional information about Picard Medical, please visit www.picardmedical.com or review the Company’s filings with the U.S. Securities and Exchange Commission at www.sec.gov.

Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. The Company 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 the Company’s expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Registration Statement and related prospectus filed in connection with the initial public offering with the SEC. Copies are available on the SEC’s website, http://www.sec.gov.

Contact:

Investors
Eric Ribner
Managing Director
LifeSci Advisors LLC
eric@lifesciadvisors.com

Picard Medical, Inc./SynCardia Systems, LLC
IR@picardmedical.com

General/Media
Brittany Lanza
blanza@syncardia.com

Praxis Precision Medicines Announces Alignment with FDA on Simplified and Accelerated Registrational Pathway for Elsunersen in Early Onset SCN2A Developmental and Epileptic Encephalopathy

Praxis Precision Medicines Announces Alignment with FDA on Simplified and Accelerated Registrational Pathway for Elsunersen in Early Onset SCN2A Developmental and Epileptic Encephalopathy




Praxis Precision Medicines Announces Alignment with FDA on Simplified and Accelerated Registrational Pathway for Elsunersen in Early Onset SCN2A Developmental and Epileptic Encephalopathy

Clear recognition of high unmet need and urgency for the SCN2A community and plausibility of the mechanism of elsunersen 

FDA agreed to proposed changes to the EMBRAVE3 trial design to be a single-arm, baseline-controlled study

Enrollment in EMBRAVE3 is quickly accelerating and topline results expected in 2026

Topline results from ongoing EMBRAVE study (Part A, n=9) expected in 1H 2026

BOSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) — Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the completion of a Type C meeting with the U.S. Food and Drug Administration (FDA) and agreement to immediately convert the EMBRAVE3 registrational study of elsunersen in early-onset SCN2A developmental and epileptic encephalopathy (DEE) into a single-arm study where all patients will receive elsunersen for 24 weeks, followed by an open-label extension.

Key Changes to EMBRAVE3

  • The current study has been immediately converted from a double-blind, sham-controlled study to a single-arm, baseline-controlled study, enrolling 30 patients reduced from 40 patients.
  • All patients currently in screening will be assigned to receive elsunersen.
  • The primary analysis will be the change from baseline in countable motor seizures.

Update on EMBRAVE Study status

  • The EMBRAVE Study Part A enrolled 9 patients randomized 3:1 to elsunersen or placebo/sham for 20 weeks, followed by a blinded transition to elsunersen for up to 2 years in an open-label extension.
  • Praxis expects to complete Part A and disclose the topline results in the first half of 2026.

“This alignment with the FDA represents a meaningful step forward for patients and families living with SCN2A-DEE. The Agency’s recognition of both the urgency of the unmet need and the strong mechanistic rationale for elsunersen enables us to move with greater clarity and speed. Converting EMBRAVE3 to a single-arm, baseline-controlled study ensures that every child entering the trial will receive active treatment from day one, while preserving a rigorous and approvable pathway. Momentum in enrollment continues to build, and we remain focused on generating the evidence needed to bring the first targeted therapy for SCN2A gain-of-function disease to patients as quickly as possible,” said Marcio Souza, president and chief executive officer.

About Elsunersen (PRAX-222)
Elsunersen is an antisense oligonucleotide (ASO) designed to selectively decrease SCN2A gene expression, directly targeting the underlying cause of early-seizure-onset SCN2A developmental and epileptic encephalopathy (DEE) to treat seizures and other symptoms in patients with gain-of-function SCN2A mutations. In vitro studies of elsunersen have demonstrated reduction in both SCN2A gene expression and protein levels. In vivo, elsunersen has demonstrated significant, dose-dependent reduction in seizures, improvement in behavioral and locomotor activity and increased survival in SCN2A mouse models, with potential to be the first disease-modifying treatment for SCN2A-DEE. Elsunersen has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the FDA, and ODD and PRIME designations from the European Medicines Agency for the treatment of SCN2A-DEE. To learn more about the EMBRAVE3 study, please visit https://www.embravestudy.com/.

About Praxis  

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for CNS disorders characterized by neuronal excitation-inhibition imbalance. Praxis is applying genetic insights to the discovery and development of therapies for rare and more prevalent neurological disorders through our proprietary small molecule platform, Cerebrum™, and antisense oligonucleotide (ASO) platform, Solidus™, using our understanding of shared biological targets and circuits in the brain. Praxis has established a diversified, multimodal CNS portfolio including multiple programs across movement disorders and epilepsy, with four clinical-stage product candidates. For more information, please visit www.praxismedicines.com and follow us on FacebookInstagramLinkedIn and Twitter/X.

Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Praxis’ future expectations, plans and prospects, including, without limitation, statements regarding the anticipated timing of clinical trials and the development of Praxis’ product candidates, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “endeavor,” “estimate,” “expect,” “anticipate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will” or “would” and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995.

The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical trials; the expected timing of clinical trials, data readouts and the results thereof, and submissions for regulatory approval or review by governmental authorities; regulatory approvals to conduct trials; and other risks concerning Praxis’ programs and operations as described in its Annual Report on Form 10-K for the year ended December 31, 2024 and as updated in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as well as other filings made with the Securities and Exchange Commission. Although Praxis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on information and factors currently known by Praxis. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Praxis undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

CONTACT: Investor Contact:
Praxis Precision Medicines
investors@praxismedicines.com
857-702-9452  

Media Contact:
Dan Ferry
Life Science Advisors
Daniel@lifesciadvisors.com
617-430-7576

Denali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded Warrants

Denali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded Warrants




Denali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded Warrants

SOUTH SAN FRANCISCO, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) — Denali Therapeutics Inc. (NASDAQ: DNLI) today announced that it intends to offer and sell $200 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock in an underwritten public offering. In addition, Denali Therapeutics intends to grant the underwriters a 30-day option to purchase up to an additional $30 million of shares of common stock. All of the shares of common stock and pre-funded warrants to be sold in the proposed offering will be sold by Denali Therapeutics. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC and Jefferies LLC are acting as joint book-running managers for the offering. H.C. Wainwright & Co. is acting as co-manager for the offering.

The shares will be offered by Denali Therapeutics pursuant to a Registration Statement on Form S-3, which was automatically effective upon filing with the SEC on February 27, 2025, and Denali Therapeutics will file a preliminary prospectus supplement to which this communication relates, copies of which can be accessed for free through the SEC’s website at www.sec.gov. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

When available, a copy of the preliminary prospectus supplement, the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from:

Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, fax: 212-902-9316, email: prospectus-ny@ny.email.gs.com; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, email: prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, telephone: 1-866-718-1649, email: prospectus@morganstanley.com; Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, telephone: (877) 821-7388, email: Prospectus_Department@Jefferies.com.

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

About Denali Therapeutics

Denali Therapeutics is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier using its proprietary TransportVehicle™ platform. With a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, Denali Therapeutics is advancing toward its goal of delivering effective medicines to transform the lives of people living with neurodegenerative, lysosomal storage and other serious diseases.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws. These statements involve risks and uncertainties that could cause actual results to differ materially, including, but not limited to, whether or not Denali Therapeutics will be able to raise capital through the sale of shares of common stock and pre-funded warrants or consummate the offering, the final terms of the offering, the satisfaction of customary closing conditions, prevailing market conditions, the anticipated use of the proceeds of the offering which could change as a result of market conditions or for other reasons, and the impact of general economic, industry or political conditions in the United States or internationally. Additional risks and uncertainties relating to the offering, Denali Therapeutics and its business can be found under the heading “Risk Factors” in Denali Therapeutics’ most recent current, quarterly and annual reports filed with the SEC and in the preliminary prospectus supplement and accompanying prospectus relating to the offering to be filed with the SEC. Denali Therapeutics assumes no duty or obligation to update or revise any forward-looking statements for any reason.

Investor Relations Contact:

Laura Hansen, Ph.D.
hansen@dnli.com

Media Contact:

Erin Patton
epatton@dnli.com

Amneal Receives U.S. FDA Approval for Epinephrine Injection in Single- and Multi-Dose Vials for U.S. Hospitals

Amneal Receives U.S. FDA Approval for Epinephrine Injection in Single- and Multi-Dose Vials for U.S. Hospitals




Amneal Receives U.S. FDA Approval for Epinephrine Injection in Single- and Multi-Dose Vials for U.S. Hospitals

  • Expands Amneal’s injectables portfolio with an essential medicine used in hospitals for emergency and perioperative care

BRIDGEWATER, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) — Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s epinephrine injection USP, 1 mg/mL (1 mL), in single-dose vials and 1 mg/mL (30 mL) multi-dose vials. This medicine is a critical therapy utilized by hospitals, emergency departments and other acute care facilities for patient care.

“Epinephrine is one of the most important and widely used emergency medicines in healthcare,” said Arash Dabestani, Pharm.D., Senior Vice President, Institutional. “By bringing both single- and multi-dose vial presentations to the institutional market, we are helping expand reliable and affordable access for hospitals and clinical providers, while reinforcing Amneal’s commitment to supplying essential medicines that support patient care across the U.S. health system.”

Epinephrine is a non-selective alpha and beta adrenergic agonist. The 1 mg/mL formulation is indicated for the emergency treatment of allergic reactions (Type 1) including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

The most common adverse reactions associated with systemically administered epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism. For prescribing information, see package inserts for single dose vial here and multidose vial here.

According to IQVIA® U.S. annual sales for epinephrine injection single- and multi-dose vials for the 12 months ended October 2025 were approximately $118 million.

About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 290 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.

Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com

Media Contact
Brandon Skop
Sr. Director, Corporate Communications
brandon.skop@amneal.com

Tevogen Celebrates Board Member Dr. Curtis Patton, Honored by Yale University for Distinguished Career and Lasting Contributions to Medical Education and Equity in Medicine

Tevogen Celebrates Board Member Dr. Curtis Patton, Honored by Yale University for Distinguished Career and Lasting Contributions to Medical Education and Equity in Medicine




Tevogen Celebrates Board Member Dr. Curtis Patton, Honored by Yale University for Distinguished Career and Lasting Contributions to Medical Education and Equity in Medicine

WARREN, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) — Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), is proud to recognize Curtis Patton, PhD, founding member of Tevogen’s Board of Directors and Professor Emeritus at Yale University, as he is honored in a new joint portrait commissioned by the Yale School of Medicine’s Program for Art in Public Spaces.

The portrait celebrates the extraordinary, decades-long contributions of Dr. Patton and James Comer, MD, MPH, Maurice Falk Professor in the Child Study Center, whose work has shaped generations of medical students, residents, fellows, and early-career faculty through their unwavering commitment to mentorship, community building, and public health leadership.

Dr. Patton’s effort across academic, public and private verticals have had a lasting impact on Tevogen, particularly as the Company continues to advance its ExacTcell™ precision T cell platform, scale Tevogen.AI’s predictive technologies, and execute on its growth initiatives, all with the ultimate goal of improving patient outcomes while achieving commercial success, including revenue forecasts exceeding $1 billion.

The portrait, created by artist Mario Moore (MFA ’13), will be unveiled on Thursday, December 11, 2025 at 4 p.m. in the Harvey Cushing/John Hay Whitney Medical Library at Yale School of Medicine.

“Dr. Patton’s leadership and scientific vision have played a pivotal role in shaping Tevogen’s foundation,” said Dr. Ryan Saadi, Founder & CEO of Tevogen. “His legacy at Yale reinforces the strength of the Company’s mission during a period of significant momentum.”

“Dr. Patton’s brilliance is matched only by his humanity. His lifelong commitment to public health and mentorship has elevated the field and all of us fortunate enough to work with him,” commented Susan M. Podlogar, of Tevogen’s board of directors.

Tevogen Bio extends its heartfelt congratulations to Dr. Patton on this well-deserved recognition.

About Tevogen

Tevogen is a next-generation, socially integrated healthcare enterprise built on the principles of affordability, efficiency, and scientific rigor. The company leverages industry-leading artificial intelligence and precision T cell therapy platforms, a patient-first and cost-disciplined operating model, and strategic engagements with global technology leaders to support the development of advanced, life-saving therapies across multiple therapeutic areas and scalable solutions for the broader healthcare system.

Tevogen Bio, the company’s lead initiative, has completed a proof-of-concept clinical trial demonstrating the potential of its single-HLA–restricted, genetically unmodified allogeneic T cells. The Tevogen Bio pipeline spans virology, oncology, and neurology, with programs built on the company’s proprietary ExacTcell™ platform.

Tevogen.AI is designed to transform drug development by accelerating target detection, helping reduce failure rates, and supporting optimized clinical trial design through proprietary predictive technologies. The platform utilizes cloud and data services from leading technology providers, including Microsoft and Databricks, to advance its long-term ambition to predict the proteome for any given protein–HLA combination, enabling rapid and cost-efficient therapeutic discovery.

Tevogen is exploring future strategic initiatives that may include domestic generics, biosimilars, medical devices, and innovative insurance solutions for healthcare providers. Together, these programs reflect Tevogen’s mission to advance sustainable innovation and broaden patient access through a faster, more efficient, and more equitable healthcare model.

Forward Looking Statements

This press release contains certain forward-looking statements, including without limitation statements relating to: Tevogen’s plans for its research and manufacturing capabilities; expectations regarding future growth; expectations regarding the healthcare and biopharmaceutical industries; and Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases and cancer. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “anticipate,” “possible,” “potential,” “goal,” “opportunity,” “project,” “believe,” “future,” and similar words and expressions or their opposites. These statements are based on management’s expectations, assumptions, estimates, projections and beliefs as of the date of this press release and are subject to a number of factors that involve known and unknown risks, delays, uncertainties and other factors not under the company’s control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements.

Factors that could cause actual results, performance, or achievements to differ from those expressed or implied by forward-looking statements include, but are not limited to: changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic conditions; the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; the risk that Tevogen may not be able to develop and maintain effective internal controls; the failure to achieve Tevogen’s commercialization and development plans and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen to grow and manage growth economically and hire and retain key employees; the risk that Tevogen may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; that Tevogen will need to raise additional capital to fully realize its business plans; risks related to the ability to develop, license or acquire new therapeutics; the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, approval and commercial development; risks associated with intellectual property protection; Tevogen’s limited operating history; and those factors discussed or incorporated by reference in Tevogen’s Annual Report on Form 10-K and subsequent filings with the SEC.

You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Tevogen undertakes no obligation to update any forward-looking statements, except as required by applicable law.

Contacts

Tevogen Bio Communications
T: 1 877 TEVOGEN, Ext 701
Communications@Tevogen.com

A photo accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/f68cfcd1-fa0f-4c28-a7a8-4299f911461d

NADP Report Shows Continued Decline in Dental Benefits Enrollment

NADP Report Shows Continued Decline in Dental Benefits Enrollment




NADP Report Shows Continued Decline in Dental Benefits Enrollment

Decreases Reflected in Commercially Insured and Government Funded Plans

DALLAS, Dec. 09, 2025 (GLOBE NEWSWIRE) — According to the recently released 2025 Dental Benefits Report published annually by the National Association of Dental Plans, nearly 284 million Americans are covered by some form of dental benefit through employer-sponsored group plans or other group or individual plans, including public benefits. This represents 83% of the population and a decline of 2.3% from last year.

The decrease in enrollment affected both commercially insured and government funded plans, with enrollment in commercial dental plans down 2.0% compared to 2023. Enrollment in publicly funded benefits fell by 3.0% in 2024 compared to 2023.

“Given the strong connection between oral health and overall health, these findings are disappointing,” said NADP executive director Mike Adelberg. “It is well documented that individuals with dental benefits coverage are more likely to go to the dentist, take their children to the dentist, receive restorative care, and experience better overall health. We hope to reverse this decline by working with policy makers, employers and our dental care partners to continue to enhance the value of dental benefits and dental care.”

Breaking down sources of coverage in the population surveyed, 51% have employer-sponsored coverage; 28% are covered through Medicaid/CHIP; 8% are covered through Medicare; 1% are covered through other public assistance programs; 3% are covered through individual plans; and 13% have no dental coverage.

Public Programs

In the public benefit sector, the percentage of individuals covered by Medicare Advantage plans fell by 11.4% dropping to 22.6 million. However, Medicaid enrollment increased by 0.6% and CHIP enrollment rose by 1.5% to 7.3 million.

Commercial Benefits

While Dental Preferred Provider Organization (DPPO) plan enrollment decreased by 1.9% in 2024, DPPO products remain the dominant dental products in the commercial market with 89% of total enrollment in commercial dental plans, unchanged from last year.

About 49% of all commercial group dental benefits are employer sponsored and 51% are voluntary benefits, paid for by individuals.

Stand-alone dental plans remain the typical vehicle for delivering dental benefits; only about 1.2% of commercial dental benefits are integrated into medical policies.

Notably, nearly half of group dental benefits, 46%, are self-insured, up from 44% last year, reversing a declining trend since 2013.

The 2025 Dental Benefits Report: Enrollment, an annual survey conducted by the National Association of Dental Plans, provides a comprehensive analysis of the shifting dental benefits landscape and its implications for the industry. To access the full report, visit knowledge.nadp.org.

About NADP
NADP is the largest non-profit trade association focused exclusively on the dental benefits industry. NADP members provide dental HMO, dental PPO, dental indemnity, and dental savings plan products to more than 200 million Americans with dental benefits. NADP members include the entire spectrum of dental carriers: companies that provide both medical and dental coverage, companies that provide only dental coverage, major national, regional, and single state companies, as well as companies organized as non-profit plans.

CONTACT:

Michael Adelberg
NADP Executive Director
(972) 457-1554
madelberg@nadp.org

EssilorLuxottica: Disclosure of Share Capital and Voting Rights Outstanding as of November 30, 2025

EssilorLuxottica: Disclosure of Share Capital and Voting Rights Outstanding as of November 30, 2025




EssilorLuxottica: Disclosure of Share Capital and Voting Rights Outstanding as of November 30, 2025

Disclosure of Share Capital and Voting Rights Outstanding
as of November 30, 2025

(Pursuant to Article L.233-8 II of the French Commercial Code and articles 221-1 and 223-16 of the General Regulations of the Autorité des Marchés Financiers)

Paris, France (December 9, 2025 – 6:00 pm) – As of November 30, 2025, shares and voting rights outstanding of EssilorLuxottica, the global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses, breaks down as indicated below.

  November 30, 2025
Shares outstanding 463,145,529
Number of real voting rights (excluding treasury shares) 463,045,403
Theoretical number of voting rights (including treasury shares) 463,145,529

It is to be noted that voting rights are capped at 31%, applicable to any shareholder, in accordance with a formula contained in article 23 of EssilorLuxottica’s by-laws1.

1EssilorLuxottica’s by-laws are available on the Company’s website under the section Governance / Publications.

Attachment

IPSEN – Buy-back programme – Art 5 of MAR – Week 49- 2025

IPSEN – Buy-back programme – Art 5 of MAR – Week 49- 2025




IPSEN – Buy-back programme – Art 5 of MAR – Week 49- 2025

Aggregated presentation by day and by market

Statement of transactions in own shares from December 1st to December 05th 2025

             
Name of the issue Identity code of the issuer
(Legal Entity Identifier)
Day of the transaction Identity code of the financial instrument Total daily volume (in number of shares) Daily weighted average purchase price of the shares Market (MIC Code)
IPSEN 549300M6SGDPB4Z94P11 01/12/2025 FR0010259150 200 124,05000 AQEU
IPSEN 549300M6SGDPB4Z94P11 01/12/2025 FR0010259150 831 123,81540 CEUX
IPSEN 549300M6SGDPB4Z94P11 01/12/2025 FR0010259150 100 124,40000 TQEX
IPSEN 549300M6SGDPB4Z94P11 01/12/2025 FR0010259150 1897 124,16958 XPAR
        3028 124,07209  

Attachment

Computerworld Names Aeroflow Health as One of the Best Midsize Places to Work in IT

Computerworld Names Aeroflow Health as One of the Best Midsize Places to Work in IT




Computerworld Names Aeroflow Health as One of the Best Midsize Places to Work in IT

The recognition highlights the company’s commitment to creating a people-first, collaborative culture that fosters creativity and innovation

ASHEVILLE, N.C., Dec. 09, 2025 (GLOBE NEWSWIRE) — Aeroflow Health, a pioneering healthcare company that leverages cutting-edge technology to support the delivery of medical products and services, has been named #16 among midsize organizations on Computerworld’s Best Places to Work in IT 2026 for its continuous leadership in healthcare technology innovation, market-leading revenue and strong employee retention.

The recognition reinforces Aeroflow’s dedication to creating a work environment that not only challenges its information technology teams but also provides consistent work/life balance and compensation. The award follows the company’s recent achievement of being recognized as #12 on The Healthcare Technology Report’s Top 50 Healthcare Technology Companies of 2025.

“These recent accolades affirm our approach to creating a workplace that fuels creativity and growth is effective,” said Casey Hite, CEO of Aeroflow Health. “At Aeroflow, we’re consistently advancing our next-generation technology to stay at the forefront of innovation and drive our mission of simplifying healthcare. Being named on this list is a testament to our commitment of ensuring our 1,000+ employees remain well-supported.“

Computerworld’s Best Places to Work in IT list is an annual ranking of the top work environments for technology professionals. The list is compiled based on a comprehensive questionnaire regarding company offerings in categories such as benefits, career development, DEI, future of work, training and retention, and is then reviewed and vetted by a panel of industry experts.

“At Aeroflow, we’ve always prided ourselves on being more than a durable medical equipment provider, and this award showcases how we’re a dominant technology-driven organization working with modern, innovative systems,” says Jason Wille, Chief Technology Officer at Aeroflow Health. “Just as technology continues to evolve, we’re constantly identifying ways to modernize and expand internal tools and benefits, ensuring our employees receive the same quality of resources and care as the patients we serve.”

To learn more about Aeroflow Health, career opportunities available or its company culture and values, please visit www.aeroflowhealth.com.

About Aeroflow Health

Aeroflow Health is a leading provider of durable medical equipment and health services, headquartered in Asheville, North Carolina. Committed to improving quality of life through innovative solutions, Aeroflow Health partners with healthcare providers and communities to offer comprehensive medical equipment and supplies, ensuring patients receive the care they need when they need it most. For more information, visit www.aeroflowhealth.com

Media Contact:

FischTank PR

aeroflow@fischtankpr.com