Johns Hopkins Health Plans Welcomes Inova Health To Medicare Advantage Network




Johns Hopkins Health Plans Welcomes Inova Health To Medicare Advantage Network

Relationship Enhances Care Access as Advantage MD Expands Virginia Service Area

HANOVER, Md., Nov. 20, 2025 (GLOBE NEWSWIRE) — Effective Jan. 1, 2026, Virginia-based Inova Health will be an in-network provider for Johns Hopkins Advantage MD, a Medicare Advantage plan from Johns Hopkins Health Plans. With Medicare’s Annual Enrollment Period underway, residents have until Dec. 7 to select coverage for 2026.

The new relationship supplements Advantage MD’s regional expansion, as the plan will now serve Fairfax County, Loudoun County, Prince William County, and the Cities of Alexandria, Manassas, and Manassas Park. The plan has served Medicare beneficiaries in Arlington County, Fairfax City and Falls Church City since 2024.

In addition to affordable coverage, the expanded network provides Advantage MD members access to Inova Health’s network of hospitals, outpatient services, and long-term care facilities, throughout Northern Virginia and parts of Maryland.

“We’re thrilled for the opportunity to serve the health care needs of the Medicare-eligible population in Northern Virgina and provide our Advantage MD members access to Inova Health’s world-class facilities and provider network,” said J.P. Holland, President and CEO of Johns Hopkins Health Plans.

Medicare-eligible Virginians will not only enjoy ease of access to the region’s top health system in Inova, but all the benefits of Advantage MD membership, including trusted doctors, high-quality care and affordable coverage. Advantage MD and Inova Health share a strong history of commitment to the communities we serve and are proud to be working together to expand access to high-quality care while uplifting the health care of Medicare-eligible Virginia residents.

“We are pleased to expand access to Inova’s clinical excellence and comprehensive care for Johns Hopkins Health Plans members in Northern Virginia,” said J. Stephen Jones, MD, FACS, President and CEO of Inova Health. “This collaboration reflects our shared commitment to ensuring our community has access to high-quality, patient-centered Inova care when and where they need it.”

Inova Health is the leading nonprofit health care provider in Northern Virginia and the Washington, D.C., metropolitan area with an integrated network of hundreds of care sites throughout Northern Virginia and Maryland. Inova was named by Press Ganey the 2025 “Health System of the Year” for leading in clinical excellence, patient experience and innovation. Its flagship hospital, Inova Fairfax Hospital, has been ranked #1 Best Hospital in both Virginia and Greater Washington by U.S. News & World Report for five consecutive years.

“Like Advantage MD, Inova shares our commitment to prioritizing the member and patient experience,” said Lori Rund, Vice President, Medicare Advantage, at Johns Hopkins Health Plans. “We look forward to working with Inova to deliver affordable, quality health care to even more members in Virginia.”

About Johns Hopkins Health Plans 

As a part of Johns Hopkins Medicine, Johns Hopkins Health Plans administers a range of physician-sponsored health plans managing more than $3 billion in annual premiums and serving more than 400,000 members. Johns Hopkins Health Plans’ robust network of providers includes Johns Hopkins Medicine physicians and providers, regional clinics and many other top-tier providers. Johns Hopkins Health Plans administers the US Family Health Plan for active-duty family members, military retirees and their families, Employer Health Programs, Priority Partners (Maryland’s largest Medicaid plan with co-owner Maryland Community Health System) and Advantage MD Medicare Advantage plans. It advocates for its members and fosters collaboration with providers to help achieve optimal health. Through its Johns Hopkins HealthCare Solutions business, Johns Hopkins Health Plans also offers the world’s leading population health analytics software, the Johns Hopkins ACG^® System, used by commercial and government health entities and employers worldwide. Learn more at hopkinshealthplans.org.

Clene to Participate at the Benchmark 14th Annual Discovery One-on-One Investor Conference




Clene to Participate at the Benchmark 14th Annual Discovery One-on-One Investor Conference

SALT LAKE CITY, Nov. 20, 2025 (GLOBE NEWSWIRE) — Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will participate at the Benchmark 14^th Annual Discovery One-on-One Investor Conference by hosting 1×1 investor meetings.

Conference Details
Date: December 4, 2025
Location: New York, New York
Format: 1×1 meetings (contact your Benchmark Representative)

About Clene
Clene Inc., (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis. CNM-Au8^® is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8^® is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on X (formerly Twitter) and LinkedIn.

Investor Contact
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
617-283-2856

Shattuck Labs to Participate in Upcoming December Investor Conferences




Shattuck Labs to Participate in Upcoming December Investor Conferences

AUSTIN, TX and DURHAM, NC, Nov. 20, 2025 (GLOBE NEWSWIRE) — Shattuck Labs, Inc. (“Shattuck” or the “Company”) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of novel therapeutics targeting tumor necrosis factor (TNF) superfamily receptors for the treatment of patients with inflammatory and immune-mediated diseases, today announced that Company management will participate in multiple investor conferences in December 2025.

Conference Details

Conference: Piper Sandler 37^th Annual Healthcare Conference
Format: Presentation and one-on-one meetings
Presenter: Taylor Schreiber, M.D., Ph.D., Chief Executive Officer
Presentation Date: Dec 2, 2025
Time: 10:10 AM EST
Location: New York, NY
Webcast link: HERE

Conference: Evercore ISI 8^th Annual HealthCONx Conference
Format: Fireside chat with Umer Raffat and Jonathan Miller, Ph.D. and one-on-one meetings (Dec 3-4)
Presenter: Taylor Schreiber, M.D., Ph.D., Chief Executive Officer
Fireside Chat Date: Dec 4, 2025
Time: 8:20 AM EST
Location: Coral Gables, FL
Webcast link: HERE

A replay of the presentations from the Piper Sandler 37^th Annual Healthcare Conference and the Evercore ISI 8^th Annual HealthCONx Conference will be available on the Events and Presentations section of the Company’s website. A replay of the webcasts will remain archived for up to 30 days following the presentation date.

About SL-325

SL-325 is a potential first-in-class Death Receptor 3 (DR3) blocking antibody designed to achieve a complete and durable blockade of the clinically validated DR3/TL1A pathway. Shattuck’s preclinical studies demonstrate high affinity binding and superior activity over TL1A antibodies and offer a data-driven rationale for targeting the TNF receptor, DR3, versus its ligand, TL1A. SL-325 is a fully Fc-silenced humanized immunoglobin G monoclonal antibody with a favorable safety profile in non-human primates, currently being evaluated in a Phase 1 clinical trial.

About Shattuck Labs, Inc.
Shattuck Labs, Inc. (Nasdaq: STTK) is a clinical-stage biotechnology company specializing in the development of potential treatments for inflammatory and immune-mediated diseases. The Company is developing a potentially first-in-class antibody for the treatment of inflammatory bowel disease (IBD) and other inflammatory and immune-mediated diseases. Shattuck’s expertise in protein engineering and the development of novel TNF receptor therapeutics come together in its lead program, SL-325, a potentially first-in-class DR3 antagonist antibody designed to achieve a more complete blockade of the clinically validated DR3/TL1A pathway. The Company has offices in both Austin, Texas and Durham, North Carolina. For more information, please visit: www.ShattuckLabs.com.

Investor & Media Contact:
Andrew R. Neill
Chief Financial Officer
Shattuck Labs, Inc.
InvestorRelations@shattucklabs.com

Alvotech and Advanz Pharma Receive Marketing Approval Across the European Economic Area for Gobivaz®, a First-in-Market Biosimilar to Simponi® (golimumab)




Alvotech and Advanz Pharma Receive Marketing Approval Across the European Economic Area for Gobivaz®, a First-in-Market Biosimilar to Simponi® (golimumab)

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Commission (EC) has granted marketing authorizations in the European Economic Area (EEA) for Gobivaz®, Alvotech’s biosimilar to Simponi® (golimumab).

The authorizations cover Gobivaz® 50 mg/0.5 mL and 100mg/mL in both pre-filled syringe with passive needle safety guard and autoinjector formats, for the treatment of adults with rheumatoid arthritis in combination with methotrexate, psoriatic arthritis with or without methotrexate, axial spondyloarthritis, ulcerative colitis and for the treatment of juvenile idiopathic arthritis in children 2 years of age and older in combination with methotrexate. The approvals apply across the European Economic Area. The EC approval follows the positive opinion issued in September by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

“This milestone marks the second biosimilar to receive approval through our partnership with Advanz Pharma and further strengthens the commercial presence we are building in Europe. As the first biosimilar to Simponi® (golimumab) to gain approval in the European market, we are committed to expanding access to high quality biologic medicines for people living with immune-mediated diseases while providing value to healthcare systems throughout the region” said Robert Wessman, Chairman and Chief Executive Officer of Alvotech.

“We welcome the EC approval of Gobivaz®, an important milestone in our partnership with Alvotech. Expanding access to high-quality biosimilars is central to Advanz Pharma’s mission, and this approval enables us to offer patients across Europe a valuable new treatment option for immune-mediated diseases.” said Steffen Wagner, Chief Executive Officer, Advanz Pharma.

Under the partnership between Alvotech and Advanz Pharma, Alvotech is responsible for the development and commercial supply of Gobivaz®, while Advanz Pharma holds the registration and exclusive commercialization rights in the EEA and the UK.

The EC approval of Gobivaz® was based on a totality of evidence, including analytical and clinical data. In April 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing efficacy, safety, and immunogenicity between its biosimilar candidate AVT05 and the reference product Simponi® in patients with moderate to severe rheumatoid arthritis (clintrials.gov/study/NCT05842213). In November 2023, Alvotech announced positive topline results from a pharmacokinetic study which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi® in healthy adult participants (clintrials.gov/study/NCT05632211).

About AVT05
AVT05 (golimumab) has been approved as Golimumab BS (golimumab) in Japan and as Gobivaz (golimumab) in the European Economic Area. Dossiers are under review in multiple countries globally.  Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha). Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis [1].

Sources
[1] Simponi product information

Use of Trademarks
Simponi^® is a registered trademark of Johnson & Johnson. Gobivaz® is a trademark of Advanz Pharma.

About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has established a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

About Advanz Pharma
Partner of choice in specialty, hospital, and rare disease medicines. Advanz Pharma is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma’s product portfolio and pipeline comprises innovative medicines, biosimilars & specialty generics, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, rheumatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity.

Alvotech Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Advanz Pharma Forward Looking Statements
Certain statements in this press release are forward-looking statements. These statements may be identified by words such as “anticipate”, “expectation”, “belief’, “estimate”, “plan”, “target”, “project”, “will”, “may”, “should” or “forecast” and similar expressions, or by their context. Although Advanz Pharma believes that these assumptions were reasonable when made, by their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions affecting the industry, intense competition in the markets in which Advanz Pharma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Advanz Pharma’s markets, and other factors beyond the control of Advanz Pharma. Neither Advanz Pharma nor any of its directors, officers, employees, advisors, or any other person is under any obligation to update or keep current the information contained in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this press release. Statements contained in this press release regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. No obligation is assumed to update any forward-looking statements. The information contained in this press release is provided as at the date of this document and is subject to change without notice.

MEDIA CONTACTS

Alvotech Global Communications and Investor Relations
Benedikt Stefansson
alvotech.ir@alvotech.com

Advanz Pharma Global Corporate Communications
Courtney Baines
courtney.baines@advanzpharma.com

Alvotech and Advanz Pharma Receive Marketing Approval Across the European Economic Area for Gobivaz®, a First-in-Market Biosimilar to Simponi® (golimumab)




Alvotech and Advanz Pharma Receive Marketing Approval Across the European Economic Area for Gobivaz®, a First-in-Market Biosimilar to Simponi® (golimumab)

REYKJAVIK, Iceland and LONDON, Nov. 20, 2025 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Commission (EC) has granted marketing authorizations in the European Economic Area (EEA) for Gobivaz^®, Alvotech’s biosimilar to Simponi^® (golimumab).

The authorizations cover Gobivaz^® 50 mg/0.5 mL and 100mg/mL in both pre-filled syringe with passive needle safety guard and autoinjector formats, for the treatment of adults with rheumatoid arthritis in combination with methotrexate, psoriatic arthritis with or without methotrexate, axial spondyloarthritis, ulcerative colitis and for the treatment of juvenile idiopathic arthritis in children 2 years of age and older in combination with methotrexate. The approvals apply across the European Economic Area. The EC approval follows the positive opinion issued in September by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

“This milestone marks the second biosimilar to receive approval through our partnership with Advanz Pharma and further strengthens the commercial presence we are building in Europe. As the first biosimilar to Simponi^® (golimumab) to gain approval in the European market, we are committed to expanding access to high quality biologic medicines for people living with immune-mediated diseases while providing value to healthcare systems throughout the region,” said Robert Wessman, Chairman and Chief Executive Officer of Alvotech.

“We welcome the EC approval of Gobivaz^®, an important milestone in our partnership with Alvotech. Expanding access to high-quality biosimilars is central to Advanz Pharma’s mission, and this approval enables us to offer patients across Europe a valuable new treatment option for immune-mediated diseases,” said Steffen Wagner, Chief Executive Officer, Advanz Pharma.

Under the partnership between Alvotech and Advanz Pharma, Alvotech is responsible for the development and commercial supply of Gobivaz^®, while Advanz Pharma holds the registration and exclusive commercialization rights in the EEA and the UK.

The EC approval of Gobivaz^® was based on a totality of evidence, including analytical and clinical data. In April 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing efficacy, safety, and immunogenicity between its biosimilar candidate AVT05 and the reference product Simponi® in patients with moderate to severe rheumatoid arthritis (clintrials.gov/study/NCT05842213). In November 2023, Alvotech announced positive topline results from a pharmacokinetic study which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi^® in healthy adult participants (clintrials.gov/study/NCT05632211).

About AVT05
AVT05 (golimumab) has been approved as Golimumab BS (golimumab) in Japan and as Gobivaz (golimumab) in the European Economic Area. Dossiers are under review in multiple countries globally. Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha). Elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis [1].

Sources
[1] Simponi product information

Use of Trademarks
Simponi^® is a registered trademark of Johnson & Johnson. Gobivaz^® is a trademark of Advanz Pharma.

About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has established a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

About Advanz Pharma
Partner of choice in specialty, hospital, and rare disease medicines. Advanz Pharma is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma’s product portfolio and pipeline comprises innovative medicines, biosimilars & specialty generics, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, rheumatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity.

Alvotech Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Advanz Pharma Forward Looking Statements
Certain statements in this press release are forward-looking statements. These statements may be identified by words such as “anticipate”, “expectation”, “belief’, “estimate”, “plan”, “target”, “project”, “will”, “may”, “should” or “forecast” and similar expressions, or by their context. Although Advanz Pharma believes that these assumptions were reasonable when made, by their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions affecting the industry, intense competition in the markets in which Advanz Pharma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Advanz Pharma’s markets, and other factors beyond the control of Advanz Pharma. Neither Advanz Pharma nor any of its directors, officers, employees, advisors, or any other person is under any obligation to update or keep current the information contained in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this press release. Statements contained in this press release regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. No obligation is assumed to update any forward-looking statements. The information contained in this press release is provided as at the date of this document and is subject to change without notice.

MEDIA CONTACTS

Alvotech Global Communications and Investor Relations
Benedikt Stefansson
alvotech.ir@alvotech.com

Advanz Pharma Global Corporate Communications
Courtney Baines
courtney.baines@advanzpharma.com

Concept Life Sciences Presents New Data Advancing Neuroinflammation and Neurodegeneration Research at Neuroscience 2025




Concept Life Sciences Presents New Data Advancing Neuroinflammation and Neurodegeneration Research at Neuroscience 2025

Three posters highlight advances in inflammasome inhibition, astrocyte neurotoxicity, and myelination models supporting translational drug discovery

CHAPEL-EN-LE-FRITH, United Kingdom, Nov. 20, 2025 (GLOBE NEWSWIRE) — Concept Life Sciences, a leading contract research organization (CRO) serving the global life sciences and pharma industry, today announces that it presented three new research posters at Neuroscience 2025, the annual meeting of the Society for Neuroscience (SfN), held in San Diego, California on 15-19 November. The studies demonstrate Concept Life Sciences’ expanding expertise in neuroinflammation, neurodegeneration, and translational cell models that enhance the predictivity of early drug discovery.

Advancing translational neuroscience and drug discovery

The three posters showcase how Concept Life Sciences applies physiologically relevant in-vitro and ex-vivo systems to model key mechanisms underlying neurodegenerative and neuroinflammatory diseases:

1. Development of a Drug Screening Cascade to Identify Novel Potent and Selective NLRP3 Inhibitors

This study establishes a validated, multi-stage phenotypic screening cascade for discovering next-generation NLRP3 inflammasome inhibitors. Using human THP-1 cells, primary human macrophages, human iPSC-derived microglia, and organotypic brain slices, the workflow delivers integrated mechanistic and functional readouts to enhance translatability in early drug discovery.

The poster can be accessed [here].

2. In-Vitro Models of OPC Maturation and Myelination for Drug Discovery

This study introduces in-vitro assays that enable robust quantification of oligodendrocyte precursor cell (OPC) proliferation, differentiation, and myelin formation. By combining High-Content and 3D Imaging with gene expression analysis and metabolite quantification, Concept Life Sciences established reproducible assays that capture the molecular and functional hallmarks of OPC maturation and myelination. These models provide a translational platform to evaluate compounds that may enhance remyelination in disorders such as multiple sclerosis, Alzheimer’s disease, and ischemic stroke.

The poster can be accessed [here].

3. Leveraging iPSC-Derived Astrocytes to Accelerate the Discovery of Novel Drugs Targeting Neuroinflammation

Concept Life Sciences validated human iPSC-derived astrocytes as a reproducible model of reactive neurotoxic astrocytes, establishing a high-value assay for evaluating compounds that modulate neuroinflammatory pathways.

The poster can be accessed [here].

Dr. Elise Malavasi, Neuroscience Associate Director at Concept Life Sciences, commented:

“Our work, presented at Neuroscience 2025, highlighted how our integrated biology platforms enable a deeper understanding of neuroinflammatory and neurodegenerative mechanisms. By combining advanced human cell systems, primary cell-based assays, and 3D models, we provide our partners with translational tools that de-risk discovery and accelerate progress toward clinical impact.”

New white paper: Building a complete picture of inflammasome activity

Ahead of its presentations at Neuroscience 2025, Concept Life Sciences launched a new white paper entitled “Advancing Inflammasome Drug Discovery: Building a Complete Picture of Inflammasome Activity for Therapeutic Success.”

The paper highlights the inflammasome as a high-value therapeutic target with the potential for intervention across a wide range of inflammatory, metabolic, neurodegenerative and autoimmune diseases. It also focuses on the importance of using a suite of physiologically relevant assays across multiple inflammasome types and cell models to generate more disease-relevant and predictive data for drug discovery. Concept Life Sciences’ integrated assay portfolio supports a comprehensive understanding of inflammasome modulation — helping discovery teams make faster, more confident candidate selections and thereby accelerating drug discovery in the inflammation and immunology space.

The white paper can be accessed here.

About Concept Life Sciences

Concept Life Sciences is a leading contract research organisation (CRO) serving the global life sciences industry. For over 25 years, Concept Life Sciences, and its heritage companies, have provided consultative, and collaborative, drug discovery and development services. Our approach, supported by passionate scientists and world-leading capabilities, enables us to overcome complex scientific challenges across a broad range of therapeutic areas, improving success rates for translating innovations into viable therapeutics. To date, Concept Life Sciences has successfully helped 29 candidates advance to the clinic.

The company offers sophisticated translational biology services coupled with exceptional end-to-end chemistry capabilities offering concept to clinic solutions. Across modalities, including small molecules, biologics, peptides, and cell & gene therapies, Concept Life Sciences seamlessly integrates capabilities and provides bespoke solutions to address drug discovery challenges.

Collectively, the company’s high-quality services across the drug discovery and development pathway have helped its customers advance their drugs from concept to clinic in as little as 32 months, well ahead of the industry average of 60 months.

Driven by a passion for science, Concept Life Sciences has around 230 employees, with over 70% holding PhDs. The company operates from state-of-the-art UK facilities, headquartered near Manchester, with additional specialist operations in Edinburgh, Dundee, and Sandwich.

Visit us at www.conceptlifesciences.com and follow us on LinkedIn.

Media contacts

Concept Life Sciences
Clare Whitewoods – Marketing Director
Clare.Whitewoods@conceptlifesciences.com

Scius Communications
Katja Stout
+44 778 943 5990
katja@sciuscommunications.com 
Daniel Gooch
+44 7747 875479
daniel@sciuscommunications.com 

IMU Biosciences Appoints Dr. Carlos Paya as Non-Executive Director, Strengthening its Board of Directors




IMU Biosciences Appoints Dr. Carlos Paya as Non-Executive Director, Strengthening its Board of Directors

PRESS RELEASE

London, UK, 20 November 2025 — IMU Biosciences (or “the Company”), a biotechnology company decoding the immune system to drive next generation health outcomes, today announced the appointment of Dr. Carlos Paya as Non-Executive Director.

Carlos has a distinguished track record of leadership spanning academic medicine and the biopharmaceutical industry, with deep expertise in drug development and commercial strategy across early-stage start-ups to large-cap pharmaceutical companies.

Carlos currently serves as Chairman of Vaxcyte and Highlight Therapeutics and is a Venture Partner at Abingworth, and YSIOS Capital. Previously, he was Chairman of Fluidigm Standard Biotools, a Board Member of Mallinckrodt Pharmaceuticals, President, Board Member and Chief Executive Officer of Immune Design Corp, President of Elan Pharmaceuticals and Vice President of Eli Lilly and Company, where he led discovery research and late-stage clinical development. He holds a CEI, Executive Business Education from the University of Chicago Booth School of Business and an MD and PhD degrees from Universidad Complutense de Madrid. He was a Professor of Medicine, Immunology and Laboratory Medicine at the Mayo Clinic, Rochester, MN.

Dr John Baker, Chief Executive Officer at IMU Biosciences, said: “Carlos has deep biopharma and life science tools expertise, including drug discovery, development and commercialisation. His insights and strategic perspectives will be instrumental as we advance the application of our proprietary immune profiling platform across diagnostics, drug development and personalised medicine. I am delighted to welcome him to the Board of Directors and look forward to working with him as we enter our next phase of growth.”

Dr Carlos Paya, Non-Executive Director at IMU Biosciences, added: “IMU’s ability to translate complex immune data into clinically actionable insights represents a transformative advancement in the understanding, diagnosis and treatment of immune-related diseases. By harnessing the world’s largest immune dataset, IMU is creating a new paradigm in immunology with the potential to significantly improve patient outcomes. I am delighted to be joining the Board of Directors and look forward to leveraging my industry and academic experience to support IMU’s continued growth.”

About IMU Biosciences

IMU’s goal is to revolutionise the way immune-related diseases are understood, diagnosed and treated. It is pioneering advanced immune profiling and AI analytics to decode the human immune system and its relationship to disease.

Starting with a simple blood sample and building immune profiles which extend from the molecular to the population level, IMU has created the world’s largest and highest-resolution immune dataset. This novel platform applies proprietary immune analysis and machine learning to decode immune variation and its disease association at an unprecedented depth and scale.

By mapping the immune system of individuals at the molecular, cellular and system level and aggregating immune profiles from tens of thousands of people, IMU translates this into population-level insights, unlocking an unparalleled understanding of immune-driven health and disease. These clinically actionable insights are enabling IMU to uncover new immune mechanisms and deliver precision approaches for diagnosing, monitoring and treating disease, prescribing the safest and most pertinent medicines and enabling the development of next generation therapies.
  
The Company was built by a team of immune specialists and technologists based on a decade of research at King’s College London and the Francis Crick Institute.

-ENDS-

Contacts:
 
John Baker, CEO, IMU Biosciences
media@imubiosciences.com                                              

ICR Healthcare
Tel: +44 (0) 20 3709 5700
Jessica Hodgson/Stephanie Cuthbert/Jonathan Edwards
IMUBiosciences@ICRHealthcare.com

Burning Rock Reports Third Quarter 2025 Financial Results




Burning Rock Reports Third Quarter 2025 Financial Results

GUANGZHOU, China, Nov. 20, 2025 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended September 30, 2025.

Recent Business Updates

• Therapy Selection
  • Presented study results at the Cell Reports Medicine on esophageal squamous cell carcinoma in September 2025. “Integrating ctDNA with clinical response evaluation improves residual disease detection post-neoadjuvant chemoradiotherapy to support organsparing strategies and that postoperative ctDNA stratifies recurrence risk beyond pathological response to inform adjuvant immunotherapy decisions”.
• Early Detection
  • PROMISE study test results presented at The Innovation in September 2025. “The PROMISE study was conducted to investigate the feasibility of a multi-omics integration strategy in multi-cancer detection blood tests across nine types of cancers in head and neck (excluding nasopharynx), esophagus, lung, stomach, liver, biliary tract, pancreas, colorectum, and ovary……Compared to the methylation-based classifier, the multimodal classifier combining methylation and protein features, exhibited an improved sensitivity of 75.1% (95% 75 confidence interval [CI], 69.3%–80.3%) at the same specificity of 98.8% with the accuracy of top predicted origin (TPO1) of 73.1% (95% CI, 66.2%–79.2%)”.
• Pharma Services
  • The OncoGuide™ OncoScreen™ Plus CDx System based on OncoScreen™ Plus to be used as a companion diagnostic for AstraZeneca’s capivasertib has received Manufacturing and Marketing Approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) in September, 2025.

Third Quarter 2025 Financial Results

Total revenues were RMB131.6 million (US$18.5 million) for the three months ended September 30, 2025, representing a 2.3% increase from RMB128.6 million for the same period in 2024.

• Revenue generated from in-hospital business was RMB52.8 million (US$7.4 million) for the three months ended September 30, 2025, representing a 17.1% decrease from RMB63.8 million for the same period in 2024, driven by a decrease in sales volume.

• Revenue generated from central laboratory business was RMB36.8 million (US$5.2 million) for the three months ended September 30, 2025, representing a 7.9% decrease from RMB40.0 million for the same period in 2024, primarily attributable to a decrease in the number of tests, as we continued our transition towards in-hospital testing.
• Revenue generated from pharma research and development services was RMB42.0 million (US$5.9 million) for the three months ended September 30, 2025, representing a 68.6% increase from RMB24.9 million for the same period in 2024, primarily attributable to an increased development and testing services performed for our pharma customers.

Cost of revenues was RMB32.8 million (US$4.6 million) for the three months ended September 30, 2025, representing an 10.9% decrease from RMB36.8 million for the same period in 2024.

Gross profit was RMB98.8 million (US$13.9 million) for the three months ended September 30, 2025, representing a 7.6% increase from RMB91.8 million for the same period in 2024. Gross margin was 75.1% for the three months ended September 30, 2025, compared to 71.4% for the same period in 2024. By channel, gross margin of central laboratory business and in-hospital business were 81.8% and 71.8% for the three months ended September 30, 2025, compared to 83.2% and 73.0% during the same period in 2024, primarily due to the cost reduction caused by the rent subsidy for the headquarter building in the third quarter of 2024; gross margin of pharma research and development services was 73.4% for the three months ended September 30, 2025, compared to 48.2% during the same period of 2024, primarily due to the significant increase in revenue from high-margin companion diagnostic (CDx) projects.

Non-GAAP gross profit, which excludes depreciation and amortization expenses, was RMB100.9 million (US$14.2million) for the three months ended September 30, 2025, representing a 3.2% increase from RMB97.8 million for the same period in 2024. Non-GAAP gross margin was 76.7% for the three months ended September 30, 2025, compared to 76.0% for the same period in 2024.

Operating expenses were RMB115.0 million (US$16.2 million) for the three months ended September 30, 2025, representing a 11.9% decrease from RMB130.4 million for the same period in 2024. The decrease was primarily driven by decreases in amortized expense on share-based compensation, budget control measures and headcount reduction to improve the Company’s operating efficiency.

• Research and development expenses were RMB41.5 million (US$5.8 million) for the three months ended September 30, 2025, representing a 15.6% decrease from RMB49.2 million for the same period in 2024, primarily due to (i) a decrease in the expenditure for research projects; (iii) a decrease in amortized expense on share-based compensation; and (iv) a decrease in amortized expenses for office building decoration.
• Selling and marketing expenses were RMB41.8 million (US$5.9 million) for the three months ended September 30, 2025, representing a 13.6% decrease from RMB48.4 million for the same period in 2024, primarily due to (i) a decrease in staff cost resulted from the reorganization of the sales department and improvement in operating efficiency; (ii) a decrease in amortized expense on share-based compensation; and (iii) a decrease in amortized expenses for office building decoration.
• General and administrative expenses were RMB31.7 million (US$4.5 million) for the three months ended September 30, 2025, representing a 3.6% decrease from RMB32.9 million for the same period in 2024, primarily due to (i) a decrease in the general and administrative personnel’s staff cost; (ii) a decrease in amortized expense on share-based compensation; and partially offset by (i) an increase in impairment expenses for accounts receivables and contract assets; (iii) an increase in operating lease.

Net loss was RMB16.8 million (US$2.4 million) for the three months ended September 30, 2025, compared to RMB35.7 million for the same period in 2024.

Cash, cash equivalents and restricted cash were RMB467.0 million (US$65.6 million) as of September 30, 2025.

About Burning Rock

Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, and ii) cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.

For more information about Burning Rock, please visit: ir.brbiotech.com.

Safe Harbor Statement

This press release contains forward-looking statements. These statements constitute “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “target,” “confident” and similar statements. Burning Rock may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about Burning Rock’s beliefs and expectations, are forward-looking statements. Such statements are based upon management’s current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond Burning Rock’s control. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. All information provided in this press release is as of the date of this press release, and Burning Rock does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.

Non-GAAP Measures

In evaluating the business, the Company considers and uses non-GAAP measures, such as non-GAAP gross profit and non-GAAP gross margin, as supplemental measures to review and assess operating performance. The presentation of these non-GAAP financial measures is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The company defines non-GAAP gross profit as gross profit excluding depreciation and amortization. The company defines non-GAAP gross margin as gross margin excluding depreciation and amortization.

The company presents these non-GAAP financial measures because they are used by management to evaluate operating performance and formulate business plans. The company believe non-GAAP gross profit and non-GAAP gross margin excluding non-cash impact of depreciation and amortization reflect the company’s ongoing business operations in a manner that allows more meaningful period-to-period comparisons.

Contact: IR@brbiotech.com