Author: Ravi Shankar

• Positive recommendation is based on phase III ALLEGORY study data showing Gazyva/Gazyvaro significantly reduced disease activity in patients with SLE compared with placebo¹
• If approved, Gazyva/Gazyvaro would be the first glycoengineered, Type II anti-CD20 therapy for SLE, potentially becoming the new standard of care
• SLE, commonly known as lupus, is a potentially life-threatening autoimmune disease that frequently leads to recurrent flares, progressive organ damage and requires long-term steroid use^2,3
• EMA approval would further strengthen Gazyva/Gazyvaro’s role across immune-mediated diseases and reinforce the potential of B cell-driven innovation across nephrology and rheumatology

Basel, 13 November 2026 – Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gazyva®/Gazyvaro® (obinutuzumab) as an add-on therapy for the treatment of adult patients with moderate-to-severe, active, autoantibody-positive systemic lupus erythematosus (SLE) despite standard therapy. A final decision from the European Commission is expected in the near future. In addition, the US Food and Drug Administration (FDA) accepted Roche’s supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro in SLE earlier this year. This recommendation builds on a growing list of approvals across immune-mediated diseases for Gazyva/Gazyvaro, including active lupus nephritis (LN) in more than 65 countries and idiopathic nephrotic syndrome (INS) in the US.⁴

“Many people with systemic lupus erythematosus experience recurring flares, progressive organ damage, and chronic steroid dependence,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “This positive CHMP recommendation brings Gazyva/Gazyvaro a step closer to offering people with SLE a new option that may achieve meaningful and sustained disease control.”

The positive recommendation is based on results from the phase III ALLEGORY study, which demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint.¹ At 52 weeks, 76.7% of people treated with Gazyva/Gazyvaro plus standard therapy achieved at least a four-point improvement in the SLE Responder Index (SRI-4), compared with 53.5% of people receiving placebo plus standard therapy (adjusted difference 23.1%, 95% confidence interval [CI]: 12.5-33.6, p<0.001).¹

Gazyva/Gazyvaro also demonstrated superiority across all key secondary endpoints, including British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response, sustained glucocorticoid reduction, sustained SRI-4 response, SRI-6 response and time to first disease flare.¹ Notably, based on the Definition of Remission in SLE (DORIS) standard, treatment more than doubled remission rates compared with placebo (33.8% versus 13.8%, adjusted difference 19.9%, 95% CI: 10.6-29.2) and significantly increased the proportion of patients achieving Lupus Low Disease Activity State (57.6% versus 25.0%, adjusted difference 32.6%, 95% CI: 22.3-43.0).¹ Gazyva/Gazyvaro demonstrated a well-tolerated safety profile in ALLEGORY, consistent with its established profile, with no new safety signals identified.¹

SLE, commonly known as lupus, is a potentially life-threatening autoimmune disease affecting three million people worldwide and up to 270,000 people in Europe.^2,5 The disease can affect multiple organ systems and may lead to recurrent disease flares, progressive organ damage and a substantial impact on quality of life.³

ALLEGORY is one of four positive phase III studies for Gazyva/Gazyvaro in immune-mediated diseases, alongside REGENCY in LN, INShore in INS and MAJESTY in primary membranous nephropathy (pMN).^6-8 The recent regulatory approvals in LN and INS, as well as the FDA filing acceptance in pMN, support the potential of Gazyva/Gazyvaro to address disease activity across a spectrum of immune-mediated diseases.

Beyond Gazyva/Gazyvaro, Roche has a broad pipeline to bring breakthrough innovation across immunology, including immune-mediated kidney diseases and lupus. Lunsumio® (mosunetuzumab), a first-in-class CD20xCD3 T-cell-engaging bispecific antibody, is being investigated in patients with SLE with or without active lupus nephritis.⁹

About Gazyva/Gazyvaro
Gazyva®/Gazyvaro® (obinutuzumab) is a humanised monoclonal antibody designed with a Type II anti-CD20 region for direct B cell death, and a glycoengineered Fc region for higher binding affinity and increased antibody-dependent cellular cytotoxicity (ADCC).¹⁰ CD20 is a protein found on certain types of B cells. Gazyva/Gazyvaro is approved for adults with lupus nephritis in more than 65 countries and for idiopathic nephrotic syndrome in children and young adults in the US.⁴ Gazyva/Gazyvaro is also approved in 100 countries for various types of haematological cancers.⁴

About the ALLEGORY study
ALLEGORY [NCT04963296] is a phase III, randomised, double-blind, placebo-controlled, multicentre study, investigating the efficacy and safety of Gazyva®/Gazyvaro® (obinutuzumab) compared with placebo in adults with systemic lupus erythematosus (SLE) on standard therapy.¹ The study enrolled approximately 300 people, who were randomised 1:1 to receive Gazyva/Gazyvaro or placebo for up to one year (52 weeks), followed by an open-label period with Gazyva/Gazyvaro for up to 104 weeks.¹ The primary endpoint is the percentage of people who achieve SLE Responder Index four at week 52.¹

About systemic lupus erythematosus   
Systemic lupus erythematosus (SLE) is a potentially life-threatening autoimmune disease that affects more than three million people worldwide, and is rising.^2,11 It is a chronic disease that causes inflammation in various parts of the body; for this reason, it can affect multiple organ systems, especially the skin, joints and kidneys.³ As multiple organ systems are affected, it can cause varying symptoms, often taking three to five years for an accurate diagnosis.^3,12 During this time, disease severity and organ damage, due to repeated flares of disease activity, typically worsens and quality of life declines.^3,13

Around half of people with SLE will develop lupus nephritis within five years of a diagnosis.¹⁴ In lupus nephritis, the disease activity primarily affects the kidneys, posing a risk of kidney failure, where dialysis and transplant are the only treatment options.¹⁵

There is a need for additional targeted therapies that can effectively control SLE disease activity and potentially delay or prevent the onset of lupus nephritis.

About Roche in Immunology
For over two decades, Roche has advanced immune system research, creating groundbreaking targeted treatments that have transformed care for people with blood disorders, neurological conditions and autoimmune diseases. With a development pipeline exploring more than 20 medical approaches, we are targeting widespread, complex conditions like chronic lung disease (COPD) and inflammatory bowel disease (IBD), alongside lupus and autoimmune kidney diseases. Our ultimate goal is to lessen the burden of chronic immune disorders on patients, healthcare systems, and society.

About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Furie RA, et al. Efficacy and Safety of Obinutuzumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2026;395:243-254. [Internet; cited 2026 November]. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2516150.
[2] Tian J, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis. 2023 Mar;82(3):351-56.
[3] Murimi-Worstell IB, et al. Association between organ damage and mortality in systemic lupus erythematosus: a systematic review and meta-analysis. BMJ Open. 2020 May 21;10(5):e031850.
[4] Roche data on file.                    
[5] Cornet A, et al. Experiences and unmet needs of persons living with systemic lupus erythematosus in Europe: Lupus Europe’s 2024 Swiss knife survey. Autoimmun Rev. 2025;24(8):103838.
[6] Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. N Engl J Med. 2025 Feb;392:1471-83. [Internet; cited 2026 November]. Available from: https://www.nejm.org/doi/10.1056/NEJMoa2410965.
[7] Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome (INShore). [Internet; cited 2026 November]. Available from: https://clinicaltrials.gov/study/NCT05627557.
[8] Fervenza FC, et al. Obinutuzumab or Tacrolimus in Primary Membranous Nephropathy. N Engl J Med. 2026;395:959-971. [Internet; cited 2026 November]. Available at: https://www.nejm.org/doi/10.1056/NEJMoa2602678.
[9] Clinicaltrials.gov. A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis (SOLUNA). [Internet; cited 2026 November]. Available from: https://clinicaltrials.gov/study/NCT07598396.[10] Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013 Oct;12(10):2031-42.
[10] Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013 Oct;12(10):2031-42.
[11] Rees F, et al. The worldwide incidence and prevalence of systemic lupus erythematosus: a systematic review of epidemiological studies. Rheumatology (Oxford). 2017 Nov 1;56(11):1945-61.
[12] Mitchell JL. Understanding the impact of delayed diagnosis and misdiagnosis of systemic lupus erythematosus (SLE). Journal of Family Medicine and Primary Care. 2024; 13(11):4819.
[13] Kandane-Rathnayake R, et al. Association of lupus low disease activity state and remission with reduced organ damage and flare in systemic lupus erythematosus patients with high disease activity. Rheumatology. 2025;64(5):2741–2748.
[14] Bechler KK, et al. Predicting patients who are likely to develop Lupus Nephritis of those newly diagnosed with Systemic Lupus Erythematosus. AMIA Annu Symp Proc. 2023 Apr 29:2022:221-30.
[15] National Kidney Foundation. Kidney Failure. [Internet: cited 2026 November]. Available from: https://www.kidney.org/kidney-topics/kidney-failure

Roche Global Media Relations
Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com

Tristan Schmitz Phone: +41 79 529 70 35	Nathalie Altermatt Phone: +41 79 771 05 25
Lorena Corfas Phone: +41 79 568 24 95	Simon Goldsborough Phone: +44 797 32 72 915
Karsten Kleine Phone: +41 79 461 86 83	Kirti Pandey Phone: +41 79 398 38 53
Yvette Petillon Phone: +41 79 961 92 50	Irène Stephan Phone:  +41 79 377 83 75
Albert Thottiyil Phone: +41 79 775 66 12

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com

Attachment

• Media Investor Release Gazyva SLE CHMP English

• Positive recommendation is based on phase III ALLEGORY study data showing Gazyva/Gazyvaro significantly reduced disease activity in patients with SLE compared with placebo¹
• If approved, Gazyva/Gazyvaro would be the first glycoengineered, Type II anti-CD20 therapy for SLE, potentially becoming the new standard of care
• SLE, commonly known as lupus, is a potentially life-threatening autoimmune disease that frequently leads to recurrent flares, progressive organ damage and requires long-term steroid use^2,3
• EMA approval would further strengthen Gazyva/Gazyvaro’s role across immune-mediated diseases and reinforce the potential of B cell-driven innovation across nephrology and rheumatology

Basel, 13 November 2026 – Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gazyva®/Gazyvaro® (obinutuzumab) as an add-on therapy for the treatment of adult patients with moderate-to-severe, active, autoantibody-positive systemic lupus erythematosus (SLE) despite standard therapy. A final decision from the European Commission is expected in the near future. In addition, the US Food and Drug Administration (FDA) accepted Roche’s supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro in SLE earlier this year. This recommendation builds on a growing list of approvals across immune-mediated diseases for Gazyva/Gazyvaro, including active lupus nephritis (LN) in more than 65 countries and idiopathic nephrotic syndrome (INS) in the US.⁴

“Many people with systemic lupus erythematosus experience recurring flares, progressive organ damage, and chronic steroid dependence,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “This positive CHMP recommendation brings Gazyva/Gazyvaro a step closer to offering people with SLE a new option that may achieve meaningful and sustained disease control.”

The positive recommendation is based on results from the phase III ALLEGORY study, which demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint.¹ At 52 weeks, 76.7% of people treated with Gazyva/Gazyvaro plus standard therapy achieved at least a four-point improvement in the SLE Responder Index (SRI-4), compared with 53.5% of people receiving placebo plus standard therapy (adjusted difference 23.1%, 95% confidence interval [CI]: 12.5-33.6, p<0.001).¹

Gazyva/Gazyvaro also demonstrated superiority across all key secondary endpoints, including British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response, sustained glucocorticoid reduction, sustained SRI-4 response, SRI-6 response and time to first disease flare.¹ Notably, based on the Definition of Remission in SLE (DORIS) standard, treatment more than doubled remission rates compared with placebo (33.8% versus 13.8%, adjusted difference 19.9%, 95% CI: 10.6-29.2) and significantly increased the proportion of patients achieving Lupus Low Disease Activity State (57.6% versus 25.0%, adjusted difference 32.6%, 95% CI: 22.3-43.0).¹ Gazyva/Gazyvaro demonstrated a well-tolerated safety profile in ALLEGORY, consistent with its established profile, with no new safety signals identified.¹

SLE, commonly known as lupus, is a potentially life-threatening autoimmune disease affecting three million people worldwide and up to 270,000 people in Europe.^2,5 The disease can affect multiple organ systems and may lead to recurrent disease flares, progressive organ damage and a substantial impact on quality of life.³

ALLEGORY is one of four positive phase III studies for Gazyva/Gazyvaro in immune-mediated diseases, alongside REGENCY in LN, INShore in INS and MAJESTY in primary membranous nephropathy (pMN).^6-8 The recent regulatory approvals in LN and INS, as well as the FDA filing acceptance in pMN, support the potential of Gazyva/Gazyvaro to address disease activity across a spectrum of immune-mediated diseases.

Beyond Gazyva/Gazyvaro, Roche has a broad pipeline to bring breakthrough innovation across immunology, including immune-mediated kidney diseases and lupus. Lunsumio® (mosunetuzumab), a first-in-class CD20xCD3 T-cell-engaging bispecific antibody, is being investigated in patients with SLE with or without active lupus nephritis.⁹

About Gazyva/Gazyvaro
Gazyva®/Gazyvaro® (obinutuzumab) is a humanised monoclonal antibody designed with a Type II anti-CD20 region for direct B cell death, and a glycoengineered Fc region for higher binding affinity and increased antibody-dependent cellular cytotoxicity (ADCC).¹⁰ CD20 is a protein found on certain types of B cells. Gazyva/Gazyvaro is approved for adults with lupus nephritis in more than 65 countries and for idiopathic nephrotic syndrome in children and young adults in the US.⁴ Gazyva/Gazyvaro is also approved in 100 countries for various types of haematological cancers.⁴

About the ALLEGORY study
ALLEGORY [NCT04963296] is a phase III, randomised, double-blind, placebo-controlled, multicentre study, investigating the efficacy and safety of Gazyva®/Gazyvaro® (obinutuzumab) compared with placebo in adults with systemic lupus erythematosus (SLE) on standard therapy.¹ The study enrolled approximately 300 people, who were randomised 1:1 to receive Gazyva/Gazyvaro or placebo for up to one year (52 weeks), followed by an open-label period with Gazyva/Gazyvaro for up to 104 weeks.¹ The primary endpoint is the percentage of people who achieve SLE Responder Index four at week 52.¹

About systemic lupus erythematosus   
Systemic lupus erythematosus (SLE) is a potentially life-threatening autoimmune disease that affects more than three million people worldwide, and is rising.^2,11 It is a chronic disease that causes inflammation in various parts of the body; for this reason, it can affect multiple organ systems, especially the skin, joints and kidneys.³ As multiple organ systems are affected, it can cause varying symptoms, often taking three to five years for an accurate diagnosis.^3,12 During this time, disease severity and organ damage, due to repeated flares of disease activity, typically worsens and quality of life declines.^3,13

Around half of people with SLE will develop lupus nephritis within five years of a diagnosis.¹⁴ In lupus nephritis, the disease activity primarily affects the kidneys, posing a risk of kidney failure, where dialysis and transplant are the only treatment options.¹⁵

There is a need for additional targeted therapies that can effectively control SLE disease activity and potentially delay or prevent the onset of lupus nephritis.

About Roche in Immunology
For over two decades, Roche has advanced immune system research, creating groundbreaking targeted treatments that have transformed care for people with blood disorders, neurological conditions and autoimmune diseases. With a development pipeline exploring more than 20 medical approaches, we are targeting widespread, complex conditions like chronic lung disease (COPD) and inflammatory bowel disease (IBD), alongside lupus and autoimmune kidney diseases. Our ultimate goal is to lessen the burden of chronic immune disorders on patients, healthcare systems, and society.

About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Furie RA, et al. Efficacy and Safety of Obinutuzumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2026;395:243-254. [Internet; cited 2026 November]. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2516150.
[2] Tian J, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis. 2023 Mar;82(3):351-56.
[3] Murimi-Worstell IB, et al. Association between organ damage and mortality in systemic lupus erythematosus: a systematic review and meta-analysis. BMJ Open. 2020 May 21;10(5):e031850.
[4] Roche data on file.                    
[5] Cornet A, et al. Experiences and unmet needs of persons living with systemic lupus erythematosus in Europe: Lupus Europe’s 2024 Swiss knife survey. Autoimmun Rev. 2025;24(8):103838.
[6] Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. N Engl J Med. 2025 Feb;392:1471-83. [Internet; cited 2026 November]. Available from: https://www.nejm.org/doi/10.1056/NEJMoa2410965.
[7] Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome (INShore). [Internet; cited 2026 November]. Available from: https://clinicaltrials.gov/study/NCT05627557.
[8] Fervenza FC, et al. Obinutuzumab or Tacrolimus in Primary Membranous Nephropathy. N Engl J Med. 2026;395:959-971. [Internet; cited 2026 November]. Available at: https://www.nejm.org/doi/10.1056/NEJMoa2602678.
[9] Clinicaltrials.gov. A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis (SOLUNA). [Internet; cited 2026 November]. Available from: https://clinicaltrials.gov/study/NCT07598396.[10] Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013 Oct;12(10):2031-42.
[10] Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013 Oct;12(10):2031-42.
[11] Rees F, et al. The worldwide incidence and prevalence of systemic lupus erythematosus: a systematic review of epidemiological studies. Rheumatology (Oxford). 2017 Nov 1;56(11):1945-61.
[12] Mitchell JL. Understanding the impact of delayed diagnosis and misdiagnosis of systemic lupus erythematosus (SLE). Journal of Family Medicine and Primary Care. 2024; 13(11):4819.
[13] Kandane-Rathnayake R, et al. Association of lupus low disease activity state and remission with reduced organ damage and flare in systemic lupus erythematosus patients with high disease activity. Rheumatology. 2025;64(5):2741–2748.
[14] Bechler KK, et al. Predicting patients who are likely to develop Lupus Nephritis of those newly diagnosed with Systemic Lupus Erythematosus. AMIA Annu Symp Proc. 2023 Apr 29:2022:221-30.
[15] National Kidney Foundation. Kidney Failure. [Internet: cited 2026 November]. Available from: https://www.kidney.org/kidney-topics/kidney-failure

Roche Global Media Relations
Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com

Tristan Schmitz Phone: +41 79 529 70 35	Nathalie Altermatt Phone: +41 79 771 05 25
Lorena Corfas Phone: +41 79 568 24 95	Simon Goldsborough Phone: +44 797 32 72 915
Karsten Kleine Phone: +41 79 461 86 83	Kirti Pandey Phone: +41 79 398 38 53
Yvette Petillon Phone: +41 79 961 92 50	Irène Stephan Phone:  +41 79 377 83 75
Albert Thottiyil Phone: +41 79 775 66 12

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com

Attachment

• Media Investor Release Gazyva SLE CHMP English

Anchorage, Alaska, Nov. 13, 2026 (GLOBE NEWSWIRE) — Nova Minerals Corp (“Nova” or the “Company”) (NYSE American: NVA | ASX: NVA) is pleased to report its financial and operational results for the quarter ended September 30, 2026, highlighting continued advancement of its flagship Estelle Gold and Critical Minerals Project in Alaska, with significant progress towards establishing a vertically integrated U.S. domestic antimony supply chain.

Quarterly Highlights

• Advancing towards 2027 production: Progressed engineering, metallurgical test work, equipment procurement and site preparations, with approximately 500 tons of processing and refining equipment delivered to Port MacKenzie as of the end of the quarter, and early earthworks underway.
• $43.4 million Department of War award: As of the end of the quarter, approximately $23.9 million of the DOW award was received, with an additional milestone achieved and $5.0 million invoiced subsequent to the end of the quarter. The remaining funding is subject to achievement of applicable program milestones and expected to be received by the end of fiscal year 2027.
• Antimony exploration: Completed drilling at the Styx and Stibium prospects and collected approximately 100 tons of antimony-bearing material to date for initial pilot-scale processing feedstock.
• Gold exploration: Completed approximately 8,000 metres of drilling during the 2026 field season, with the RPM program focused on expanding the deposit and enhancing resource confidence, alongside property-wide geological mapping and sampling.
• Gold Studies: Completed bench-scale flotation testing to assess and optimise gold recoveries.
• Financial position: Held cash and cash equivalents of approximately $17.8 million at September 30, 2026. Cash expenditures of approximately $9.0 million during the quarter principally reflecting advancement of the 2026 field program, gold and antimony mining studies, operating costs and final payments for processing equipment.
• Quarterly result: Reported a net loss of approximately $12.0 million, compared with approximately $6.4 million in the prior-year period, primarily reflecting increased exploration, drilling, mining studies and antimony development expenditures.

Subsequent Events to End of Quarter

On October 27, 2026, the Company received all final approvals from the Alaska Department of Natural Resources for the integrated antimony three-year pilot-scale development, covering ore extraction at Styx and Stibium, ore sorting and processing at Whiskey Bravo, and downstream processing and refining at Port MacKenzie.

Nova Minerals CEO, Mr. Christopher Gerteisen, commented:

“Securing final permits for our pilot-scale integrated antimony development is a major milestone for Nova and brings us a significant step closer to establishing technical feasibility of our antimony processing and refining process, leading the way for Nova to provide a secure U.S. domestic antimony supply chain.

“With permitting complete, approximately 500 tons of processing equipment delivered and substantial preparatory work advanced during the quarter, with our focus now on progressing development towards our targeted 2027 pilot-scale production timeframe to complete delivery of military grade antimony trisulfide required under the DoW award.

“We continue to advance our flagship Estelle gold project, having completed an extensive 2026 drilling program and progressed the technical studies supporting the Gold Pre-Feasibility Study. We believe the combination of our gold and antimony assets provides a strong platform for Nova’s future growth.”

Going Concern Statement Required by NYSE American Company Guide Section 610(b)

The Company’s audited consolidated financial statements included in the Form 10-K contained a report of its independent registered public accounting firm with an explanatory paragraph expressing substantial doubt about the Company’s ability to continue as a going concern. The conditions that gave rise to the going concern assessment, and management’s plans to address them, are described in Note 3 to the consolidated financial statements. This statement is made in compliance with Section 610(b) of the NYSE American Company Guide, which requires a listed company that receives an audit opinion containing a going concern emphasis to make a public announcement of that fact, and does not reflect any change or amendment to the Company’s audited consolidated financial statements or the report of its independent registered public accounting firm.

About Nova Minerals Corp

Nova Minerals Corp is advancing one of the world’s largest undeveloped gold deposits into production and securing a US domestic supply of the critical mineral antimony. The Company is focused on the exploration and development of the Estelle Gold and Critical Minerals Project, located in Alaska, a tier-one mining jurisdiction.

Estelle hosts two defined multi-million-ounce gold resources, and more than 20 prospects distributed along a 35-kilometre mineralized trend, in the prolific Tintina Gold Belt, a province which hosts a >220 million ounce (Moz) documented gold endowment and some of the world’s largest gold mines and discoveries including Kinross Gold Corporation’s Fort Knox Gold Mine. In parallel, Nova is advancing its critical minerals strategy, fully-funded by a $43.4 million U.S. Department of War award to develop a domestic antimony supply chain, targeted for production in 2027.

Further discussion and analysis of the Estelle Project is available through the interactive Vrify 3D animations, presentations, and videos, all available on the Company’s website www.novamineralscorp.com.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act which are subject to the “safe harbor” created by those sections. All statements, other than statements of historical fact, contained in this press release are forward-looking statements and that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nova Minerals Corp’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Forward-looking statements contained in this announcement are made as of this date, and Nova Minerals Corp undertakes no duty to update such information except as required under applicable law.

For further information:

Nova Minerals:	Media:	Investor Relations:
Craig Bentley	Jenna Shinderman	Dave Gentry, CEO
Executive Director	Sodali & Co	RedChip Companies, Inc.
Ph: 1-720-550-4223	Ph: 1-631-918-4047	Ph: 1-407-644-4256
E: craig@novamineralscorp.com	E: jenna.shinderman@sodali.com	E: NVA@redchip.com

Anchorage, Alaska, Nov. 13, 2026 (GLOBE NEWSWIRE) — Nova Minerals Corp (“Nova” or the “Company”) (NYSE American: NVA | ASX: NVA) is pleased to report its financial and operational results for the quarter ended September 30, 2026, highlighting continued advancement of its flagship Estelle Gold and Critical Minerals Project in Alaska, with significant progress towards establishing a vertically integrated U.S. domestic antimony supply chain.

Quarterly Highlights

• Advancing towards 2027 production: Progressed engineering, metallurgical test work, equipment procurement and site preparations, with approximately 500 tons of processing and refining equipment delivered to Port MacKenzie as of the end of the quarter, and early earthworks underway.
• $43.4 million Department of War award: As of the end of the quarter, approximately $23.9 million of the DOW award was received, with an additional milestone achieved and $5.0 million invoiced subsequent to the end of the quarter. The remaining funding is subject to achievement of applicable program milestones and expected to be received by the end of fiscal year 2027.
• Antimony exploration: Completed drilling at the Styx and Stibium prospects and collected approximately 100 tons of antimony-bearing material to date for initial pilot-scale processing feedstock.
• Gold exploration: Completed approximately 8,000 metres of drilling during the 2026 field season, with the RPM program focused on expanding the deposit and enhancing resource confidence, alongside property-wide geological mapping and sampling.
• Gold Studies: Completed bench-scale flotation testing to assess and optimise gold recoveries.
• Financial position: Held cash and cash equivalents of approximately $17.8 million at September 30, 2026. Cash expenditures of approximately $9.0 million during the quarter principally reflecting advancement of the 2026 field program, gold and antimony mining studies, operating costs and final payments for processing equipment.
• Quarterly result: Reported a net loss of approximately $12.0 million, compared with approximately $6.4 million in the prior-year period, primarily reflecting increased exploration, drilling, mining studies and antimony development expenditures.

Subsequent Events to End of Quarter

On October 27, 2026, the Company received all final approvals from the Alaska Department of Natural Resources for the integrated antimony three-year pilot-scale development, covering ore extraction at Styx and Stibium, ore sorting and processing at Whiskey Bravo, and downstream processing and refining at Port MacKenzie.

Nova Minerals CEO, Mr. Christopher Gerteisen, commented:

“Securing final permits for our pilot-scale integrated antimony development is a major milestone for Nova and brings us a significant step closer to establishing technical feasibility of our antimony processing and refining process, leading the way for Nova to provide a secure U.S. domestic antimony supply chain.

“With permitting complete, approximately 500 tons of processing equipment delivered and substantial preparatory work advanced during the quarter, with our focus now on progressing development towards our targeted 2027 pilot-scale production timeframe to complete delivery of military grade antimony trisulfide required under the DoW award.

“We continue to advance our flagship Estelle gold project, having completed an extensive 2026 drilling program and progressed the technical studies supporting the Gold Pre-Feasibility Study. We believe the combination of our gold and antimony assets provides a strong platform for Nova’s future growth.”

Going Concern Statement Required by NYSE American Company Guide Section 610(b)

The Company’s audited consolidated financial statements included in the Form 10-K contained a report of its independent registered public accounting firm with an explanatory paragraph expressing substantial doubt about the Company’s ability to continue as a going concern. The conditions that gave rise to the going concern assessment, and management’s plans to address them, are described in Note 3 to the consolidated financial statements. This statement is made in compliance with Section 610(b) of the NYSE American Company Guide, which requires a listed company that receives an audit opinion containing a going concern emphasis to make a public announcement of that fact, and does not reflect any change or amendment to the Company’s audited consolidated financial statements or the report of its independent registered public accounting firm.

About Nova Minerals Corp

Nova Minerals Corp is advancing one of the world’s largest undeveloped gold deposits into production and securing a US domestic supply of the critical mineral antimony. The Company is focused on the exploration and development of the Estelle Gold and Critical Minerals Project, located in Alaska, a tier-one mining jurisdiction.

Estelle hosts two defined multi-million-ounce gold resources, and more than 20 prospects distributed along a 35-kilometre mineralized trend, in the prolific Tintina Gold Belt, a province which hosts a >220 million ounce (Moz) documented gold endowment and some of the world’s largest gold mines and discoveries including Kinross Gold Corporation’s Fort Knox Gold Mine. In parallel, Nova is advancing its critical minerals strategy, fully-funded by a $43.4 million U.S. Department of War award to develop a domestic antimony supply chain, targeted for production in 2027.

Further discussion and analysis of the Estelle Project is available through the interactive Vrify 3D animations, presentations, and videos, all available on the Company’s website www.novamineralscorp.com.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act which are subject to the “safe harbor” created by those sections. All statements, other than statements of historical fact, contained in this press release are forward-looking statements and that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nova Minerals Corp’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Forward-looking statements contained in this announcement are made as of this date, and Nova Minerals Corp undertakes no duty to update such information except as required under applicable law.

For further information:

Nova Minerals:	Media:	Investor Relations:
Craig Bentley	Jenna Shinderman	Dave Gentry, CEO
Executive Director	Sodali & Co	RedChip Companies, Inc.
Ph: 1-720-550-4223	Ph: 1-631-918-4047	Ph: 1-407-644-4256
E: craig@novamineralscorp.com	E: jenna.shinderman@sodali.com	E: NVA@redchip.com

HOUSTON, Nov. 13, 2026 (GLOBE NEWSWIRE) — NOV Inc. (NYSE: NOV) announced today that its Board of Directors declared a regular quarterly cash dividend of $0.09 per share of common stock, payable on December 18, 2026 to each stockholder of record on December 4, 2026.

About NOV
NOV delivers technology-driven solutions to empower the global energy industry. For more than 160 years, NOV has pioneered innovations that enable its customers to safely and efficiently produce abundant energy while minimizing environmental impact. NOV powers the industry that powers the world.

Cautionary Statement for the Purpose of the “Safe Harbor” Provisions of the Private Securities Litigation Reform Act of 1995
Statements made in this press release that are forward-looking in nature are intended to be “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934 and may involve risks and uncertainties. These statements may differ materially from the actual future events or results. Readers are referred to documents filed by NOV with the Securities and Exchange Commission, including the Annual Report on Form 10-K, which identify significant risk factors which could cause actual results to differ from those contained in the forward-looking statements. These statements speak only as of the date of this document, and we undertake no obligation to update or revise the statements, except as may be required by law.

Visit www.nov.com for more information.

Source: NOV Inc.

CONTACT: 
Amie D’Ambrosio
Director, Investor Relations
(713) 375-3826
amie.dambrosio@nov.com

HOUSTON, Nov. 13, 2026 (GLOBE NEWSWIRE) — NOV Inc. (NYSE: NOV) announced today that its Board of Directors declared a regular quarterly cash dividend of $0.09 per share of common stock, payable on December 18, 2026 to each stockholder of record on December 4, 2026.

About NOV
NOV delivers technology-driven solutions to empower the global energy industry. For more than 160 years, NOV has pioneered innovations that enable its customers to safely and efficiently produce abundant energy while minimizing environmental impact. NOV powers the industry that powers the world.

Cautionary Statement for the Purpose of the “Safe Harbor” Provisions of the Private Securities Litigation Reform Act of 1995
Statements made in this press release that are forward-looking in nature are intended to be “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934 and may involve risks and uncertainties. These statements may differ materially from the actual future events or results. Readers are referred to documents filed by NOV with the Securities and Exchange Commission, including the Annual Report on Form 10-K, which identify significant risk factors which could cause actual results to differ from those contained in the forward-looking statements. These statements speak only as of the date of this document, and we undertake no obligation to update or revise the statements, except as may be required by law.

Visit www.nov.com for more information.

Source: NOV Inc.

CONTACT: 
Amie D’Ambrosio
Director, Investor Relations
(713) 375-3826
amie.dambrosio@nov.com

President and CEO David Bibby to provide an update on the Company’s latest developments and strategic growth priorities during the virtual investor conference on November 18, 2026, at 11:30 AM ET.

VANCOUVER, British Columbia, Nov. 13, 2026 (GLOBE NEWSWIRE) — Hypercharge Networks Corp. (TSXV: HC; OTC: HCNWF; FSE: PB7) (the “Company” or “Hypercharge”), a leading EV charging operator, is pleased to announce that David Bibby, President and CEO, will present at the Small Cap Growth Virtual Investor Conference, hosted by Virtual Investor Conferences, on Wednesday, November 18, 2026.

During the presentation, Mr. Bibby will provide an update on Hypercharge’s latest corporate developments, business performance, and strategic growth priorities, including the Company’s continued expansion across North America. The presentation will be followed by a live, interactive question-and-answer session.

Presentation Details

• Event: Small Cap Growth Virtual Investor Conference
• Date: Wednesday, November 18, 2026
• Time: 11:30 AM ET
• Location: Virtual
• Registration & Live Webcast: Register to Attend

Investors are encouraged to pre-register for the event and complete the online system check ahead of the presentation. An archived webcast will also be available for those unable to attend live.

Investors interested in scheduling one-on-one meetings with Hypercharge management can do so through the conference’s meeting platform. For more information about the Small Cap Growth Virtual Investor Conference, visit virtualinvestorconferences.com.

About Hypercharge
Hypercharge Networks Corp. (TSXV: HC; OTC: HCNWF; FSE: PB7) is a leading provider of smart electric vehicle (EV) charging solutions for residential and commercial buildings, fleet operations, and other rapidly growing sectors. Driven by its mission to accelerate EV adoption and enable the shift towards a carbon neutral economy, Hypercharge is committed to offering seamless, simple solutions, including industry-leading hardware, innovative and integrated software, and comprehensive services, backed by a robust network of public and private charging stations. Learn more: https://hypercharge.com/.

On behalf of the Company,
Hypercharge Networks Corp.
David Bibby, President & CEO

Contact
Media & Investor Relations:
Kyle Kingsnorth, Head of Marketing
kyle.kingsnorth@hypercharge.com | +1 (888) 320-2633

Forward-Looking Statements
This news release contains forward-looking statements and forward-looking information (collectively, “forward-looking statements”) within the meaning of applicable securities laws. Any statements that are contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. More particularly and without limitation, this news release contains forward-looking statements regarding the Company’s planned participation in the Small Cap Growth Virtual Investor Conference on November 18, 2026, including the timing and content of the presentation, the availability of the live and archived webcasts, the anticipated question-and-answer session, and opportunities for investors to engage with Company management. Forward-looking statements are often identified by terms such as “may”, “could”, “should”, “anticipate”, “will”, “estimates”, “believes”, “intends”, “expects” and similar expressions which are intended to identify forward-looking statements. Forward-looking statements are inherently uncertain, and the actual performance may be affected by a number of material factors, assumptions and expectations, many of which are beyond the control of the Company. Readers are cautioned that assumptions used in the preparation of any forward-looking statements 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. Readers are further cautioned not to place undue reliance on any forward-looking statements, as such information, although considered reasonable by management of the Company at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

The forward-looking statements contained in this news release are made as of the date of this news release, and are expressly qualified by the foregoing cautionary statement. Except as expressly required by applicable securities law, the Company undertakes no obligation to update publicly or to revise any of the included forward-looking statements, whether as a result of new information, future events or otherwise.

Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this news release.

President and CEO David Bibby to provide an update on the Company’s latest developments and strategic growth priorities during the virtual investor conference on November 18, 2026, at 11:30 AM ET.

VANCOUVER, British Columbia, Nov. 13, 2026 (GLOBE NEWSWIRE) — Hypercharge Networks Corp. (TSXV: HC; OTC: HCNWF; FSE: PB7) (the “Company” or “Hypercharge”), a leading EV charging operator, is pleased to announce that David Bibby, President and CEO, will present at the Small Cap Growth Virtual Investor Conference, hosted by Virtual Investor Conferences, on Wednesday, November 18, 2026.

During the presentation, Mr. Bibby will provide an update on Hypercharge’s latest corporate developments, business performance, and strategic growth priorities, including the Company’s continued expansion across North America. The presentation will be followed by a live, interactive question-and-answer session.

Presentation Details

• Event: Small Cap Growth Virtual Investor Conference
• Date: Wednesday, November 18, 2026
• Time: 11:30 AM ET
• Location: Virtual
• Registration & Live Webcast: Register to Attend

Investors are encouraged to pre-register for the event and complete the online system check ahead of the presentation. An archived webcast will also be available for those unable to attend live.

Investors interested in scheduling one-on-one meetings with Hypercharge management can do so through the conference’s meeting platform. For more information about the Small Cap Growth Virtual Investor Conference, visit virtualinvestorconferences.com.

About Hypercharge
Hypercharge Networks Corp. (TSXV: HC; OTC: HCNWF; FSE: PB7) is a leading provider of smart electric vehicle (EV) charging solutions for residential and commercial buildings, fleet operations, and other rapidly growing sectors. Driven by its mission to accelerate EV adoption and enable the shift towards a carbon neutral economy, Hypercharge is committed to offering seamless, simple solutions, including industry-leading hardware, innovative and integrated software, and comprehensive services, backed by a robust network of public and private charging stations. Learn more: https://hypercharge.com/.

On behalf of the Company,
Hypercharge Networks Corp.
David Bibby, President & CEO

Contact
Media & Investor Relations:
Kyle Kingsnorth, Head of Marketing
kyle.kingsnorth@hypercharge.com | +1 (888) 320-2633

Forward-Looking Statements
This news release contains forward-looking statements and forward-looking information (collectively, “forward-looking statements”) within the meaning of applicable securities laws. Any statements that are contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. More particularly and without limitation, this news release contains forward-looking statements regarding the Company’s planned participation in the Small Cap Growth Virtual Investor Conference on November 18, 2026, including the timing and content of the presentation, the availability of the live and archived webcasts, the anticipated question-and-answer session, and opportunities for investors to engage with Company management. Forward-looking statements are often identified by terms such as “may”, “could”, “should”, “anticipate”, “will”, “estimates”, “believes”, “intends”, “expects” and similar expressions which are intended to identify forward-looking statements. Forward-looking statements are inherently uncertain, and the actual performance may be affected by a number of material factors, assumptions and expectations, many of which are beyond the control of the Company. Readers are cautioned that assumptions used in the preparation of any forward-looking statements 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. Readers are further cautioned not to place undue reliance on any forward-looking statements, as such information, although considered reasonable by management of the Company at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

The forward-looking statements contained in this news release are made as of the date of this news release, and are expressly qualified by the foregoing cautionary statement. Except as expressly required by applicable securities law, the Company undertakes no obligation to update publicly or to revise any of the included forward-looking statements, whether as a result of new information, future events or otherwise.

Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this news release.

European Commission to make final decision on arimoclomol MAA following negative CHMP opinion

BOSTON, Nov. 13, 2026 (GLOBE NEWSWIRE) — Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company committed to redefining what’s possible in bringing life-changing therapeutics to people living with rare diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application (MAA) for arimoclomol for the treatment of Niemann-Pick disease type C (NPC), a rare, progressive and life-threatening neurodegenerative disorder that affects approximately 1,000 people in Europe. The European Commission is expected to issue its final decision on the Marketing Authorization Application within 67 days.

Zevra will continue to support eligible patients currently receiving arimoclomol through its global Expanded Access Program (EAP), subject to applicable regulatory requirements and in coordination with national authorities. The Company remains focused on helping ensure continuity of treatment for patients currently benefiting from arimoclomol through the program.

“We are deeply disappointed by the CHMP’s opinion, particularly given the significant unmet medical need faced by individuals and families living with NPC,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra Therapeutics. “We remain grateful to the patients, caregivers, investigators, advocacy organizations and healthcare providers who have been part of the arimoclomol journey. While this outcome is not what the NPC community hoped for, our priority remains supporting patients and families.”

Zevra believes the robust data package, which included clinical and real-world evidence for arimoclomol, provides important support for its therapeutic benefit in NPC. The application was supported by data from the pivotal NPC 002 Phase 2/3 trial, which demonstrated that arimoclomol in combination with miglustat reduced disease progression compared with placebo over 12 months. Long-term open-label extension data showed that the treatment effect was sustained over multiple years. The Company will continue to advance scientific understanding of NPC and collaborate with stakeholders across the global NPC community.

“The NPC community is profoundly disappointed by this decision,” said Sandra Cowie, President of the International Niemann-Pick Disease Alliance (INPDA). “Families affected by NPC face a relentlessly progressive disease that impacts every aspect of daily life. People living with NPC and their caregivers across Europe have been waiting for access to additional treatment options, making this outcome particularly difficult for those who continue to face the daily realities of this devastating disease. INPDA remains committed to advocating for people living with NPC and ensuring that the voices of those living with NPC and their families are heard.”

About Zevra Therapeutics, Inc.
Zevra Therapeutics, Inc. is a commercial-stage company with a late-stage pipeline committed to redefining what is possible in bringing life-changing therapies to people living with rare diseases. The Company is focused on broadening access through geographic expansion opportunities, progressing its pipeline toward key milestones, and delivering meaningful therapeutics. The commercialization of its lead product, marketed in the U.S. for Niemann-Pick disease type C (NPC), a rare, progressive neurodegenerative disease, provides a strong corporate foundation and validates its ability to advance therapies from development to market. Zevra’s vision is realized through disciplined execution of its strategic plan and core values — patient centricity, integrity, accountability, innovation, and courage — which guide its efforts to deliver long-term value.

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

Caution Concerning Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation statements regarding ensuring continuity of treatment for patients currently receiving arimoclomol through its global EAP. Forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the “Risk Factors” section of Zevra’s Annual Report on Form 10-K for the year ended December 31, 2025, filed on March 9, 2026, as well as Zevra’s other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release.  

Investor Contact
Nichol Ochsner 
+1 (732) 754-2545 
nochsner@zevra.com  

Media Contact
Julie Downs
+1 (508) 246-3230
jdowns@zevra.com

European Commission to make final decision on arimoclomol MAA following negative CHMP opinion

BOSTON, Nov. 13, 2026 (GLOBE NEWSWIRE) — Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company committed to redefining what’s possible in bringing life-changing therapeutics to people living with rare diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application (MAA) for arimoclomol for the treatment of Niemann-Pick disease type C (NPC), a rare, progressive and life-threatening neurodegenerative disorder that affects approximately 1,000 people in Europe. The European Commission is expected to issue its final decision on the Marketing Authorization Application within 67 days.

Zevra will continue to support eligible patients currently receiving arimoclomol through its global Expanded Access Program (EAP), subject to applicable regulatory requirements and in coordination with national authorities. The Company remains focused on helping ensure continuity of treatment for patients currently benefiting from arimoclomol through the program.

“We are deeply disappointed by the CHMP’s opinion, particularly given the significant unmet medical need faced by individuals and families living with NPC,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra Therapeutics. “We remain grateful to the patients, caregivers, investigators, advocacy organizations and healthcare providers who have been part of the arimoclomol journey. While this outcome is not what the NPC community hoped for, our priority remains supporting patients and families.”

Zevra believes the robust data package, which included clinical and real-world evidence for arimoclomol, provides important support for its therapeutic benefit in NPC. The application was supported by data from the pivotal NPC 002 Phase 2/3 trial, which demonstrated that arimoclomol in combination with miglustat reduced disease progression compared with placebo over 12 months. Long-term open-label extension data showed that the treatment effect was sustained over multiple years. The Company will continue to advance scientific understanding of NPC and collaborate with stakeholders across the global NPC community.

“The NPC community is profoundly disappointed by this decision,” said Sandra Cowie, President of the International Niemann-Pick Disease Alliance (INPDA). “Families affected by NPC face a relentlessly progressive disease that impacts every aspect of daily life. People living with NPC and their caregivers across Europe have been waiting for access to additional treatment options, making this outcome particularly difficult for those who continue to face the daily realities of this devastating disease. INPDA remains committed to advocating for people living with NPC and ensuring that the voices of those living with NPC and their families are heard.”

About Zevra Therapeutics, Inc.
Zevra Therapeutics, Inc. is a commercial-stage company with a late-stage pipeline committed to redefining what is possible in bringing life-changing therapies to people living with rare diseases. The Company is focused on broadening access through geographic expansion opportunities, progressing its pipeline toward key milestones, and delivering meaningful therapeutics. The commercialization of its lead product, marketed in the U.S. for Niemann-Pick disease type C (NPC), a rare, progressive neurodegenerative disease, provides a strong corporate foundation and validates its ability to advance therapies from development to market. Zevra’s vision is realized through disciplined execution of its strategic plan and core values — patient centricity, integrity, accountability, innovation, and courage — which guide its efforts to deliver long-term value.

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

Caution Concerning Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation statements regarding ensuring continuity of treatment for patients currently receiving arimoclomol through its global EAP. Forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the “Risk Factors” section of Zevra’s Annual Report on Form 10-K for the year ended December 31, 2025, filed on March 9, 2026, as well as Zevra’s other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release.  

Investor Contact
Nichol Ochsner 
+1 (732) 754-2545 
nochsner@zevra.com  

Media Contact
Julie Downs
+1 (508) 246-3230
jdowns@zevra.com