主要目的：考察中国健康受试者在餐后条件下单剂量口服四川科瑞德制药股份有限公司提供的溴吡斯的明片（受试制剂，T，60mg）与持证商Mylan Products Ltd的溴吡斯的明片（参比制剂，R，60mg）后的体内药代动力学特征，进行生物等效性评价。次要目的：评价单剂量口服溴吡斯的明片受试制剂（规格：60mg）及参比制剂（规格：60mg）在中国健康受试者中的安全性。

[Translation]

Primary objective: To investigate the in vivo pharmacokinetic characteristics of pyridostigmine bromide tablets (test preparation, T, 60 mg) provided by Sichuan Kred Pharmaceutical Co., Ltd. and pyridostigmine bromide tablets (reference preparation, R, 60 mg) from Mylan Products Ltd, a licensee, after a single oral dose in healthy Chinese subjects, and to evaluate bioequivalence. Secondary objective: To evaluate the safety of a single oral dose of pyridostigmine bromide tablets (test preparation, T, 60 mg) and reference preparation (specification: 60 mg) in healthy Chinese subjects.

Start Date12 Aug 2025

Sponsor / Collaborator

Sichuan Credit Pharmaceutical Co., Ltd.

CTR20252198

/ Active, not recruitingNot Applicable

溴吡斯的明片在中国健康受试者中空腹状态下的人体生物等效性试验

[Translation] Human bioequivalence study of pyridostigmine bromide tablets in Chinese healthy subjects under fasting condition

主要目的：考察中国健康受试者在空腹条件下单剂量口服四川科瑞德制药股份有限公司提供的溴吡斯的明片（受试制剂，T，60mg）与持证商Mylan Products Ltd的溴吡斯的明片（参比制剂，R，60mg）后的体内药代动力学特征，进行生物等效性评价。次要目的：评价单剂量口服溴吡斯的明片受试制剂（规格：60mg）及参比制剂（规格：60mg）在中国健康受试者中的安全性。

[Translation]

Primary objective: To investigate the in vivo pharmacokinetic characteristics of pyridostigmine bromide tablets (test preparation, T, 60 mg) provided by Sichuan Kred Pharmaceutical Co., Ltd. and pyridostigmine bromide tablets (reference preparation, R, 60 mg) from Mylan Products Ltd, a licensee, after a single oral dose under fasting conditions in healthy Chinese subjects, and to evaluate bioequivalence. Secondary objective: To evaluate the safety of a single oral dose of pyridostigmine bromide tablets (test preparation, T, 60 mg) and reference preparation (specification: 60 mg) in healthy Chinese subjects.

Start Date23 Jun 2025

Sponsor / Collaborator

Sichuan Credit Pharmaceutical Co., Ltd.

CTIS2025-521177-14-00

/ Not yet recruitingPhase 1

An open label, randomized, single-dose, two-treatment, two-period, cross-over pilot bioequivalence study comparing Pyridostigmine Bromide, P.R.Tab, 180 mg/tab, VIANEX S.A., Greece versus Mestinon® retard 180 mg/prolonged-release tablet, Viatris Healthcare GmbH, Germany, in healthy male and female volunteers under fasting conditions.

Start Date15 May 2025

Sponsor / Collaborator

VIANEX SA

100 Clinical Results associated with Pyridostigmine Bromide

100 Translational Medicine associated with Pyridostigmine Bromide

100 Patents (Medical) associated with Pyridostigmine Bromide

2,350

Literatures (Medical) associated with Pyridostigmine Bromide

01 Dec 2025·IMMUNOLOGIC RESEARCH

Dysautonomia: a common comorbidity of systemic disease

Review

Author: Blitshteyn, Svetlana

Abstract:

Referring to a broad spectrum of the autonomic symptoms, autonomic disorders, and general dysfunction of the autonomic nervous system, dysautonomia is one of the common and under-recognized comorbidities of a wide variety of systemic disease, including diabetes, autoimmune disorders, vitamin deficiencies, and hormonal dysregulation. The most common autonomic disorders encountered in clinical practice are postural orthostatic tachycardia syndrome (POTS), neurocardiogenic syncope (NCS), and orthostatic hypotension (OH), which may be undiagnosed or often mislabeled with psychiatric disorders. Typical clinical features of dysautonomia, such as orthostatic dizziness/lightheadedness, orthostatic intolerance, palpitations, exercise intolerance, cognitive dysfunction, and fatigue, should prompt a diagnostic investigation for dysautonomia, which includes an in-office 10-min stand test or a tilt table test in conjunction with other autonomic function tests if available. Treatment approach consists of non-pharmacologic and pharmacologic therapies with beta blockers, midodrine, ivabradine, pyridostigmine, fludrocortisone, stimulants, and other medications. In clinical setting, dysautonomia may present a diagnostic and therapeutic challenge in patients with various systemic disorders and may require a high index of suspicion on the part of the clinician. Importantly, diagnosing and treating dysautonomia is critical to providing comprehensive and personalized medical care to complex patients with chronic illness, who are typically highly symptomatic with multi-systemic complaints as a result of comorbid, and often undiagnosed, dysautonomia.

21 Oct 2025·NEUROLOGY

Obstetric and Neonatal Outcomes in Patients With Maternal Myasthenia Gravis

Article

Author: Hoff, Jana Midelfart ; Danielsson, Kim Christian ; Cohen, Jacqueline M. ; Bjørk, Marte-Helene ; Lindroos, Jenny Linnea Victoria ; Gilhus, Nils Erik ; Hikmat, Omar

BACKGROUND AND OBJECTIVES:

Muscle weakness, autoantibodies, and medication use in myasthenia gravis (MG) can complicate pregnancy and delivery. Vaginal delivery is encouraged despite increased risk of acute operative delivery. Our aim was to assess childbirth outcomes related to MG in a current, unselected, nationwide birth cohort.

METHODS:

This cohort study included all singleton births in the Medical Birth Registry of Norway from 1999 to 2022. Maternal MG, defined as MG diagnosis or pyridostigmine use, was identified from current and previous pregnancies. We compared adverse pregnancy, delivery, and neonatal outcomes between MG and non-MG births, with mode of delivery as the main outcome. Odds ratios (ORs) with 95% CIs, adjusted for year of birth, maternal age, parity, civil status, and autoimmune comorbidities, were estimated with logistic regression. In subanalyses, we investigated cesarean section (C-section) rates within Robson-10 subgroups and C-section indications.

RESULTS:

There were 134 MG births and 1,351,032 non-MG births. Elective C-section was twice as likely if the mother had MG (adjusted OR [aOR] 1.8, 95% CI 1.1-3.1), but emergency C-section and operative vaginal delivery were not more common. MG increased the risk of induction (aOR 1.5, 1.0-2.3), neuraxial anesthesia (aOR 1.5, 1.1-2.1), episiotomy (aOR 1.8, 1.1-3.0), preterm prelabor rupture of membranes (aOR 2.7, 1.1-6.6), prolonged hospitalization after delivery (aOR 1.8, 1.3-2.7), low birthweight (aOR 2.4, 1.3-4.4), feeding problems (aOR 4.9, 2.5-9.5), and transfer to a neonatal unit (aOR 5.1, 3.6-7.2). Transient neonatal MG (TNMG) was diagnosed in 5 of 134 children (4%). In subanalyses, the crude C-section rate was increased in preterm MG births (50% in MG vs 19% in non-MG) and in MG births after previous C-section (75% in MG vs 47% in non-MG).

DISCUSSION:

In this registry-based study, the higher rate of elective interventions suggests a proactive management of MG deliveries. The lower C-section threshold for MG births with relative obstetric indications may be justified, but most vaginal deliveries were uncomplicated. Adverse outcomes were generally not increased in the MG group compared with the general population, although episiotomy and prolonged hospitalizations were more frequent. Notably, 40% of MG-exposed infants had feeding difficulties and hypotonia or required neonatal care, suggesting underdiagnosis of TNMG.

01 Oct 2025·BRITISH JOURNAL OF ANAESTHESIA

Association of sugammadex, neostigmine, or pyridostigmine for reversal of neuromuscular block with postoperative bradycardia: a multicentre, retrospective observational study

Article

Author: Jeon, Yunseok ; Kim, Hye-Bin ; Oh, Ah-Ran ; Cho, Youn Joung ; Kim, Heezoo ; Chung, Jaeyeon ; Nam, Karam ; Lee, Dong Ju ; Park, Jungchan ; Kim, Hyo Sung ; Ju, Jae-Woo ; Kim, In Jung

BACKGROUND:

The aim of this study was to evaluate the risk of bradycardia after sugammadex administration for reversal of neuromuscular block compared with neostigmine and pyridostigmine.

METHODS:

This multicentre retrospective observational study included adult patients who underwent surgery under general anaesthesia between 2011 and 2021 in three university hospitals in Korea. The risk of bradycardia, defined as relative (≥10%, ≥20%, ≥30%, or ≥40%) or absolute (≥5, ≥10, ≥15, or ≥20 beats min^-1) decreases in heart rate (HR) from baseline within 30 min after the administration of sugammadex, neostigmine, or pyridostigmine was compared using logistic regression with stabilised inverse probability of treatment weighting.

RESULTS:

A total of 359 414 patients were analysed; sugammadex, neostigmine, and pyridostigmine were administered in 107 018, 97 754, and 154 642 patients, respectively. The overall incidence of bradycardia in the sugammadex group was similar to that of the neostigmine group. Specifically, the risk of a ≥20% decrease in HR was not significantly different between the sugammadex and neostigmine groups (9.8% vs 10.2%; odds ratio [95% confidence interval]: 1.00 [0.97-1.03]), though it was significantly higher in the sugammadex group than in the pyridostigmine group (9.8% vs 5.8%; 1.93 [1.87-1.98]). Restricted cubic spline curves suggested a linear increase in the risk of a ≥20% decrease in HR as the dose of sugammadex increased.

CONCLUSIONS:

The incidence of bradycardia after sugammadex administration was low, and its adjusted risk was not significantly different from that of neostigmine, the most commonly used acetylcholinesterase inhibitor for reversal of neuromuscular block.

News (Medical) associated with Pyridostigmine Bromide

22 May 2025

·www.prnewswire.com

Johnson & Johnson's IMAAVY Gets FDA Approval, Taking on Top Players in Myasthenia Gravis Market | DelveInsight

The FDA has approved Johnson & Johnson's anti-FcRn antibody, nipocalimab, for the treatment of generalized myasthenia gravis. The drug will be sold under the brand name IMAAVY. This approval positions J&J to challenge leading competitors in the myasthenia gravis market, such as AstraZeneca, which markets the monoclonal antibodies SOLIRIS and ULTOMIRIS. J&J will also be competing with Argenx's VYVGART and UCB's RYSTIGGO and ZILBRYSQ. LAS VEGAS, May 22, 2025 /PRNewswire/ -- Myasthenia gravis is an autoimmune disorder in which antibodies disrupt the communication between nerves and muscles, resulting in skeletal muscle weakness. This weakness primarily affects voluntary muscles that control eye movement, facial expression, swallowing, and limb function. The condition is predominantly driven by autoantibodies targeting either the acetylcholine receptor (AChR-Ab) or a receptor-associated protein known as muscle-specific tyrosine kinase (MuSK-Ab). According to DelveInsight's analysis, there were approximately 300,000 diagnosed prevalent cases of myasthenia gravis across the 7MM in 2024. This number is expected to grow steadily over the forecast period (2025–2034), with a projected CAGR. The current myasthenia gravis therapeutics market mainly consists of symptomatic treatments such as acetylcholinesterase inhibitors like Mestinon. However, achieving full clinical remission with symptomatic therapy alone is challenging. As a result, immunosuppressive drugs are frequently introduced. First-line immunotherapy typically involves high-dose oral corticosteroids such as prednisone or prednisolone, which can induce a rapid response within 2 to 4 weeks. To reduce reliance on steroids and improve long-term disease control, nonsteroidal immunosuppressants (NSISTs) are often used. These include antimetabolites (e.g., azathioprine, mycophenolate mofetil, methotrexate, and cyclophosphamide) and calcineurin inhibitors (e.g., tacrolimus and cyclosporine). While NSISTs may be used as standalone treatments, they usually take 6 to 9 months to produce noticeable effects. Immunomodulatory therapies, including intravenous immunoglobulin (IVIg) and plasmapheresis (PLEX), are typically reserved for acute exacerbations or myasthenic crises. They are also employed as chronic treatments in patients who cannot tolerate or do not respond to standard immunosuppressants. Although traditional immunosuppressive strategies can help manage symptoms, achieving long-term, stable remission remains difficult. Additionally, about 15% of patients are considered treatment-refractory, meaning they either fail to respond to or cannot tolerate multiple immunosuppressive options. These patients often face the dual challenge of persistent symptoms and the adverse effects of long-term immunosuppression. Learn more about the myasthenia gravis disease market @ Myasthenia Gravis Treatment Medications The myasthenia gravis treatment market is well-established, with multiple approved drugs for myasthenia gravis, including SOLIRIS, ULTOMIRIS, RYSTIGGO, ZILBRYSQ, and VYVGART, among others. Alexion Pharmaceuticals' SOLIRIS is a monoclonal antibody that targets and inhibits complement protein C5, thereby blocking the formation of the terminal complement complex. This action helps reduce complement-driven hemolysis in PNH and thrombotic microangiopathy in aHUS. Although its exact mechanism in gMG and NMOSD is not fully known, it is believed to decrease complement complex accumulation. Between 2017 and 2023, SOLIRIS gained regulatory approvals in Japan, the US, and the EU for treating gMG, including pediatric indications in Japan. ULTOMIRIS (ravulizumab), also from Alexion Pharmaceuticals, is the first long-acting C5 inhibitor, offering rapid, complete, and sustained suppression of complement activity. It binds to C5, preventing its cleavage and subsequent formation of the membrane attack complex (C5b-9). ULTOMIRIS is effective in managing terminal complement-mediated hemolysis in PNH and thrombotic microangiopathy in aHUS. Although the precise mechanism in gMG and NMOSD remains unclear, it is thought to reduce complement deposition at the neuromuscular junction and block aquaporin-4 antibody-mediated complement activation. It received approvals from the US FDA, EMA, and Japan's PMDA in 2022. Get an in-depth assessment on generalized myasthenia gravis medication for adults @ ULTOMIRIS vs SOLIRIS for Myasthenia Gravis UCB Biopharma's RYSTIGGO is a subcutaneously administered, humanized monoclonal antibody that binds with high affinity to the human neonatal Fc receptor (FcRn). It received regulatory approval from the US FDA and Japan's PMDA in 2023, followed by the EC in January 2024. ZILBRYSQ, also developed by UCB Biopharma, is the first once-daily subcutaneous peptide-based inhibitor specifically targeting complement protein C5. It works by blocking C5 cleavage and the formation of the terminal complement complex C5b-9. Although its precise action in gMG remains uncertain, it is thought to limit C5b-9 accumulation at the neuromuscular junction. ZILBRYSQ gained approval from the US FDA, EMA, and PMDA in 2023. VYVGART, from Argenx, is a human IgG1 antibody fragment that targets FcRn, leading to a decrease in circulating IgG autoantibodies. It is the first FcRn blocker to receive regulatory approval. Argenx's VYVGART HYTRULO (also marketed as VYVDURA) combines efgartigimod alfa, an FcRn inhibitor, with hyaluronidase, an endoglycosidase, for treating adults with generalized myasthenia gravis. This formulation was approved by the US FDA and EMA in 2023 and by the PMDA in January 2024. Uncover the mechanism of FcRn inhibitor myasthenia gravis medication @ Myasthenia Gravis MoA On April 30, 2025, the FDA approved Johnson & Johnson's nipocalimab, branded as IMAAVY, as a new therapy for gMG. This approval puts IMAAVY among the list of approved drugs for myasthenia gravis treatment. The approval, which J&J says encompasses the widest eligible patient population with gMG, includes individuals aged 12 and above who test positive for AChR or anti-muscle-specific kinase (MuSK) antibodies. IMAAVY functions by inhibiting the FcRn protein, which plays a role in maintaining circulating IgG antibodies, key drivers in many autoimmune disorders. By blocking FcRn, IMAAVY significantly reduces harmful IgG autoantibodies while preserving the body's overall immune response, according to clinical data. J&J sees broader potential for IMAAVY beyond gMG, believing its mechanism of action could apply across multiple autoimmune conditions due to IgG's involvement in various diseases. The FDA's decision followed results from the ongoing Phase III Vivacity-MG3 trial, which evaluates IMAAVY in combination with standard care versus placebo and standard care in 199 adult gMG patients, including 153 antibody-positive individuals. Additionally, J&J is conducting a Phase II/III pediatric trial called Vibrance, where IMAAVY, combined with standard care, achieved its primary goal by reducing total serum IgG levels by 69% over 24 weeks. J&J acquired IMAAVY through its USD 6.5 billion acquisition of Momenta Pharmaceuticals in 2020, with the FcRn inhibitor myasthenia gravis serving as the centerpiece of that deal. The company is aiming for blockbuster status, forecasting peak annual sales of over USD 5 billion for the myasthenia gravis medication. Dive deep into the myasthenia gravis treatment cost @ Generalized Myasthenia Gravis Drug with Copay Myasthenia gravis pipeline possesses some drugs in mid- and late-stage development to be approved in the near future. The expected launch of myasthenia gravis treatment medications, such as Batoclimab (Immunovant Sciences GmbH), Descartes-08 (Cartesian Therapeutics), and others, are expected to further create a positive impact on the myasthenia gravis disease market. Discover which therapies are expected to grab major myasthenia gravis therapeutics market share @ Market Analysis on Myasthenia Gravis Batoclimab is a fully humanized monoclonal antibody designed to inhibit neonatal Fc receptors by blocking the interaction between FcRn and IgG, thereby promoting the breakdown of autoantibodies. It has received Orphan Drug Designation (ODD) from both the US FDA and the EMA. In March 2025, Immunovant announced topline results from its Phase III trial evaluating batoclimab in patients with myasthenia gravis. Descartes-08 represents the first RNA-engineered CAR T-cell (rCAR-T) therapy developed for autoimmune conditions. This therapy uses cytotoxic T-cells programmed to target and eliminate pathogenic plasma cells that produce autoantibodies. Created from a patient's own blood, Descartes-08 has also received ODD from the US FDA for treating myasthenia gravis. In December 2024, Cartesian Therapeutics shared encouraging updated findings from its Phase IIb study of Descartes-08 in myasthenia gravis. Furthermore, in January 2025, the FDA agreed to the company's Phase III AURORA trial design under a Special Protocol Assessment, with trial initiation planned for the first half of 2025. Curious about what the new myasthenia gravis treatments are in development? Visit Myasthenia Gravis Clinical Trials The anticipated launch of these emerging myasthenia gravis treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the myasthenia gravis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the myasthenia gravis market size in the 7MM is expected to grow from USD 5.2 billion in 2024 at a significant CAGR by 2034. According to DelveInsight's analysis, the myasthenia gravis market growth is anticipated with the introduction of emerging therapies, leading to an expansion in the myasthenia gravis market size throughout the forecast period (2025–2034). This anticipated myasthenia gravis market growth is driven by advancements in treatment options, greater healthcare access, and a rising myasthenia gravis prevalence, which together foster higher demand for innovative and effective therapies. DelveInsight's latest published market report titled Myasthenia Gravis Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which myasthenia gravis treatment market leader is going to capture the largest market share. The report provides comprehensive insights into the country-specific myasthenia gravis treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The myasthenia gravis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Diagnosed Prevalent Cases of Myasthenia Gravis Gender-specific Diagnosed Prevalent Cases of Myasthenia Gravis Age-specific Diagnosed Prevalent Cases of Myasthenia Gravis Diagnosed Prevalent Cases of Myasthenia Gravis by MGFA Classification Diagnosed Prevalent Cases of Generalized Myasthenia Gravis by Antibody Serology The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM myasthenia gravis market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this myasthenia gravis market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the myasthenia gravis market. Also, stay abreast of the mitigating factors to improve your market position in the myasthenia gravis therapeutic space. Related Reports Myasthenia Gravis Epidemiology Forecast Myasthenia Gravis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted myasthenia gravis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Myasthenia Gravis Pipeline Myasthenia Gravis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Harbour BioMed (Guangzhou) Co. Ltd., Kyverna Therapeutics, Cabaletta Bio, Takeda, Hoffmann-La Roche, Immunovant Sciences GmbH, Regeneron Pharmaceuticals, Novartis Pharmaceuticals, Janssen Research & Development, LLC, Momenta Pharmaceuticals, Inc., Amgen, Dianthus Therapeutics, Cartesian Therapeutics, COUR Pharmaceutical Development Company, Inc., Alexion Pharmaceuticals, Inc., among others. Generalized Myasthenia Gravis Market Generalized Myasthenia Gravis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key gMG companies including Alexion Pharmaceuticals, Argenx, UCB Biopharma, Argenx-Halozyme Therapeutics, Horizon Therapeutics, Hoffmann-La Roche, Janssen Research & Development, LLC, Immunovant Sciences GmbH, Bristol Myers Squibb, Biogen Inc., Pfizer Inc., Novartis AG, Sanofi S.A., Roche Holding AG, Johnson & Johnson, Takeda Pharmaceutical Company Limited, AbbVie Inc., Eli Lilly and Company, Merck & Co., Inc., GlaxoSmithKline plc, AstraZeneca plc, Amgen Inc., Boehringer Ingelheim International GmbH, Genentech, Inc., Gilead Sciences, Inc., Celgene Corporation, Vertex Pharmaceuticals Incorporated , among others. Generalized Myasthenia Gravis Pipeline Generalized Myasthenia Gravis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key gMG companies, including Biocon, Cartesian Therapeutics, UCB, Momenta Pharmaceuticals, HanAll Biopharma, Roche, Alexion, Novartis, Takeda, BioMarin, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 3Drug ApprovalOrphan DrugClinical Result

21 Oct 2024

·www.biospace.com

Amneal Receives U.S. FDA Approval of New Drug Application for Pyridostigmine Bromide Extended-Release Tablets

Pyridostigmine Bromide Extended Release is a once-daily soman nerve agent pretreatment pyridostigmine product for the U.S. Armed Services and U.S. allies developed utilizing Amneal’s GRANDE ® drug delivery technology Developed with the support of Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company based in the U.S., today announced that it has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Pyridostigmine Bromide Extended-Release (PB ER) Tablets USP 105 mg. PB ER 105 mg tablets are a once-daily, orally administered product indicated for pretreatment against the lethal effects of soman nerve agent poisoning in adults developed for the U.S. Armed Services and U.S. allies. This product offers potential for improved compliance and steady 24-hour release of the drug’s therapeutic benefit, which is intended to provide an alternative to the current PB product that is administered every eight hours and avoiding the need for service members to self-administer three times a day. This product was not previously disclosed and was developed with Amneal’s GRANDE ® drug delivery technology, which is an advanced gastric retention system that allows for sustained delivery drug release. This project was funded in part by the U.S. government under Agreement W911QY-21-9-0018. “Amneal is proud to receive our second NDA approval this year, after the recent approval of CREXONT for Parkinson’s disease. This new pyridostigmine therapy speaks to Amneal’s expertise in developing new innovative product formulations and our ongoing work with the U.S. government on new solutions. With the approval of pyridostigmine bromide extended-release tablets, we are proudly supporting the U.S. military,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal. The most frequently reported serious adverse reactions were breathing difficulties, dizziness, and loss of consciousness. Other reported adverse reactions observed included dysmenorrhea, nosebleeds, reduced vision in one eye, and decreased tactile sensitivity. Disclaimer: The views and opinions of authors expressed herein do not necessarily state or reflect those of the U.S. government and shall not be used for advertising or product endorsement purposes. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit . Disclaimer The views expressed herein are those of Amneal and may not reflect the official policy or position of the Department of Defense (DoD) or the U.S. Government. Reference herein to any specific commercial products, process or service by trade name, trademark, manufacturer, or otherwise, does not constitute or imply its endorsement, recommendation, or favoring by the U.S. government and shall not be used for advertising or product endorsement purposes. Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. Contacts Investor Contact Anthony DiMeo VP, Investor Relations anthony.dimeo@amneal.com

NDADrug Approval

15 Oct 2024

·www.globenewswire.com

argenx Highlights Data Showing Patient Impact Across Multiple Immunology Programs at 2024 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting and Myasthenia Gravis Foundation of America Scientific Sessions

Long-term and real-world data of VYVGART® (efgartigimod alfa-fcab) and VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) demonstrate speed of onset, depth of response, and durability of response VYVGART demonstrates consistent, favorable safety profile from follow-up safety data that totals >8,000 patient years; no vaccinations required and no impact on human serum albumin levels Real-world data show more than 50 percent of gMG patients demonstrate substantial and sustained reduction in steroid use following VYVGART initiation argenx continues to expand its reach in neurology through pipeline programs, including empasiprubart advancing in MMN and ARGX-119 in ALS and CMS October 15, 2024 – 7:00am CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the presentation of clinical and real-world data across its growing immunology pipeline at the 2024 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America (MGFA) Scientific Sessions in Savannah, GA from October 15-18, 2024. “VYVGART continues to deliver impactful benefits to patients in terms of safety, speed of onset, depth of response, and durability of response,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. “The robust data we are showing at AANEM and MGFA continue to confirm VYVGART as the leading innovative biologic with an established ability to reduce steroid usage, drive minimal symptom expression for gMG patients, and reduce CIDP symptoms quickly. In addition to VYVGART, we are excited to highlight our growing neurology pipeline, including empasiprubart and ARGX-119, through which we can advance our mission of delivering transformative outcomes for even more patients.” VYVGART and VYVGART Hytrulo Demonstrate Rapid, Deep and Sustained Responses in gMG and CIDP The data presented at AANEM continue to demonstrate the significant impact of VYVGART (including VYVGART Hytrulo), the first-in-class neonatal Fc receptor (FcRn) blocker for people living with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART is setting a new treatment standard in gMG and has shown rapid, deep and sustained responses, enabling a majority of patients to achieve minimal symptom expression (MSE) with a consistent and favorable safety profile and more than 8,000 patient years of safety data. Based on real-world data, more than half of patients can reduce steroid use by >5mg/day following VYVGART initiation. In CIDP, a majority of patients in the ADHERE trial responded to VYVGART Hytrulo and experienced reduced risk of relapse versus placebo and improvements in motor function and muscle strength, regardless of prior CIDP treatment. Highlights from VYVGART data presented at AANEM and MGFA: Early Line Use and Meaningful Steroid Reduction: VYVGART demonstrates consistent improvement across gMG patient subtypes, including those on mestinon alone, indicating its efficacy in early line use. Real-world gMG data show that at one-year post VYVGART initiation, 55% of patients reduced corticosteroid use by ≥5 mg/day and 42% of patients had achieved steroid doses of ≤5mg/day.Expansion to Seronegative and Ocular MG: argenx is honoring its long-term commitment to the broader MG community with two Phase 3 studies ongoing in additional MG patient populations, including seronegative (ADAPT-SERON) and ocular MG (ADAPT-OCULUS). Seronegative (AChR-) gMG patients evaluated in VYVGART clinical studies experienced consistent and clinically meaningful MG-ADL improvements, including patients achieving MSE.Sustained Functional Benefit in CIDP: VYVGART Hytrulo showed sustained functional benefit in motor function and muscle strength, regardless of prior treatment, which was maintained through ADHERE and the open-label extension study (through week 24).Consistent, Favorable Safety Profile: VYVGART’s consistent and favorable safety profile has been established across multiple autoimmune diseases with no increase in the incidence of adverse events with increased exposure. The unique safety profile of VYVGART is further supported by no black box warnings, no labs or immunoglobulin (Ig) monitoring, and no vaccination requirements. Advancing Immunology Pipeline Across Two First-in-Class Opportunities to Reach New Patients argenx will also highlight two additional pipeline candidates, including Phase 2 ARDA data of empasiprubart (anti-C2 inhibitor) for the treatment of multifocal motor neuropathy (MMN), and clinical trial designs of ARGX-119 (muscle-specific kinase (MuSK) agonist) for the treatment of congenital myasthenic syndromes (CMS) and amyotrophic lateral sclerosis (ALS). Cohort 1 data from the Phase 2 ARDA study will be presented in a poster, showing treatment with empasiprubart for MMN reduced the risk of IVIg retreatment by 91% (HR: 0.09 [95% CI: 0.02–0.44]) and demonstrated significant improvement in grip strength in both hands as compared to placebo. Data from a Patient Global Impression of Change scale show 94.4% of patients said they improved on empasiprubart from the start of the study, compared to 11.1% of placebo patients. As part of its commitment to the MMN community, argenx initiated the iMMersioN longitudinal study of ~150 patients to collect data on the impact of disease and burden of current treatment options on clinical outcomes and quality of life measures. A Phase 3 study of empasiprubart in MMN will start by the end of 2024. argenx posters included in MGFA Scientific Sessions All MGFA posters to be presented on Tuesday, October 15, 12:00 – 12:45pm ETPosters with an asterisk (*) will also be presented in AANEM scientific program Full TitlePresentation DetailsPatterns of Efgartigimod Dosing in Clinical Practice in the United StatesPoster # MG9Real-World Reduction in Oral Glucocorticoid Utilization at 1-Year Following Efgartigimod Initiation*Poster # MG31 / AANEM Poster # 262Efficacy, Safety, and Pharmacodynamics of Efgartigimod PH20 SC Across Bodyweight Quartiles: A Post hoc Analysis of the ADAPT-SC+ TrialPoster # MG32Fixed Cycle and Every-Other-Week Dosing of Intravenous Efgartigimod for Generalized Myasthenia Gravis: Part A of ADAPT NXT*Poster # MG33 /AANEM Poster # 182Design of a Phase 3 Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Subcutaneous Efgartigimod PH20 Administered by Prefilled Syringe in Adults with Ocular Myasthenia GravisPoster # MG38Phase 3 Trial Investigating Impact of Intravenous Efgartigimod in Anti-Acetylcholine Receptor Antibody Negative Generalized Myasthenia Gravis*Poster # MG39 / AANEM Poster # 178Observed Efficacy of Efgartigimod in Generalized Myasthenia Gravis Across Patient Subgroups in the ADAPT-SC+ StudyPoster # MG68Exploring the Impact of Non-Steroidal Immunosuppressive Drugs and Steroids on the Development of Comorbidities in Patients with Myasthenia Gravis in the National Veterans Affairs Health NetworkPoster # MG86Quality of Life of Patients with Symptomatic Ocular MG: Comparison with the General PopulationPoster # MG87Steroid Use, Toxicity, and Monitoring in Patients With Generalized Myasthenia Gravis: A Survey Of Neurologists In The United States*Poster # MG89 / AANEM Poster # 235Comparative Risk-Benefit Profiles of Immunomodulatory Therapies for Patients with Generalized Myasthenia GravisPoster # MG98 argenx posters included in AANEM Scientific Program * Session Times: Session I: Wednesday, October 16, 6:15 - 6:45pm ETSession II: Thursday, October 17, 9:30 - 10am ETSession III: Thursday, October 17, 2:45 - 3:15pm ET Full TitlePresentation Details*Long-Term Safety and Efficacy of Efgartigimod PH20 SC in Generalized Myasthenia Gravis: Interim Analysis of Anti-Acetylcholine Receptor Antibody Seronegative Participants in ADAPT-SC+Poster # 144Session I & Session IICombined Analyses of Participants With Anti-Acetylcholine Receptor Seronegative Generalized Myasthenia Gravis Treated With Efgartigimod Across Clinical StudiesPoster # 146Session I & Session IISafety, Tolerability, Pharmacokinetics, Immunogenicity, and Efficacy of ARGX-119 in Participants With DOK7 Congenital Myasthenic Syndromes: Phase 1b Study in ProgressPoster # 165Session I & Session IIIEfficacy and Safety of Subcutaneous Efgartigimod PH20SC in Chronic Inflammatory Demyelinating Polyneuropathy: ADHERE Trial Subgroup AnalysisPoster # 176Session I & Session IIEfficacy and Safety of Subcutaneous Efgartigimod PH20 in Chronic Inflammatory Demyelinating Polyneuropathy: ADHERE/ADHERE+ TrialPoster # 177Session I & Session IIISafety Profile of Intravenous Efgartigimod From Clinical Trials in Immunoglobulin G–Mediated Autoimmune DiseasesPoster # 180Session I & Session IISafety Profile of Subcutaneous Efgartigimod PH20 From Clinical Trials in Immunoglobulin G–Mediated Autoimmune DiseasesPoster # 181Session I & Session IIIEmpasiprubart (ARGX-117) in Multifocal Motor Neuropathy: Initial Safety and Efficacy Data of the Phase 2 ARDA StudyPoster # 198Session I & Session IILong-Term Safety, Tolerability, and Efficacy of Subcutaneous Efgartigimod PH20 in Participants With Generalized Myasthenia Gravis: Interim Results of the ADAPT-SC+ StudyPoster # 212Session I & Session IIISafety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of ARGX-119 in Patients with Amyotrophic Lateral Sclerosis: A Phase 2a Study in ProgressPoster # 237Session I & Session IIRisk of Serious Infections and Malignancies in Adult Myasthenia Gravis Patients: A US Claims Database StudyPoster # 251Session I & Session IIChronic Steroid Toxicity in Adults With Myasthenia Gravis in the United States Based on Electronic Health RecordsPoster # 263Session I & Session IISubcutaneous Efgartigimod PH20 in Chronic Inflammatory Demyelinating Polyneuropathy: Key Secondary Outcomes from the ADHERE TrialPoster # 280Session I & Session IIIEmpasiprubart (ARGX-117) in Multifocal Motor Neuropathy: Baseline Characteristics and MMN Confirmation Committee Outcome of the Phase ARDA Study Cohort 1Poster # 293Session I & Session IICOVID-19 Vaccination Response in Participants Receiving Efgartigimod IV or Efgartigimod PH20 SC in ADAPT+ or ADAPT-SC+Poster # 298Session I & Session IIISteroid Use, Toxicity, and Monitoring in Patients with Chronic Inflammatory Demyelinating Polyneuropathy: A Survey of Neurologists in The United StatesPoster # 306Session I & Session IIIClinical Outcomes, Disease Course, and Quality of Life in Patients With Multifocal Motor Neuropathy: iMMersioN, Study in ProgressPoster # 307Session I & Session II More information on the data presented at the 2024 AANEM Annual Meeting can be found here. See FDA-approved Important Safety Information below, full Prescribing Information for VYVGART and full Prescribing Information for VYVGART Hytrulo for additional information. Important Safety Information What is VYVGART® (efgartigimod alfa-fcab)?VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive). IMPORTANT SAFETY INFORMATIONDo not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. VYVGART can cause serious allergic reactions and a decrease in blood pressure leading to fainting. VYVGART may cause serious side effects, including: Infection. VYVGART may increase the risk of infection. The most common infections were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.Allergic Reactions (hypersensitivity reactions). VYVGART can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with VYVGART.Infusion-Related Reactions. VYVGART can cause infusion-related reactions. The most frequent symptoms and signs reported with VYVGART were high blood pressure, chills, shivering, and chest, abdominal, and back pain. Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction. Before taking VYVGART, tell your doctor if you: take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,have received or are scheduled to receive a vaccine (immunization), orhave any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding. What are the common side effects of VYVGART?The most common side effects of VYVGART are respiratory tract infection, headache, and urinary tract infection. These are not all the possible side effects of VYVGART. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088. Please see the full Prescribing Information for VYVGART and talk to your doctor. What is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)?VYVGART HYTRULO is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).VYVGART HYTRULO is a prescription medicine used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) IMPORTANT SAFETY INFORMATIONDo not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting. VYVGART HYTRULO may cause serious side effects, including: Infection. VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.Allergic Reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab.Infusion-Related Reactions. VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain. Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction. Before taking VYVGART HYTRULO, tell your doctor if you: take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,have received or are scheduled to receive a vaccine (immunization), orhave any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding. What are the common side effects of VYVGART HYTRULO?The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives. These are not all the possible side effects of VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088. Please see the full Prescribing Information for VYVGART HYTRULO and talk to your doctor. About VYVGARTVYVGART is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker in the United States, EU, China and Canada for the treatment of adults with generalized myasthenia gravis (gMG) who are anti- acetylcholine receptor (AChR) antibody positive and in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). About VYVGART® HytruloVYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART®, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the reduction of circulating IgG. It is the first-and-only approved FcRn blocker administered by subcutaneous injection. VYVGART Hytrulo is the proprietary name in the U.S. for subcutaneous efgartigimod alfa and recombinant human hyaluronidase PH20. It may be marketed under different proprietary names following approval in other regions. About Generalized Myasthenia Gravis (gMG)Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months,1 where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population. About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. Although confirmation of disease pathophysiology is still emerging, there is increasing evidence that IgG antibodies play a key role in the damage to the peripheral nerves. People with CIDP experience fatigue, muscle weakness and a loss of feeling in their arms and legs that can get worse over time or may come and go. These symptoms can significantly impair a person's ability to function in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair. About EmpasiprubartEmpasiprubart (ARGX-117) is a first-in-class humanized monoclonal antibody that binds C2 and blocks activation of both the classical and lectin pathways of the complement cascade, leaving the alternative pathway intact for its antimicrobial properties. By blocking complement activity upstream of C3 and C5, empasiprubart has the potential to reduce tissue inflammation and cellular damage, representing a broad pipeline opportunity across multiple severe autoimmune indications. In addition to multifocal motor neuropathy, argenx is evaluating empasiprubart in delayed graft function following kidney transplant, dermatomyositis and chronic inflammatory demyelinating polyneuropathy. About Multifocal Motor NeuropathyMultifocal motor neuropathy (MMN) is a rare, severe, chronic autoimmune disease of the peripheral nervous system. The disease is characterized by slowly progressive, asymmetric muscle weakness mainly of the hands, forearms and lower legs. MMN is often associated with the presence of anti-GM1 IgM autoantibodies, leading to activation of the classical complement pathway, driving subsequent axon damage. High-dose IVIg is the only approved treatment for MMN and patients typically experience disease progression despite therapy, indicating an unmet need for efficacious and better tolerated therapeutic options. About ARGX-119ARGX-119 is a humanized agonistic monoclonal antibody (mAb) that targets and activates muscle-specific kinase (MuSK) to promote maturation and stabilization of the neuromuscular junction (NMJ). MuSK is a receptor kinase that has a critical role in the structure and function of the NMJ. ARGX-119 is being developed as a potential therapy for patients with neuromuscular disease. About Congenital Myasthenic Syndromes (CMS) Congenital Myasthenic Syndromes (CMS) are a heterogenous group of rare genetic disorders of the neuromuscular junction (NMJ) that lead to muscle weakness. CMS cases are classified into subtypes depending on the underlying genetic mutation. While clinical features vary widely across and within subtypes, the predominant manifestation of CMS is fatigable weakness. Age of onset varies widely; while many patients are diagnosed in infancy or early childhood, patients with milder phenotypes may not present or be diagnosed until adulthood. About Amyotrophic Lateral Sclerosis (ALS) ALS is a neurodegenerative disorder of the brain and spinal cord leading to deteriorating muscle function, weakness and atrophy. The multisystemic nature can have impacts throughout the body with specific signs and symptoms associated with lower motor neuron and upper motor neuron loss. Life expectancy is typically 2.5-5 years from diagnosis. About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK, Canada and China. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, X/Twitter, Instagram, Facebook, and YouTube. ContactsMedia:Ben Petokbpetok@argenx.com Investors:Alexandra Roy (US)aroy@argenx.com Lynn Elton (EU)lelton@argenx.com Forward-Looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “aim,” and “will,” and include statements argenx makes regarding the anticipated timing of the initiation of the Phase 3 clinical trial for empasiprubart in MMN and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements in products and product candidates; the acceptance of argenx's products and product candidates by patients as safe, effective and cost-effective; the impact of governmental laws and regulations on our business; disruptions caused on our reliance of third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law. ###

Clinical ResultPhase 2Phase 3Phase 1

100 Deals associated with Pyridostigmine Bromide

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KEGG	Wiki	ATC	Drug Bank
D00487	Pyridostigmine Bromide	N07AA02	DBSALT000190

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Indication	Country/Location	Organization	Date
Poisoning	United States	Amneal Pharmaceuticals LLC	04 Oct 2024
Neurotoxicity Syndromes	United States	U.S. Army War College	05 Feb 2003
Lambert-Eaton Myasthenic Syndrome	China	Shanghai Zhongxi Sunve Pharmaceutical Co., Ltd.	01 Jan 1995
Myasthenia Gravis	United States	Bausch Health US LLC	06 Apr 1955

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02941328 \| EUCTR2011-004369-34-NL (Pubmed)	Phase 2	Spinal Muscular Atrophy	35	Pyridostigmine	ulthcubddl(jqhdzaftjl) = wzterloevr kescprgcuw (zznsqpsypn, 0.00 - 1.49) View more	-	01 Jan 2023
NCT04343963 (Pubmed) Manual	Phase 2/3	COVID-19	188	SOC+Pyridostigmine Bromide	bhwifqiztm(cjbolukjzs) = tmcrkmfeay ftcufojodo (jkznltblmg ) View more	Positive	08 Nov 2022
				SOC+Placebo	bhwifqiztm(cjbolukjzs) = fmxteieyay ftcufojodo (jkznltblmg ) View more
NCT03674541 (CTgov)	Phase 2	Postural Orthostatic Tachycardia Syndrome \| Fatigue Syndrome, Chronic \| Ventricular Dysfunction ... View more	45	Pyridostigmine Bromide (Study Drug - Pyridostigmine)	wevqgxaruo(pokymffdtf) = xmnhufwubu yudehkgbgw (ahaysdfcqy, 13.4) View more	-	04 Oct 2022
				Placebo (Placebo)	igycfjkcxd(agalvzvlfi) = wuydvdzvfh jwfuemhltm (zacchtscbt, snjafwtftt - rglgufoghp) View more
MDS2022	Not Applicable	Hypotension, Orthostatic	-	Pyridostigmine	fiojzyualj(zhcclhvrpy) = ytfxrpnzvm amvmtkrijw (aryfcmupqo )	-	15 Sep 2022
				Midodrine	fiojzyualj(zhcclhvrpy) = fxziapavsa amvmtkrijw (aryfcmupqo )
NCT03674541 (Pubmed \| Chest) Manual	Not Applicable	Fatigue Syndrome, Chronic	45	Pyridostigmine Bromide	iuwbvomflv(nbhbdtdzvb) = tquwkjczqz ryawdvwkqq (gukormxyea, 13.4)	Positive	05 May 2022
				Placebo	iuwbvomflv(nbhbdtdzvb) = dxwgvpzdlp ryawdvwkqq (gukormxyea, 21.3)
NCT00518154 (CTgov)	Phase 2	HIV Infections	7	Pyridostigmine	xvnsawxbln(xgbeihbslf) = szzztsgajs dxwpexcbjx (wwcutwcyuc, 43.1) View more	-	14 Nov 2019
NCT02850276 (ANGI, CTgov)	Early Phase 1	Inflammation \| HIV Infections \| Peripheral Nervous System Diseases	76	Pyridostigmine	fusceidigz(ynkwkdfhdm) = mtzmbsxvxj rbmkijqwbi (ezzmtdstee, qmuhcwwsxx - msotatpucs) View more	-	29 May 2019
NCT02308124 (CTgov)	Phase 4	Neurogenic Orthostatic Hypotension	87	pyridostigmine+Midodrine	etyyibzicj(unbukcjaxs) = zwtjlcmtlv fvckckynxb (gnderhjgum, 9.9) View more	-	17 Apr 2017
NCT00518154 (Pubmed \| Front Immunol)	Phase 2	HIV Infections Add-on	7	Pyridostigmine	tlhtfxwywv(yetxynghsm) = bpredfemtg rlnexliuky (irzavfuuri )	-	01 Jan 2017
NCT01415921 (APP-HF, CTgov)	Phase 2	Heart failure NYHA class III \| Heart Failure	33	Pyridostigmine Bromide (Pyridostigmine Bromide)	tdqlcskkoz(icyryxbuuy) = wnlyryghgu xfxkhhvdpu (hfaxqktjhs, 12.8) View more	-	25 Oct 2016
				Pyridostigmine Bromide (Placebo)	tdqlcskkoz(icyryxbuuy) = xfybkxhdhv xfxkhhvdpu (hfaxqktjhs, 14.8) View more

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