Latest news with #CIDP
Yahoo
31-07-2025
- Business
- Yahoo
argenx Reports Half Year 2025 Financial Results and Provides Second Quarter Business Update
$949 million in second quarter global product net sales VYVGART SC launch in CIDP progresses with more than 2,500 patients on treatment globally ARGX-119 to advance to registrational study in CMS following positive proof of concept data; three additional topline data readouts across pipeline remain on track for second half of 2025 Management to host conference call today at 2:30 PM CET (8:30 AM ET) July 31, 2025 7:00 AM 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 its half year 2025 results and provided a second quarter business update. 'We continue to make meaningful progress towards our Vision 2030, advancing bold innovation that has already reached more than 15,000 patients globally' said Tim Van Hauwermeiren, Chief Executive Officer of argenx. 'VYVGART is delivering strong growth across all indications, formulations and regions. We are still in the early stages of capturing the full market opportunity in MG and CIDP, with the recent launch of the VYVGART SC prefilled syringe driving demand from new patients and prescribers. In MG, we are shaping the market as the fastest growing biologic, moving earlier in the patient treatment paradigm, and working toward the broadest possible label. In CIDP, we continue to see consistent patient growth, with ample runway to reach the 12,000 patients in the U.S. who remain inadequately controlled on standard of care. This is just the beginning of the larger growth opportunity ahead. With six registrational and six proof-of-concept readouts expected by the end of 2026, we are executing on our proven innovation playbook that is delivering pipeline-in-a-product opportunities aimed at transforming care for patients with high unmet need.' Advancing Towards Vision 2030 argenx has established its strategic priorities to advance Vision 2030, aiming to treat 50,000 patients globally with its medicines, secure 10 labeled indications across all approved medicines, and advance five pipeline candidates into Phase 3 development by 2030. Expand global VYVGART opportunity and launch VYVGART SC as prefilled syringe VYVGART® (IV: efgartigimod alfa-fcab and SC: efgartigimod alfa and hyaluronidase-qvfc) is a first-and-only IgG Fc-antibody fragment that targets the neonatal Fc receptor (FcRn). It is approved in three indications, including generalized myasthenia gravis (gMG) globally, primary immune thrombocytopenia (ITP) in Japan, and chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S., Japan, China, and the EU. The VYVGART-SC prefilled syringe (PFS) is now approved for use in the U.S. and EU. Generated global product net sales (inclusive of both VYVGART and VYVGART SC) of $949 million in the second quarter of 2025 Strong underlying fundamentals across key patient and prescriber metrics with 97% operational growth in product net sales year-over-year from second quarter 2024, and 19% from the first quarter of 2025 First patient dosed in Germany following European Commission (EC) approval for VYVGART-SC (vial and PFS) for CIDP PFS decision on approval for gMG and CIDP expected in Japan and Canada by end of year Evidence generation through label-enabling studies: Topline results expected in second half of 2025 for seronegative gMG (ADAPT-SERON) and first half of 2026 for ocular MG (ADAPT OCULUS) Topline results expected in second half of 2026 to support FDA submission of VYVGART IV for primary ITP (ADVANCE-NEXT) Execute 10 registrational and 10 proof-of-concept studies across efgartigimod, empasiprubart and ARGX-119 to advance the next wave of launches argenx continues to demonstrate breadth and depth within its immunology pipeline, advancing multiple first-in-class product candidates with potential across high-need indications. Efgartigimod Development Efgartigimod is being studied across 15 severe autoimmune diseases, highlighting the broad potential of FcRn biology in neurology, rheumatology, and beyond. Registrational studies are currently ongoing in idiopathic inflammatory myopathies (IIM or myositis), thyroid eye disease (TED), and Sjögren's disease Topline results from ALKIVIA study evaluating three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS) and dermatomyositis (DM)) expected in second half of 2026 Topline results from two registrational UplighTED studies (TED) expected in second half of 2026 Topline results from registrational UNITY study (Sjögren's disease) expected in 2027 Proof-of-concept studies ongoing in lupus nephritis (LN), systemic sclerosis (SSc) and antibody mediated rejection (AMR); topline results expected for LN in fourth quarter of 2025, SSc in second half of 2026, and AMR in 2027 Empasiprubart Development Empasiprubart, a first-in-class, humanized, monoclonal antibody that specifically binds to C2, is currently being evaluated in four indications. These include registrational studies in multifocal motor neuropathy (MMN) and CIDP, and proof-of-concept studies in delayed graft function (DGF) and DM. Topline results from registrational EMPASSION study (MMN) evaluating empasiprubart head-to-head versus IVIg expected in second half of 2026 Registrational EMVIGORATE study ongoing in CIDP evaluating empasiprubart head-to-head versus IVIg Topline results expected for DGF in the second half of 2025 and for DM in first half of 2026 ARGX-119 Development ARGX-119, a first-in-class agonist antibody that targets muscle-specific kinase (MuSK), is being evaluated in congenital myasthenic syndromes (CMS), amyotrophic lateral sclerosis (ALS), and spinal muscular atrophy (SMA). Registrational study to start in CMS in 2026 following positive Phase 1b proof-of-concept data Phase 2a proof-of-concept study ongoing in ALS; topline results expected in first half of 2026 SMA proof-of-concept study on track to start by end of year ARGX-119 R&D webinar to be hosted on September 16, 2025 Advance four new pipeline molecules and generate sustainable value through continued investment in Immunology Innovation Program argenx continues to invest in its Immunology Innovation Program (IIP) to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates have been nominated, including: ARGX-213, targeting FcRn and further solidifying argenx's leadership in this biology; ARGX-121, a first-in-class molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and a fourth pipeline candidate, a first-in-class sweeping antibody for which the target has not yet been disclosed. Phase 1 results from ongoing ARGX-109 study expected in second half of 2025, and from ongoing ARGX-213 and ARGX-121 studies expected in first half of 2026 Entered strategic collaboration with Unnatural Products (UNP) to expand argenx discovery capabilities into the oral peptide space. This partnership reinforces argenx's commitment to enhance the patient experience and advance its pipeline of precision therapies. SECOND QUARTER 2025 FINANCIAL RESULTS argenx SEUNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS Three Months Ended Six Months Ended 30 June, 30 June, (in thousands of $ except per share data) 2025 2024 2025 2024 Product net sales $ 948,594 $ 477,635 $ 1,738,644 $ 875,918 Other operating income* 18,593 11,793 35,913 26,023 Total operating income $ 967,187 $ 489,428 $ 1,774,557 $ 901,941 Cost of sales $ (110,747) $ (52,383) $ (191,552) $ (95,561) Research and development expenses (327,697) (225,286) (636,767) (450,255) Selling, general and administrative expenses (324,902) (255,699) (601,150) (491,694) Loss from investment in a joint venture (2,780) (1,521) (5,087) (3,313) Total operating expenses $ (766,126) $ (534,889) $ (1,434,556) $ (1,040,823) Operating profit/(loss) $ 201,061 $ (45,461) $ 340,001 $ (138,882) Financial income $ 38,399 $ 38,933 $ 75,517 $ 77,828 Financial expense (1,126) (572) (2,261) (1,084) Exchange gains/(losses) 48,565 (7,903) 76,003 (27,215) Profit/(Loss) for the period before taxes $ 286,899 $ (15,003) $ 489,260 $ (89,353) Income tax (expense)/benefit $ (41,541) $ 44,069 $ (74,433) $ 56,822 Profit/(Loss) for the period $ 245,358 $ 29,066 $ 414,827 $ (32,531) Profit/(Loss) for the period attributable to: Owners of the parent $ 245,358 $ 29,066 $ 414,827 $ (32,531) Weighted average number of shares used for basic profit/(loss) per share 61,084,250 59,490,437 61,034,202 59,400,217 Basic profit/(loss) per share (in $) 4.02 0.49 6.80 (0.55) Weighted average number of shares used for diluted profit/(loss) per share 65,639,446 63,893,007 65,653,007 59,400,217 Diluted profit/(loss) per share (in $) 3.74 0.45 6.32 (0.55) *Comparative figures have been presented to be consistent with the one adopted in the current period with respect to the combination of collaboration revenue and other operating income. DETAILS OF THE FINANCIAL RESULTS Total operating income for the three and six months ended June 30, 2025, was $967 million and $1,775 million, respectively, compared to $489 million and $902 million, respectively, for the same periods in 2024, and mainly consists of: Product net sales of VYVGART and VYVGART SC for the three and six months ended June 30, 2025, were $949 million and $1,739 million, respectively, compared to $478 million and $876 million, respectively, for the same periods in 2024. Other operating income for the three and six months ended June 30, 2025, was $19 million and $36 million, respectively, compared to $12 million and $26 million, respectively, for the same periods in 2024. The other operating income for the three and six months ended June 30, 2025 and 2024, primarily relates to research and development tax incentives and payroll tax rebates. Total operating expenses for the three and six months ended June 30, 2025 were $766 million and $1,435 million, respectively, compared to $535 million and $1,041 million, respectively, for the same periods in 2024, and mainly consist of: Cost of sales for the three and six months ended June 30, 2025, was $111 million and $192 million, respectively, compared to $52 million and $96 million for the same periods in 2024, respectively. The cost of sales was related to the sale of VYVGART and VYVGART SC. Research and development expenses for the three and six months ended June 30, 2025, were $328 million and $637 million, respectively, compared to $225 million and $450 million, respectively, for the same periods in 2024. The research and development expenses mainly relate to: the clinical development and expansion of efgartigimod in 15 severe autoimmune diseases; the ramp-up of studies for the development of empasiprubart into MMN, DGF, DM and CIDP; the investments for ARGX-119 in proof-of-concept studies ongoing in ALS, CMS and SMA; and other discovery and preclinical pipeline candidates. Selling, general and administrative expenses for the three and six months ended June 30, 2025, were $325 million and $601 million, respectively, compared to $256 million and $492 million, respectively, for the same periods in 2024. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the global commercialization of VYVGART franchise, and personnel expenses. Financial income for the three and six months ended June 30, 2025, was $38 million and $76 million, respectively, compared to $39 million and $78 million, respectively, for the same periods in 2024. Exchange gains for the three and six months ended June 30, 2025, were $49 million and $76 million, respectively, compared to $8 million and $27 million, respectively, of exchange losses for the same periods in 2024. Exchange gains/losses are mainly attributable to unrealized exchange rate gains or losses on the cash, cash equivalents and current financial assets denominated in Euro. Income tax for the three and six months ended June 30, 2025 and 2024 is detailed below: Three Months Ended Six Months Ended 30 June, 30 June, (in millions of $) 2025 2024 2025 2024 Current tax (expense)/benefit $ (41) $ (9) $ (70) $ (16) Deferred tax (expense)/benefit (1) 53 (4) 72 Income tax (expense)/benefit $ (42) $ 44 $ (74) $ 57 Profit for the three- and six-month periods ended June 30, 2025, was $245 million and $415 million, respectively, compared to a profit of $29 million and a loss of $33 million, respectively, for the same periods in 2024. The basic profit per share was $4.02 for the three months ended June 30, 2025, compared to a basic profit per share of $0.49 for the same period in 2024. The basic profit per share was $6.80 for the six months ended June 30, 2025, compared to a basic loss per share of $0.55 for the same period in 2024. Cash flow from operating activities for the six months ended June 30, 2025 was $362 million compared to a cash flow used in operating activities for the same period in 2024 of $126 million. FINANCIAL GUIDANCE The financial guidance on the combined research and development and selling, general and administrative remains unchanged at approximately $2.5 billion. EXPECTED 2025 FINANCIAL CALENDAR October 30, 2025: Third Quarter 2025 Financial Results and Business Update February 26, 2025: Full-year 2025 Financial Results and Fourth Quarter 2025 Business Update CONFERENCE CALL DETAILS The half-year 2025 financial results and second quarter business update will be discussed during a conference call and webcast presentation today at 2:30 pm CET/8:30 am ET. A webcast of the live call may be accessed on the Investors section of the argenx website at A replay of the webcast will be available on the argenx website. Dial-in numbers: Please dial in 15 minutes prior to the live call. Belgium 32 800 50 201 France 33 800 943355 Netherlands 31 20 795 1090 United Kingdom 44 800 358 0970 United States 1 888 415 4250 Japan 81 3 4578 9081 Switzerland 41 43 210 1132 This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014). About argenx argenx 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 and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit and follow us on LinkedIn, Instagram, Facebook, and YouTube. For further information, please contact: Media:Ben Petokbpetok@ Investors:Alexandra Roy aroy@ 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 'advance,' 'aim,' 'committed,' 'continue,' 'expand,' 'expect,' 'growth,' and 'progress' and include statements argenx makes concerning its innovation agenda and growth strategy, including (i) its Vision 2030 to reach 50,000 patients globally across 10 labeled indications and to advance fix pipeline candidates into Phase 3 development by 2030 across efgartigimod, empasiprubart and ARGX-119 to create significant opportunity to expand into new therapeutic areas and reach broader patient populations and (ii) its goal to transform care for patients with high unmet need; its confidence regarding its growth trajectory; its commitment to improving the lives of people suffering from severe autoimmune diseases; its expectation regarding the insights from proof-of-concept and registrational studies across various programs; the advancement of anticipated clinical development, data readouts and regulatory milestones and plans, including: (1) the PFS decision on approval for gMG and CIDP expected in Japan and Canada by end of 2025, (2) topline results for seronegative gMG (ADAPT-SERON) expected in second half of 2025 and for ocular and pediatric MG (ADAPT-OCULUS, JR) expected in first half of 2026, (3) topline results for ADVANCE-NEXT to support FDA submission of VYVGART IV for primary ITP expected in second half of 2026, (4) new therapeutic areas and ongoing registrational studies in three subsets of myositis, thyroid eye disease (TED), and Sjögren's disease, with topline results from (a) ALKIVIA expected in second half of 2026, (b) two registrational UplightTED studies expected in second half of 2026 and (c) registrational UNITY study expected in 2027, (5) proof-of-studies ongoing in LN, SSc and AMR, with topline results expected in fourth quarter of 2025, second half of 2026 and 2027, respectively, (6) its plans to develop empasiprubart, including (a) registrational EMPASSION study in MMN, with topline results expected in second half of 2026, (b) registrational EMVIGORATE study in CIDP, expected to start in first half of 2025 and (c) topline results for DGM and DM expected in second half of 2025 and first half of 2026, respectively, (7) its plans to develop ARGX-119, including: (a) the registrational study to start in CMS in 2026; (b) Phase 2a proof-of-concept study in ALS, with topline results expected in first half of 2026; and (c) SMA proof-of-concept study; and (8) its plans to advance four new pipeline molecules and generate sustainable value through continue investment in its IIP, through (a) ongoing studies for ARGX-213 and ARGX-121, with results expected in first half of 2026, (b) ARGX-109, with Phase 1 results expected in second half of 2025, and (c) a fourth pipeline candidate, a first-in-class sweeping antibody for which the target has not yet been disclosed; 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 but not limited to, 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; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; its reliance on 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 in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
06-07-2025
- Business
- Yahoo
Sanofi's (NASDAQ:SNY) Riliprubart Granted Orphan Frug Designation in Japan
Sanofi (NASDAQ:SNY) is one of the 11 Best 52-Week Low Stocks to Buy Right Now. On June 30, Sanofi (NASDAQ:SNY) announced that its Riliprubart has been granted orphan drug designation in Japan for chronic inflammatory demyelinating polyneuropathy. Riliprubart is a monoclonal antibody that specifically inhibits activated C1s in the classical complement pathway. The treatment is designed to block a very specific part of the immune system's response. Orphan drug designation is a special status granted by regulatory bodies for medicines that target rare diseases or conditions where there is a high unmet medical need. Dozens of pharmaceutical capsules piled on top of one another to show the scale of the company's drug contributions to the industry. This is a significant achievement for Sanofi (NASDAQ:SNY) because, despite existing treatments, around 30% of patients do not respond adequately, leaving a significant unmet medical need. Sanofi (NASDAQ:SNY) presented 76-week long-term data from a phase 2 clinical trial at the Peripheral Nerve Society meeting in Edinburgh. The results suggest sustained efficacy and safety of Riliprubart in a broad range of CIDP patients. Management noted that two phase 3 studies are underway to further evaluate the treatment. While we acknowledge the potential of SNY as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
30-06-2025
- Business
- Yahoo
BofA Remains Bullish on Argenx (ARGX) With a Buy Rating and $804 PT
Argenx SE (NASDAQ:ARGX) is one of the 11 Best Strong Buy Stocks to Invest in Now. On June 16, Bank of America Securities analyst Tazeen Ahmad maintained a bullish stance on Argenx SE (NASDAQ:ARGX), giving it a Buy rating with an $804 price target. The analyst based the optimistic rating on the promising growth prospects of the company's Vyvgart, especially in the treatment of CIDP and gMG. A lab setting filled with scientific equipment and researchers in lab coats working together to develop new therapies for autoimmune diseases. The expert neurologist consulted in the report stated that Vyvgart has a suitable efficacy and a favorable safety profile, which is either comparable to or superior to that of the present treatments, such as IVIg. This factor has resulted in a notable uptake, especially in patients who have not responded well to IVIg. The analyst expects Vyvgart to capture around half the market share in CIDP over time, contributing to the positive rating for Argenx SE (NASDAQ:ARGX). Ahmad further stated that Vyvgart's role in the treatment of gMG is expanding, as it is becoming the leading biologic choice because of its safety and efficacy. The expected approval of the pre-filled syringe (PFS) may further support Vyvgart's adoption, especially in large hospitals and rural areas with challenging infusion coordination. Argenx SE (NASDAQ:ARGX) is a global immunology company that develops treatments for severe autoimmune diseases. The company operates through four segments: the United States, Japan, EMEA, and China. While we acknowledge the potential of ARGX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
30-06-2025
- Health
- Yahoo
Press Release: Riliprubart granted orphan drug designation in Japan for chronic inflammatory demyelinating polyneuropathy
Riliprubart granted orphan drug designation in Japan for chronic inflammatory demyelinating polyneuropathy Two phase 3 studies are currently underway testing riliprubart in people with CIDP as a potential first-in-class treatment Japanese Ministry of Health, Labour and Welfare decision adds to similar designations in the US and Europe, underscoring global regulatory recognition of the potential for riliprupart to address significant unmet medical needs for people living with this rare neurological condition Paris, June 30, 2025. The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted orphan drug designation to riliprubart, a monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway for people with chronic inflammatory demyelinating polyneuropathy (CIDP). Despite available therapies, many CIDP patients are left with residual symptoms, including weakness, numbness, and fatigue that can lead to long-term morbidity and diminished quality of life. Approximately 30% of people with CIDP do not respond to standard therapies. The MHLW grants orphan drug designation to medicines that address rare medical diseases or conditions with unmet medical needs. There are currently approximately 4,000 people diagnosed with CIDP in Japan. Global Head of Neurology Development, Sanofi'The orphan drug designation of riliprubart for people living with CIDP in Japan underscores our commitment to applying our deep understanding of the immune system to address rare neurological disorders with significant unmet medical needs. While CIDP therapies exist, many individuals continue to experience debilitating symptoms, including pain, fatigue and weakness. Our ongoing development of riliprubart reflects our dedication to challenging the status quo in neurology with the goal of improving people's lives.' Long-term, 76-week sustained efficacy and safety data from riliprubart's phase 2 study were presented at the Peripheral Nerve Society meeting in Edinburgh, UK on May 17-20, 2025. Findings suggest a potential sustained long-term benefit provided by riliprubart across a broad spectrum of participants with CIDP. Riliprubart is currently being tested in two separate phase 3 studies: MOBILIZE in patients refractory to standard of care (clinical study identifier: NCT06290128) and VITALIZE in IVIg-treated patients (clinical study identifier: NCT06290141). About riliprubartSAR445088 (riliprubart) is an IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway of the innate immune system. By blocking C1s, riliprubart has the potential to inhibit key inflammatory mechanisms that drive demyelination and axonal damage in CIDP. Riliprubart is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. For more information on riliprubart clinical studies, please visit CIDPCIDP is a rare neurological condition that causes progressive weakness and sensory impairment in the arms and legs. CIDP occurs when the body's immune system attacks the myelin sheaths around nerve cells in the peripheral nervous system. Timely diagnosis of CIDP is important because it allows for appropriate treatment, which is essential to preventing long-term disability. However, despite available therapies, many individuals are left with residual symptoms, including weakness, numbness, and fatigue that can lead to long-term morbidity and diminished quality-of-life. Approximately 30% of people with CIDP do not respond to standard therapies. In people with CIDP who do respond, about 70% of the response is considered incomplete. Less than one-third of people with CIDP remain in remission without continued therapy. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | Berland | +1 215 432 0234 | Léo Le Bourhis | +33 6 75 06 43 81 | Victor Rouault | +33 6 70 93 71 40 | Timothy Gilbert | +1 516 521 2929 | Ubaldi | +33 6 30 19 66 46 | Investor RelationsThomas Kudsk Larsen |+44 7545 513 693 | Alizé Kaisserian | +33 6 47 04 12 11 | Lauscher | +1 908 612 7239 | Browne | +1 781 249 1766 | Nathalie Pham | +33 7 85 93 30 17 | Elgoutni | +1 617 710 3587 | Thibaud Châtelet | +33 6 80 80 89 90 | Li | +33 6 84 00 90 72 | Sanofi forward-looking statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans' and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. Attachment Press ReleaseError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
24-06-2025
- Business
- Yahoo
Argenx Secures EC Approval for Subcutaneous VYVGART in CIDP Treatment
Argenx (NASDAQ:ARGX) is one of the best biotech stocks to invest in now. On June 20, Argenx announced that the European Commission/EC approved VYVGART (efgartigimod alfa) 1000mg for subcutaneous/SC injection. The approval is for its use as a monotherapy in adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy/CIDP who have previously been treated with corticosteroids or immunoglobulins. VYVGART SC is available as a vial or prefilled syringe and offers a flexible administration option, which allows it to be given by a patient, caregiver, or healthcare professional. Treatment begins with a weekly dose regimen, which can be adjusted to every other week based on clinical evaluation. This marks the first approval of an IgG Fc-antibody fragment specifically targeting the neonatal Fc receptor (FcRn) for CIDP in Europe, and it represents the first novel mechanism of action for CIDP treatment in 30+ years. A lab setting filled with scientific equipment and researchers in lab coats working together to develop new therapies for autoimmune diseases. The EC's decision follows a positive recommendation from the Committee for Medicinal Products for Human Use/CHMP and is supported by the results of the ADHERE clinical trial, which is the largest study conducted to date on CIDP patients. CIDP is a rare, debilitating, and often progressive immune-mediated neuromuscular disorder affecting the peripheral nervous system. The EC approval covers all 27 European Union Member States, as well as Iceland, Liechtenstein, and Norway. Argenx (NASDAQ:ARGX) is a commercial-stage biopharma company that develops various therapies for the treatment of autoimmune diseases in the US, Japan, China, the Netherlands, and internationally. While we acknowledge the potential of ARGX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
