Advicenne（3MM）株式概要Advicenne S.A.は、希少な腎疾患の治療薬の開発、商業化、販売をフランス国内外で行っているスペシャリティファーマである。 詳細3MM ファンダメンタル分析スノーフレーク・スコア評価2/6将来の成長1/6過去の実績0/6財務の健全性0/6配当金0/6報酬収益は年間16.49%増加すると予測されています 過去5年間の収益は年間10.2%増加しました。 リスク分析キャッシュランウェイが1年未満である German市場と比較して、過去 3 か月間の株価の変動が非常に大きいマイナスの株主資本 現在は利益が出ておらず、今後3年間で利益が出る見込みはない +2 さらなるリスクすべてのリスクチェックを見る3MM Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair Value€Current Price€0.8214.3% 割安 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-15m14m2016201920222025202620282031Revenue €13.7mEarnings €2.0mAdvancedSet Fair ValueView all narrativesAdvicenne S.A. 競合他社BiofronteraSymbol: XTRA:B8FKMarket cap: €14.6mTFF PharmaceuticalsSymbol: MUN:0K30Market cap: €9.7mCantourage GroupSymbol: XTRA:HIGHMarket cap: €75.3mPEPTONIC medicalSymbol: DB:28LMarket cap: €560.2m価格と性能株価の高値、安値、推移の概要Advicenne過去の株価現在の株価€0.8252週高値€2.2052週安値€0.81ベータ0.981ヶ月の変化-33.09%3ヶ月変化-57.79%1年変化-53.50%3年間の変化-80.43%5年間の変化-90.58%IPOからの変化-92.75%最新ニュースお知らせ • May 23Advicenne S.A. Announces Board ChangesAdvicenne S.A. announced changes to its governance following its Annual General Meeting (AGM) held on May 21, 2026. The Annual General Meeting appointed Mr. André Ulmann, a director, and Mr. Adrian Hepner, an independent director, to three-year terms. At the board meeting held following the AGM, Mr. Didier Laurens was appointed Chairman of the Board. Ms. Charlotte Sibley was appointed Chair of the Remuneration Committee (Remco).Board Change • May 20Less than half of directors are independentNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. 1 independent director (5 non-independent directors). Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.お知らせ • Apr 16Advicenne S.A., Annual General Meeting, May 21, 2026Advicenne S.A., Annual General Meeting, May 21, 2026. Location: 2 rue de la chaussee d antin, paris Franceお知らせ • Jan 21+ 1 more updateAdvicenne S.A. to Report Fiscal Year 2025 Results on Mar 26, 2026Advicenne S.A. announced that they will report fiscal year 2025 results on Mar 26, 2026お知らせ • Jan 19Advicenne S.A. Accepts for Review the New Drug Application for Sibnayal, A Fixed Combination of Potassium Citrate and Potassium Bicarbonate for the Treatment of Distal Renal Tubular AcidosisAdvicenne announced that the FDA (Food and Drug Administration) has accepted for review the New Drug Application (NDA) for Sibnayal®? (ADV7103), a fixed combination of potassium citrate and potassium bicarbonate for the treatment of distal Renal Tubular Acidosis (dRTA). The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) for September 3rd, 2026. Following the submission of the New Drug Application (N DA) dossier on November 2, 2025, the U.S. FDA completed its standard 60-day filing review. During this period, Advicenne satisfactorily addressed several questions raised by the Agency. As agreed with the FDA, the 505(b)(2) application incorporates the European clinical studies that also underpin the recently renewed Marketing Authorization dossier in Europe.お知らせ • Jan 12Advicenne Successfully Renewed the Marketing Authorization of Sibnayal in European UnionAdvicenne obtains the renewal of its Marketing Authorization (MA) for Sibnayal® (fixed combination of potassium citrate and potassium bicarbonate) for the treatment of distal Renal Tubular Acidosis (dRTA) in the European Union. The European Medicines Agency (EMA) has renewed the marketing authorization for Sibnayal™ starting in January 2026. This renewal, which is mandatory five years after the initial issuance, definitively validates the marketing authorization. It marks a major milestone for the continued commercial development of Sibnayal®® in Europe. It is part of a busy regulatory program, with marketing authorization obtained in the Kingdom of Saudi Arabia in July 2025 and, more recently, the filing of a registration application with the US Food & Drug Administration.最新情報をもっと見るRecent updatesお知らせ • May 23Advicenne S.A. Announces Board ChangesAdvicenne S.A. announced changes to its governance following its Annual General Meeting (AGM) held on May 21, 2026. The Annual General Meeting appointed Mr. André Ulmann, a director, and Mr. Adrian Hepner, an independent director, to three-year terms. At the board meeting held following the AGM, Mr. Didier Laurens was appointed Chairman of the Board. Ms. Charlotte Sibley was appointed Chair of the Remuneration Committee (Remco).Board Change • May 20Less than half of directors are independentNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. 1 independent director (5 non-independent directors). Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.お知らせ • Apr 16Advicenne S.A., Annual General Meeting, May 21, 2026Advicenne S.A., Annual General Meeting, May 21, 2026. Location: 2 rue de la chaussee d antin, paris Franceお知らせ • Jan 21+ 1 more updateAdvicenne S.A. to Report Fiscal Year 2025 Results on Mar 26, 2026Advicenne S.A. announced that they will report fiscal year 2025 results on Mar 26, 2026お知らせ • Jan 19Advicenne S.A. Accepts for Review the New Drug Application for Sibnayal, A Fixed Combination of Potassium Citrate and Potassium Bicarbonate for the Treatment of Distal Renal Tubular AcidosisAdvicenne announced that the FDA (Food and Drug Administration) has accepted for review the New Drug Application (NDA) for Sibnayal®? (ADV7103), a fixed combination of potassium citrate and potassium bicarbonate for the treatment of distal Renal Tubular Acidosis (dRTA). The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) for September 3rd, 2026. Following the submission of the New Drug Application (N DA) dossier on November 2, 2025, the U.S. FDA completed its standard 60-day filing review. During this period, Advicenne satisfactorily addressed several questions raised by the Agency. As agreed with the FDA, the 505(b)(2) application incorporates the European clinical studies that also underpin the recently renewed Marketing Authorization dossier in Europe.お知らせ • Jan 12Advicenne Successfully Renewed the Marketing Authorization of Sibnayal in European UnionAdvicenne obtains the renewal of its Marketing Authorization (MA) for Sibnayal® (fixed combination of potassium citrate and potassium bicarbonate) for the treatment of distal Renal Tubular Acidosis (dRTA) in the European Union. The European Medicines Agency (EMA) has renewed the marketing authorization for Sibnayal™ starting in January 2026. This renewal, which is mandatory five years after the initial issuance, definitively validates the marketing authorization. It marks a major milestone for the continued commercial development of Sibnayal®® in Europe. It is part of a busy regulatory program, with marketing authorization obtained in the Kingdom of Saudi Arabia in July 2025 and, more recently, the filing of a registration application with the US Food & Drug Administration.Board Change • Dec 30Less than half of directors are independentNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. 1 independent director (5 non-independent directors). Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.お知らせ • Nov 05Advicenne Submitted to US FDA the Registration Application for Sibnayal® in dRTA TreatmentAdvicenne announced the submission of the registration application for Sibnayal® (fixed-dose combination of potassium citrate and potassium bicarbonate) for the treatment of distal Renal Tubular Acidosis (dRTA) to the US Food and Drug Administration (US FDA). Sibnayal®® has been designated orphan drug in dRTA in the USA. The evaluation of the dossier should take approximately 12 months. The company will communicate on the main stages of the evaluation process as well as on the expected date of the US authorities' decision, which should be known within a few weeks.お知らせ • Jul 29Advicenne Receives Marketing Authorization and Reimbursement for Sibnayal®? in Saudi ArabiaAdvicenne obtains marketing authorization (MA) and reimbursement status for Sibnayal®? (a fixed combination of potassium citrate and potassium bicarbonate) in the Kingdom of Saudi Arabia (KSA). Marketing authorization for Sibnayal™? (ADV7103) in distal Renal Tubular Acidosis (dRTA) in KSA has been granted, based on the European registration dossier. Furthermore, Saudi authorities have agreed a reimbursement rate in line with the best European pricing. This achievement results of a close collaboration between Advicenne and its local partner, Taiba Healthcare, a leading distributor of pharmaceutical products in the Gulf region. Advicenne will act as the marketing authorization holder, while Taiba Healthcare will manage local marketing activities. The incidence of dRTA is higher in Gulf countries than in Europe or the United States, and prevalence in KSA could be estimated around 600 to 800 patients. Sibnayal®®? is already prescribed through early access programs in several Gulf countries outside Saudi Arabia. This milestone paves the way for registrations in GCC countries where the application is filed.お知らせ • Apr 08Advicenne S.A., Annual General Meeting, May 15, 2025Advicenne S.A., Annual General Meeting, May 15, 2025. Location: 2 rue de la chaussee d antin, paris Franceお知らせ • Jan 29Advicenne Reaches A Significant Milestone with the Us FDA in the Development of Adv7103 in CystinuriaAdvicenne provided an update on recent exchanges with the U.S. FDA about the development of ADV7103 in cystinuria, and announces that it has reached an important milestone. As previously stated, the company has engaged in a new round of discussions with the US FDA to finalize the development plan for ADV7103 in cystinuria in the United States. During the latest meeting, Advicenne has presented a set of data, with the active presence of American opinion leaders, and the “International Cystinuria Foundation”, the main cystinuria patient group, specifically: The preliminary clinical results obtained in Europe in cystinuria patients, The European and American expert opinions on medical needs in this rare kidney disease, A proposed clinical development plan with a biological endpoint. Following this meeting, the FDA accepted Advicenne’s proposition of a biological primary endpoint for the evaluation of ADV7103 in cystinuria; a significant step in preparing for a clinical trial of limited duration and number of patients. Advicenne is now preparing the submission of the final draft of the pivotal trial in cystinuria to the FDA. The choice of the biological primary endpoint should enable the company to enroll patients both in the United States and Europe, and to consider filing simultaneously registration applications in both territories. ADV7103 has orphan drug status in the cystinuria indication in both Europe and the USA. Cystinuria affects around 30,000 patients in the US and 40,000 in Europe and represents a significant potential market for ADV7103.お知らせ • Nov 29Advicenne S.A. to Report First Half, 2025 Results on Sep 18, 2025Advicenne S.A. announced that they will report first half, 2025 results on Sep 18, 2025Board Change • Oct 03Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 5 non-independent directors. Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.お知らせ • Oct 01Advicenne Achieves Major Milestones in the US Due to Several Positive FDA Opinion on ADV7103Advicenne announced the achievement of major milestones in the development program of its ADV7103 drug in the U.S, and the search for commercial partners. ADV7103 in dRTA (Distal Renal Tubular Acidosis): European data deemed satisfactory by the FDA for filing without additional clinical studies in the US. After numerous exchanges with experts from the US Food & Drug Administration (FDA), the Agency has concluded that European clinical data can be used to support an application for registration in dTRA. As a result, Advicenne will not conduct a specific clinical study in the U.S., significantly reducing the time and cost required to file a marketing authorization application in the U.S. for this indication. The FDA's positive opinion was based on consideration of all the clinical data available from the European clinical program. Specifically, the pivotal phase III study (B21CS) and the long-term safety extension study (B22CS), which provide Advicenne with clinical data on efficacy and safety for patients followed over a period of more than 6 years. These studies, presented to the European Renal Association(ERA) and the European Society of Pediatric Nephrology (ESPN), are supplemented by data from real-life cohorts (Real World Evidence - RWE), and extensive European pharmacovigilance data. Following an initial phase of discussions, the FDA considered that the drug's safety data met its requirements in terms of long-term tolerability. This first phase opened the path to a discussion on the relevance of efficacy data from these same studies. This was the purpose of the second phase of exchanges with complementary analysis data from the studies. ADV7103 has orphan drug status in the dRTA indication in the US. The results of the above studies will be reported at an analysts' meeting to be scheduled shortly. ADV7103 in cystinuria: preparation for clinical development in consultation with the FDA. ADV7103 has been granted orphan drug designation (ODD) for the treatment of cystinuria in March 2024, adding to the existing orphan drug status for this indication in Europe. This validated Advicenne's regulatory and clinical strategy with the FDA. The ODD application was supported by preliminary clinical results in European patients with cystinuria and extensive data on the population size and expert opinion on the unmet need in this indication. Following this success, the Company wishes to discuss the proposed clinical development plan that will serve as the basis for a marketing authorization in this indication. A round of discussions will be launched before the end of the year. This clinical program proposed has strong support from experts in this condition from both Europe and the United States, as well as from the International Cystinuria Foundation, representing the patient population. There is broad agreement that alkalinization is a cornerstone of treatment and that there is no satisfactory alkalinizing treatment that provides well tolerated, 24-hour pH control, indicated by recent data from the European Cystinuria Registry showing only on fourth of cystinuria patients followed in Europe have a urinary pH above 7.5, the therapeutic target set by international recommendations. Pending the conclusion of discussions with the FDA and agreement on the clinical program, Advicenne plans to initiate a clinical trial in cystinuria. This study would recruit patients simultaneously in the United States and Europe and enable a registration application to be filed in both markets. In Europe, ADV7103 also has orphan drug status in this indication. The recent news flow is expected to generate further interest, which the Company intends to pursue actively, particularly from the end of 2024.Reported Earnings • Apr 10Full year 2023 earnings released: €0.67 loss per share (vs €1.16 loss in FY 2022)Full year 2023 results: €0.67 loss per share (improved from €1.16 loss in FY 2022). Revenue: €3.48m (up 18% from FY 2022). Net loss: €7.03m (loss narrowed 39% from FY 2022). Revenue is forecast to grow 25% p.a. on average during the next 2 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 28% per year but the company’s share price has fallen by 48% per year, which means it is significantly lagging earnings.New Risk • Mar 29New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (27% average weekly change). Negative equity (-€14m). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Shareholders have been diluted in the past year (24% increase in shares outstanding). Revenue is less than US$5m (€2.7m revenue, or US$3.0m). Market cap is less than US$100m (€25.6m market cap, or US$27.7m).Board Change • Mar 27Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 4 non-independent directors. Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.Board Change • Jan 24Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 4 non-independent directors. Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.お知らせ • Dec 29+ 2 more updatesAdvicenne S.A. to Report First Half, 2024 Results on Sep 18, 2024Advicenne S.A. announced that they will report first half, 2024 results on Sep 18, 2024お知らせ • Nov 30+ 2 more updatesAdvicenne S.A. to Report Fiscal Year 2022 Results on Mar 30, 2023Advicenne S.A. announced that they will report fiscal year 2022 results After-Market on Mar 30, 2023お知らせ • Jun 30Advicenne Announces Commercial Launch of Sibnayal in Great BritainAdvicenne S.A. announced that Sibnayal, combination of potassium citrate and potassium bicarbonate, has been made available to patients suffering from distal Renal Tubular Acidosis (dRTA) in Great Britain. Sibnayal has been approved in Great Britain since July 2021. Sibnayal has been added on the Department of Health list of drugs and is immediately available for doctors and patients in its indication. Advicenne has obtained, from the National Health Service (NHS) the selling price of Sibnayal® in Great-Britain and is now actively working to provide the National Institute for Health and Care Excellence (NICE) with additional information allowing positive opinion on the prescription’s guidance of Sibnayal. The next session with NICE is planned on August 4.お知らせ • Jun 10Advicenne S.A. Announces Executive ChangesAdvicenne S.A. announced that Mr. André Ulmann as a non-voting director, for a three-year term. The Board of Directors meeting held after this Meeting appointed as Chairman of the Board of Directors Mr. Philippe Boucheron, who will continue to serve as Chairman of the Remuneration Committee. The Board also noted the change in the permanent representative of Bpifrance Investissement, in the person of Mr. Thibaut Roulon who will also be member of the Audit Committee chaired by Mrs. Catherine Dunand. The Board of Directors of Advicenne is now composed of the following members: Philippe Boucheron, Director, Chairman of the Board; Mr. Didier Laurens, director, Chief Executive Officer; Cemag Invest, represented by Catherine Dunand, Director; Bpifrance Investissement, represented by Mr. Thibaut Roulon, Director; Irdi Soridec Gestion, represented by Mr. Jean-Michel Petit, director; Mrs. Charlotte Sibley, independent director; Mrs. Hege Hellstrom, independent director; Mr. André Ulmann, observer. The Combined General Meeting was an opportunity to present the progress of the Company's various programs and strategy.お知らせ • Apr 22Advicenne Appoints Philippe Boucheron as Chairman of Its Board of DirectorsAdvicenne announced the appointment of Philippe BOUCHERON as Chairman of the Board of Directors following the next Annual General Meeting to be held on June 9, 2022. This appointment follows David Horn SOLOMON’s decision not to seek the renewal of his term as director, entailing therefore the termination of his duties as Chairman of the Board of Directors from that same date.お知らせ • Mar 31Advicenne Announces the Release of Results of a Study Showing Improved Quality of Life in Patients Living With DRTa and Treated by ADV7103Advicenne announced the publication, in the peer-reviewed journal Orphanet Journal of Rare Disease, results of a study showing improvement in the long-term quality of life in patients with distal Renal Tubular Acidosis (dRTA) and treated with ADV7103. The patients' quality of life was assessed through interviews and conducted as part of the clinical development of ADV7103 after more than 5 years of treatment on average (62 +/- 6 months). The level of treatment satisfaction was 9 on a scale of 10 and the treatment met or exceeded expectations in 74% of patients (14 patients out of 17). These results confirm the interest of ADV7103 in the treatment of dRTA and the advantage of a bi-daily dosing compared to the usual management of this disease.お知らせ • Jan 25Advicenne Ordinary Shareholders' Meeting Approves Delisting from Regulated Market of Euronext BrusselsThe ordinary shareholders' meeting of Advicenne S.A. held on January 24, 2022, approved the proposed transfer of the listing of the Company's shares from the regulated market of Euronext Paris (Compartment C) to the multilateral trading facility of Euronext Growth Paris ('Euronext Growth Paris'), the proposed delisting of its shares from the regulated market of Euronext Brussels, and empowered the board of directors to carry out these transfer and concomitant delisting.Breakeven Date Change • Jan 14Forecast to breakeven in 2023The analyst covering Advicenne expects the company to break even for the first time. New forecast suggests losses will reduce by 61% per year to 2022. The company is expected to make a profit of €7.21m in 2023. Average annual earnings growth of 103% is required to achieve expected profit on schedule.お知らせ • Dec 20Advicenne Announces Positive Opinion from the French Transparency Commission (HAS) for Its Drug Sibnayal™ in dRTAAdvicenne announced is has received a positive opinion from the French Transparency Commission (HAS) with its lead asset, Sibnayal™ eligible for reimbursement with a Moderate Level SMR (Medical Rendered Service) and a Level IV ASMR (Medical Rendered Service Improvement), in the treatment of distal Renal Tubular Acidosis (dRTA) in adults, adolescents and children over the age of 1. This decision makes Sibnayal™ the only specialty pharmaceutical product reimbursed in the treatment of dRTA in France, which will significantly ease access to treatment of the disease for both patients and their doctors. The French Transparency Commission (HAS " Haute Autorité de Santé), in its opinion, acknowledges thecontribution of the twice-daily dosing formulation of Sibnayal™ which significantly improves the quality of life of patients as well as compliance to long-term treatment plans. These factors contribute to the continuous improvement of disease indicators, particularly bone mineral density, as shown by the clinical development of Sibnayal™ over a period of at least 4 years.Reported Earnings • Oct 01First half 2021 earnings released: €0.93 loss per share (vs €0.92 loss in 1H 2020)The company reported a poor first half result with increased losses, weaker revenues and weaker control over costs. First half 2021 results: Revenue: €1.36m (down 16% from 1H 2020). Net loss: €7.99m (loss widened 3.8% from 1H 2020).お知らせ • Jul 03Advicenne Receives Medicines and Healthcare products Regulatory Agency Approval to Market Sibnayal™ (ADV7103) in the UK for the Treatment of dRTAAdvicenne announced that the Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Sibnayal™ (ADV7103) in the UK, for the treatment of distal renal tubular acidosis (dRTA). With this authorization, and following the recent approval by the European Commission to market Sibnayal™ for the treatment of dRTA in the European Union, Advicenne is now able to bring to market in the EU and the UK the first and only label-approved drug for the treatment of dRTA in adults, adolescents and children aged one year and older. Advicenne now has the opportunity to make a significant difference to patients suffering from dRTA, classified as an orphan condition in Europe. Distal renal tubular acidosis (dRTA) is an orphan disease characterized by a failure in the renal excretion of acids generated through metabolism and for which there is no approved treatment. The excess of acids thus accumulated in the blood leads to an imbalance in pH (acidosis) as well as multiple other complications such as growth retardation and rickets (a disease affecting bone development) in children, and a series of metabolic disorders such as low potassium levels, elevated calcium in the urine resulting in kidney stones, the formation of calcium deposits in the kidneys (calcinosis) as well as possible kidney failure.お知らせ • Jun 24Advicenne S.A. announced that it has received €9.42128 million in fundingAdvicenne S.A. (ENXTPA:ADVIC) announced a private placement of 1,319,507 new ordinary shares at a price of €7.14 per share for gross proceeds of approximately €9,421,280 on June 23, 2021. The transaction included participation from certain investors.Executive Departure • May 12Chief Executive Officer Peter Meeus has left the companyOn the 3rd of May, Peter Meeus' tenure as Chief Executive Officer of the company ended after less than a year in the role. We don't have any record of a personal shareholding under Peter's name. Peter is the only executive to leave the company over the last 12 months. Under Peter's leadership, the company delivered a total shareholder return of -22%.お知らせ • May 04Advicenne Receives European Commission Approval to Market ADV7103 (Sibnayal™) and announces Leadership Changes to support CommercialisationAdvicenne announced that the European Commission (EC) has granted marketing authorisation to ADV7103 (Sibnayal™), for the treatment of distal renal tubular acidosis (dRTA). This approval makes ADV7103 the first and only label-approved drug for the treatment of dRTA in adults, adolescents and children aged one year and older. With the approval, Advicenne has the opportunity to make a significant difference to patients suffering from dRTA, classified as an orphan condition affecting no more than 1 to 2 individuals per 10,000 people in Europe. The EC marketing authorisation will be valid in all EU Member States, in the United Kingdom as well as in the European Economic Area (EEA) countries (Iceland, Liechtenstein and Norway). ADV7103 is developed as a multi-particulate formulation in 2mm granules, a novel pioneering delivery technology created by Advicenne that contains two active pharmaceutical ingredients. This approach not only has led to an excellent effectiveness in controlling metabolic acidosis, but also to ease the administration and aid compliance and quality of life in patients of all ages. About dRTA: Distal renal tubular acidosis (dRTA) is an orphan disease characterized by a failure in the renal excretion of acids generated through metabolism and for which there is no approved treatment. The excess of acids thus accumulated in the blood leads to an imbalance in pH (acidosis) as well as multiple other complications such as growth retardation and rickets (a disease affecting bone development) in children, and a series of metabolic disorders such as low potassium levels, elevated calcium in the urine resulting in kidney stones, the formation of calcium deposits in the kidneys (calcinosis) as well as possible kidney failure. Whether genetic or acquired as a consequence of an immune disease, dRTA affects an estimated 30,000 patients in Europe and approximately 20,000 in the United States. About the Phase III European program in dRTA (B21CS pivotal study & B22CS extension study): B21CS was a multicenter pivotal study that enrolled 37 patients suffering from dRTA, including adults, adolescents, children and infants and aimed to assess the efficacy of ADV7103 compared to Standard of Care (SoC) on blood and urine biomarkers of metabolic acidosis. Patients took the SoC treatment for five consecutive days followed by five days of two daily doses of ADV7103, an innovative prolonged-release granule combination of potassium citrate and potassium bicarbonate. Based on the blood and urine parameters, the study results demonstrated the effectiveness and suggested clinical benefit of ADV7103 in dRTA patients in comparison with the SoC. The B22CS extension study was an open-label clinical study that confirmed the efficacy and safety of ADV7103 after 24 months of treatment. ADV7103 has successfully met the primary and secondary endpoints of the study and demonstrated its ability to treat biological disorders caused by dRTA.お知らせ • Mar 21Advicenne Expects Imminent Marketing Authorization for ADV7103 (Sibnayal™) for dRTA in EuropeAdvicenne announced that it anticipates imminent European Marketing Authorization for its lead product, ADV7103 (Sibnayal™). Concurrently, and in order to prevent any delays to the potential patient availability of the product, the Company has decided to withdraw its application for the Orphan Drug Designation (ODD), as it was informed by EMA that additional data would be needed to grant /confirm ODD status. As such, Advicenne will be able to make ADV7103 available to patients suffering from dRTA in Europe in the shortest possible timeframe. In Europe, dRTA is classified as an orphan condition affecting less than 2.1 per 10,000 people. The approval will make ADV7103 the first and only label-approved drug for the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older. Given the debilitating consequences of the condition, the Company is convinced that with ADV7103 it has the opportunity to make a significant difference to patients sufferering from dRTA. ADV7103 is developed as a multi-particulate formulation in 2mm granules, a novel pioneering delivery technology created by Advicenne that contains two active pharmaceutical ingredients. This approach not only has led to an excellent effectiveness in controlling metabolic acidosis, but also to ease the administration and aid compliance and quality of life in patients of all ages.お知らせ • Feb 19+ 1 more updateAdvicenne S.A. Provides an Update as its Operations EvolveAdvicenne provides an update on the overall progress of the Company. In Europe, with the recent positive CHMP Opinion for its lead medicine ADV7103-Sibnayal™, Advicenne should receive the EMA Marketing Authorization (MAA) for Sibnayal™ soon. The company is currently pursuing discussions with several partners for its commercialization in most countries of the European Community. Meanwhile the clinical program in cystinuria in the EU is progressing. In spite of the hurdles encountered due to the ongoing COVID-19 crisis, the submission for Marketing Authorization is expected by late 2022. Advicenne has been able to maintain a satisfactory level of activity, and the team has been doing a great job in all the aspects of the Sibnayal pre-launch, from market access to manufacturing and securement of the supply chain. In the US, Advicenne Inc, Advicenne’s US affiliate, has made significant progress in building a team of highly qualified professionals. The pivotal Phase III ARENA trial of ADV7103 for distal Renal Tubular Acidosis (dRTA) is resuming. The submission for Marketing Authorization is expected in late 2022. Meanwhile the launch of Ozalin™ by Primex under an exclusive license is progressing. Advicenne is confident in the continuous positive execution of the €40 million licensing deal signed in 2016. Focus and streamlining, as well as effective cost management are practices put in place by the Company during these difficult times. The Company was able to secure €4.3 million of non-dilutive financing through a PGE (French state guaranteed loan) at the end of 2020. Thanks to the positive evolution of the company a number of financing options are now open to secure the development of the Company in the mid term.Is New 90 Day High Low • Feb 06New 90-day high: €12.10The company is up 90% from its price of €6.36 on 06 November 2020. The German market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 14% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €74.48 per share.Is New 90 Day High Low • Jan 20New 90-day high: €11.70The company is up 96% from its price of €5.96 on 21 October 2020. The German market is up 11% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 22% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €71.72 per share.お知らせ • Jan 08+ 1 more updateAdvicenne Appoints Peter Meeus as Chief Executive Officer, Effective February 15, 2021Advicenne announced the appointment of Peter Meeus as Chief Executive Officer of Advicenne, effective February 15, 2021 . Peter Meeus brings over 25 years of experience in the life sciences industry to Advicenne. Prior to joining Advicenne, Peter Meeus served as Senior Vice-President and Head of Product & Portfolio Strategy at Biocon Biologics, based in Singapore. Earlier, he was Head of Region Europe at Shire, before its acquisition by Takeda, and had a long career at Novartis and Novo Nordisk A/S, culminating in his role as Vice-President and Head of their UK and Irish Business.お知らせ • Dec 11Advicenne Receives Positive CHMP Opinion Recommending Approval of ADV7103 (sibnayal) for the Treatment of Distal Renal Tubular Acidosis (dRTA)Advicenne announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of its lead product ADV7103 (Sibnayal) as therapy for distal renal tubular acidosis (dRTA). The European Commission (EC) will now review the CHMP recommendation and a final decision on the Marketing Authorisation of ADV7103 in the European Union is expected in the coming weeks/months. This CHMP positive opinion is based on results of a pivotal Phase III trial (B21CS) and its twenty-four-month extension study (B22CS) conducted in adult and pediatric patients with dRTA demonstrating the clinically relevant therapeutic effect of ADV7103. While the standard of care (SoC) medicine requires three to six daily intakes including during night, ADV7103 treatment consists of only two doses per day and provides complete night-time coverage for patients. In addition, gastrointestinal tolerability was improved. Plasma potassium and urinary calcium was normalized. In order to make ADV7103 quickly and broadly available in all EU countries, Advicenne has decided to set up partnerships with specialized distributors. This approach will allow Advicenne to allocate its resources on the clinical development of ADV7103 in the United States and to develop its second indication for the medicine in cystinuria.Is New 90 Day High Low • Dec 04New 90-day high: €8.46The company is up 18% from its price of €7.18 on 04 September 2020. The German market is up 4.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €60.80 per share.Is New 90 Day High Low • Nov 19New 90-day high: €7.58The company is up 5.0% from its price of €7.24 on 20 August 2020. The German market is up 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €56.73 per share.Is New 90 Day High Low • Oct 19New 90-day low: €5.96The company is down 18% from its price of €7.26 on 21 July 2020. The German market is flat over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €34.43 per share.Is New 90 Day High Low • Sep 30New 90-day low: €6.46The company is down 12% from its price of €7.32 on 02 July 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €35.89 per share.Reported Earnings • Sep 29First half earnings releasedOver the last 12 months the company has reported total losses of €14.6m, with losses widening by 81% from the prior year. Total revenue was €2.55m over the last 12 months, down 64% from the prior year.株主還元3MMDE PharmaceuticalsDE 市場7D-1.2%6.4%3.9%1Y-53.5%26.5%2.6%株主還元を見る業界別リターン: 3MM過去 1 年間で26.5 % の収益を上げたGerman Pharmaceuticals業界を下回りました。リターン対市場: 3MMは、過去 1 年間で2.6 % のリターンを上げたGerman市場を下回りました。価格変動Is 3MM's price volatile compared to industry and market?3MM volatility3MM Average Weekly Movement15.0%Pharmaceuticals Industry Average Movement6.4%Market Average Movement6.1%10% most volatile stocks in DE Market12.9%10% least volatile stocks in DE Market2.7%安定した株価: 3MMの株価は、 German市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 3MMの weekly volatility ( 15% ) は過去 1 年間安定していますが、依然としてGermanの株式の 75% よりも高くなっています。会社概要設立従業員CEO（最高経営責任者ウェブサイト200711Didier Laurenswww.advicenne.comスペシャリティファーマであるAdvicenne S.A.は、希少腎疾患治療薬の開発、商業化、販売をフランス国内外で行っている。同社は、代謝性疾患、遠位尿細管性アシドーシス、シスチン尿症の治療薬Sibnayalを提供しています。また、重度、身体障害、または症状を引き起こす不安や許容できない苦痛の短期症状治療薬であるクロバザム製剤Likozamや、てんかん発作治療薬であるレベチラセタムのガレヌス型製剤Levidcenも販売している。アドビセンヌ社は2007年に設立され、フランスのパリに本社を置いている。もっと見るAdvicenne S.A. 基礎のまとめAdvicenne の収益と売上を時価総額と比較するとどうか。3MM 基礎統計学時価総額€12.50m収益（TTM）-€9.53m売上高(TTM)€6.40m2.0xP/Sレシオ-1.3xPER（株価収益率3MM は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計3MM 損益計算書（TTM）収益€6.40m売上原価€6.93m売上総利益-€524.00kその他の費用€9.01m収益-€9.53m直近の収益報告Dec 31, 2025次回決算日Sep 17, 2026一株当たり利益（EPS）-0.66グロス・マージン-8.18%純利益率-148.84%有利子負債／自己資本比率-72.1%3MM の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/25 20:11終値2026/05/25 00:00収益2025/12/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Advicenne S.A. 1 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。3 アナリスト機関Stephanie LefebvreGilbert DupontJean-Pierre LozaIn Extenso Financement & MarchéJean-Pierre TabartTPICAP Midcap
お知らせ • May 23Advicenne S.A. Announces Board ChangesAdvicenne S.A. announced changes to its governance following its Annual General Meeting (AGM) held on May 21, 2026. The Annual General Meeting appointed Mr. André Ulmann, a director, and Mr. Adrian Hepner, an independent director, to three-year terms. At the board meeting held following the AGM, Mr. Didier Laurens was appointed Chairman of the Board. Ms. Charlotte Sibley was appointed Chair of the Remuneration Committee (Remco).
Board Change • May 20Less than half of directors are independentNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. 1 independent director (5 non-independent directors). Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.
お知らせ • Apr 16Advicenne S.A., Annual General Meeting, May 21, 2026Advicenne S.A., Annual General Meeting, May 21, 2026. Location: 2 rue de la chaussee d antin, paris France
お知らせ • Jan 21+ 1 more updateAdvicenne S.A. to Report Fiscal Year 2025 Results on Mar 26, 2026Advicenne S.A. announced that they will report fiscal year 2025 results on Mar 26, 2026
お知らせ • Jan 19Advicenne S.A. Accepts for Review the New Drug Application for Sibnayal, A Fixed Combination of Potassium Citrate and Potassium Bicarbonate for the Treatment of Distal Renal Tubular AcidosisAdvicenne announced that the FDA (Food and Drug Administration) has accepted for review the New Drug Application (NDA) for Sibnayal®? (ADV7103), a fixed combination of potassium citrate and potassium bicarbonate for the treatment of distal Renal Tubular Acidosis (dRTA). The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) for September 3rd, 2026. Following the submission of the New Drug Application (N DA) dossier on November 2, 2025, the U.S. FDA completed its standard 60-day filing review. During this period, Advicenne satisfactorily addressed several questions raised by the Agency. As agreed with the FDA, the 505(b)(2) application incorporates the European clinical studies that also underpin the recently renewed Marketing Authorization dossier in Europe.
お知らせ • Jan 12Advicenne Successfully Renewed the Marketing Authorization of Sibnayal in European UnionAdvicenne obtains the renewal of its Marketing Authorization (MA) for Sibnayal® (fixed combination of potassium citrate and potassium bicarbonate) for the treatment of distal Renal Tubular Acidosis (dRTA) in the European Union. The European Medicines Agency (EMA) has renewed the marketing authorization for Sibnayal™ starting in January 2026. This renewal, which is mandatory five years after the initial issuance, definitively validates the marketing authorization. It marks a major milestone for the continued commercial development of Sibnayal®® in Europe. It is part of a busy regulatory program, with marketing authorization obtained in the Kingdom of Saudi Arabia in July 2025 and, more recently, the filing of a registration application with the US Food & Drug Administration.
お知らせ • May 23Advicenne S.A. Announces Board ChangesAdvicenne S.A. announced changes to its governance following its Annual General Meeting (AGM) held on May 21, 2026. The Annual General Meeting appointed Mr. André Ulmann, a director, and Mr. Adrian Hepner, an independent director, to three-year terms. At the board meeting held following the AGM, Mr. Didier Laurens was appointed Chairman of the Board. Ms. Charlotte Sibley was appointed Chair of the Remuneration Committee (Remco).
Board Change • May 20Less than half of directors are independentNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. 1 independent director (5 non-independent directors). Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.
お知らせ • Apr 16Advicenne S.A., Annual General Meeting, May 21, 2026Advicenne S.A., Annual General Meeting, May 21, 2026. Location: 2 rue de la chaussee d antin, paris France
お知らせ • Jan 21+ 1 more updateAdvicenne S.A. to Report Fiscal Year 2025 Results on Mar 26, 2026Advicenne S.A. announced that they will report fiscal year 2025 results on Mar 26, 2026
お知らせ • Jan 19Advicenne S.A. Accepts for Review the New Drug Application for Sibnayal, A Fixed Combination of Potassium Citrate and Potassium Bicarbonate for the Treatment of Distal Renal Tubular AcidosisAdvicenne announced that the FDA (Food and Drug Administration) has accepted for review the New Drug Application (NDA) for Sibnayal®? (ADV7103), a fixed combination of potassium citrate and potassium bicarbonate for the treatment of distal Renal Tubular Acidosis (dRTA). The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) for September 3rd, 2026. Following the submission of the New Drug Application (N DA) dossier on November 2, 2025, the U.S. FDA completed its standard 60-day filing review. During this period, Advicenne satisfactorily addressed several questions raised by the Agency. As agreed with the FDA, the 505(b)(2) application incorporates the European clinical studies that also underpin the recently renewed Marketing Authorization dossier in Europe.
お知らせ • Jan 12Advicenne Successfully Renewed the Marketing Authorization of Sibnayal in European UnionAdvicenne obtains the renewal of its Marketing Authorization (MA) for Sibnayal® (fixed combination of potassium citrate and potassium bicarbonate) for the treatment of distal Renal Tubular Acidosis (dRTA) in the European Union. The European Medicines Agency (EMA) has renewed the marketing authorization for Sibnayal™ starting in January 2026. This renewal, which is mandatory five years after the initial issuance, definitively validates the marketing authorization. It marks a major milestone for the continued commercial development of Sibnayal®® in Europe. It is part of a busy regulatory program, with marketing authorization obtained in the Kingdom of Saudi Arabia in July 2025 and, more recently, the filing of a registration application with the US Food & Drug Administration.
Board Change • Dec 30Less than half of directors are independentNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. 1 independent director (5 non-independent directors). Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.
お知らせ • Nov 05Advicenne Submitted to US FDA the Registration Application for Sibnayal® in dRTA TreatmentAdvicenne announced the submission of the registration application for Sibnayal® (fixed-dose combination of potassium citrate and potassium bicarbonate) for the treatment of distal Renal Tubular Acidosis (dRTA) to the US Food and Drug Administration (US FDA). Sibnayal®® has been designated orphan drug in dRTA in the USA. The evaluation of the dossier should take approximately 12 months. The company will communicate on the main stages of the evaluation process as well as on the expected date of the US authorities' decision, which should be known within a few weeks.
お知らせ • Jul 29Advicenne Receives Marketing Authorization and Reimbursement for Sibnayal®? in Saudi ArabiaAdvicenne obtains marketing authorization (MA) and reimbursement status for Sibnayal®? (a fixed combination of potassium citrate and potassium bicarbonate) in the Kingdom of Saudi Arabia (KSA). Marketing authorization for Sibnayal™? (ADV7103) in distal Renal Tubular Acidosis (dRTA) in KSA has been granted, based on the European registration dossier. Furthermore, Saudi authorities have agreed a reimbursement rate in line with the best European pricing. This achievement results of a close collaboration between Advicenne and its local partner, Taiba Healthcare, a leading distributor of pharmaceutical products in the Gulf region. Advicenne will act as the marketing authorization holder, while Taiba Healthcare will manage local marketing activities. The incidence of dRTA is higher in Gulf countries than in Europe or the United States, and prevalence in KSA could be estimated around 600 to 800 patients. Sibnayal®®? is already prescribed through early access programs in several Gulf countries outside Saudi Arabia. This milestone paves the way for registrations in GCC countries where the application is filed.
お知らせ • Apr 08Advicenne S.A., Annual General Meeting, May 15, 2025Advicenne S.A., Annual General Meeting, May 15, 2025. Location: 2 rue de la chaussee d antin, paris France
お知らせ • Jan 29Advicenne Reaches A Significant Milestone with the Us FDA in the Development of Adv7103 in CystinuriaAdvicenne provided an update on recent exchanges with the U.S. FDA about the development of ADV7103 in cystinuria, and announces that it has reached an important milestone. As previously stated, the company has engaged in a new round of discussions with the US FDA to finalize the development plan for ADV7103 in cystinuria in the United States. During the latest meeting, Advicenne has presented a set of data, with the active presence of American opinion leaders, and the “International Cystinuria Foundation”, the main cystinuria patient group, specifically: The preliminary clinical results obtained in Europe in cystinuria patients, The European and American expert opinions on medical needs in this rare kidney disease, A proposed clinical development plan with a biological endpoint. Following this meeting, the FDA accepted Advicenne’s proposition of a biological primary endpoint for the evaluation of ADV7103 in cystinuria; a significant step in preparing for a clinical trial of limited duration and number of patients. Advicenne is now preparing the submission of the final draft of the pivotal trial in cystinuria to the FDA. The choice of the biological primary endpoint should enable the company to enroll patients both in the United States and Europe, and to consider filing simultaneously registration applications in both territories. ADV7103 has orphan drug status in the cystinuria indication in both Europe and the USA. Cystinuria affects around 30,000 patients in the US and 40,000 in Europe and represents a significant potential market for ADV7103.
お知らせ • Nov 29Advicenne S.A. to Report First Half, 2025 Results on Sep 18, 2025Advicenne S.A. announced that they will report first half, 2025 results on Sep 18, 2025
Board Change • Oct 03Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 5 non-independent directors. Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
お知らせ • Oct 01Advicenne Achieves Major Milestones in the US Due to Several Positive FDA Opinion on ADV7103Advicenne announced the achievement of major milestones in the development program of its ADV7103 drug in the U.S, and the search for commercial partners. ADV7103 in dRTA (Distal Renal Tubular Acidosis): European data deemed satisfactory by the FDA for filing without additional clinical studies in the US. After numerous exchanges with experts from the US Food & Drug Administration (FDA), the Agency has concluded that European clinical data can be used to support an application for registration in dTRA. As a result, Advicenne will not conduct a specific clinical study in the U.S., significantly reducing the time and cost required to file a marketing authorization application in the U.S. for this indication. The FDA's positive opinion was based on consideration of all the clinical data available from the European clinical program. Specifically, the pivotal phase III study (B21CS) and the long-term safety extension study (B22CS), which provide Advicenne with clinical data on efficacy and safety for patients followed over a period of more than 6 years. These studies, presented to the European Renal Association(ERA) and the European Society of Pediatric Nephrology (ESPN), are supplemented by data from real-life cohorts (Real World Evidence - RWE), and extensive European pharmacovigilance data. Following an initial phase of discussions, the FDA considered that the drug's safety data met its requirements in terms of long-term tolerability. This first phase opened the path to a discussion on the relevance of efficacy data from these same studies. This was the purpose of the second phase of exchanges with complementary analysis data from the studies. ADV7103 has orphan drug status in the dRTA indication in the US. The results of the above studies will be reported at an analysts' meeting to be scheduled shortly. ADV7103 in cystinuria: preparation for clinical development in consultation with the FDA. ADV7103 has been granted orphan drug designation (ODD) for the treatment of cystinuria in March 2024, adding to the existing orphan drug status for this indication in Europe. This validated Advicenne's regulatory and clinical strategy with the FDA. The ODD application was supported by preliminary clinical results in European patients with cystinuria and extensive data on the population size and expert opinion on the unmet need in this indication. Following this success, the Company wishes to discuss the proposed clinical development plan that will serve as the basis for a marketing authorization in this indication. A round of discussions will be launched before the end of the year. This clinical program proposed has strong support from experts in this condition from both Europe and the United States, as well as from the International Cystinuria Foundation, representing the patient population. There is broad agreement that alkalinization is a cornerstone of treatment and that there is no satisfactory alkalinizing treatment that provides well tolerated, 24-hour pH control, indicated by recent data from the European Cystinuria Registry showing only on fourth of cystinuria patients followed in Europe have a urinary pH above 7.5, the therapeutic target set by international recommendations. Pending the conclusion of discussions with the FDA and agreement on the clinical program, Advicenne plans to initiate a clinical trial in cystinuria. This study would recruit patients simultaneously in the United States and Europe and enable a registration application to be filed in both markets. In Europe, ADV7103 also has orphan drug status in this indication. The recent news flow is expected to generate further interest, which the Company intends to pursue actively, particularly from the end of 2024.
Reported Earnings • Apr 10Full year 2023 earnings released: €0.67 loss per share (vs €1.16 loss in FY 2022)Full year 2023 results: €0.67 loss per share (improved from €1.16 loss in FY 2022). Revenue: €3.48m (up 18% from FY 2022). Net loss: €7.03m (loss narrowed 39% from FY 2022). Revenue is forecast to grow 25% p.a. on average during the next 2 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 28% per year but the company’s share price has fallen by 48% per year, which means it is significantly lagging earnings.
New Risk • Mar 29New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (27% average weekly change). Negative equity (-€14m). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Shareholders have been diluted in the past year (24% increase in shares outstanding). Revenue is less than US$5m (€2.7m revenue, or US$3.0m). Market cap is less than US$100m (€25.6m market cap, or US$27.7m).
Board Change • Mar 27Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 4 non-independent directors. Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
Board Change • Jan 24Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 4 non-independent directors. Independent Director Charlotte Sibley was the last independent director to join the board, commencing their role in 2018. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
お知らせ • Dec 29+ 2 more updatesAdvicenne S.A. to Report First Half, 2024 Results on Sep 18, 2024Advicenne S.A. announced that they will report first half, 2024 results on Sep 18, 2024
お知らせ • Nov 30+ 2 more updatesAdvicenne S.A. to Report Fiscal Year 2022 Results on Mar 30, 2023Advicenne S.A. announced that they will report fiscal year 2022 results After-Market on Mar 30, 2023
お知らせ • Jun 30Advicenne Announces Commercial Launch of Sibnayal in Great BritainAdvicenne S.A. announced that Sibnayal, combination of potassium citrate and potassium bicarbonate, has been made available to patients suffering from distal Renal Tubular Acidosis (dRTA) in Great Britain. Sibnayal has been approved in Great Britain since July 2021. Sibnayal has been added on the Department of Health list of drugs and is immediately available for doctors and patients in its indication. Advicenne has obtained, from the National Health Service (NHS) the selling price of Sibnayal® in Great-Britain and is now actively working to provide the National Institute for Health and Care Excellence (NICE) with additional information allowing positive opinion on the prescription’s guidance of Sibnayal. The next session with NICE is planned on August 4.
お知らせ • Jun 10Advicenne S.A. Announces Executive ChangesAdvicenne S.A. announced that Mr. André Ulmann as a non-voting director, for a three-year term. The Board of Directors meeting held after this Meeting appointed as Chairman of the Board of Directors Mr. Philippe Boucheron, who will continue to serve as Chairman of the Remuneration Committee. The Board also noted the change in the permanent representative of Bpifrance Investissement, in the person of Mr. Thibaut Roulon who will also be member of the Audit Committee chaired by Mrs. Catherine Dunand. The Board of Directors of Advicenne is now composed of the following members: Philippe Boucheron, Director, Chairman of the Board; Mr. Didier Laurens, director, Chief Executive Officer; Cemag Invest, represented by Catherine Dunand, Director; Bpifrance Investissement, represented by Mr. Thibaut Roulon, Director; Irdi Soridec Gestion, represented by Mr. Jean-Michel Petit, director; Mrs. Charlotte Sibley, independent director; Mrs. Hege Hellstrom, independent director; Mr. André Ulmann, observer. The Combined General Meeting was an opportunity to present the progress of the Company's various programs and strategy.
お知らせ • Apr 22Advicenne Appoints Philippe Boucheron as Chairman of Its Board of DirectorsAdvicenne announced the appointment of Philippe BOUCHERON as Chairman of the Board of Directors following the next Annual General Meeting to be held on June 9, 2022. This appointment follows David Horn SOLOMON’s decision not to seek the renewal of his term as director, entailing therefore the termination of his duties as Chairman of the Board of Directors from that same date.
お知らせ • Mar 31Advicenne Announces the Release of Results of a Study Showing Improved Quality of Life in Patients Living With DRTa and Treated by ADV7103Advicenne announced the publication, in the peer-reviewed journal Orphanet Journal of Rare Disease, results of a study showing improvement in the long-term quality of life in patients with distal Renal Tubular Acidosis (dRTA) and treated with ADV7103. The patients' quality of life was assessed through interviews and conducted as part of the clinical development of ADV7103 after more than 5 years of treatment on average (62 +/- 6 months). The level of treatment satisfaction was 9 on a scale of 10 and the treatment met or exceeded expectations in 74% of patients (14 patients out of 17). These results confirm the interest of ADV7103 in the treatment of dRTA and the advantage of a bi-daily dosing compared to the usual management of this disease.
お知らせ • Jan 25Advicenne Ordinary Shareholders' Meeting Approves Delisting from Regulated Market of Euronext BrusselsThe ordinary shareholders' meeting of Advicenne S.A. held on January 24, 2022, approved the proposed transfer of the listing of the Company's shares from the regulated market of Euronext Paris (Compartment C) to the multilateral trading facility of Euronext Growth Paris ('Euronext Growth Paris'), the proposed delisting of its shares from the regulated market of Euronext Brussels, and empowered the board of directors to carry out these transfer and concomitant delisting.
Breakeven Date Change • Jan 14Forecast to breakeven in 2023The analyst covering Advicenne expects the company to break even for the first time. New forecast suggests losses will reduce by 61% per year to 2022. The company is expected to make a profit of €7.21m in 2023. Average annual earnings growth of 103% is required to achieve expected profit on schedule.
お知らせ • Dec 20Advicenne Announces Positive Opinion from the French Transparency Commission (HAS) for Its Drug Sibnayal™ in dRTAAdvicenne announced is has received a positive opinion from the French Transparency Commission (HAS) with its lead asset, Sibnayal™ eligible for reimbursement with a Moderate Level SMR (Medical Rendered Service) and a Level IV ASMR (Medical Rendered Service Improvement), in the treatment of distal Renal Tubular Acidosis (dRTA) in adults, adolescents and children over the age of 1. This decision makes Sibnayal™ the only specialty pharmaceutical product reimbursed in the treatment of dRTA in France, which will significantly ease access to treatment of the disease for both patients and their doctors. The French Transparency Commission (HAS " Haute Autorité de Santé), in its opinion, acknowledges thecontribution of the twice-daily dosing formulation of Sibnayal™ which significantly improves the quality of life of patients as well as compliance to long-term treatment plans. These factors contribute to the continuous improvement of disease indicators, particularly bone mineral density, as shown by the clinical development of Sibnayal™ over a period of at least 4 years.
Reported Earnings • Oct 01First half 2021 earnings released: €0.93 loss per share (vs €0.92 loss in 1H 2020)The company reported a poor first half result with increased losses, weaker revenues and weaker control over costs. First half 2021 results: Revenue: €1.36m (down 16% from 1H 2020). Net loss: €7.99m (loss widened 3.8% from 1H 2020).
お知らせ • Jul 03Advicenne Receives Medicines and Healthcare products Regulatory Agency Approval to Market Sibnayal™ (ADV7103) in the UK for the Treatment of dRTAAdvicenne announced that the Medicines & Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Sibnayal™ (ADV7103) in the UK, for the treatment of distal renal tubular acidosis (dRTA). With this authorization, and following the recent approval by the European Commission to market Sibnayal™ for the treatment of dRTA in the European Union, Advicenne is now able to bring to market in the EU and the UK the first and only label-approved drug for the treatment of dRTA in adults, adolescents and children aged one year and older. Advicenne now has the opportunity to make a significant difference to patients suffering from dRTA, classified as an orphan condition in Europe. Distal renal tubular acidosis (dRTA) is an orphan disease characterized by a failure in the renal excretion of acids generated through metabolism and for which there is no approved treatment. The excess of acids thus accumulated in the blood leads to an imbalance in pH (acidosis) as well as multiple other complications such as growth retardation and rickets (a disease affecting bone development) in children, and a series of metabolic disorders such as low potassium levels, elevated calcium in the urine resulting in kidney stones, the formation of calcium deposits in the kidneys (calcinosis) as well as possible kidney failure.
お知らせ • Jun 24Advicenne S.A. announced that it has received €9.42128 million in fundingAdvicenne S.A. (ENXTPA:ADVIC) announced a private placement of 1,319,507 new ordinary shares at a price of €7.14 per share for gross proceeds of approximately €9,421,280 on June 23, 2021. The transaction included participation from certain investors.
Executive Departure • May 12Chief Executive Officer Peter Meeus has left the companyOn the 3rd of May, Peter Meeus' tenure as Chief Executive Officer of the company ended after less than a year in the role. We don't have any record of a personal shareholding under Peter's name. Peter is the only executive to leave the company over the last 12 months. Under Peter's leadership, the company delivered a total shareholder return of -22%.
お知らせ • May 04Advicenne Receives European Commission Approval to Market ADV7103 (Sibnayal™) and announces Leadership Changes to support CommercialisationAdvicenne announced that the European Commission (EC) has granted marketing authorisation to ADV7103 (Sibnayal™), for the treatment of distal renal tubular acidosis (dRTA). This approval makes ADV7103 the first and only label-approved drug for the treatment of dRTA in adults, adolescents and children aged one year and older. With the approval, Advicenne has the opportunity to make a significant difference to patients suffering from dRTA, classified as an orphan condition affecting no more than 1 to 2 individuals per 10,000 people in Europe. The EC marketing authorisation will be valid in all EU Member States, in the United Kingdom as well as in the European Economic Area (EEA) countries (Iceland, Liechtenstein and Norway). ADV7103 is developed as a multi-particulate formulation in 2mm granules, a novel pioneering delivery technology created by Advicenne that contains two active pharmaceutical ingredients. This approach not only has led to an excellent effectiveness in controlling metabolic acidosis, but also to ease the administration and aid compliance and quality of life in patients of all ages. About dRTA: Distal renal tubular acidosis (dRTA) is an orphan disease characterized by a failure in the renal excretion of acids generated through metabolism and for which there is no approved treatment. The excess of acids thus accumulated in the blood leads to an imbalance in pH (acidosis) as well as multiple other complications such as growth retardation and rickets (a disease affecting bone development) in children, and a series of metabolic disorders such as low potassium levels, elevated calcium in the urine resulting in kidney stones, the formation of calcium deposits in the kidneys (calcinosis) as well as possible kidney failure. Whether genetic or acquired as a consequence of an immune disease, dRTA affects an estimated 30,000 patients in Europe and approximately 20,000 in the United States. About the Phase III European program in dRTA (B21CS pivotal study & B22CS extension study): B21CS was a multicenter pivotal study that enrolled 37 patients suffering from dRTA, including adults, adolescents, children and infants and aimed to assess the efficacy of ADV7103 compared to Standard of Care (SoC) on blood and urine biomarkers of metabolic acidosis. Patients took the SoC treatment for five consecutive days followed by five days of two daily doses of ADV7103, an innovative prolonged-release granule combination of potassium citrate and potassium bicarbonate. Based on the blood and urine parameters, the study results demonstrated the effectiveness and suggested clinical benefit of ADV7103 in dRTA patients in comparison with the SoC. The B22CS extension study was an open-label clinical study that confirmed the efficacy and safety of ADV7103 after 24 months of treatment. ADV7103 has successfully met the primary and secondary endpoints of the study and demonstrated its ability to treat biological disorders caused by dRTA.
お知らせ • Mar 21Advicenne Expects Imminent Marketing Authorization for ADV7103 (Sibnayal™) for dRTA in EuropeAdvicenne announced that it anticipates imminent European Marketing Authorization for its lead product, ADV7103 (Sibnayal™). Concurrently, and in order to prevent any delays to the potential patient availability of the product, the Company has decided to withdraw its application for the Orphan Drug Designation (ODD), as it was informed by EMA that additional data would be needed to grant /confirm ODD status. As such, Advicenne will be able to make ADV7103 available to patients suffering from dRTA in Europe in the shortest possible timeframe. In Europe, dRTA is classified as an orphan condition affecting less than 2.1 per 10,000 people. The approval will make ADV7103 the first and only label-approved drug for the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older. Given the debilitating consequences of the condition, the Company is convinced that with ADV7103 it has the opportunity to make a significant difference to patients sufferering from dRTA. ADV7103 is developed as a multi-particulate formulation in 2mm granules, a novel pioneering delivery technology created by Advicenne that contains two active pharmaceutical ingredients. This approach not only has led to an excellent effectiveness in controlling metabolic acidosis, but also to ease the administration and aid compliance and quality of life in patients of all ages.
お知らせ • Feb 19+ 1 more updateAdvicenne S.A. Provides an Update as its Operations EvolveAdvicenne provides an update on the overall progress of the Company. In Europe, with the recent positive CHMP Opinion for its lead medicine ADV7103-Sibnayal™, Advicenne should receive the EMA Marketing Authorization (MAA) for Sibnayal™ soon. The company is currently pursuing discussions with several partners for its commercialization in most countries of the European Community. Meanwhile the clinical program in cystinuria in the EU is progressing. In spite of the hurdles encountered due to the ongoing COVID-19 crisis, the submission for Marketing Authorization is expected by late 2022. Advicenne has been able to maintain a satisfactory level of activity, and the team has been doing a great job in all the aspects of the Sibnayal pre-launch, from market access to manufacturing and securement of the supply chain. In the US, Advicenne Inc, Advicenne’s US affiliate, has made significant progress in building a team of highly qualified professionals. The pivotal Phase III ARENA trial of ADV7103 for distal Renal Tubular Acidosis (dRTA) is resuming. The submission for Marketing Authorization is expected in late 2022. Meanwhile the launch of Ozalin™ by Primex under an exclusive license is progressing. Advicenne is confident in the continuous positive execution of the €40 million licensing deal signed in 2016. Focus and streamlining, as well as effective cost management are practices put in place by the Company during these difficult times. The Company was able to secure €4.3 million of non-dilutive financing through a PGE (French state guaranteed loan) at the end of 2020. Thanks to the positive evolution of the company a number of financing options are now open to secure the development of the Company in the mid term.
Is New 90 Day High Low • Feb 06New 90-day high: €12.10The company is up 90% from its price of €6.36 on 06 November 2020. The German market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 14% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €74.48 per share.
Is New 90 Day High Low • Jan 20New 90-day high: €11.70The company is up 96% from its price of €5.96 on 21 October 2020. The German market is up 11% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 22% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €71.72 per share.
お知らせ • Jan 08+ 1 more updateAdvicenne Appoints Peter Meeus as Chief Executive Officer, Effective February 15, 2021Advicenne announced the appointment of Peter Meeus as Chief Executive Officer of Advicenne, effective February 15, 2021 . Peter Meeus brings over 25 years of experience in the life sciences industry to Advicenne. Prior to joining Advicenne, Peter Meeus served as Senior Vice-President and Head of Product & Portfolio Strategy at Biocon Biologics, based in Singapore. Earlier, he was Head of Region Europe at Shire, before its acquisition by Takeda, and had a long career at Novartis and Novo Nordisk A/S, culminating in his role as Vice-President and Head of their UK and Irish Business.
お知らせ • Dec 11Advicenne Receives Positive CHMP Opinion Recommending Approval of ADV7103 (sibnayal) for the Treatment of Distal Renal Tubular Acidosis (dRTA)Advicenne announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of its lead product ADV7103 (Sibnayal) as therapy for distal renal tubular acidosis (dRTA). The European Commission (EC) will now review the CHMP recommendation and a final decision on the Marketing Authorisation of ADV7103 in the European Union is expected in the coming weeks/months. This CHMP positive opinion is based on results of a pivotal Phase III trial (B21CS) and its twenty-four-month extension study (B22CS) conducted in adult and pediatric patients with dRTA demonstrating the clinically relevant therapeutic effect of ADV7103. While the standard of care (SoC) medicine requires three to six daily intakes including during night, ADV7103 treatment consists of only two doses per day and provides complete night-time coverage for patients. In addition, gastrointestinal tolerability was improved. Plasma potassium and urinary calcium was normalized. In order to make ADV7103 quickly and broadly available in all EU countries, Advicenne has decided to set up partnerships with specialized distributors. This approach will allow Advicenne to allocate its resources on the clinical development of ADV7103 in the United States and to develop its second indication for the medicine in cystinuria.
Is New 90 Day High Low • Dec 04New 90-day high: €8.46The company is up 18% from its price of €7.18 on 04 September 2020. The German market is up 4.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €60.80 per share.
Is New 90 Day High Low • Nov 19New 90-day high: €7.58The company is up 5.0% from its price of €7.24 on 20 August 2020. The German market is up 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €56.73 per share.
Is New 90 Day High Low • Oct 19New 90-day low: €5.96The company is down 18% from its price of €7.26 on 21 July 2020. The German market is flat over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €34.43 per share.
Is New 90 Day High Low • Sep 30New 90-day low: €6.46The company is down 12% from its price of €7.32 on 02 July 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is down 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €35.89 per share.
Reported Earnings • Sep 29First half earnings releasedOver the last 12 months the company has reported total losses of €14.6m, with losses widening by 81% from the prior year. Total revenue was €2.55m over the last 12 months, down 64% from the prior year.
