Duyuru • Jul 02
Advicenne Announces Unlimited Renewal of Marketing Authorization for Sibnayal in United Kingdom Advicenne S.A. announced the unlimited renewal of the Marketing Authorization (MA) for Sibnayal (a fixed-dose combination of potassium citrate and potassium bicarbonate) for the treatment of distal Renal Tubular Acidosis (dRTA) in the United Kingdom. The Medicines and Healthcare products Regulatory Agency (MHRA) has granted the unlimited renewal of MA for Sibnayal effective June 2026. This renewal, which is mandatory five years after the initial grant, definitively validates the MA in the United Kingdom. Following the renewal of the marketing authorization in the European Union, the decision by the British authorities highlights the therapeutic profile of Sibnayal in the treatment of dRTA, a serious renal condition affecting children and adults. Advicenne’s regulatory program is particularly robust, with several marketing authorizations obtained for Sibnayal in the Gulf countries, the recent reimbursement approvals for Likozam and Sibnayal in the French market, as well as the review of the registration dossier for ADV7103 by the U.S. Food and Drug Administration and a decision expected on September 3, 2026. Sibnayal (ADV7103) has received its Marketing Approval for distal renal tubular acidosis in EU, GB, KSA and UAE, and has been filed for a US NDA. ADV7103 is currently in late-stage development in cystinuria in Europe and the US. Duyuru • May 23
Advicenne S.A. Announces Board Changes Advicenne 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 20
Less than half of directors are independent No 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. Duyuru • Apr 16
Advicenne S.A., Annual General Meeting, May 21, 2026 Advicenne S.A., Annual General Meeting, May 21, 2026. Location: 2 rue de la chaussee d antin, paris France Duyuru • Jan 19
Advicenne 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 Acidosis Advicenne 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. Duyuru • Jan 12
Advicenne Successfully Renewed the Marketing Authorization of Sibnayal in European Union Advicenne 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 30
Less than half of directors are independent No 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. Duyuru • Nov 05
Advicenne Submitted to US FDA the Registration Application for Sibnayal® in dRTA Treatment Advicenne 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. Duyuru • Jul 29
Advicenne Receives Marketing Authorization and Reimbursement for Sibnayal®? in Saudi Arabia Advicenne 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. Duyuru • Apr 08
Advicenne S.A., Annual General Meeting, May 15, 2025 Advicenne S.A., Annual General Meeting, May 15, 2025. Location: 2 rue de la chaussee d antin, paris France Duyuru • Jan 29
Advicenne Reaches A Significant Milestone with the Us FDA in the Development of Adv7103 in Cystinuria Advicenne 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. Duyuru • Nov 29
Advicenne S.A. to Report First Half, 2025 Results on Sep 18, 2025 Advicenne S.A. announced that they will report first half, 2025 results on Sep 18, 2025 Board Change • Oct 03
Less than half of directors are independent Following 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. Duyuru • Oct 01
Advicenne Achieves Major Milestones in the US Due to Several Positive FDA Opinion on ADV7103 Advicenne 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 10
Full 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 29
New minor risk - Financial data availability The 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 27
Less than half of directors are independent Following 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 24
Less than half of directors are independent Following 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. Duyuru • Jun 30
Advicenne Announces Commercial Launch of Sibnayal in Great Britain Advicenne 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. Duyuru • Jun 10
Advicenne S.A. Announces Executive Changes Advicenne 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. Duyuru • Apr 22
Advicenne Appoints Philippe Boucheron as Chairman of Its Board of Directors Advicenne 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. Duyuru • Mar 31
Advicenne Announces the Release of Results of a Study Showing Improved Quality of Life in Patients Living With DRTa and Treated by ADV7103 Advicenne 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. Duyuru • Jan 25
Advicenne Ordinary Shareholders' Meeting Approves Delisting from Regulated Market of Euronext Brussels The 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 14
Forecast to breakeven in 2023 The 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. Duyuru • Dec 20
Advicenne Announces Positive Opinion from the French Transparency Commission (HAS) for Its Drug Sibnayal™ in dRTA Advicenne 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 01
First 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). Duyuru • Jul 03
Advicenne Receives Medicines and Healthcare products Regulatory Agency Approval to Market Sibnayal™ (ADV7103) in the UK for the Treatment of dRTA Advicenne 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. Duyuru • Jun 24
Advicenne S.A. announced that it has received €9.42128 million in funding Advicenne 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 12
Chief Executive Officer Peter Meeus has left the company On 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%. Duyuru • May 04
Advicenne Receives European Commission Approval to Market ADV7103 (Sibnayal™) and announces Leadership Changes to support Commercialisation Advicenne 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. Duyuru • Mar 21
Advicenne Expects Imminent Marketing Authorization for ADV7103 (Sibnayal™) for dRTA in Europe Advicenne 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. Is New 90 Day High Low • Feb 06
New 90-day high: €12.10 The 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 20
New 90-day high: €11.70 The 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. Duyuru • Dec 11
Advicenne 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 04
New 90-day high: €8.46 The 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 19
New 90-day high: €7.58 The 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 19
New 90-day low: €5.96 The 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 30
New 90-day low: €6.46 The 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 29
First half earnings released Over 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.