Latest news with #Sibnayal®
Business Wire
3 days ago
- Business
- Business Wire
Advicenne Receives Marketing Authorization and Reimbursement for Sibnayal® in Saudi Arabia
PARIS--(BUSINESS WIRE)--Regulatory News: Advicenne (Euronext Growth® - FR0013296746 - ALDVI), a pharmaceutical company specializing in the development and marketing of innovative treatments for people suffering from rare kidney diseases, 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 achievment results of a close collaboration between Advicenne and its local partner, Taïba Healthcare, a leading distributor of pharmaceutical products in the Gulf region. Advicenne will act as the marketing authorization holder, while Taïba 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. Didier Laurens, CEO of Advicenne, declared: 'I am particularly proud of this important achievement and wish to congratulate both Advicenne and Taïba Healthcare teams, whose efforts were instrumental in informing and convincing the Saudi health authorities. The reimbursement obtained, comparable to the highest levels recorded in Europe, further attests to the significant therapeutic value of Sibnayal® in a region with one of the highest prevalence rates of dRTA worldwide.' About Advicenne Advicenne (Euronext: ALDVI) is a specialty pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead product Sibnayal® (ADV7103) has received its Marketing Approval for distal renal tubular acidosis in EU and GB. ADV7103 is currently in late-stage development in cystinuria in Europe and in dRTA and cystinuria in the US and in Canada. Headquartered in Paris, Advicenne, listed on the Euronext Paris stock exchange since 2017, has now been listed on Euronext Growth Paris since its transfer on March 30, 2022. For additional information, see: Disclaimer This press release contains certain forward-looking statements concerning Advicenne group and its business, including its prospects and product candidate development. Such forward-looking statements are based on assumptions that Advicenne considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the 2024 Universal Registration Document filed with the French financial market authority on April 29, 2025 (a copy of which is available on and to the development of economic conditions, financial markets and the markets in which Advicenne operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Advicenne or not currently considered material by Advicenne. The occurrence of all or part of such risks could cause actual results, financial conditions, performance, or achievements of Advicenne to be materially different from such forward-looking statements. Advicenne expressly declines any obligation to update such forward-looking statements.
Business Wire
21-07-2025
- Business
- Business Wire
Advicenne Raises 2.6 Million Euros in Its Capital Increase and Extends Its Financial Visibility
PARIS--(BUSINESS WIRE)--Regulatory News: Advicenne (Euronext Growth® - FR0013296746 - ALDVI), a pharmaceutical company specializing in the development and marketing of innovative treatments for people suffering from rare kidney diseases (the "Company"), raised a total of nearly €2.6 million through the issue of 1,895,948 New Shares at a unit price of €1.35 as part of the capital increase through the issue of new ordinary shares (the 'New Shares') with shareholders' pre-emptive subscription rights (the 'DPS') announced on June 30, 2025. This transaction will extend financial visibility until the end of the third quarter of 2026. Didier Laurens, Chief Executive Officer of Advicenne, comments: "I would like to extend my warmest thanks to the shareholders who, through this operation, are supporting Advicenne's continued development, first and foremost Bpifrance. We can be proud of their confidence in the project supported by all Advicenne employees. This transaction puts the finishing touches to the optimization of our financing. Now, more than ever, we are focusing on the upcoming filing of ADV7103 for registration in the dRTA in the United States, and the extension of our financial visibility enables us to project ourselves calmly towards this objective.' Philippe Boucheron, Deputy Director, Biotech and Medtech Investment Division of Bpifrance and Chairman of Advicenne, highlights: 'We were keen to support Advicenne and its team. Opportunities to invest in a commercial company in our sector which has developed its own drug from lab to market are rare, particularly in France. Following the launch of Sibnayal® in Europe, Advicenne's team has continued to work hard on the US marketing authorization application in dRTA, which will be a powerful driver of value creation.' A Capital Increase to secure the US ambitions This Capital Increase is part of the financing of Advicenne's growth, particularly in the U.S. The funds will be allocated as follows: around 70% for the completion of ADV7103's regulatory activities in dRTA in the U.S and its clinical development plan in cystinuria, and the conclusion of an industrial and commercial partnership; around 30% for the continued marketing activities of Sibnayal® in Europe and the financing requirements of the Company's ongoing operations. This Capital Increase ensures the financing of Advicenne's anticipated cash requirements at least until the end of the 3rd quarter of 2026. This extended financial visibility considers the restructuring agreement for the loan granted by the European Investment Bank, announced on June 30, 2025. It also ensures the finalization of the registration dossier for ADV7103 in dRTA in the U.S and its filing during Q4 2025, with a view to obtaining approval by the end of Q3 2026. During this period, Advicenne will also complete the development plan for ADV7103 in cystinuria. In Europe, the objective is to accelerate the adoption and sales growth of Sibnayal®, working in parallel for the enhancement of its reimbursement, especially in France. Results of the capital increase with pre-emptive subscription rights The capital increase with pre-emptive subscription rights received a total demand for 1,257,403 new shares at a unit price of €1.35, on the basis of 2 new shares for every 13 existing shares held, i.e. a total amount of €1,697,494.05, representing around 66% of the initial offering (€2,559,529.80). Subscriptions were distributed as follows: - 283,430 New Shares by irrevocable entitlement, representing 14.9% of the New Shares to be issued; - 774,150 New Shares subject to reduction, representing 40.8% of the New Shares to be issued. The take-up rate for reducible applications was therefore 100%. to which were added : - 199,823 New Shares on an unrestricted basis, representing 10.5% of the New Shares to be issued, allocated by the Board of Directors under its right to freely allocate unsubscribed shares on an irreducible and reducible basis, as provided for in Article L.225-134 I. 2° of the French Commercial Code. In accordance with their subscription commitments: - the FPS Innovation 1 fund, managed by Bpifrance Investissement, which also manages the Innobio fund, the Company's reference shareholder, subscribed to 740,740 New Shares for a total amount of €999,999; and - Didier Laurens, Managing Director of the Company, subscribed to 37,037 New Shares for a total amount of €49,999.95. It should be noted that the guaranteed commitments for a total of €1,500,000 signed by 6 investors (the 'Guarantors') have been partially exercised up to 57% of their commitment, i.e. 638,545 New Shares. In return for their guaranteed commitments, the Guarantors received a remuneration corresponding to 10% of the amount of their subscription commitment by way of guarantee. Guarantorss Allocation shares Allocation EUR Friedland Gestion 85,139 114,937.65 € Gestys 85,139 114,937.65 € Hamilton Stuart Capital 63,854 86,202.90 € Market Wizards 212,848 287,344.80 € Maitice 42,569 57,468.15 € Treecap BV 148,996 201,144.60 € TOTAL 638,545 862,035.75 € Expand Settlement and delivery of the New Shares Following settlement and delivery, which will take place on July 24, 2025, Advicenne's share capital will amount to €2,843,923.80, comprising 14,219,619 shares with a par value of €0.20 each. Application will be made for the New Shares to be admitted to trading on Euronext Growth in Paris on the same day, on the same quotation line as the existing shares (ISIN code FR0013296746 - mnemonic code ALDVI). Impact of the Capital Increase on the shareholder structure To the best of the Company's knowledge, the breakdown of share capital and voting rights post-Capital Increase is as follows: Capital breakdown (post-capital increase) on a non-diluted basis Shares % Voting rights % Didier Laurens, CEO 37,037.0 0.26% 37,037.0 0.22% Employees, Consultants and committee members 108,778.0 0.76% 217,556.0 1.29% Sub Total Management & Employees 145,815.0 1.03% 254,593.0 1.51% Bpifrance Investissement1 3,405,245.0 23.95% 4,730,813.0 28.05% Cemag Invest 2,217,928.0 15.60% 2,983,574.0 17.69% Irdi Soridec Gestion 435,511.0 3.06% 435,511.0 2.58% Sub Total Board 6,058,684.0 42.61% 8,149,898.0 48.32% Free float 7,957,041 55.95% 8,461,486 50.17% Treasury shares2 58,079 0.41% 0.0 0.00% Total 14,219,619 100,00% 16,865,977 100,00% Expand 1 All funds managed by Bpifrance (including FPS Innovation 1). 2 as of 30/06/2025. Capital breakdown (post-capital increase) on a diluted basis Shares % Voting rights % Didier Laurens 337,037 2.23% 337,037 1.89% Employees, consultants and committee members 553,778 3.66% 662,556 3.72% Sub Total Management & Employees 960,815 6.35% 1,069,593 6.01% Bpifrance Investissement1 3,405,245 22.49% 4,730,813 26.60% Cemag Invest 2,217,928 14.65% 2,983,574 16.77% Irdi Soridec Gestion 435,511 2.88% 435,511 2.45% Charlotte Sibley 25,000 0.17% 25,000 0.14% Sub Total Board of Directors 6,083,684 40.18% 8,174,898 45.96% Free float 8,039,166 53.10% 8,543,611 48.03% Treasury shares2 58,079 0.38% 0 0.00% Total 15,141,744 100,00% 17,788,102 100,00% Expand 1 All funds managed by Bpifrance (including FPS Innovation 1). 2 as of 30/06/2025. Impact of the Capital Increase on the situation of the shareholder The impact of the issue of New Shares on the shareholding of a shareholder who held 1% of the Company's capital prior to the Capital Increase and who did not subscribe to it is as follows: Shareholder interest (%) Non diluted basis* Diluted basis** Before issuance of the New Shares via the Offering 1,00% 0,93% After issuance of 1,895,948 New Shares via the Offering (completion of the capital increase to 100%) 0,87% 0,81% Expand * on the basis of 12,323,671 existing shares at the date of this press release ** if all BSPCEs are exercised, representing a total of 922,125 shares. The impact of the Capital Increase on consolidated shareholders' equity per share (calculated on the basis of consolidated shareholders' equity at December 31, 2025) is as follows: Equity per share (in €) Non diluted basis* Diluted basis** Before issuance of the New Shares via the Offering -€1.55 -€1.44 After issuance of 1,895,948 New Shares via the Offering (completion of the capital increase to 100%) -€1.16 -€1.09 Expand * on the basis of 12,323,671 existing shares at the date of this press release ** if all BSPCEs are exercised, representing a total of 922,125 shares. Reminder of the other terms of the Capital Increase Legal framework of the offer The offer was carried out on the basis of the 11th and 17th resolutions adopted by the Combined General Meeting of shareholders on May 15, 2025, and by the Board of Directors of Advicenne on June 27, 2025, which decided to implement the delegation of powers granted to it, and launched the capital increase with preferential subscription rights. A notice to shareholders concerning the transaction was published on July 2, 2025 in the Bulletin des Annonces Légales et Obligatoires (BALO). Prospectus In accordance with the provisions of Article L.411-2-1 1° of the French Monetary and Financial Code and Article 211-2 of the General Regulations of the Autorité des Marchés Financiers (the 'AMF'), the Capital Increase did not give rise to a prospectus submitted for AMF approval, as the total amount of the offering calculated over a twelve-month period does not exceed €8,000,000. Undertaking to abstain from trading and to retain shares The Company has undertaken to abstain from trading for a period of 6 months in connection with the Capital Increase. Resumption of exercise rights for holders of BSPCEs issued by the Company Holders of BSPCEs issued by the Company are hereby informed of the resumption of their rights to the allocation of new shares in the Company as from the settlement-delivery of the New Shares, i.e. July 24, 2025. The rights of holders of warrants issued by the Company who have not exercised their right to receive shares in the Company by July 4, 2025 (00:00 Paris time) will be preserved in accordance with legal and regulatory provisions. Risk factors Risk factors relating to the Company and its 2024 universal registration document, available in the Investor Relations section of its website ( The occurrence of any or all these risks could have an adverse effect on the Company's business, financial situation, results, development or prospects. Capital Increase Partners TP ICAP Global Coordinator, Lead Manager and Bookrunner Bird & Bird Legal advice Expand About Advicenne Advicenne (Euronext: ALDVI) is a specialty pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead product Sibnayal® (ADV7103) has received its Marketing Approval for distal renal tubular acidosis in EU and GB. ADV7103 is currently in late-stage development in cystinuria in Europe and in dRTA and cystinuria in the US and in Canada. Headquartered in Paris, Advicenne, listed on the Euronext Paris stock exchange since 2017, has now been listed on Euronext Growth Paris since its transfer on March 30, 2022. For additional information, see: Forward-looking statements This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, product development and potential, and statements regarding future performance. Forward-looking statements are often identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Advicenne's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond Advicenne's control, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include in particular those inherent in the marketing and commercialization of drugs developed by Advicenne as well as those developed or identified in the public documents filed by Advicenne with the Autorité des marchés financiers, including those listed in chapter 3 "Risk Factors" of Advicenne's universal registration document filed with the Autorité des marchés financiers on April 28, 2023 and in the 2023 half-year report, available free of charge on the website of the Company (( Subject to applicable regulations, in particular articles 223-1 et seq. of the general regulations of the Autorité des marchés financiers, Advicenne does not undertake to update any forward-looking information or statements. Disclaimer This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of common shares in any state or jurisdiction in which such offer, solicitation or sale would be unlawful in the absence of registration or approval under the securities laws of such state or jurisdiction. The distribution of this press release may be subject to specific regulations in certain countries. Persons in possession of this document are required to inform themselves about and to observe any such local restrictions. This press release constitutes a promotional communication and not a prospectus within the meaning of Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017 (as amended the "Prospectus Regulation"). With respect to member states of the European Economic Area other than France (the "Member States"), no action has been or will be taken to permit a public offering of the securities that would require the publication of a prospectus in any of these Member States. Consequently, the securities cannot and will not be offered in any Member State (other than France), except in accordance with the exemptions provided for in Article 1(4) of the Prospectus Regulation, or in other cases not requiring the publication by Advicenne of a prospectus under the Prospectus Regulation and/or the regulations applicable in those Member States. This press release does not constitute an offer of securities to the public in the United Kingdom. This press release may not be published, distributed or disseminated in the United States (including its territories and possessions). This press release does not constitute an offer or solicitation to buy, sell or subscribe for any securities in the United States. The securities mentioned in this press release have not been registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), or any applicable state or federal securities laws, and may not be offered or sold in the United States absent registration under the Securities Act, except pursuant to an applicable exemption from, or in a transaction not subject to, registration under the Securities Act. Advicenne does not intend to register the offering in whole or in part in the United States under or pursuant to the Securities Act or to conduct a public offering in the United States. This press release may not be distributed directly or indirectly in the United States, Canada, Australia or Japan. Lastly, this press release may be drafted in either French or English. In the event of any discrepancies between the two texts, the French version shall prevail.
Business Wire
29-04-2025
- Business
- Business Wire
Advicenne 2024 Universal Registration Document Made Available
PARIS--(BUSINESS WIRE)--Regulatory News: Advicenne (Euronext Growth Paris ALDVI - FR0013296746), a specialty pharmaceutical company dedicated to the development and commercialization of innovative treatments for those suffering from rare renal diseases, announces today that its 2024 Universal Registration Document has been filed with the French Autorité des Marchés Financiers (AMF). The Universal Registration Document includes the annual report, the management report, the Board of Directors' report on corporate governance and the Statutory Auditors' reports. It also contains a description of the share buyback program. The Universal Registration Document is available on Advicenne's website ( in the Investors/Financial Information section and on the AMF website ( About Advicenne Advicenne (Euronext: ALDVI) is a specialty pharmaceutical company founded in 2007, specializing in the development of innovative treatments in Nephrology. Its lead product Sibnayal® (ADV7103) has received its Marketing Approval for distal renal tubular acidosis in EU and GB. ADV7103 is currently in late-stage development in cystinuria in Europe and in dRTA and cystinuria in the US and in Canada. Headquartered in Paris, Advicenne, listed on the Euronext Paris stock exchange since 2017, has now been listed on Euronext Growth Paris since its transfer on March 30, 2022. For additional information see: Disclaimer This press release contains certain forward-looking statements concerning Advicenne group and its business, including its prospects and product candidate development. Such forward-looking statements are based on assumptions that Advicenne considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the 2023 Universal Registration Document filed with the French financial market authority on April 5, 2024 (a copy of which is available on and to the development of economic conditions, financial markets and the markets in which Advicenne operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Advicenne or not currently considered material by Advicenne. The occurrence of all or part of such risks could cause actual results, financial conditions, performance, or achievements of Advicenne to be materially different from such forward-looking statements. Advicenne expressly declines any obligation to update such forward-looking statements.
