Corporate Profile

For more than 10 years, Advicenne has been dedicated to developing innovative, effective and safe treatments for people living with rare renal diseases who have very limited therapeutic options. Thanks to our expertise in reformulation and drug delivery, we are uniquely positioned to develop and make available innovative treatments for both children and adults with rare renal diseases.

At Advicenne we are dedicated to improving patients’ daily health and life. Our employees in France and the United States are committed to tackle the challenge of high unmet medical need to improve quality of life for patients and their caregivers.

Sibnayal® (combination of Potassium citrate and Potassium bicarbonate) was in 2021 approved by the European Medicine Agency and MHRA.

Headquartered in Paris and listed on Euronext Growth (Euronext: ALDVI) since 2022. www.advicenne.com

Advicenne Stock Quote

ALDVI (Euronext Growth)

Press releases

October 1, 2024 - Advicenne achieves major milestones in the US thanks to several positive FDA opinions on ADV7103

September 18, 2024 - Advicenne reports its First Half financial results as of June 30, 2024, and updates on its activities

July 18, 2024 - Advicenne announces an 8.8% increase in gross sales for H1 2024 and provides an update on its activities

May 15, 2024 - Advicenne announces the approval of all resolutions supported by the Board of Directors at its Combined General Meeting

April 5, 2024 - Advicenne 2023 Universal Registration Document made available

March 28, 2024 - Strong improvement of 2023 results thanks to sustained commercial activity on Sibnayal®

March 25, 2024 - FDA grants Orphan Drug Designation to ADV7103 for the treatment of cystinuria

January 23, 2024 - Advicenne reports 2023 gross sales up 20% to €4.43 million

December 28, 2023 - Advicenne announces its 2024 financial calendar

October 2, 2023 - Advicenne announces the results of its capital increase with preferential subscription rights

September 25, 2023 - Advicenne announces its participation in several scientific conferences and the presentation of updated clinical results about ADV7103

September 11, 2023 - Advicenne reports its First Half Financial results as of June 30, 2023 and updates on its activities

July 12, 2023 - Advicenne announces 51% growth in Sibnayal® gross sales in H1 2023 to almost €1.0 million

June 14, 2023 - Advicenne announces long-term results of the European clinical development program for ADV7103

June 9, 2023 - Advicenne announces the approval of all resolutions supported by the Board of Directors at its Combined General Meeting

May 19, 2023 - Advicenne annual combined general meeting of June 8, 2023 – Availability of preparatory documents

April 28, 2023 - Advicenne 2022 Universal Registration Document made available

March 30, 2023 - Advicenne reports its financial results for the year ended December 31, 2022

March 6, 2023 - Advicenne announces the launch of Sibnayal® in Denmark

February 28, 2023 - Advicenne completes European commercial coverage of Sibnayal® through its agreement with Avanzanite Bioscience

February 14, 2023 - Advicenne and SPA announce an exclusive distribution agreement for the marketing of Sibnayal® in Italy, Spain and Portugal

February 1, 2023 - Advicenne provides an update on its commercial partnerships in Europe and the Middle East

January 24, 2023 - Advicenne reports 2022 sales up 13% to €3.7 million

December 13, 2022 - Advicenne obtains Orphan Drug Designation for ADV7103 in the United States for the treatment of distal Renal Tubular Acidosis (dRTA)

December 5, 2022 - Advicenne announces the second tranche drawdown of its non-dilutive financing agreement with the EIB

November 30, 2022 - Advicenne announces its financial calendar for 2023

November 3, 2022 - Advicenne announces its upcoming participation in two of the most important international investor conferences

October 5, 2022 - Advicenne announces the extension of the intellectual property of its drug Sibnayal®

September 21, 2022 - Advicenne reports its First Half Financial results as of June 30, 2022

September 14, 2022 - Advicenne updates on availability of Sibnayal® to patients and caregivers in Great Britain

June 30, 2022 - Advicenne announces commercial launch of Sibnayal® in Great Britain

June 28, 2022 - Advicenne announces commercialization agreement with Taïba Healthcare for Sibnayal® in Middle-East

June 10, 2022 - Advicenne provides an update on its activities following its Annual General Meeting and Board of Directors meeting on June 9, 2022

May 30, 2022 - Advicenne announces the launch of its new website

April 29, 2022 - Advicenne 2021 Universal Registration Document made available

April 21, 2022 - Advicenne appoints Philippe Boucheron as Chairman of its Board of Directors

April 5, 2022 - A case report highlights the interest of a long-term treatment with ADV-7103 in dRTA

March 31, 2022 - Advicenne Reports its Financial Results for the Year ended 31 December 2021

March 30, 2022 - Advicenne announces the release of results of a study showing improved quality of life in patients living with DRTa and treated by ADV7103

March 28, 2022 - Advicenne announces the transfer of its shares from Euronext Paris and Euronext Brussels to Euronext Growth Paris on March 30, 2022

January 21, 2022 - Advicenne ordinary shareholders’ meeting approved the project to transfer Advicenne’s shares listing to the Euronext Growth Paris market and delisting from the regulated market of Euronext Brussels

January 18, 2022 - Advicenne reports 2021 sales up 20% to €3.3 million

January 4, 2022 - Advicenne announces commercialization agreement with FrostPharma AB for Sibnayal™ in the Nordic region

December 27, 2021 - Advicenne announces its financial calendar for 2022

December 20, 2021 - Advicenne announces positive opinion from the French Transparency Commission (HAS) for its drug Sibnayal™ in dRTA

December 7, 2021 - Advicenne announces significant progress in marketing its lead product Sibnayal™ in Europe

December 3, 2021 - Proposed transfer of the listing of Advicenne’s shares to the Euronext Growth Paris market and delisting from the regulated market of Euronext Brussels

September 29, 2021 - Advicenne Reports 2021 Half Year Financial Results

July 2, 2021 - Advicenne Receives MHRA Approval to Market Sibnayal™ (ADV7103) in the UK for the Treatment of dRTA

June 23, 2021 - Advicenne successfully raises circa €9.4m in a placement reserved to a category of persons

June 22, 2021 - Advicenne launches a reserved capital increase by means of an accelerated bookbuild offering for an amount of approx. EUR 10m

June 15, 2021 - Advicenne provides an update on its activities following its Annual General Meeting

June 10, 2021 - Live Broadcast of the Annual General Meeting on June 14th, at 11:00 a.m

May 17, 2021 - Advicenne receives positive feedback from the US FDA on pathway to approval and amended Phase III study protocol for its treatment of distal renal tubular acidosis (dRTA)

May 3, 2021 - Advicenne Receives European Commission Approval to Market ADV7103 (Sibnayal™) and announces Leadership Changes to support Commercialisation

April 28, 2021 - Advicenne Reports its Full-Year Financial Results to December 31, 2020 and Confirms its 2021 Outlook

April 23, 2021 - 2021 Financial Calendar

March 25, 2021 - Precision on the press release dated March 19, 2021

March 19, 2021 - Advicenne expects imminent marketing authorization for ADV7103 (Sibnayal™) for dRTA in Europe

February 18, 2021 - Advicenne Provides an Update as its Operations Evolve

January 7, 2021 - Advicenne Announces the Appointment of Peter Meeus as Chief Executive Officer

December 10, 2020 - Advicenne receives positive CHMP opinion recommending approval of ADV7103 (Sibnayal®) for the treatment of distal renal tubular acidosis (dRTA)

October 27, 2020 - Advicenne obtains non-dilutive loan facility of €4.3 million guaranteed by the French State

September 25, 2020 - Advicenne Presents 2020 Half-Year Financial Report and Provides Update on Outlook and Recent Developments

August 11, 2020 - Advicenne Strengthens Its Financial Structure Through the Implementation of its €20 Million Financing Agreement with the European Investment Bank, with the Drawdown of a First Tranche of €7.5 Million

May 26, 2020 - Advicenne Shareholders Adopt All Resolutions Recommended by the Board of Directors at Its Combined Shareholders Meeting

May 25, 2020 - Advicenne Gears Up for Accelerated Growth

May 5, 2020 - Advicenne Combined Shareholders Meeting to Be Held on May 26 Behind Closed Doors

March 13, 2020 - Advicenne Reports Full-Year 2019 Financial Results and Confirms Operational Outlook for 2020

March 13, 2020 - Advicenne Announces the Appointment of André Ulmann as Interim Chief Executive Officer

March 10, 2020 - Advicenne Makes ADV7103 8 mEq and 24 mEq Prolonged-Release Granules Available Within Framework of French Temporary Authorization for Use (TAU) Scheme

January 28, 2020 - Advicenne Publishes its Financial Calendar for 2020

December 18, 2019 - Advicenne’s Lead Candidate Approved for Orphan Drug Designation in the Treatment of Cystinuria in Europe

November 15, 2019 - Advicenne intends to appoint David Horn Solomon as Chairman of the Board of Directors in line with its International Strategy

October 28, 2019 - Advicenne Presented Additional Efficacy Data on ADV7103 in the Treatment of dRTA at International Pediatric Nephrology Association Congress

September 27, 2019 - Advicenne Publishes its 2019 Half-Year Financial Report

September 24, 2019 - Advicenne Presents 2019 Half-Year Financial Report and Confirms Financial Outlook

September 20, 2019 - Advicenne to present eight posters on the positive results of ADV7103 in the treatment of rare nephrological diseases at major international conferences

September 4, 2019 - Advicenne secures production of ADV7103 through long-term manufacturing supply agreement with Elaiapharm Lundbeck

September 3, 2019 - Advicenne to attend the J.P. Morgan Pan European Small / Mid Cap Conference in London

August 29, 2019 - Advicenne Announces First Patient Enrolled in US ARENA-2 Pivotal Phase III Clinical Trial Evaluating ADV7103 in distal Renal Tubular Acidosis (dRTA)

July 26, 2019 - Advicenne to Present at the Solebury Trout European Biotech Investor Day in NYC

July 18, 2019 - Financial Visibility and Accelerated Development

June 13, 2019 - Advicenne confirms prevalence of distal renal tubular acidosis (dRTA) and cystinuria at ISPOR conference

June 12, 2019 - Advicenne announces the successful listing of its shares on the regulated market of Euronext Brussels

May 23, 2019 - Advicenne announces its intention to list on the regulated market of Euronext Brussels

April 30, 2019 - Advicenne Publishes its 2018 Annual Financial Report

April 9, 2019 - Advicenne to attend Smallcap Event 2019 on April 16-17, 2019 in Paris

March 21, 2019 - Advicenne Reports Full Year 2018 Financial Results and Confirms Operational Outlook for 2019

March 12, 2019 - Advicenne Announces Submission of European Marketing Authorization Application (MAA) for ADV7103 as Treatment for Distal Renal Tubular Acidosis (dRTA)

January 7, 2019 - Advicenne’s Flagship ADV7103 Receives Authorization for Pivotal Phase II/III Cystinuria Study in Belgium

December 21, 2018 - Advicenne Publishes its Financial Calendar for 2019

October 26, 2018 - Advicenne Wins Prestigious Prix Galien – Medstartup Award for Best Innovative Trial Design Leading to Quicker and Better Therapeutic Outcomes

October 15, 2018 - Advicenne Receives Health Canada Clearance to Extend its Pivotal Phase III Trial of ADV7103 in Canada

October 4, 2018 - Advicenne to present additional data on ADV7103 at the European Society for Paediatric Nephrology during its 51st Annual Meeting

September 25, 2018 - Advicenne Prepares its Expansion with Highly Experienced Industry Professionals

September 20, 2018 - Advicenne Reports First-Half 2018 Results and Confirms Outlook for 2018

September 12, 2018 - Advicenne receives approval for Marketing Authorization for ADV6209 in Pediatric Moderate Sedation

September 5, 2018 - Advicenne announces FDA clearance of IND to commence pivotal Phase 3 trial of ADV7103 for distal Renal Tubular Acidosis

July 2, 2018 - Advicenne confirms ADV7103’ safety and efficacy after 24 months in the Phase III Extension Study

May 31, 2018 - Advicenne Announces ADV7103 Poster Presentation at the 55th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress

May 15, 2018 - Advicenne enters into partnership with the European Society for Paediatric Nephrology (ESPN) aiming to improve patient care for distal Renal Tubular Acidosis (dRTA) in Europe

May 4, 2018 - Advicenne receives authorisation from French regulation authorities to initiate pivotal phase II/III trial of ADV7103 in Cystinuria

April 30, 2018 - Advicenne publishes its annual financial report

April 18, 2018 - Advicenne 2017 Financial Results and Operational Perspectives for 2018

February 12, 2018 - Advicenne announces its financial calendar for 2018 and cash position as of December 31st, 2017

January 24, 2018 - Advicenne appoints Linda Law, MD as US Vice President, Clinical Development and Medical Affairs

January 5, 2018 - Partial exercise of over – allotment option

December 5, 2017 - Success of the IPO

November 21, 2017 - Advicenne launches IPO on Euronext’s regulated market in Paris

November 6, 2017 - ADV7103: 6-month data presented at ASN

November 2, 2017 - Advicenne announces the registration of its Document De Base in relation to its planned IPO on Euronext’s regulated market in Paris

September 20, 2017 - Advicenne to Present a Poster at the 9th EuPFI Conference on ADV7103, an Innovative age-adapted Product for distal Renal Tubular Acidosis

September 11, 2017 - Advicenne Announces Positive Pivotal Phase III Clinical Data for ADV7103 in Adults and Children Suffering from distal Renal Tubular Acidosis

July 2, 2017 - Advicenne Receives Orphan Drug Designation from the EU for ADV7103 for the Treatment of distal Renal Tubulopathy

June 21, 2017 - Advicenne to Present Preliminary Phase III Clinical Data on ADV7103 at the Upcoming European Society of Paediatric Nephrology’s Annual Meeting

March 20, 2017 - Advicenne Announces the Closing of a €16 Million Financing Round

September 1, 2016 - Advicenne appoints Ludovic Robin as Chief Business & Strategy Officer

February 23, 2016 - Advicenne Pharma sells its drug candidate ADV6209 for moderate sedation to the Swiss Primex Pharmaceuticals

April 23, 2015 - French marketing authorization approval for Levidcen

February 20, 2014 - Advicenne has signed a license agreement with Desitin, on a new anti-epileptic for the French market, Levidcen micro-granules

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