Entries by Mithra Pharmaceuticals

Mithra Announces European Approval of Estelle®

Liege, Belgium, 20 May 2021 –18:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, is very pleased to announce that the European Commission has accepted the registration application for the novel combined oral contraceptive Estelle®. This decision follows the adoption of a positive opinion by the Committee for Medicinal Products for […]

Mithra takes note of François Fornieri’s indictment

Liege, Belgium, 28 avril 2021 – 21:15 CET – Mithra Pharmaceuticals SA (Euronext Brussels: MITRA), a company dedicated to Women’s Health, announces having been informed of François Fornieri’s indictment of alleged insider dealing charges following his audition held in Liège today by the federal judicial police. Mithra reminds that since February 04, 2021, Mr. Fornieri […]

Mithra Releases 2020 Annual Report and Invitation to its Securities holders’ Meeting

Liege, Belgium, 20 April 2021 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces the publication of its 2020 Annual Report and the invitation to its ordinary and extraordinary general meeting of securities holders. 2020 Annual Report The Annual Report which outlines Mithra’s achievements in 2020 includes the […]

Mayne Pharma and Mithra Announce FDA Approval of New Oral Contraceptive Estelle®

15 April 2021, 22:30 CEST, Adelaide, Australia and Liege, Belgium: Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are very pleased to announce that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for the novel combined oral contraceptive Estelle® under the trademark Nextstellis® (15 […]

Richter and Mithra Receive Positive CHMP Opinion for Estelle®

Budapest, Hungary – Liege, Belgium – 26 March 2021 – 13:15 CET – Gedeon Richter Plc. (“Richter”) and Mithra Pharmaceuticals (“Mithra”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for a novel combined oral contraceptive containing 15 mg estetrol (E4) […]

Mithra Reports Full Year 2020 Financial Results

Strengthening of the financial resources and balance sheet structure via various funding transactions for an amount of EUR 260 million, diversifying the sources of financing Record cash position of EUR 138.7 million allowing the continuation of our Business Development strategy for Donesta® and R&D projects beyond Women’s Health, notably in Covid-19 treatment Licensing milestones from […]

Mithra and Searchlight Pharma Announce Estelle® Approval in Canada

First E4-based product approved internationally Canadian regulatory approval is the first in the world for the novel combined oral contraceptive Estelle® Innovative product developed by Mithra containing the unique native estrogen Estetrol (E4) and drospirenone (DRSP) Approval supported by two large multinational Phase 3 studies conducted in 3,725 women Commercial launch in Canada anticipated mid-summer […]

Mithra and Farmitalia Announce Commercial Launch of Myring™ in Italy, the Fourth Largest Market in the World

Successful launch of Mithra’s hormonal contraceptive ring in Italy under the trademark Kirkos® Italy is the third largest European market and the fourth worldwide, with 2 million vaginal rings sold per year Mithra CDMO pursues the manufacturing of its Myring™ orders for new commercial launches planned for 2021 Liege, Belgium, 2 March 2021 – 7:30 […]