Mithra Extra Analyses for Donesta Push Timelines Further
This morning, Mithra announced a slip in the timelines for Donesta, as the regulatory submission is pushed one year out to 4Q24, leading to potential launch around end 2025/early 2026. Reason for the delay is an additional analysis to be done by Mithra on endometrial biopsy samples in order to address the whole menopause population. We adjust our TP from € 2.0 to € 1.7, while re-iterating a Hold rating.Mithra Pharmaceuticals SA is a Belgium-based company active in the pharmaceutical industry. The Company is dedicated to provide products and services for the fertility, contraception and menopause of women. It has a number of patent families regarding Estetrol (E4), a natural estrogen produced by the human foetus, which enables the investigation of fertility and contraception products. Mithra is focused on the development of two late-stage E4-based products: Estelle, a 5th generation oral contraceptive, and Donesta, a hormone therapy for Vasomotor Symptoms in menopause. Mithra develops a contraceptive vaginal ring called Myring and Zoreline, a biodegradable subcutaneous implant for hormone dependant cancer.
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