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XY Therapeutics is developing a first-in-class medical treatment for male infertility based on modulation of the RANKL/RANK/OPG pathway in reproductive organs. Their proprietary asset, delivered as a single injection, has shown in preclinical and early clinical studies (including a randomized trial) to increase sperm production and function in selected infertile men. The company has also developed a biomarker for patient selection, now being advanced as a companion diagnostic. The therapy is currently in a Phase 2a clinical trial and, if successful, would represent a significant breakthrough in a field with very few treatment options.
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