Earnings ·
Monopar Therapeutics initiates rolling NDA submission to FDA for ALXN1840, reports $5.3M Q2 loss
MNPRMonopar Therapeutics
On August 12, 2026, Monopar Therapeutics Inc. reported financial results for the second quarter ended June 30, 2026, and announced it initiated a rolling New Drug Application (NDA) submission to the FDA on July 22, 2026, for ALXN1840, its first-in-class treatment for Wilson disease. The company reported a net loss of $5.3 million ($0.62 per share), compared to a $2.5 million loss in the prior year period, with cash and investments totaling $134.3 million sufficient to fund operations through at least December 31, 2027. R&D expenses increased to approximately $4.8 million due to higher contractor and personnel costs, while General and Administrative expenses rose to roughly $1.9 million. The filing also highlighted the appointment of Susan Rodriguez as Chief Commercial and Strategy Officer and board member Nicole Sweeny to support commercial launch preparations for ALXN1840. Monopar Therapeutics is a clinical-stage biopharmaceutical company developing innovative treatments for Wilson disease and advanced cancers.