Mineralys shares surge 11.40% intraday as ICER to assess lorundrostat combination and FDA accepts NDA with December 2026 PDUFA date.

Mineralys surged 11.40% intraday, driven by news that ICER announced on March 30 to assess the clinical value of Mineralys’ lorundrostat in combination with AstraZeneca’s baxdrostat for hypertension treatment, with a planned CEPAC meeting in October 2026. Additionally, the company submitted an NDA for lorundrostat to the FDA in December 2025, which was accepted with a PDUFA target action date set for December 22, 2026.