MLYS News & Events

Mineralys Therapeutics presented new clinical data for lorundrostat at the 35th European Meeting on Hypertension and Cardiovascular Protection in Gdansk, Poland. The analysis evaluated the efficacy and safety of once-daily lorundrostat 50 mg by CKD status among 800 participants with uncontrolled or resistant hypertension enrolled in the randomized, double-blind, placebo-controlled Phase 3 Launch-HTN trial. Among participants with CKD, 71% were receiving three or more anti-hypertensive medications at baseline, compared with 56% of those without CKD. In addition, 31% of participants with CKD had systolic blood pressure greater than or equal to 160 mmHg at baseline, versus 17% of participants without CKD. Lorundrostat demonstrated significant reductions in SBP that were comparable between CKD and non-CKD participants. At week 12, placebo-adjusted SBP reductions were 9.6 mmHg in participants with CKD and 12.2 mmHg in those without CKD. A greater proportion of lorundrostat-treated participants also achieved target SBP of less than130 mmHg at week 12 compared with placebo, both among CKD participants and non-CKD participants.

Jefferies analyst Dennis Ding notes that AstraZeneca's (AZN) Baxfendy was approved by the FDA as the first-ever aldosterone synthase inhibitor, adding that Baxfendy's approval may be "incrementally constructive" for Mineralys Therapeutics (MLYS) partnering discussions now that there's full visibility on the label, pricing, and payer access. Baxfendy will be available in pharmacies no later than June 9, roughly six to seven months ahead of lorundrostat's PDUFA deadline of December 22, notes the analyst, who has a Hold rating on Mineralys shares.

"We continue to make strong progress advancing lorundrostat toward potential approval, moving closer towards our goal of delivering what we believe has the potential to be a best-in-class aldosterone synthase inhibitor for patients with uncontrolled or resistant hypertension," said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. "The FDA's acceptance of our NDA in the first quarter marks a significant milestone for Mineralys. We continue to advance pre-commercial activities to support a successful launch of lorundrostat while maintaining strategic flexibility."