MLYS News & Events

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."