Mineralys FDA acceptance of lorundrostat NDA for uncontrolled hypertension, Dec 22 PDUFA

 

Mineralys gets FDA acceptance of lorundrostat NDA for uncontrolled hypertension with Dec 22 2026 PDUFA date, prepares U.S. launch, seeks global partner

• Company preparing U.S. launch focused on fourth-line resistant patients, expanding to third-line over time.
• Management still seeking a global partner but building stand-alone commercial capability to preserve flexibility.
• Differentiation versus baxdrostat centers on Advance-HTN data, proteinuria effects, and diverse trial populations.
• Payers reportedly receptive to covering fourth-line resistant patients and maintaining parity access between ASIs.
• Physicians value lorundrostat's absolute systolic reduction, roughly nineteen millimeters, and inclusive Black representation.
• Safety profile remains consistent in open-label extension, and long-term durability and tolerability data publication is planned.
• Reports fiscal Q1 2026 non-GAAP EPS $-0.47 (+41% YoY) on revenue $0, beating EPS and revenue estimates.
• Q1 2026 net loss was $39.3 million, as R&D decreased while G&A ramped.
• Cash and investments of $646.1 million expected to fund operations and programs into 2028.
• Main risk is competitive launch, pricing, and access dynamics versus first-to-market AstraZeneca baxdrostat.
• Main concern: Executing differentiation and securing attractive access versus AstraZeneca’s baxdrostat while partnership timing remains uncertain.
• Mixed quarter, driven by NDA acceptance, launch readiness spending, and ongoing but unresolved partnering discussions.

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