MIRUM PHARMAC. DL-,0001 Aktie

Mirum reported Q2 2024 revenue of USD 176.2 million, of which USD 129 million came from LIVMARLI, and raised its full-year guidance to USD 680–700 million. Management cited near-term catalysts including the PDUFA decision for Zilurgisertib (Sept. 26, 2024), topline updates for Brelovitug and ongoing Volixibat studies (PBC/PSC). 2024 remains an investment year with expanded production and cash flow near break-even; positive operating cash flow is expected again in 2025. Growth prospects depend on expanding LIVMARLI into adult PFIC patients, international rollout and pipeline success, while clinical, regulatory and manufacturing risks persist. » Więcej na de.investing.com

Mirum expects 2026 revenue of $680–700 million and lays out a tight timeline with several potential stock catalysts, including a PDUFA date for zilurgisertib at the end of the month and Phase III readouts for brelovitug (AZURE‑1 later this month, AZURE‑4 in Q4). Other expected data: EXPAND results in Q4, VANTAGE results in Q1, and multiple filings (BLA/BLA‑/NDA/sNDA) in the first half of next year. Management highlights opportunities in underdiagnosed indications such as hepatitis delta, but also notes regulatory uncertainties for volixibat/PSC following FDA guidance; Mirum is also expanding use of AI tools such as Microsoft Copilot. » Więcej na de.investing.com

Mirum Pharmaceuticals announced a growth plan focused on acquisitions, product launches and indication expansions for neglected therapies in rare diseases. The company reports three approved drugs with annualized revenues of around $680–700 million, with LIVMARLI seen as the main growth driver and a projected peak sales potential of over $1 billion. Near‑term catalysts include several phase‑III readouts (including LIVMARLI, Brelovitug and Volixibat) and a PDUFA decision for zilurgisertib; Volixibat faces a complex FDA pathway but received breakthrough designation and is heading toward an NDA submission in H1 2025. Management sees no immediate financing need, prefers acquisitions over a sale process and aims for profitability via capital‑efficient acquisitions and commercialization. » Więcej na de.investing.com