Please see the following USPI, US ISI, EU SmPC and Canadian Product Monograph for complete LIVMARLI product information:

US Important Safety Information (https://livmarli.com/important-safety-information/)

US Prescribing Information (https://files.mirumpharma.com/livmarli/livmarli-prescribinginformation.pdf?_ga=2.264585739.54248471…

EU SmPC (https://ec.europa.eu/health/documents/community-register/html/h1704.htm)

Canadian Product Monograph (https://files.mirumpharma.com/livmarli/livmarli-product-monograph-en.pdf)

Learn more about the latest research for Mirum’s investigational therapies: MRM-3379 (https://mirumpharma.com/wp-content/uploads/2025/09/FXS-NDD-2025-Mouse-Model-Poster_FINAL.pdf), volixibat in PSC (https://s29.q4cdn.com/633867992/files/doc_presentations/2024/Jun/Mirum-VISTAS-and-VANTAGE-Interim-Analysis-Results-Presentation.pdf)and PBC (https://mirumpharma.com/wp-content/uploads/2025/05/Heneghan-M-EASL-2025-VANTAGE-28-week-data-with-volixibat-in-PBC.pdf), and brelovitug (https://www.natap.org/2025/AASLD/AASLD_22.htm). LIVMARLI is also currently being evaluated in the Phase 3 EXPAND study (https://clinicaltrials.gov/study/NCT06553768) in additional settings of cholestatic pruritus.

References
What is hepatitis delta? Hepatitis B Foundation. Accessed January 14, 2026. https://www.hepb.org/research-and-programs/hepdeltaconnect/what-is-hepatitis-delta/
Agarwal K, Jucov A, Dobryanska M, et al. Brelovitug (BJT-778) monotherapy achieved 100% virologic response in patients with chronic hepatitis D: on treatment week 48 phase 2 study results. Presented at: AASLD 2025; November 7-11, 2025; Washington, D.C.
Sagnelli C, Sagnelli E, Russo A, Pisaturo M, Occhiello L, Coppola N. HBV/HDV co-infection: epidemiological and clinical changes, recent knowledge and future challenges. Life (Basel). 2021;11(2):169. doi:10.3390/life11020169
Negro F, Lok AS. Hepatitis D: a review. JAMA. 2023;330(24):2376-2387. doi:10.1001/jama.2023.23242
Hunter J, Rivero-Arias O, Angelov A, Kim E, Fotheringham I, Leal J. Epidemiology of fragile X syndrome: A systematic review and meta‐analysis. doi:10.1002/ajmg.a.36511 

Please see the following USPI, US ISI, EU SmPC and Canadian Product Monograph for complete LIVMARLI product information:
US Important Safety Information (<a href="https://url.us.m.mimecastprotect.com/s/bwVyCPNAG8f3jM7qfKFJIxpnsA?domain=livmarli.com">https://livmarli.com/important-safety-information/)</a>
US Prescribing Information (<a href="https://url.us.m.mimecastprotect.com/s/htO9CQWBXRso2r5mHpHLIG_iA6?domain=files.mirumpharma.com">https://files.mirumpharma.com/livmarli/livmarli-prescribinginformation.pdf?_ga=2.264585739.54248471&hellip;</a>
EU SmPC (<a href="https://url.us.m.mimecastprotect.com/s/CwOFCR6DX7S5MBA8HlIvI1nf8o?domain=ec.europa.eu">https://ec.europa.eu/health/documents/community-register/html/h1704.htm)</a>
Canadian Product Monograph (<a href="https://url.us.m.mimecastprotect.com/s/ZFWiCVOKW9TgW9D1fnSwIERAH4?domain=files.mirumpharma.com">https://files.mirumpharma.com/livmarli/livmarli-product-monograph-en.pdf)</a>
Learn more about the latest research for Mirum&rsquo;s investigational therapies: MRM-3379 (<a href="https://url.us.m.mimecastprotect.com/s/I77MCW6X1RSDMGAvu9T6IozbFi?domain=mirumpharma.com">https://mirumpharma.com/wp-content/uploads/2025/09/FXS-NDD-2025-Mouse-Model-Poster_FINAL.pdf)</a>, volixibat in PSC (<a href="https://url.us.m.mimecastprotect.com/s/uvqvCXD2PRSO80x3i5UKIWn68q?domain=s29.q4cdn.com">https://s29.q4cdn.com/633867992/files/doc_presentations/2024/Jun/Mirum-VISTAS-and-VANTAGE-Interim-Analysis-Results-Presentation.pdf)and</a>&nbsp;PBC (<a href="https://url.us.m.mimecastprotect.com/s/1lLACYENZRSAnOzPfEc9Ixzj5Z?domain=mirumpharma.com">https://mirumpharma.com/wp-content/uploads/2025/05/Heneghan-M-EASL-2025-VANTAGE-28-week-data-with-volixibat-in-PBC.pdf)</a>, and brelovitug (<a href="https://url.us.m.mimecastprotect.com/s/Q6swCZ6NgRSQk23yiDfrIB9qQl?domain=natap.org">https://www.natap.org/2025/AASLD/AASLD_22.htm).</a>&nbsp;LIVMARLI is also currently being evaluated in the Phase 3 EXPAND study (<a href="https://url.us.m.mimecastprotect.com/s/MKQSC1wPMDSqP57KSLBhrIVZK76?domain=clinicaltrials.gov">https://clinicaltrials.gov/study/NCT06553768)</a> in additional settings of cholestatic pruritus.
References
<ol>
<li>What is hepatitis delta? Hepatitis B Foundation. Accessed January 14, 2026. <a href="https://url.us.m.mimecastprotect.com/s/Lu8SCjRNBPHRBP7kcgSmImHxCI?domain=hepb.org/">https://www.hepb.org/research-and-programs/hepdeltaconnect/what-is-hepatitis-delta/</a></li>
<li>Agarwal K, Jucov A, Dobryanska M, et al. Brelovitug (BJT-778) monotherapy achieved 100% virologic response in patients with chronic hepatitis D: on treatment week 48 phase 2 study results. Presented at: AASLD 2025; November 7-11, 2025; Washington, D.C.</li>
<li>Sagnelli C, Sagnelli E, Russo A, Pisaturo M, Occhiello L, Coppola N. HBV/HDV co-infection: epidemiological and clinical changes, recent knowledge and future challenges.&nbsp;Life (Basel). 2021;11(2):169. doi:10.3390/life11020169</li>
<li>Negro F, Lok AS. Hepatitis D: a review.&nbsp;JAMA. 2023;330(24):2376-2387. doi:10.1001/jama.2023.23242</li>
<li>Hunter J, Rivero-Arias O, Angelov A, Kim E, Fotheringham I, Leal J. Epidemiology of fragile X syndrome: A systematic review and meta‐analysis. doi:10.1002/ajmg.a.36511&nbsp;</li>
</ol>

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&D and device development. Available every Friday morning. 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.&nbsp;

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Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We’ll analyze the week’s biggest business news—from mergers and marketing to drug R&D and device development. Available every Friday morning.

 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We&rsquo;ll analyze the week&rsquo;s biggest business news&mdash;from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.
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Mirum’s first acquisition targets a major unmet need in hepatitis delta. Hear how the Bluejay deal reshapes its rare disease pipeline.