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;

The Top Line

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.
&nbsp;

Mirum’s first acquisition targets a major unmet need in hepatitis delta. Hear how the Bluejay deal reshapes its rare disease pipeline.

How Mirum is Advancing Rare Disease Care Through Strategic M&A (Sponsored)

The leaders of this year’s list of the most anticipated drug launches will likely come as no surprise: Fierce’s annual report on the biggest potential launches of 2026 details how the next obesity meds from Novo Nordisk and Eli Lilly are expected to rake in a respective $17.2 billion and $11.8 billion in annual sales by 2032, so long as they score their expected approvals this year.

Elsewhere in the report are candidates from the likes of Gilead Sciences, Johnson & Johnson, AstraZeneca and other biopharmas big and small, spanning a range of indications from breast cancer to essential tremor. All together, predicted 2032 sales for the year’s top 10 weigh in at nearly $46 billion.

In this week’s episode of “The Top Line,” Fierce’s Andrea Park and Gabrielle Masson dive into the report, mapping out how it stacks up against last year’s edition and digging into the enormous sales potential of the top two drugs on the list. 

To learn more about the topics in this episode: 


Top 10 most anticipated drug launches of 2026


Novo Nordisk stock crashes after CagriSema misses phase 3 weight-loss goal


Lilly's obesity pill largely maintains weight lost on injectable GLP-1s


Top 10 most anticipated drug launches of 2025 

The leaders of this year&rsquo;s list of the most anticipated drug launches will likely come as no surprise: Fierce&rsquo;s annual report on the biggest potential launches of 2026 details how the next obesity meds from Novo Nordisk and Eli Lilly are expected to rake in a respective $17.2 billion and $11.8 billion in annual sales by 2032, so long as they score their expected approvals this year.
Elsewhere in the report are candidates from the likes of Gilead Sciences, Johnson &amp; Johnson, AstraZeneca and other biopharmas big and small, spanning a range of indications from breast cancer to essential tremor. All together, predicted 2032 sales for the year&rsquo;s top 10 weigh in at nearly $46 billion.
In this week&rsquo;s episode of &ldquo;The Top Line,&rdquo; Fierce&rsquo;s Andrea Park and Gabrielle Masson dive into the report, mapping out how it stacks up against last year&rsquo;s edition and digging into the enormous sales potential of the top two drugs on the list.&nbsp;
To learn more about the topics in this episode:&nbsp;
<ul>
<li aria-setsize="-1" data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="1" data-aria-level="1">
<a href="https://www.fiercepharma.com/marketing/top-10-most-anticipated-drug-launches-2026">Top 10 most anticipated drug launches of 2026</a>
</li>
</ul>
<ul>
<li aria-setsize="-1" data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="2" data-aria-level="1">
<a href="https://www.fiercebiotech.com/biotech/novo-nordisk-stock-crashes-after-cagrisema-misses-phase-3-weight-loss-goal">Novo Nordisk stock crashes after CagriSema misses phase 3 weight-loss goal</a>
</li>
</ul>
<ul>
<li aria-setsize="-1" data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="3" data-aria-level="1">
<a href="https://www.fiercebiotech.com/biotech/lillys-obesity-pill-largely-maintains-weight-lost-injectable-glp-1s-putting-novos-wegovy">Lilly's obesity pill largely maintains weight lost on injectable GLP-1s</a>
</li>
</ul>
<ul>
<li aria-setsize="-1" data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}" data-aria-posinset="4" data-aria-level="1">
<a href="https://www.fiercepharma.com/marketing/top-10-most-anticipated-drug-launches-2025">Top 10 most anticipated drug launches of 2025</a>&nbsp;
</li>
</ul>

The biggest potential drug launches of 2026

Artificial intelligence is reshaping medical communications, but it is not a substitute for human judgment. In this episode of The Top Line, experts from RTI Health Solutions explore how AI is being used across scientific writing, editing and information discovery—and why guardrails are essential.

The conversation examines practical applications of AI, including literature screening, early-stage drafting and editorial support, while addressing the limitations that can undermine quality and trust. Panelists share real-world examples showing how different tools can produce conflicting results and why expert review is required to ensure accuracy and relevance.

Listen to the full interview to gain insight into how organizations can harness AI’s efficiency while keeping scientific rigor and the human perspective at the center of their work.

Artificial intelligence is reshaping medical communications, but it is not a substitute for human judgment. In this episode of The Top Line, experts from RTI Health Solutions explore how AI is being used across scientific writing, editing and information discovery&mdash;and why guardrails are essential.
The conversation examines practical applications of AI, including literature screening, early-stage drafting and editorial support, while addressing the limitations that can undermine quality and trust. Panelists share real-world examples showing how different tools can produce conflicting results and why expert review is required to ensure accuracy and relevance.
Listen to the full interview to gain insight into how organizations can harness AI&rsquo;s efficiency while keeping scientific rigor and the human perspective at the center of their work.

RTI Health experts explain how AI can help medical communications without replacing rigor, judgment or trust.

Why human expertise still matters in AI-driven med comms (Sponsored)

In this week’s episode of “The Top Line,” Fierce checks in with professional services juggernaut KPMG on the biopharma rebound many industry watchers predicted in the closing months of 2025.

Fierce Pharma’s Fraiser Kansteiner sits down with Kristin Cirello Pothier, principal and U.S. and Americas region life sciences sector leader, as well as global deal advisory and strategy leader for health and life sciences at KPMG, to discuss the firm’s latest industry outlook. Pothier also explains how drugmakers are cutting through the noise and reflects on the technology, indication and valuation factors shaping today’s dealmaking appetite.

To learn more about the topics in this episode: 
2026 forecast: After a surge of M&A in Q4, will the trend continue?
Halozyme catches M&A wave to snap up Surf Bio in delivery tech deal worth up to $400M
Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report
In quick reversal, Trump calls off tariff threat related to Greenland pursuit

In this week&rsquo;s episode of &ldquo;The Top Line,&rdquo; Fierce checks in with professional services juggernaut KPMG on the biopharma rebound many industry watchers predicted in the closing months of 2025.
Fierce Pharma&rsquo;s Fraiser Kansteiner sits down with Kristin Cirello Pothier, principal and U.S. and Americas region life sciences sector leader, as well as global deal advisory and strategy leader for health and life sciences at KPMG, to discuss the firm&rsquo;s latest industry outlook. Pothier also explains how drugmakers are cutting through the noise and reflects on the technology, indication and valuation factors shaping today&rsquo;s dealmaking appetite.
To learn more about the topics in this episode:&nbsp;
<ul>
<li><a href="https://www.fiercepharma.com/pharma/2026-forecast-after-surge-ma-q4-will-trend-continue-next-year">2026 forecast: After a surge of M&amp;A in Q4, will the trend continue?</a></li>
<li><a href="https://www.fiercepharma.com/pharma/halozyme-catches-ma-wave-snap-surf-bio-delivery-tech-deal-worth-400m">Halozyme catches M&amp;A wave to snap up Surf Bio in delivery tech deal worth up to $400M</a></li>
<li><a href="https://www.fiercepharma.com/manufacturing/pharma-manufacturing-output-surged-25-countries-braced-us-tariffs-atradius">Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report</a></li>
<li><a href="https://www.fiercepharma.com/pharma/trumps-new-tariff-threats-around-greenland-threaten-upend-eu-trade-deal">In quick reversal, Trump calls off tariff threat related to Greenland pursuit</a></li>
</ul>

How Mirum is Advancing Rare Disease Care Through Strategic M&A (Sponsored)

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