Every clinical setback carries lessons. That’s why Fierce revisits major trial failures each year: not to dwell on disappointment, but to understand what went wrong and what it signals for the road ahead.

The 2025 edition of Fierce Biotech’s clinical trial flops report highlights a familiar pattern. Large drugmakers account for a disproportionate share of high-profile misses, reflecting the reality that many of the industry’s most ambitious late-stage programs now sit inside big pharma portfolios.

On this episode of "The Top Line," Fierce Biotech's James Waldron and Fierce Pharma's Fraiser Kansteiner discuss the failures that stood out in 2025 and what they suggest about the challenges facing drug development.

To learn more about the topics in this episode: 
2025's top 10 clinical trial flops
Sanofi ousts Paul Hudson after 'bumpy ride,' enlists Merck KGaA CEO to lead the French pharma

Every clinical setback carries lessons. That&rsquo;s why Fierce revisits major trial failures each year: not to dwell on disappointment, but to understand what went wrong and what it signals for the road ahead.
The 2025 edition of Fierce Biotech&rsquo;s clinical trial flops report highlights a familiar pattern. Large drugmakers account for a disproportionate share of high-profile misses, reflecting the reality that many of the industry&rsquo;s most ambitious late-stage programs now sit inside big pharma portfolios.
On this episode of "The Top Line," Fierce Biotech's James Waldron and Fierce Pharma's Fraiser Kansteiner discuss the failures that stood out in 2025 and what they suggest about the challenges facing drug development.
To learn more about the topics in this episode:&nbsp;
<ul>
<li><a href="https://www.fiercebiotech.com/biotech/2025s-top-10-clinical-trial-flops">2025's top 10 clinical trial flops</a></li>
<li><a href="https://www.fiercepharma.com/pharma/sanofi-ousts-paul-hudson-after-bumpy-ride-poaches-merck-kgaa-ceo-lead-company">Sanofi ousts Paul Hudson after 'bumpy ride,' enlists Merck KGaA CEO to lead the French pharma</a></li>
</ul>

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;

What were the biggest clinical trial flops of 2025? 

Community oncology is playing an increasingly important role in how cancer care is delivered across the United States, with a growing share of patients treated outside large academic medical centers. In this sponsored episode of The Top Line, host Chris Hayden sits down with Kirk Kaminsky, executive vice president and group president of North American Pharmaceutical Services for McKesson, to examine what this shift means for patients, providers and the industry.

Kaminsky explains how advances in cancer science have transformed many diagnoses into long-term conditions, increasing the need for accessible, high-quality care in local communities. He discusses the challenges community practices face as innovation accelerates, including evolving reimbursement models, operational pressures and the adoption of new technologies.

The conversation also explores the role of community oncology in expanding access to clinical trials and accelerating research, as well as how artificial intelligence is being used to improve both clinical and administrative workflows. Kaminsky shares his outlook on the next five to 10 years of cancer care and why supporting community oncology will be critical to continued progress. Listen to the full interview to learn more.

Community oncology is playing an increasingly important role in how cancer care is delivered across the United States, with a growing share of patients treated outside large academic medical centers. In this sponsored episode of The Top Line, host Chris Hayden sits down with Kirk Kaminsky, executive vice president and group president of North American Pharmaceutical Services for McKesson, to examine what this shift means for patients, providers and the industry.
Kaminsky explains how advances in cancer science have transformed many diagnoses into long-term conditions, increasing the need for accessible, high-quality care in local communities. He discusses the challenges community practices face as innovation accelerates, including evolving reimbursement models, operational pressures and the adoption of new technologies.
The conversation also explores the role of community oncology in expanding access to clinical trials and accelerating research, as well as how artificial intelligence is being used to improve both clinical and administrative workflows. Kaminsky shares his outlook on the next five to 10 years of cancer care and why supporting community oncology will be critical to continued progress. Listen to the full interview to learn more.

McKesson’s Kirk Kaminsky discusses community oncology, trials and AI in cancer care.

Community oncology’s growing role in the future of cancer care (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

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://livmarli.com/important-safety-information/">https://livmarli.com/important-safety-information/)</a>
US Prescribing Information (<a href="https://files.mirumpharma.com/livmarli/livmarli-prescribinginformation.pdf?_ga=2.264585739.54248471">https://files.mirumpharma.com/livmarli/livmarli-prescribinginformation.pdf?_ga=2.264585739.54248471&hellip;</a>
EU SmPC (<a href="https://ec.europa.eu/health/documents/community-register/html/h1704.htm">https://ec.europa.eu/health/documents/community-register/html/h1704.htm)</a>
Canadian Product Monograph (<a href="https://files.mirumpharma.com/livmarli/livmarli-product-monograph-en.pdf">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://mirumpharma.com/wp-content/uploads/2025/09/FXS-NDD-2025-Mouse-Model-Poster_FINAL.pdf">https://mirumpharma.com/wp-content/uploads/2025/09/FXS-NDD-2025-Mouse-Model-Poster_FINAL.pdf)</a>, volixibat in PSC&nbsp; (<a href="https://s29.q4cdn.com/633867992/files/doc_presentations/2024/Jun/Mirum-VISTAS-and-VANTAGE-Interim-Analysis-Results-Presentation.pdf">https://s29.q4cdn.com/633867992/files/doc_presentations/2024/Jun/Mirum-VISTAS-and-VANTAGE-Interim-Analysis-Results-Presentation.pdf)</a> and PBC (<a href="https://mirumpharma.com/wp-content/uploads/2025/05/Heneghan-M-EASL-2025-VANTAGE-28-week-data-with-volixibat-in-PBC.pdf">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://www.natap.org/2025/AASLD/AASLD_22.htm">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://clinicaltrials.gov/study/NCT06553768">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://www.hepb.org/research-and-programs/hepdeltaconnect/what-is-hepatitis-delta/">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>

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

What were the biggest clinical trial flops of 2025?

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