Thesis

Street consensus, scenarios, merits, risks, and invalidation triggers

AI-assisted
Thesis Summary

Mirum Pharmaceuticals is transitioning from a high-burn clinical-stage biotech into a self-funding, commercial-stage rare disease leader. The company's growth is anchored by the commercial expansion of LIVMARLI in pediatric cholestatic liver diseases and its bile acid portfolio, which together drove $521.3 million in net product sales in 2025. With 2026 sales guidance raised to $660-$680 million, Mirum is entering a catalyst-rich period. Key pipeline assets, including volixibat (PSC/PBC) and brelovitug (HDV), have delivered positive clinical readouts, significantly de-risking their paths to market. Furthermore, the strategic in-licensing of zilurgisertib for FOP introduces a near-term commercial launch opportunity with a PDUFA date in September 2026. While near-term profitability remains impacted by one-time acquisition costs, the underlying commercial unit economics are highly attractive, supporting a path to positive operating cash flow and GAAP profitability by 2027-2028.

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This section is the 12-month view: analyst targets and the probability-weighted scenarios built from them. The intrinsic value at the top of this page answers a different question: what the business is worth today.
Street view · analyst 12-month targets14 analysts · as of 18 Aug 2026
Low · most bearish analyst$118.00
Mean target$138.21
High · most bullish analyst$183.00
Our research · scenarios, merits, risks, and invalidation triggersResearch as of 18 Sep 2026
Scenarios · 12-month scenario targetsAnchored at research date
Bear CaseDownside scenario
$118.00

LIVMARLI sales growth slows due to competitive pressure from Ipsen's Bylvay. The FDA requests additional clinical data for volixibat in PSC, delaying the NDA timeline. Zilurgisertib receives a Complete Response Letter (CRL) or faces severe commercial headwinds due to a highly competitive landscape in FOP. Brelovitug's Phase 3 data fails to show a clear advantage over Gilead's Hepcludex, limiting its market potential and extending the company's cash burn.

Base CaseCentral scenario
$138.21
Matches the consensus mean

LIVMARLI and the bile acid portfolio achieve the raised 2026 guidance of $660-$680 million. Volixibat's NDA in PSC is successfully submitted in H2 2026, leading to approval and launch in late 2027. Zilurgisertib is approved on its September 2026 PDUFA date, contributing to near-term revenue. Brelovitug's Phase 3 trials read out positively in late 2026, keeping the asset on track for a 2027 regulatory filing. The company achieves positive operating cash flow in 2027 and reaches GAAP profitability by 2028.

Bull CaseUpside scenario
$183.00

LIVMARLI continues to outperform expectations globally, particularly through increased identification of adolescent and adult PFIC patients. Volixibat receives accelerated FDA approval in PSC by late 2027, establishing a first-in-class blockbuster franchise. Zilurgisertib is approved in September 2026 and captures a dominant share of the ultra-rare FOP market, while brelovitug's Phase 3 readouts in late 2026 demonstrate superior efficacy over competitors, driving peak sales expectations above $2.5 billion across the portfolio.

Scenarios are anchored to street consensus at the research date, with our probabilities and rationale.

Key Investment Merits
  • Strong commercial execution with LIVMARLI driving 55% YoY growth in Q1 2026, supported by a raised full-year sales guidance of $660-$680 million.
  • De-risked late-stage pipeline with positive Phase 2b readouts for volixibat in PSC (VISTAS) and brelovitug in HDV (AZURE-1).
  • Near-term regulatory catalyst with zilurgisertib's FDA PDUFA date on September 26, 2026, under Priority Review.
  • Robust balance sheet with $420.6 million in cash and investments as of March 31, 2026, providing a strong runway to fund commercial expansion.
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Key Investment Risks
  • Concentration risk with the majority of current revenues dependent on the LIVMARLI franchise.
  • Intense competition in rare liver diseases, particularly from Ipsen's Bylvay and Gilead's Hepcludex.
  • Regulatory and clinical execution risks associated with upcoming NDA submissions and Phase 3 trial readouts.
  • Near-term GAAP unprofitability due to high R&D expenses and one-time acquisition-related costs.
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Thesis Invalidation Triggers
  1. A regulatory rejection (CRL) or significant approval delay for zilurgisertib in September 2026.
  2. Failure of brelovitug's Phase 3 AZURE-1 or AZURE-4 trials to meet primary endpoints in late 2026.
  3. A material slowdown in LIVMARLI sales growth or loss of market share to Ipsen's Bylvay.
  4. Inability to submit the volixibat NDA in PSC in H2 2026 due to regulatory hurdles.
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All scenarios are estimates and subject to change. Past performance is not indicative of future results.

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AI-assisted, source-linked narrative; figures from company filings (SEC EDGAR) and market data. Dates shown per section. Not investment advice. Terms of Use.