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Madrigal Q1 Earnings Beat, MASH Drug Sales Drive Top Line, Stock Up

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Key Takeaways

  • MDGL posted Q1 revenues of $311.3M, fueled entirely by strong Rezdiffra sales growth in MASH.
  • Rezdiffra reached 42,250 treated patients by March-end, up 2.5 times from Q1 2025 levels.
  • Madrigal is advancing multiple late-stage Rezdiffra studies, with key data expected in 2027 and 2028.

Madrigal Pharmaceuticals (MDGL - Free Report) reported first-quarter 2026 loss of $3.25 per share, narrower than the Zacks Consensus Estimate of a loss of $3.61. In the same quarter last year, the company had incurred a loss of $2.61 per share.

In the first quarter, MDGL generated total revenues of $311.3 million, up significantly year over year, entirely from product sales of its metabolic dysfunction-associated steatohepatitis (MASH) drug Rezdiffra (resmetirom), which was approved in 2024. The metric beat the Zacks Consensus Estimate of $301 million. Rezdiffra is the first marketed drug in MDGL’s portfolio, which was launched in April 2024 and posted significant year-over-year growth, driven by increased demand.

Madrigal shares gained 7.4% on Wednesday, as investors were impressed by the better-than-expected earnings results.

MDGL’s Q4 Results in Detail

In March 2024, the FDA granted accelerated approval to Rezdiffra, making it the first and currently the only approved therapy for the MASH indication. The eligible patient population includes adults with noncirrhotic MASH with moderate to advanced liver fibrosis. Rezdiffra has also received conditional approval as the first and only therapy in the EU to treat adults with noncirrhotic MASH with moderate-to-advanced liver fibrosis. Per Madrigal, more than 42,250patients are receiving the treatment as of March 31, 2026, up 2.5 times from first-quarter 2025, reflecting continued strong physician adoption and high patient demand.

During the quarter, research and development expenses more than doubled to $108.7 million in the first quarter of 2026. The massive increase can be primarily attributed to one-time, upfront business development expenses of $54.3 million.

Year to date, Madrigal shares have lost 7.3% against the industry’s 0.9% growth.

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Selling, general and administrative expenses also nearly doubled in the reported quarter to $268.5 million. This exponential rise was on account of increased commercial launch activities for Rezdiffra, including significant increases in headcount to support marketing efforts.

Madrigal had cash, cash equivalents and marketable securities worth $817.9 million as of March 31, 2026, compared with $988.6 million as of Dec. 31, 2025.

MDGL’s Pipeline & Other Updates

As the FDA and EU approved Rezdiffra under the accelerated pathway, the continued approval will be based on promising long-term safety and efficacy data from the pivotal phase III MAESTRO-NASH biopsy study. This late-stage study, which provided the data for the drug's accelerated approval for MASH, is ongoing as an outcomes study, with data expected in 2028. The goal is to generate confirmatory 54-month data to verify the drug's clinical benefits and support full approval for the noncirrhotic MASH indication.

In addition to the study, a second phase III outcomes study (MAESTRO-NASH OUTCOMES) is underway, evaluating the progression to liver decompensation events in patients with compensated MASH cirrhosis treated with Rezdiffra compared with placebo. Top-line data is expected in 2027. A positive outcome from this study is also expected to support the full approval of Rezdiffra for noncirrhotic MASH and expand the eligible patient population for Rezdiffra with an additional indication.

The open-label extension (OLE) arm of the MAESTRO-NAFLD-1 study is also currently evaluating the drug in patients with compensated MASH cirrhosis. In 2025, Madrigal reported positive two-year data from the OLE arm. The results reinforce Rezdiffra’s potential benefit for patients with compensated MASH cirrhosis and support the ongoing MAESTRO-NASH OUTCOMES study's potential success.

Earlier in 2026, Madrigal also added six preclinical siRNA programs to strengthen its pipeline and advance next-generation, genetically targeted MASH therapies alongside Rezdiffra. Such efforts demonstrate MDGL’s commitment to establishing the drug as the standard-of-care treatment for MASH.

Recently, Madrigal expanded its MASH pipeline through a licensing agreement with Arrowhead Pharmaceuticals for global rights to ARO-PNPLA3, a clinical-stage siRNA candidate targeting the genetically validated PNPLA3 mutation linked to MASH. The asset is aimed at a genetically defined patient population representing roughly 30% of moderate-to-advanced fibrosis cases, with phase I data showing up to a 46% reduction in liver fat after a single high dose in PNPLA3 homozygous patients.

MDGL’s Zacks Rank & Stocks to Consider

Madrigal currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) , Immatics (IMTX - Free Report) and Inovio Pharmaceuticals (INO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have declined from $2.82 to $2.79. CPRX shares have gained 30.8% year to date.

Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.

Over the past 60 days, estimates for Immatics’ 2026 loss per share have narrowed from $1.61 to $1.49. IMTX shares have gained 9.6% year to date.

Immatics’ earnings beat estimates in three of the trailing four quarters and missed on the remaining occasion, delivering an average negative surprise of 8.06%.

Over the past 60 days, estimates for Inovio Pharmaceuticals’ 2026 loss per share have narrowed from $1.26 to $1.06. INO shares have plunged 28.8% year to date.

Inovio Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 57.94%.

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