We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
MDGL Stock Soars 11% on New Patent Protecting Rezdiffra Dosing Rights
Read MoreHide Full Article
Key Takeaways
MDGL rose 10.9% as a new U.S. patent is set to protect Rezdiffra's FDA-approved dosing regimen.
The patent, valid through 2044, will be listed in the FDA's Orange Book, blocking generic competition.
Over 17,000 patients are already on Rezdiffra as MDGL expands clinical data to support full approval.
Madrigal Pharmaceuticals (MDGL - Free Report) shares soared 10.9% on Wednesday. The uptrend was observed after the U.S. Patent and Trademark Office issued a Notice of Allowance for a new U.S. patent related to the FDA-approved weight-based dosing regimen of MDGL’s only marketed product, Rezdiffra (resmetirom).
In 2024, the FDA granted accelerated approval to Rezdiffra, making it the first and currently the only approved therapy for the metabolic dysfunction-associated steatohepatitis (MASH) indication. The eligible patient population includes adults with noncirrhotic MASH with moderate to advanced liver fibrosis.
The upcoming patent, offering protection until Sept. 30, 2044, will be listed in the FDA’s Orange Book, potentially strengthening Rezdiffra’s market exclusivity. This will ensure that generic versions of the drug cannot enter the market and undercut its sales. Madrigal Pharmaceuticals views this as a major milestone, reinforcing the value of its clinical development efforts and supporting its long-term strategy for treating MASH.
The drug’s commercial launch is off to a strong start in the United States, driven by early patient demand for the drug. Per Madrigal Pharmaceuticals, more than 17,000 patients are currently receiving Rezdiffra treatment as of March 31, 2025.
Year to date, MDGL shares have gained 11.8% compared with the industry’s 6.3% growth.
Image Source: Zacks Investment Research
MDGL’s MASH Clinical Pipeline Progressing Well
Madrigal Pharmaceuticals’ regulatory filing seeking approval for Rezdiffra for the MASH indication is currently under review in the EU. A final decision is expected in August.
As the FDA 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. The goal is to generate confirmatory 54-month data that could verify the clinical benefits and support the full approval of the drug 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 to treat compensated MASH cirrhosis.
The open-label extension (OLE) arm of the MAESTRO-NAFLD-1 study is also currently evaluating the drug in patients with compensated MASH cirrhosis. Two-year data from the OLE arm showed that patients treated with Rezdiffra achieved marked reductions in liver damage.
The results reinforce Rezdiffra’s potential benefit for patients with compensated MASH cirrhosis and support the potential success of the ongoing MAESTRO-NASH OUTCOMES study. These ongoing studies demonstrate Madrigal Pharmaceuticals’ commitment to establishing the drug as the standard-of-care treatment for MASH.
Madrigal Pharmaceuticals, Inc. Price and Consensus
In the past 90 days, Verona Pharma’s bottom-line estimates for 2025 have significantly improved from a loss of 7 cents per share to earnings of 22 cents. During the same timeframe, estimates for 2026 earnings per share have improved from $2.21 to $2.88. VRNA stock has soared 125.5% so far this year.
Verona Pharma’s earnings beat estimates in one of the trailing four quarters and missed the mark on the other three occasions, delivering an average negative surprise of 6.76%.
In the past 90 days, Agenus’ bottom-line estimates for 2025 have significantly improved from a loss of $4.66 per share to earnings of $1.56. During the same timeframe, estimates for 2026 loss per share have narrowed from $5.02 to $1.99. AGEN stock has surged 132.1% so far this year.
Agenus’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%.
BAYRY’s 2025 earnings per share estimate has increased from $1.19 to $1.30 for 2025 over the past 90 days, while that for 2026 has gone up from $1.28 to $1.35 over the same timeframe. Year to date, shares of Bayer have surged 65.6%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
MDGL Stock Soars 11% on New Patent Protecting Rezdiffra Dosing Rights
Key Takeaways
Madrigal Pharmaceuticals (MDGL - Free Report) shares soared 10.9% on Wednesday. The uptrend was observed after the U.S. Patent and Trademark Office issued a Notice of Allowance for a new U.S. patent related to the FDA-approved weight-based dosing regimen of MDGL’s only marketed product, Rezdiffra (resmetirom).
In 2024, the FDA granted accelerated approval to Rezdiffra, making it the first and currently the only approved therapy for the metabolic dysfunction-associated steatohepatitis (MASH) indication. The eligible patient population includes adults with noncirrhotic MASH with moderate to advanced liver fibrosis.
The upcoming patent, offering protection until Sept. 30, 2044, will be listed in the FDA’s Orange Book, potentially strengthening Rezdiffra’s market exclusivity. This will ensure that generic versions of the drug cannot enter the market and undercut its sales. Madrigal Pharmaceuticals views this as a major milestone, reinforcing the value of its clinical development efforts and supporting its long-term strategy for treating MASH.
The drug’s commercial launch is off to a strong start in the United States, driven by early patient demand for the drug. Per Madrigal Pharmaceuticals, more than 17,000 patients are currently receiving Rezdiffra treatment as of March 31, 2025.
Year to date, MDGL shares have gained 11.8% compared with the industry’s 6.3% growth.
Image Source: Zacks Investment Research
MDGL’s MASH Clinical Pipeline Progressing Well
Madrigal Pharmaceuticals’ regulatory filing seeking approval for Rezdiffra for the MASH indication is currently under review in the EU. A final decision is expected in August.
As the FDA 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. The goal is to generate confirmatory 54-month data that could verify the clinical benefits and support the full approval of the drug 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 to treat compensated MASH cirrhosis.
The open-label extension (OLE) arm of the MAESTRO-NAFLD-1 study is also currently evaluating the drug in patients with compensated MASH cirrhosis. Two-year data from the OLE arm showed that patients treated with Rezdiffra achieved marked reductions in liver damage.
The results reinforce Rezdiffra’s potential benefit for patients with compensated MASH cirrhosis and support the potential success of the ongoing MAESTRO-NASH OUTCOMES study. These ongoing studies demonstrate Madrigal Pharmaceuticals’ commitment to establishing the drug as the standard-of-care treatment for MASH.
Madrigal Pharmaceuticals, Inc. Price and Consensus
Madrigal Pharmaceuticals, Inc. price-consensus-chart | Madrigal Pharmaceuticals, Inc. Quote
MDGL’s Zacks Rank and Stocks to Consider
Madrigal Pharmaceuticals currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Verona Pharma (VRNA - Free Report) , Agenus (AGEN - Free Report) and Bayer (BAYRY - Free Report) . While VRNA sports a Zacks Rank #1 (Strong Buy), AGEN and BAYRY carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 90 days, Verona Pharma’s bottom-line estimates for 2025 have significantly improved from a loss of 7 cents per share to earnings of 22 cents. During the same timeframe, estimates for 2026 earnings per share have improved from $2.21 to $2.88. VRNA stock has soared 125.5% so far this year.
Verona Pharma’s earnings beat estimates in one of the trailing four quarters and missed the mark on the other three occasions, delivering an average negative surprise of 6.76%.
In the past 90 days, Agenus’ bottom-line estimates for 2025 have significantly improved from a loss of $4.66 per share to earnings of $1.56. During the same timeframe, estimates for 2026 loss per share have narrowed from $5.02 to $1.99. AGEN stock has surged 132.1% so far this year.
Agenus’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%.
BAYRY’s 2025 earnings per share estimate has increased from $1.19 to $1.30 for 2025 over the past 90 days, while that for 2026 has gone up from $1.28 to $1.35 over the same timeframe. Year to date, shares of Bayer have surged 65.6%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.