EU Panel Backs Conditional Approval for Liver Disease Drug Rezdiffra

Health care stocks were rising premarket Friday with the iShares Biotechnology ETF up 0.9% and the Health Care Select Sector SPDR Fund 0.3% higher recently.

Regeneron Pharmaceuticals and Sanofi said the US Food and Drug Administration approved Dupixent for the treatment of adult patients with bullous pemphigoid. Shares of Sanofi and Regeneron Pharmaceuticals were up 1% pre-bell.

Madrigal Pharmaceuticals shares were up nearly 2% after the company said it received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for resmetirom to treat noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis.

Evolent Health shares were nearly 2% higher after the company reiterated its Q2 and 2025 adjusted earnings before interest, taxes, depreciation and amortization guidance.

The broad market exchange-traded fund, SPDR S&P 500 ETF Trust , was up 0.2% and the actively traded Invesco QQQ Trust rose 0.2% in Friday's premarket activity, as geopolitical tensions in the Middle East intensify and uncertainty surrounding tariffs and Fed interest-rate guidance adds to investor nervousness.

US stock futures were narrowly mixed with S&P 500 Index futures down 0.1%, Dow Jones Industrial Average futures slipping 0.2%, and Nasdaq futures inching up 0.1% before the start of regular trading.

The Philadelphia Fed Manufacturing Index for June will be released at 8:30 am ET, followed by the May leading indicators report at 10 am ET.

The weekly Baker Hughes oil-and-gas rig count posts at 1 pm ET.

In premarket action, bitcoin was up by 1.6% and the cryptocurrency fund ProShares Bitcoin Strategy ETF was 2% higher.

Power Play:

Industrial

Industrial Select Sector SPDR Fund advanced 0.2% while the Vanguard Industrials Index Fund and the iShares US Industrials ETF (IYJ) were inactive.

GMS stock was up more than 28% before the opening bell after the company said it received an unsolicited $95.20 acquisition proposal from QXO . Home Depot has also submitted a proposal, according to multiple media reports.

Winners and Losers:

Technology

Technology Select Sector SPDR Fund rose 0.1%, and the iShares US Technology ETF was flat, while the iShares Expanded Tech Sector ETF was down 0.9%. Among semiconductor ETFs, SPDR S&P Semiconductor ETF rose 0.2%, while the iShares Semiconductor ETF rose by 0.5%.

Wallbox shares were up more than 10% in recent Friday premarket activity after the company said Thursday it is collaborating with PowerGo to deploy AC and DC electrical vehicle charging infrastructure at Essendi hotels in the Netherlands.

Financial

Financial Select Sector SPDR Fund advanced 0.02%. Direxion Daily Financial Bull 3X Shares was up 0.5%%, while its bearish counterpart Direxion Daily Financial Bear 3X Shares was 0.4% lower.

FinVolution Group shares were down 1% pre-bell Friday after the company said Thursday that it is planning a private offering of $130 million principal amount of convertible senior notes due 2030.

Health Care

The Health Care Select Sector SPDR Fund rose 0.4%. The Vanguard Health Care Index Fund was down less than 0.1% while the iShares US Healthcare ETF rose 0.07%. The iShares Biotechnology ETF was 0.2% higher.

Madrigal Pharmaceuticals stock was up nearly 3% premarket after the company said it received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for resmetirom to treat noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis.

Consumer

The Consumer Staples Select Sector SPDR Fund was up 0.2%, while the Vanguard Consumer Staples Fund was marginally lower. The iShares US Consumer Staples ETF was inactive, and the Consumer Discretionary Select Sector SPDR Fund gained 0.4%. The VanEck Retail ETF was inactive, while the SPDR S&P Retail ETF was up 0.1%

Tesla shares were up more than 1% pre-bell ahead of the tentatively scheduled Sunday launch of its autonomous Robtaxi service in Austin, Texas.

Energy

The iShares US Energy ETF was down 0.6%, while the Energy Select Sector SPDR Fund was up by 0.1%.

Commodities

Front-month US West Texas Intermediate crude oil gained 0.2% to $75.27 per barrel on the New York Mercantile Exchange. Natural gas was up 2.4% to $4.09 per 1 million British Thermal Units. United States Oil Fund was 0.2% higher, while the United States Natural Gas Fund increased by 2%.

Gold futures for August retreated 1.3% to $3,363 an ounce on the Comex, while silver futures declined by 2.4% to $36.35 an ounce. SPDR Gold Shares was down 0.5%, and the iShares Silver Trust fell 1.4%.

By Colin Kellaher

Madrigal Pharmaceuticals said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of its Rezdiffra treatment for adults with the liver disease noncirrhotic MASH who have moderate to advanced fibrosis.

Madrigal on Friday said a green light would make Rezdiffra the first medication approved in the E.U. for MASH, which is the fastest-growing indication for liver transplantation in Europe.

The West Conshohocken, Pa., biopharmaceutical company said it expects a final decision from the European Commission, which generally follows the CHMP's advice, in the August.

The U.S. Food and Drug Administration in March 2024 granted accelerated approval to Rezdiffra, which generated sales of more than $137 million in the first quarter of 2025.

Write to Colin Kellaher at colin.kellaher@wsj.com

Madrigal Pharmaceuticals said Friday it received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for resmetirom to treat noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis.

The recommendation followed positive results from the phase 3 Maestro-Nash trial, showing both fibrosis reduction and MASH resolution, the company said.

If approved by the European Commission in August, resmetirom will be the first treatment for MASH in the EU, Madrigal said.

The drug has also been approved by the Food and Drug Administration for MASH in the US, under certain conditions, the company added.

Madrigal shares rose by more than 1.5% in recent Friday premarket activity.