SNAPSHOT

Madrigal touts Rezdiffra’s breakout year as Novo’s Wegovy enters the MASH market

Madrigal’s Rezdiffra generated $958.4M in 2025 sales and reached 36,250 patients, as the company welcomes Novo Nordisk’s Wegovy into the MASH market and projects long-term growth despite investor concerns.

Backstory: Rezdiffra received approval in 2024 as the first treatment for metabolic dysfunction-associated steatohepatitis (MASH). 2025 was its breakout year, with Q4 sales more than tripling compared to the same period the previous year.

Yes, but: Last summer, Novo’s GLP-1 blockbuster Wegovy added a MASH indication, raising questions about competitive pressure. Investors reacted cautiously to Madrigal’s latest earnings, sending shares down 8% after a wider-than-expected loss.

Big picture: Madrigal argues that competition could expand, not shrink, the MASH market, similar to how multiple therapies fueled growth in psoriasis and inflammatory bowel disease. The company sees decades of runway in a largely untapped category.

Zoom in: The company is building a broader MASH pipeline, including combination strategies, aiming to establish long-term leadership as the category evolves. Rezdiffra is performing so well that CEO Bill Sibold called it the “best launch” of his career, and that’s saying a lot from someone who was once part of the launch team for Sanofi and Regeneron’s blockbuster Dupixent.

What’s next: Madrigal is advancing a phase 3 trial in compensated MASH cirrhosis, with data expected in 2027. Approval could expand Rezdiffra’s addressable market by 245,000 patients.

SNIPPETS

What’s happening in biotech today?

🕯️ Light a candel: Candel Therapeutics has secured a conditional $100M non-dilutive financing deal from RTW Investments to support the planned U.S. launch of its prostate cancer therapy, aglatimagene besadenovec (CAN-2409), pending FDA approval. The funding is tied to approval in intermediate- to high-risk localized prostate cancer, with Candel aiming to submit its biologics license application in the fourth quarter. In exchange, RTW will receive tiered single-digit royalties on U.S. net sales, subject to a cap. The therapy, an adenovirus-based injection administered into the prostate, showed a 14.5% relative improvement in disease-free survival in phase 3 trials. Candel is also pursuing additional financing through a loan facility and a planned public stock offering.

 📉 Trial flop: Novartis has discontinued development of its anti-cancer protein QEQ278 after a phase 1 trial in 30 patients with advanced solid tumors showed no objective responses and worsening disease in most participants, though no safety concerns were identified. The candidate, designed to target NKG2D ligands to enhance natural killer cell recognition of tumors, had previously shown limited efficacy, and its removal from the pipeline was decided in 2024, with the trial status only recently updated after the final participant ended treatment. The setback reflects broader challenges in targeting NKG2D pathways, as other companies have also abandoned similar programs, while Biogen separately discontinued a combination arm of an MS trial for strategic reasons.

🇮🇳 India exit: Novartis is keeping busy by selling its 70.68% stake in Novartis India Limited, a Bombay Stock Exchange-listed unit focused on older and off-patent medicines, to a consortium of private equity firms for about $159M, with the buyers also offering to acquire up to an additional 26% from public shareholders. The move follows a 2024 strategic review and aligns with Novartis’ shift toward innovative medicines after spinning off Sandoz in 2023. While exiting this legacy drugs business, Novartis will retain its separate commercial operations, R&D teams and corporate center in India.

🍷 Tis but a scratch: Grail’s shares fell more than 45% after the company announced that its large NHS-Galleri trial of the Galleri multi-cancer blood test failed to achieve its primary endpoint of significantly reducing late-stage (stage 3 and 4) cancers compared with standard care in 142,000 participants. However, the company reported favorable trends in a prespecified group of 12 deadly cancers, including reductions in stage IV diagnoses of more than 20% in later screening rounds and increased detection of earlier-stage cancers. Grail plans to extend follow-up by 6–12 months to assess longer-term effects. The trial remains central to potential FDA approval and a possible U.K. national screening program.

 ✅ Green mark: The FDA has approved AstraZeneca’s Calquence (acalabrutinib) in combination with AbbVie and Roche’s Venclexta (venetoclax) as the first all-oral, fixed-duration regimen for previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, offering a 14-month alternative to much longer BTK inhibitor therapies. The approval is based on the phase 3 Amplify trial, where the combination reduced the risk of disease progression or death by 35% versus chemoimmunotherapy, with fewer deaths observed at 41 months’ follow-up. The decision intensifies competition with BeOne’s Brukinsa, which has recently surpassed Calquence in sales, as BeOne advances its own fixed-duration BTK/BCL-2 combination and questions the strength of AstraZeneca’s data.

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