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Madrigal signs a $4.4B deal with a Chinese RNAi company & FDA refuses to file Moderna's vaccine

AuthorAuthor

Joachim Eeckhout & Eduardo Longoria
February 12, 2026

 

Good morning!

San Diego– and Shanghai–based GluBio Therapeutics is advancing two molecular glue drugs designed to boost fetal hemoglobin. These drugs could offer a cheaper and simpler alternative to expensive and complicated gene editing therapies for sickle cell disease and beta thalassaemia.

Why it matters: GluBio’s candidates are chronic oral therapies that mimic the biology behind CRISPR/Vertex’s $2.2M gene editing treatment, Casgevy, but without the one-time, high-complexity procedure. GluBio will run a Phase 1a in China — faster and at a fraction of U.S. cost — a structure that clearly appealed to Sanofi, which invested $30 million in GluBio for a front-row seat and first rights to negotiate a license.

Bottom line: With only ~60 patients treated so far with Casgevy compared to a population of around 100,000 patients just in the U.S., the commercial runway for alternatives looks wider than expected, and the sickle cell story may not end with gene editing.

—Joachim E.

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SNAPSHOT

Madrigal extends its MASH pipeline in a $4.4B deal with a Chinese RNAi company

Madrigal Pharmaceuticals licensed six preclinical RNA interference (RNAi) programs from China’s Suzhou Ribo Life Science in a deal worth up to $4.4 billion, aiming to expand its pipeline for the liver disease Metabolic Dysfunction-Associated Steatohepatitis (MASH).

Why it matters: As competition intensifies in the fast-growing MASH market, Madrigal is moving to strengthen its position beyond its approved drug, Rezdiffra, by targeting the disease with next-generation gene-silencing therapies.

Backstory: Madrigal became the first company to win U.S. approval for a MASH treatment with Rezdiffra, a milestone after years of industry failures. Despite skepticism about the market’s size, Rezdiffra sales have exceeded expectations, and increased awareness has driven up to a 50% rise in diagnoses since launch. Meanwhile, Novo Nordisk expanded Wegovy’s approval into MASH and acquired Akero Therapeutics for $4.7 billion, signaling escalating competition.

Big picture: MASH, once called NASH, is emerging as a major biotech battleground. Drugmakers are racing to develop combination therapies that target multiple biological drivers of the disease, mirroring strategies used in cancer and metabolic disorders.

Zoom in: Madrigal will pay $60 million upfront and up to $4.4 billion in milestone payments. The six RNAi candidates are preclinical and designed to silence genes that produce proteins linked to MASH. Madrigal plans to test them in combination with Rezdiffra. The deal marks its second partnership with a China-based biotech and brings its MASH pipeline to more than 10 programs.

What’s next: Madrigal will advance the RNAi candidates into clinical testing while positioning Rezdiffra as a foundational therapy amid growing competitive pressure.

SNIPPETS

What’s happening in biotech today?

🛑 FDA snub: The FDA has declined to review Moderna’s application for its mRNA-based influenza vaccine, mRNA-1010, issuing a “refuse-to-file” letter stating that the Phase 3 trial was not “adequate and well-controlled” because the comparator vaccine did not reflect the best available standard of care at the time, though no safety or efficacy concerns were cited. Moderna publicly disputed the decision, arguing it contradicts prior FDA guidance and noting it had also submitted data using a high-dose comparator. The setback comes amid heightened scrutiny of mRNA vaccines under HHS Secretary Robert F. Kennedy Jr., creating further uncertainty for Moderna’s pipeline, including its planned combination COVID-flu shot and long-term financial outlook.

🇨🇭 Swiss spotlight: Araris Biotech AG, a Zurich-based oncology company now owned by Japan’s Taiho Pharmaceutical, has expanded its collaboration with Chugai Pharmaceutical, a Roche subsidiary, through a research agreement and exercised an option-to-license focused on next-generation antibody–drug conjugates (ADCs) using Araris’ platform. The deal includes upfront, development, regulatory, and commercial milestone payments worth up to $780 million, plus royalties on net sales. Araris will develop novel ADCs using antibodies provided by Chugai, which will fund research and assume responsibility for development and commercialization upon exercising the license.

🤝 Rare deal: French biopharma THX Pharma has signed a licensing agreement with Biocodex worth up to €173 million, including €12 million upfront, up to €161 million in milestones, and double-digit tiered royalties, to develop two drug candidates targeting three rare genetic disorders. Biocodex gains exclusive global rights to Batten-1, a Phase 3–ready candidate for juvenile Batten disease, and U.S. and Canadian rights to TX01, aimed at Gaucher disease type 1 and Niemann-Pick type C. THX Pharma will lead clinical development, while Biocodex will support development and manage commercialization in licensed territories, aiming to address significant unmet needs in rare pediatric diseases.

 🦠 Microbiome win: Microbiotica reported positive phase 1b results for its oral precision microbiome therapy MB310 in mild-to-moderate ulcerative colitis, with 63% of treated patients achieving clinical remission compared to 30% on placebo in a 29-patient study. The therapy, a consortium of eight commensal bacterial strains, met primary and secondary endpoints for safety, efficacy signals, and bacterial engraftment, with rapid and sustained colonization observed and improvements in histological markers and inflammatory biomarkers. All treated patients entering follow-up maintained remission. The company plans to advance MB310 into larger Phase 2/3 trials and explore partnering and financing options in 2026.

💉 Dose dilemma: Upstream Bio’s phase 2 trial of its TSLP receptor antagonist verekitug in severe asthma met its primary endpoint, with a 56% reduction in annualized asthma exacerbation rate (AAER) at 100 mg dosed every 12 weeks, comparable to AstraZeneca and Amgen’s Tezspire. However, the 24-week regimens showed weaker results, with the 400-mg dose achieving a 39% AAER reduction, falling short of investor hopes for strong efficacy with less frequent dosing. The outcome matched management’s base-case expectations but disappointed markets seeking best-case performance, sending shares down 23%. Upstream now plans to select a single dose for phase 3 amid competition from other long-acting TSLP-targeting therapies.

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