SNAPSHOT

Takeda’s $4B psoriasis pill shows blockbuster promise in major trials

Takeda’s experimental drug zasocitinib succeeded in two Phase 3 psoriasis studies, showing superior results to placebo and Amgen’s Otezla.

Why it matters: This sets Takeda up to challenge Bristol Myers Squibb’s Sotyktu in the competitive TYK2 inhibitor market, potentially reshaping treatment for plaque psoriasis and other autoimmune diseases.

Backstory: Takeda acquired zasocitinib from Nimbus Therapeutics in 2022 for $4B after promising Phase 2 results. It was one of the biggest single-drug biotech deals in recent years.

Big picture: The race is heating up for safe, oral alternatives to blockbuster injectable autoimmune drugs like Humira. TYK2 inhibitors are emerging as strong contenders, with BMS’s Sotyktu having already been approved for psoriasis in 2022.

Zoom in: Zasocitinib met its co-primary goals. In two trials of 693 and 1,108 patients with moderate-to-severe plaque psoriasis, ≥75% showed reduction in PASI scores (measuring skin lesions) and improved sPGA ratings (severity of the disease) after 4 months. Over 50% of patients had “clear or almost clear” skin, with 30% showing “completely clear” skin.

What’s next: Takeda plans to file for U.S. and global approvals in 2026 and will present detailed trial data at an upcoming medical meeting. Head-to-head studies vs. BMS’s Sotyktu are also underway. Though that is not where the competition stops; Johnson & Johnson and Protagonist also have a psoriasis drug under review that zasocitinib will need to contend with.

SNIPPETS

What’s happening in biotech today?

💸 AML funding: Orum Therapeutics has raised approximately $100M ($145B Korean won) in a funding round led by KB Investments to advance its lead drug candidate, ORM-1153, into clinical testing for acute myeloid leukemia (AML). The biotech, which develops “degrader-antibody conjugates” combining antibody-drug conjugates (ADCs) with protein degraders, shifted focus to ORM-1153 after halting development of its previous lead due to liver toxicity concerns. ORM-1153 targets CD123, a protein commonly overexpressed in AML, and could enter clinical trials by late 2026. Orum also holds partnerships with BMS and Vertex Pharmaceuticals and completed a South Korean IPO earlier in 2025.

 🤝 ASO alliance: GSK has entered a collaboration with CAMP4 Therapeutics, paying $17.5M upfront to co-develop antisense oligonucleotide (ASO) therapies targeting regulatory RNAs (regRNAs) for neurodegenerative and kidney diseases. The deal allows GSK to apply CAMP4's platform to identify regRNAs that modulate gene expression, enabling the creation of ASO candidates aimed at boosting the activity of underperforming genes. GSK will handle development and commercialization, with additional milestone payments and tiered royalties involved. The partnership aligns with GSK’s ongoing investment in antisense technologies, complementing its previous collaborations with companies like Ionis and Wave Life Sciences.

💃 $1B dream: Athira Pharma has acquired near-global rights to lasofoxifene, a selective estrogen receptor modulator originally developed by Pfizer, through a licensing deal with Sermonix Pharmaceuticals. Pfizer returned the asset after a 2009 FDA rejection, and Sermonix later repositioned it for oncology, launching a phase 3 trial in ER-positive, HER2-negative breast cancer with ESR1 mutations. Athira is supporting development with a $34.9M equity investment, $16.8M in service payments, and ongoing monthly payments credited toward up to $100M in milestones. Backed by a $90M private placement, Athira aims to commercialize lasofoxifene, which could achieve $1B in U.S. peak sales.

🛟 Vaccine lifeline: After losing U.S. government funding, Moderna has secured up to $54.3M from the Coalition for Epidemic Preparedness Innovations (CEPI) to support a phase 3 trial of its mRNA-based H5 pandemic influenza vaccine, mRNA-1018. The study, beginning in early 2026 in the U.S. and U.K., builds on positive phase 1/2 results and aligns with CEPI’s 100 Days Mission for pandemic preparedness. As part of the agreement, Moderna will reserve 20% of its vaccine manufacturing for low- and middle-income countries at affordable pricing. The deal provides a critical path forward after the U.S. Department of Health and Human Services canceled major BARDA contracts earlier in 2025.

🦠 Hep D duo: Vir Biotechnology has licensed European, Australian, and New Zealand rights to its hepatitis D combination therapy, tobevibart and elebsiran, to Norgine in a deal worth up to €550M ($645M). Norgine will pay €55M upfront and cover 25% of external costs for Vir’s ongoing clinical trials, including a head-to-head phase 2b study against Gilead’s bulevirtide. Vir retains rights in the U.S. and other markets outside greater China, aiming to extend its cash runway through late 2027. Mid-stage data showed strong antiviral activity, and the partnership is intended to support global commercialization of the dual-mechanism therapy in a limited-treatment market.

SNAP AGAIN

DBV’s Phase 3 win puts peanuts back on the menu

DBV Technologies’ Viaskin patch succeeded in a pivotal Phase 3 trial, reviving its bid for FDA approval five years after a rejection.

Why it matters: If approved, Viaskin could offer a simpler, needle-free option for desensitizing children to peanuts by gently retraining their immune system. This matters even more as allergy rates rise and existing therapies struggle to gain traction.

Backstory: Viaskin was rejected by the FDA in 2020 over concerns about patch adhesion and efficacy data. Previous efforts in 2017 and 2018 also failed, but DBV persisted through redesigns, a clinical hold, and new trials and raised up to $307M this year alone to fund development.

Big picture: Palforzia, the only FDA-approved peanut allergy treatment, faced limited uptake and will be discontinued in 2026. Viaskin could fill that gap with a more convenient alternative for families.

Zoom in: The trial, dubbed Vitesse, enrolled 654 children ages 4–7. After 12 months, 47% of Viaskin-treated kids met response criteria vs. 15% on placebo. Two children had anaphylaxis but remained on therapy; no serious treatment-related events were reported. Most side effects were mild-to-moderate skin reactions.

What’s next: DBV plans to resubmit to the FDA in early 2026, aiming for approval in children aged 4 to 7. Viaskin might even qualify for priority review due to its breakthrough therapy status.

SPEED READ

More news

• FoRx Therapeutics raised US$50M in Series A funding to advance its PARG inhibitor FORX-428 through Phase I trials targeting PARP-resistant solid tumours by mid-2026.

• Insmed’s stock fell nearly 17% after its drug brensocatib failed a Phase 2 trial for chronic rhinosinusitis, halting momentum despite strong lung disease sales and a new acquisition.

• Daiichi Sankyo and Merck's Phase 3 trial of antibody-drug conjugate I-DXd for small cell lung cancer is under partial FDA hold after unexpected patient deaths from interstitial lung disease.

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