SNAPSHOT

Zenas drug trial success fails to impress Wall Street, shares crash 55%

Zenas BioPharma’s drug obexelimab met its trial goals for treating IgG4-related disease, but underwhelmed investors due to lower efficacy when compared to rival Amgen’s Uplizna.

Why it matters: The disappointing results cast doubt on obexelimab’s commercial viability, slashing Zenas’ market value and raising uncertainty about its future in a competitive market. This could prove particularly costly as the company has already secured a $300M royalty deal with Royalty Pharma, including $75M upfront and milestone-based payments tied to trial success and FDA approval.

Backstory: IgG4-related disease is a rare autoimmune condition. Until 2025, it was treated with steroids or off-label use of older drugs like Rituxan. Amgen’s Uplizna was the first drug specifically approved for it, setting a high bar for competitors.

Zoom in: Zenas enrolled 194 patients in the Phase 3 trial in which Obexelimab showed to reduce flare-up risk by 56%, achieving statistical success.

Yes, but: Unfortunately for Zenas, Amgen’s Uplizna showed an 87% risk reduction in its trials. Analysts suggested a 65% reduction was needed for obexelimab to be considered commercially viable. Despite unique features, like in-home dosing and possibly lower infection risk, obexelimab may struggle to gain traction.

Big picture: The outcome highlights the challenges biotech firms face when launching new therapies into markets with recently approved, highly effective treatments. Even successful trials can fail commercially if the drug doesn't clearly outperform rivals.

What’s next: Zenas plans to file for FDA approval in Q2 2026. Its multiple sclerosis program is ongoing, but approval is likely years away.

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SNIPPETS

What’s happening in biotech today?

🚀 IPO ignition: Aktis Oncology is targeting up to $209.6 million from what may be the first American biotech IPO of 2026. The company plans to allocate $140–$150 million to fund its ongoing Phase 1b trial of Ac-AKY-1189 for Nectin-4 expressing tumors, and $70–$80 million for a Phase 1b trial of its second asset, Ac-AKY-2519, targeting B7-H3. Backed by major pharma investors, Aktis specializes in miniprotein radiopharmaceuticals and expects the IPO funds to support operations through mid-2028.

 🤝 Autoimmune alliance: Sanofi has entered a new partnership with AI-driven biotech Earendil Labs, committing $160 million in upfront and near-term milestone payments to develop multiple bispecific antibody programs for autoimmune and inflammatory diseases. The deal could reach a total value of $2.56 billion, including additional milestone payments and tiered royalties of up to low double-digit percentages on future product sales. Sanofi will oversee the development and global commercialization of all resulting candidates. This follows a previous 2025 collaboration involving bispecifics targeting ulcerative colitis and skin inflammation. The move reflects Sanofi’s broader strategy to expand its immunology pipeline through significant biotech partnerships.

 💉 Slim shot: MetaVia reported 9.1% average weight loss over 54 days in a phase 1 trial of its dual GLP-1/glucagon agonist, DA-1726, in adults with obesity, alongside reductions in waist circumference and liver stiffness. The once-weekly subcutaneous therapy also improved fasting glucose levels and showed mild to moderate gastrointestinal side effects, with no treatment-related discontinuations. The company plans 16-week studies with faster titration regimens up to 64 mg, aiming to differentiate its candidate through dosing convenience and its unique 3:1 GLP-1 to glucagon ratio. Despite the promising data, MetaVia’s stock fell 9%, reflecting investor caution amid strong competition from more advanced obesity treatments.

⛔ Cooperation cancellation: TME Pharma has announced the termination of its ophthalmology collaboration with the Singapore Eye Research Institute (SEPI), just seven months after the partnership was established to advance the anti-CCL2 RNA aptamer NOX-E36 into clinical trials. The financially struggling biotech, which ended 2025 with only $2 million in cash, now plans to initiate lower-cost animal studies to validate NOX-E36 for local administration in glaucoma surgery. TME emphasized the breakup was unrelated to the drug’s potential and is pursuing new partnerships. Its brain cancer asset, NOX-A12, remains in a paused phase 1/2 trial pending a new partner, with strategic updates expected soon.

🧬 Cancer collab: Insilico Medicine has entered a multi-year research and development collaboration with Servier, valued at up to $888 million, to discover and develop new oncology therapies using Insilico’s AI-driven drug discovery platforms. The agreement includes up to $32 million in upfront and near-term research payments, with Insilico leading early discovery and Servier assuming responsibility for clinical validation, regulatory activities, and global commercialization. The partnership targets difficult cancer indications and leverages Insilico’s proven ability to rapidly generate preclinical candidates, having nominated 20 between 2021 and 2024. Both companies will share R&D costs throughout the collaboration.

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