SNAPSHOT

FDA clears first-ever anti-APRIL drug for rare kidney disease

Otsuka’s Voyxact has become the first FDA-approved anti-APRIL therapy for IgA nephropathy (IgAN), a rare autoimmune kidney disease.

Why it matters: This approval introduces a new treatment option for a disease that still leads to kidney failure despite existing therapies, impacting up to 130,000 U.S. patients and opening a multibillion-dollar market.

Backstory: Otsuka acquired the drug—scientifically known as sibeprenlimab—through its 2018 purchase of Visterra. The treatment, now called Voyxact, is administered monthly via self-injection.

Big picture: The market for IgAN treatments is rapidly heating up, with major players like Vertex, Biogen, and Novartis pursuing similar therapies.

Zoom in: Voyxact works by blocking APRIL, a protein driving IgAN progression. In late-stage trials, it reduced proteinuria by 51% over nine months, compared to a 2% increase in the placebo group. Side effects included infections and injection site reactions. Final data on kidney function impact (eGFR) is expected in 2026.

What's next: Ongoing trial results will further clarify Voyxact’s long-term impact. Vera Therapeutics’ competing APRIL/BAFF blocker, atacicept, could join the market as early as next year.

SNIPPETS

What’s happening in biotech today?

🏆 IgAN win: And still in the IgAN field, Renalys Pharma has reported positive top-line results from its Phase III trial of sparsentan (RE-021), a dual endothelin and angiotensin II receptor antagonist, in Japanese patients with IgAN. The study’s primary endpoint, percent change from baseline in 24-hour urine protein-to-creatinine ratio after 36 weeks, showed a significant reduction of 58.54%, confirming the drug’s efficacy. Sparsentan was well-tolerated, with no new safety concerns identified in the Japanese population. Based on these findings, Renalys plans to file a New Drug Application in Japan in 2026, aiming to bring a new therapeutic option to patients with IgAN.

🧠 CNS no more: SK Biopharmaceuticals has expanded its oncology pipeline by licensing the global rights to WT-7695, a preclinical radiopharmaceutical targeting carbonic anhydrase IX (CA9), from the Wisconsin Alumni Research Foundation. WT-7695, developed in collaboration with the University of Wisconsin-Madison, is a small molecule that binds to CA9, a protein highly expressed in clear cell renal cell carcinoma and other solid tumors. The acquisition follows SK’s earlier deal for another radiopharmaceutical, SKL35501, and marks a strategic move into oncology beyond its central nervous system focus. SK plans to conduct global clinical trials in the US, aiming to develop WT-7695 as a best-in-class therapy.

📝 Protocol tweak: The FDA has delayed its decision on Ascendis Pharma’s dwarfism drug candidate, TransCon CNP, by three months to February 28, 2026, in order to review a recently submitted revision to the post-marketing study protocol. Initially slated for a November 30, 2025, decision under priority review, the delay stems solely from this protocol adjustment, which analysts interpret as a positive sign that the FDA is satisfied with the drug’s safety and efficacy data from the Phase 3 trial. TransCon CNP, a once-weekly prodrug targeting children with achondroplasia, is expected to compete with BioMarin’s daily-injected Voxzogo, offering potential advantages in dosing convenience and side effect profile.

🔌 Circuit quest: BioMed X has launched a new neuroscience research collaboration with AbbVie at its New Haven, Connecticut institute, focusing on developing circuit-based model systems to study anhedonia, a key symptom of depression and other psychiatric disorders. The project aims to uncover the disrupted brain microcircuits and molecular targets involved in anhedonia using interdisciplinary methods such as neurobiology, molecular biology, AI, and clinical data. Global researchers are invited to submit proposals by January 18, 2026. This marks the third collaboration between BioMed X and AbbVie, following prior projects in Alzheimer’s disease and immunology, and reflects their ongoing commitment to translational biomedical innovation.

🚦Hold delay: Vanda Pharmaceuticals announced that the FDA has extended its expedited re-review of a partial clinical hold on long-term studies of tradipitant for motion sickness, shifting the deadline to December 5 due to leadership changes at the agency’s review division. However, the New Drug Application for tradipitant remains on schedule for a December 30 decision. The FDA has issued initial labeling comments, initiating formal negotiations with Vanda. Tradipitant aims to become the first new pharmacologic treatment for motion sickness in over 40 years, potentially offering an alternative to current generics like scopolamine and dimenhydrinate, which are often limited by sedative side effects.

SNAP AGAIN

Valneva shuts Nantes site, cuts 30 jobs to streamline R&D

Valneva, the vaccine developer based in France and Austria, is closing its Nantes facility, eliminating 30 roles, mostly in R&D, as it consolidates operations in Lyon and Vienna.

Why it matters: The move reflects Valneva’s push to cut costs and refocus its R&D efforts amid financial strain, including revenue pressure after the FDA suspended one of its key vaccines.

Backstory: The Nantes site hosted some preclinical R&D but was costly and duplicative of efforts in Vienna. The FDA’s August suspension of Valneva’s chikungunya vaccine added pressure on revenue and R&D budgets.

Big picture: Valneva also markets vaccines for Japanese encephalitis (Ixiaro/Jespect) and cholera (Dukoral), but the chikungunya vaccine setback highlights the challenges small biopharmas face in managing regulatory risk while sustaining innovation.

Zoom in: Thankfully, no R&D programs will be cut as operations will now be split between Lyon (general operations) and Vienna (R&D hub). The site closure affects 30 of 39 employees in Nantes, with Valneva promising transition support.

What's next: Valneva is banking on its Lyme disease vaccine, developed with Pfizer, now in phase 3 trials. Regulatory filings in the U.S. and Europe are expected next year, pending positive results.

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