The biopharmaceutical landscape continues to evolve at a remarkable pace, driven by breakthroughs in targeted therapies, novel modalities, and a deepening understanding of disease mechanisms. As we approach 2026, the anticipated approvals of innovative biologics promise to address unmet needs across rare diseases, autoimmune disorders, infectious threats, and chronic conditions. This article highlights eight pivotal drugs/vaccines with high probability of being approved in 2026. These are: tividenofusp alfa, VLA15, imlifidase, ABBV-RGX-314, ianalumab, rocatinlimab, imsidolimab, and atacicept. 

Over the last two years, the FDA’s Center for Drug Evaluation and Research (CDER) approved 96 novel drugs, with biologics comprising approximately 29% (28) of these approvals (Figure 1).^1-3 Over the same time, another FDA’s branch, the Center for Biologics Evaluation and Research (CBER), approved additional 24 biological products.^4,5 Biologics shone in areas such as oncology, where nearly half of first-quarter approvals were biologics or biosimilars, and vaccines, with notable advancements like the CAPVAXIVE pneumococcal conjugate vaccine. The approval of 13 new monoclonal antibodies in 2024, accounting for more than 25% of drugs greenlit that year, set a new record.² 

---

---

Last year started at a slow pace, but in mid-2025 approvals accelerated, so that by the end of the year 46 novel drug therapies were authorized by the CDER, getting close to 2024 (50 new drugs). Twelve of these approvals were biologics, among which the most notable were garadacimab and donidalorsen—breakthrough medicines for the treatment of hereditary angioedema. In addition to novel molecules, FDA approved many new vaccines and biosimilars, including first-ever biosimilars to insulin aspart, as well as expanded labels for several already available products such as durvalumab.

Looking to 2026 and beyond, the biologics pipeline is poised for transformative growth, with some analytics forecasting over 60% share of biologics and gene therapies in new drug approvals by 2030.⁶ Among the highlighted candidates, several hold blockbuster potential, defined today as exceeding $3 billion in annual sales, due to large patient populations and unmet needs. For instance, ABBV-RGX-314, a one-time gene therapy for wet age-related macular degeneration (AMD) and diabetic retinopathy, targets a market of millions affected by vision loss, potentially rivaling established anti-VEGF therapies like aflibercept.⁷ Similarly, VLA15, a Lyme disease vaccine, could achieve widespread adoption in endemic regions, generating blockbuster revenues through preventive care models.^8,9 Autoimmune-focused mAbs such as ianalumab (for Sjögren’s disease), rocatinlimab (atopic dermatitis), and imsidolimab (generalized pustular psoriasis) are likely contenders, addressing chronic, high-prevalence conditions with durable responses and fewer injections than current standards. Rare disease therapies like tividenofusp alfa (Hunter syndrome) and atacicept (IgA nephropathy) may not reach blockbuster status but could command premium pricing due to orphan designations and limited competition.

The biopharmaceutical industry’s focus is sharpening on immunology and autoimmunity, with mAbs and fusion proteins (e.g., targeting BAFF-R, OX40, IL-36R) leading R&D efforts for their precision and tolerability. Advanced therapies, including gene editing, mRNA platforms, and allogeneic cell products—are expanding into ophthalmology and infectious diseases, promising one-time cures over lifelong treatments. However, challenges like manufacturing scalability, long-term safety (e.g., immune responses in gene therapies), and equitable access persist. With AI accelerating discovery and regulatory pathways like FDA Breakthrough designations expediting approvals, 2026 could mark a pivotal year for biologics, potentially reducing treatment burdens and improving outcomes for millions.

Fusion proteins that treat the hard-to-treat

Tividenofusp alfa (Denali/BioMarin)

Hunter syndrome is a progressive X-linked genetic disorder in which the absence of iduronate-2-sulfatase (IDS) causes harmful accumulation of glycosoaminoglycans in various organs and tissues. For years, enzyme replacement therapy (ERT) has been used to drain these molecules from patients’ bodies but couldn’t touch what mattered most to families: the neurological decline that starts in early childhood.¹⁰ Tividenofusp alfa is built to change that equation. It takes the missing enzyme, iduronate-2-sulfatase (IDS), and fuses it to an engineered “TransportVehicle” that recognizes the transferrin receptor on the blood–brain barrier (Figure 2). Think of it as hitching a ride on a legitimate courier to cross the checkpoint; once inside, the cargo is handed off to lysosomes in brain and peripheral tissues alike. Early human studies reported that the enzyme didn’t just nibble at biomarkers—it drove cerebrospinal fluid heparan sulfate toward normal and kept it there over long follow-up, alongside encouraging gains in hearing, cognition and adaptive behavior. That durability, plus a tolerability profile dominated by manageable infusion-related reactions, convinced regulators to let the program move quickly. In July 2025, the FDA accepted Denali’s application for accelerated approval, granted Priority Review.^11-13 Denali continues to run a randomized Phase 2/3  study (COMPASS), to support broader approvals.¹⁴ Notably, COMPASS pits tividenofusp directly against idursulfase – the incumbent peripheral ERT—at a 2:1 randomization, a design that should help quantify the clinical value of brain delivery instead of relying on indirect comparisons. Regulators have also signaled comfort with the platform’s trajectory by layering on Fast Track and Breakthrough Therapy in the U.S. and PRIME in the EU, a trio of designations that typically comes with close scientific dialogue on endpoints, manufacturing controls and post-marketing commitments. Currently, the PDUFA date is scheduled for April 5, 2026, meaning that among the discussed candidates, tividenofusp alfa is the closest to receiving the FDA’s nod. And the stakes are really high: a first BBB-penetrant ERT would validate receptor-mediated shuttling for other lysosomal and neurodegenerative targets, opening up a new important lane for the treatment of now incurable CNS diseases.

---

---

If approved on schedule, the near-term questions will be practical ones that CDMOs and treatment centers can solve together: how to guarantee lot-to-lot consistency for an engineered fusion (ensuring the transferrin-receptor binding and IDS activity stay synchronised), how to desgin release assays that capture both parts of the molecule’s job, and how to track neurocognitive outcomes in the real world once biomarkers have normalized. Families will care about the lived experience—weekly or biweekly infusion routines, infusion-center capacity, and whether earlier treatment changes developmental trajectories. For biopharma industry, the stakes are even higher: a first BBB-penetrant ERT would validate receptor-mediated shuttling for other lysosomal and neurodegenerative targets, opening up a new important lane for the treatment of hitherto incurable CNS diseases.

Atacicept (Vera Therapeutics)

IgA nephropathy is a chronic kidney disease in which IgA antibodies build up in the glomeruli, causing inflammation and tissue destruction. It is often treated downstream, where proteinuria shows up and kidneys are already straining. Atacicept tries to turn off the tap closer to the source. It’s a TACI-Fc fusion protein that joins two B-cell survival cytokines—BAFF and APRIL—that help sustain the cells producing the aberrant galactose-deficient IgA1 thought to kick-start the disease.¹⁵ In June 2025, Vera announced that its pivotal ORIGIN study hit the mark: patients on atacicept saw about a 46% reduction from baseline in proteinuria and a 42% advantage over placebo at week 36, a magnitude that resonates clinically and statistically.¹⁶ Safety tracked close to placebo in the topline cut, and the company set out a straightforward plan: submit a BLA in Q4 2025 for accelerated approval, then read out longer-horizon kidney function to convert to full approval. That timeline puts a U.S. decision squarely in 2026, which is exactly what nephrology clinics have been preparing for.¹⁷

Because accelerated approval in kidney disease leans on surrogates, everyone will watch eGFR over time. Here the backdrop is reassuring: earlier controlled and extension data suggested stabilization trends, and the ongoing extension of the ORIGIN study is designed to deliver the three-year kidney function curves reviewers want to see.¹⁸ Results at 96 weeks of follow-up were highly encouraging, demonstrating continuing reduction in proteinuria and preservation of glomerular filtration capacity.¹⁹ 

Meanwhile, the day-to-day realities favor a biologic in chronic care: atacicept is administered once-weekly via subcutaneous route, meshing well with nursing-led programs and home treatment.¹⁶ If approved, expect positioning as a disease-biology therapy rather than a symptomatic add-on—potentially used alongside SGLT2s and, where appropriate, tapered steroids. For CDMOs, the near-term work is classic but nontrivial: reproducible glycoforms, a tight handle on Fc-fusion biophysics, and validated potency assays that reflect dual BAFF/APRIL neutralization. For payers, the cost-effectiveness considerations will revolve around the proteinuria effect size, early eGFR signals, and how atacicept stacks against complement-pathway drugs now moving through the same clinics.^18,19

Smarter switches for misfiring immunity

Ianalumab (Novartis)

Sjögren’s has long sat in therapeutic limbo: too complex for symptomatic care alone, yet historically unrewarding for targeted drugs. Ianalumab changes the conversation by going straight to the survival signal that keeps autoreactive B cells in play – BAFF acting through its BAFF-R receptor.²⁰ Blocking the receptor rather than the ligand appears to matter; in August 2025, Novartis reported that both of its global Phase 3 studies, NEPTUNUS-1 and NEPTUNUS-2, met their primary endpoints on disease activity, the first time any program has convincingly moved the needle at this scale in Sjögren’s.²¹ The two trials covered complementary dosing patterns (monthly IV and flexible SC schedules) and together enrolled several hundred patients, with safety described as favorable in topline updates. In August 2026 another good news arrived as ianalumab was announced to delay treatment failure in immune thrombocytopenia (ITP), another autoimmune condition in which BAFF protein seems to play a pivotal role.²² 

Novartis says it will take the package to regulators worldwide, setting up a 2026 decision window and, potentially, a first targeted therapy for this condition^.23 For clinicians, the appeal is obvious: a route to tamp down the B-cell biology that drives systemic manifestations of numerous autoimmune diseases; for payers, the story will hinge on the size and duration of patient-reported gains as well as steroid-sparing effects. If the filings proceed in line with the assumed timeline, Sjögren’s clinics could be re-tooling their care pathways as early as next year.

Rocatinlimab/AMG-451 (Amgen/Kyowa Kirin)

Atopic dermatitis is a crowded indication when it comes to therapeutic modalties, but many patients still cycle through different options because the usual cytokine suspects don’t fully capture their disease. Rocatinlimab comes at the problem from a different angle than other drugs, dampening the OX40 costimulatory signal that helps sustain pathogenic T-cell responses. That idea now has late-stage momentum behind it: in March 2025 Amgen and Kyowa Kirin reported that the pivotal ROCKET IGNITE trial met co-primary and all key secondary endpoints across two dose strengths versus placebo, while earlier ROCKET HORIZON data showed clinically meaningful proportions of patients achieving near-clear skin on a validated global assessment.^24,25 The sponsors emphasize durability as well, pointing to longer-term maintenance in extension cohorts and to extended-interval dosing that could ease clinic flow and patient burden.²⁶ 

Global responsibilities are clear, Amgen leads ex-Japan with co-promotion options for Kyowa Kirin, so if filings land as guided, 2026 approvals look realistic. In practice, dermatologists may position rocatinlimab for patients who need a mechanistic alternative to IL-4/IL-13 blockers or who value less frequent maintenance dosing, while health systems weigh comparative effectiveness and visit intensity against entrenched incumbents.

Imsidolimab (Vanda/Anaptys)

Few conditions demand speed like generalized pustular psoriasis, where neutrophilic flares can turn life-threatening within days.²⁷ The IL-36 pathway sits at the center of this storm, and imsidolimab, an antibody against the IL-36 receptor, has completed two registration-enabling trials, including phase 3 GEMINI-1 trial, showing rapid disease control and maintained clarity (Figure 3).^28,29

---

---

In February 2025, Vanda secured global rights from Anaptys and moved straight into technology transfer and regulatory preparation for the U.S. and EU.³⁰ That sequence matters because it suggests confidence not only in efficacy but also in the manufacturability and release testing needed for a rare-disease launch. 

With class precedent already established for IL-36 blockade, reviewers are familiar with endpoints and safety monitoring; the differentiators are likely to be dosing practicality, durability through subsequent flares, and real-world immunogenicity. Assuming the filings track to plan, 2026 becomes a credible first approval year – one that would expand clinician choice in a setting where options are limited and time is precious.

New shield against old pathogen

VLA15 (Valneva/Pfizer)

For the first time in decades, a human Lyme vaccine is within touching distance. The previous vaccine, LYMErix, was approved in 1998, only to be voluntarily withdrawn four years later by its manufacturer after sudden sales collapse amid lawsuits and never substantiated claims of vaccine-induced arthritis. Post-licensure monitoring and FDA review in 2001 did not find higher rates of arthritis in vaccinated people compared with controls, yet the damage to confidence was already done; uptake fell from about 1.5 million doses in 1999 to roughly 10,000 by 2002, and the product was pulled despite the absence of a safety signal. Public-health historians now point to LYMErix as a cautionary tale about how litigation and misinformation can sink an effective vaccine even when advisory reviews and safety data are reassuring.³¹

VLA15 is built on the same fundamental idea—neutralizing outer surface protein A (OspA) to block Borrelia transmission from tick to human—but it reflects two decades of progressive learning. Where LYMErix targeted a single OspA from B. burgdorferi sensu stricto (the dominant North American species), VLA15 is multivalent, covering six OspA serotypes to address the broader species complex circulating across North America and Europe.³² Early clinical studies have shown the multivalent formulation to be immunogenic and generally well tolerated, and the pivotal VALOR trial is designed around physician-confirmed Lyme as an endpoint rather than surrogate immunobridging alone.

After weathering a disruption in 2023 caused by a GCP-noncompliant site network, the enrollment in VALOR trial was quickly rebuilt and the recruitment is now complete.³³ The vaccine developers, Valneva and Pfizer, have repeatedly reiterated their plan to file on both sides of the Atlantic in 2026, contingent on clean efficacy and safety.³⁴ That cadence is echoed across company pages and press releases and has been picked up by trade coverage, which also notes recently reported Phase 2 booster data showing a solid anamnestic response after a third annual dose—useful real-world scaffolding for a long-term schedule. If VALOR lands as expected, the launch narrative becomes almost self-evident: seasonal clinics in high-incidence states and regions, employer and travel programs for outdoor workers, and pediatric inclusion that broadens public-health reach. For CDMOs, this is classic protein-subunit craft with a twist—lot-to-lot immunogenicity across six OspA variants, clarity on booster manufacturing slots, and strain coverage that will need periodic reconfirmation as surveillance evolves.

Closer look at new gene therapy

ABBV-RGX-314 (AbbVie/REGENXBIO)

Wet age-related macular degeneration (AMD) has been a triumph of biologics and a burden of logistics. Millions of clinic visits each year are spent on anti-VEGF injections that rescue vision but demand relentless adherence.^35,36 ABBV-RGX-314 aims to solve this issue with a one-time AAV8 vector that turns the retina into its own anti-VEGF factory after a subretinal procedure.³⁷ Pivotal programs called ATMOSPHERE and ASCENT are the decision-makers here, and both are geared to answer not only whether vision can be maintained, but whether injection burden can be sustainably reduced versus state-of-the-art comparators like aflibercept.³⁸ Pivotal wet-AMD readouts planned for 2026 have set expectations appropriately: if efficacy and safety are decisive and filings move swiftly, a late-2026 decision could happen.³⁹ However, more recent communications from AbbVie and REGENXBIO suggest that potential approval is more likely in 2027.⁴⁰

For AMD patients, approval of ABBV-RGX-314 would mark a significant progress, offering a one-time treatment instead of repeated injections. For payers and health systems, the high costs of novel gene therapy are likely to be counterbalanced by multi-year capacity relief in crowded retina clinics. For CDMOs and vector manufacturers, this is about reproducible AAV quality attributes, surgeon-friendly DP presentations, and solid comparability as programs transition from Phase 3 to launch.

Enzymatic match-maker

Imlifidase (Hansa)

Highly sensitized kidney-transplant candidates often stall at the last step: a positive crossmatch that predicts catastrophic rejection.⁴¹ Imlifidase offers a timed reset. It’s a bacterial endopeptidase that quickly cleaves human IgG, transiently clearing the donor-specific antibodies that block transplantation and opening a window in which a graft can take.⁴² Europe granted conditional approval in 2020 for this desensitization use, paired with a real-world effectiveness commitment.⁴³ In the United States, momentum has been building: the pivotal, randomized ConfIdeS study completed recruitment and randomization, and its 12-month eGFR endpoint is designed as a surrogate reasonably likely to predict long-term benefit under the accelerated-approval framework.⁴⁴ Hansa has repeatedly pointed to a H2-2025 BLA submission, setting up a potential 2026 FDA decision if the effect size and safety prove persuasive.⁴⁵ It’s a niche, center-driven intervention but transformative for the people it reaches; for transplant programs and manufacturers alike, the operational challenge is choreography—synchronizing drug timing, organ allocation, and immunosuppression while ensuring dependable enzyme activity and lot release across sites.

A short summary of all biologics discussed in our article is presented in Table 1.

---

---

Crossing barriers, changing care: the biologics wave of 2026

From a brain-penetrant enzyme replacement for Hunter syndrome to an off-the-shelf T-cell therapy for EBV-driven post-transplant disease—this year’s wave of biologics shows how far the modern medicine has reached. The BBB-shuttled fusion protein tividenofusp alfa crystallizes the promise of getting large molecules into protected compartments and aims to reset expectations in lysosomal disease by addressing CNS decline, not just peripheral biomarkers. Vaccines such as VLA15, a multivalent OspA subunit shot, reassert their public-health muscle, but this time aiming at completely different pathogens, for which no effective prevention methods are available. VLA15 is poised to bring the first human Lyme vaccine in decades to North America and Europe, a timely answer to expanding tick ranges and rising incidence of borreliosis. For CDMOs, these programs blend familiar crafts with modern demands: multi-valent lot consistency, rapid strain/antigen updates, and seasonal scale that flexes without sacrificing release speed or quality.

Ianalumab, a BAFF receptor blocker, may deliver the first targeted therapy for Sjögren’s disease and signal a pivot toward B-cell pathway precision in conditions long managed with symptomatic care. Rocatinlimab brings a mechanistic alternative in atopic dermatitis by dialing down OX40 costimulation and, with it, the pathogenic T-cell circuits that escape IL-4/IL-13 blockade – promising fewer visits through extended-interval maintenance. In dermatology’s most acute corner, imsidolimab extends the IL-36 class with a second option for generalized pustular psoriasis, turning days-to-control into a realistic goal and giving clinicians a choice in dosing and durability. These antibodies underscore a broader 2026 theme: not just more biologics, but better-targeted ones that meet patients where current standards fall short.

Gene and enzyme interventions round out the year’s “one-and-done” and “just-in-time” stories. ABBV-RGX-314, an AAV8 vector delivering a retinal anti-VEGF, aims to swap monthly injections for a single procedure in wet AMD, shifting the health-system math to operating-room time and forcing payers to weigh sky-high upfront cost against multi-year capacity relief. Imlifidase, a bacterial protease that cleaves human IgG, opens a narrow window for highly sensitized kidney-transplant candidates, in which a life-saving graft can proceed. And in nephrology, atacicept, a TACI-Fc fusion that merges BAFF and APRIL, pushes the field upstream in IgA nephropathy by targeting the autoantibody machinery that drives disease rather than merely treating proteinuria downstream.

The 2026 is expected to be yet another year bringing a huge wave of innovative biologics. Although the recent years were marked by stagnation in terms of the number of FDA-licensed biologics, the outlook remains optimistic—share of biologics among all approved drugs is forecasted to reach 60% by 2030.6 The dominance of monoclonal antibodies and other therapeutic proteins is likely to continue in 2026 and beyond, however new modalties, such as cell and gene therapies, are getting traction and may eventually dethrone the more “classic” biologics. Another visible trend in recent years is the increasing availability of medicines for rare or often neglected conditions. Next year will be no different in this respect—for example, we will probably witness the appearance of a breakthrough treatment for Hunter disease. Another recurring theme is the development of drugs against already validated targets, but with more convenient administration route or dosing scheme. The finest example of such progress is the already discussed gene therapy for wet AMD, which limits the treatment to only one injection.

For patients, that all adds up to something simple and long awaited: biologics that not only work but fit into lives—fewer injections, fewer flares, fewer missed chances at a transplant or healthy birth. For the biologics industry and its CDMO partners, 2026 isn’t just another step forward; it’s a clear signal that precision in design, delivery, and deployment will be now the standard, not the exception.

With a strong background in clinical pharmacology and evidence-based medicine, Adam Tuszyner specializes in regulatory science and clinical development for biologic drugs. He has authored and co-developed a wide range of regulatory documents, including FDA and EMA briefing materials and responses to agency queries. His career highlights include participation in pivotal scientific advice with regulators and involvement in biosimilar drug approvals.

---

---

References

1. De La Torre, Beatriz G., and Fernando Albericio. “The Pharmaceutical Industry in 2024: An Analysis of the FDA Drug Approvals From the Perspective of Molecules.” Molecules, vol. 30, no. 3, Jan. 2025, p. 482. https://doi.org/10.3390/molecules30030482.

2. Center for Drug Evaluation And Research. “Novel Drug Approvals for 2024.” U.S. Food And Drug Administration, 14 July 2025, www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024.

3. Center for Drug Evaluation And Research. “Novel Drug Approvals for 2025.” U.S. Food And Drug Administration, 16 Sept. 2025, www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025.

4. Center for Biologics Evaluation and Research. “2025 Biological License Application Approvals.” U.S. Food and Drug Administration, 16 Jan 2026, https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2025-biological-license-application-approvals.

5. Center for Biologics Evaluation and Research. “2025 Biological License Application Approvals.” U.S. Food and Drug Administration, 07 Feb 2025, https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2024-biological-license-application-approvals.

6. Tran, Bao. “The Future of Pharma: 2030 Market Predictions and Drug Innovation Stats.” PatentPC, 19 Aug. 2025, https://patentpc.com/blog/the-future-of-pharma-2030-market-predictions-and-drug-innovation-stats.

7. REGENXBIO press release. “AbbVie and REGENXBIO Announce Updates on the ABBV-RGX-314 Clinical Program”, January 13 2025.

8. “What You Need to Know About a Promising Vaccine Candidate that May Stem the Growing Risk of Lyme Disease”. Pfizer.

9. Akingbola, Adewunmi, et al. “The mRNA-1647 Vaccine: A Promising Step Toward the Prevention of Cytomegalovirus Infection (CMV).” Human Vaccines & Immunotherapeutics, vol. 21, no. 1, Jan. 2025, https://doi.org/10.1080/21645515.2025.2450045.

10. Muenzer, Joseph, et al. “The role of enzyme replacement therapy in severe Hunter syndrome—an expert panel consensus.” European journal of pediatrics 171.1 (2012): 181-188.

11. Denali Therapeutics Inc. “Denali Therapeutics Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Tividenofusp Alfa for Hunter Syndrome (MPS II).” GlobeNewswire News Room, 7 July 2025, www.globenewswire.com/news-release/2025/07/07/3110980/0/en/Denali-Therapeutics-Announces-FDA-Acceptance-and-Priority-Review-of-Biologics-License-Application-BLA-for-Tividenofusp-Alfa-for-Hunter-Syndrome-MPS-II.html.

12. Burton, Barbara, et al. “P026: Interim analysis of the efficacy and safety of weekly intravenous tividenofusp alfa in mucopolysaccharidosis type II: A phase 1/2 study.” Genetics in Medicine Open 3 (2025).

13. Denali Therapeutics Inc. “Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) With Tividenofusp Alfa.” GlobeNewswire News Room, 6 Feb. 2025, www.globenewswire.com/news-release/2025/02/06/3022238/0/en/Denali-Therapeutics-Announces-Primary-Analysis-and-Long-Term-Follow-Up-of-Phase-1-2-Study-in-Hunter-Syndrome-MPS-II-with-Tividenofusp-Alfa.html.

14. ClinicalTrials.gov. clinicaltrials.gov/study/NCT05371613.

15. Cheung, Chee Kay, et al. “The role of BAFF and APRIL in IgA nephropathy: pathogenic mechanisms and targeted therapies.” Frontiers in nephrology 3 (2024): 1346769.

16. “Vera Therapeutics Announces Atacicept Achieved 46% Proteinuria Reduction in ORIGIN Phase 3 Trial in Adults with IgA Nephropathy” Vera Therapeutics News Release, June 2 2025. https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-atacicept-achieved-46-proteinuria.

17. BioSpace. “Vera Therapeutics Provides Business Update and Reports Second Quarter 2025 Financial Results.” BioSpace, 6 Aug. 2025, www.biospace.com/press-releases/vera-therapeutics-provides-business-update-and-reports-second-quarter-2025-financial-results.

18. Barratt, Jonathan, et al. “WCN25-2522 ORIGIN Extend: A Long-Term Extension Study of Atacicept in IgAN.” Kidney International Reports, vol. 10, no. 2, Jan. 2025, p. S211. https://doi.org/10.1016/j.ekir.2024.11.405.

19. Jha, Vivekanand, et al. “WCN25-2470 Long-term Results From the ORIGIN Phase 2b Study of Atacicept for the Treatment of IgAN.” Kidney International Reports, vol. 10, no. 2, Jan. 2025, pp. S210–11. https://doi.org/10.1016/j.ekir.2024.11.404.

20. Wioland, Catherine, et al. “IANALUMAB’S DUAL MODE OF ACTION: TARGETING B CELLS THROUGH ENHANCED B CELL DEPLETION AND BLOCKADE OF B CELL-ACTIVATING FACTOR RECEPTOR SIGNALING.” The Journal of Rheumatology. Vol. 52. No. Suppl 1. The Journal of Rheumatology, 2025.

21. “Novartis Announces Both Ianalumab Phase III Clinical Trials Met Primary Endpoint in Patients With Sjögren’s Disease.” Novartis, www.novartis.com/news/media-releases/novartis-announces-both-ianalumab-phase-iii-clinical-trials-met-primary-endpoint-patients-sjogrens-disease.

22. “Novartis Ianalumab Phase III Trial Meets Primary Endpoint in ITP, Demonstrating Statistically Significant Improvement in Time to Treatment Failure.” Novartis, www.novartis.com/news/media-releases/novartis-ianalumab-phase-iii-trial-meets-primary-endpoint-itp-demonstrating-statistically-significant-improvement-time-treatment-failure.

23. Foster, Edwin. “The Breakthrough Potential of Novartis’ Ianalumab in Sjögren’s Disease: A Strategic Investment Opportunity.” Ainvest, 11 Aug. 2025, www.ainvest.com/news/breakthrough-potential-novartis-ianalumab-sj-gren-disease-strategic-investment-opportunity-2508.

24. “Amgen and Kyowa Kirin provide top-line results from rocatinlimab phase 3 ignite study in adults with moderate to severe atopic dermatitis.” Amgen, www.amgen.com/newsroom/press-releases/2025/03/amgen-and-kyowa-kirin-provide-top-line-results-from-rocatinlimab-phase-3-ignite-study-in-adults-with-moderate-to-severe-atopic-dermatitis.

25. “Kyowa Kirin Announces Top-line Data From Rocatinlimab Phase 3 ROCKET HORIZON Trial for Adults With Moderate to Severe Atopic Dermatitis.” Kyowa Kirin US, www.kkna.kyowakirin.com/media-center/kyowa-kirin-announces-top-line-data-from-rocatinlimab-phase-3-rocket-horizon-trial-for-adults-with-moderate-to-severe-atopic-dermatitis.

26. Guttman-Yassky, Emma, et al. “Rocatinlimab: A Novel T-Cell Rebalancing Therapy Targeting the OX40 Receptor in Atopic Dermatitis.” Dermatology and Therapy (2025): 1-19.

27. Choon, Siew Eng, Alexander A. Navarini, and Andreas Pinter. “Clinical course and characteristics of generalized pustular psoriasis.” American Journal of Clinical Dermatology 23.Suppl 1 (2022): 21-29.

28. Warren, Richard B., et al. “Imsidolimab, an anti-interleukin-36 receptor monoclonal antibody, for the treatment of generalized pustular psoriasis: results from the phase II GALLOP trial.” British Journal of Dermatology 189.2 (2023): 161-169.

29. “Anaptys announces positive top-line GEMINI-2 phase 3 clinical trial results of imsidolimab (IL-36R) in generalized pustular psoriasis” Anaptys Bio, https://ir.anaptysbio.com/news-releases/news-release-details/anaptys-announces-positive-top-line-gemini-2-phase-3-clinical/.

30. Vanda Pharmaceuticals Inc. “Vanda Pharmaceuticals and Anaptys Announce Exclusive Global License Agreement for Vanda to Develop and Commercialize Imsidolimab, an IL-36R Antagonist.” PR Newswire, 3 Feb. 2025, www.prnewswire.com/news-releases/vanda-pharmaceuticals-and-anaptys-announce-exclusive-global-license-agreement-for-vanda-to-develop-and-commercialize-imsidolimab-an-il-36r-antagonist-302366027.html.

31. Gavura, Scott. “What Happened to the Lyme Vaccine? | Science-Based Medicine.” Science-Based Medicine, 4 Oct. 2018, https://sciencebasedmedicine.org/what-happened-to-the-lyme-vaccine.

32. Comstedt, Pär, et al. “The Novel Lyme Borreliosis Vaccine VLA15 Shows Broad Protection Against Borrelia Species Expressing Six Different OspA Serotypes.” PLoS ONE, vol. 12, no. 9, Sept. 2017, p. e0184357. https://doi.org/10.1371/journal.pone.0184357.

33. Valneva. “Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial for Lyme Disease Vaccine Candidate, VLA15 – Valneva.” Valneva, 5 Dec. 2023, https://valneva.com/press-release/pfizer-and-valneva-complete-recruitment-for-phase-3-valor-trial-for-lyme-disease-vaccine-candidate-vla15.

34. Valneva. “Valneva Reports Half Year 2025 Financial Results and Provides Corporate Updates” August 12, 2025.

35. Shahzad, Haris, et al. “Non-adherence and non-persistence to intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy: a systematic review and meta-analysis.” Systematic Reviews 12.1 (2023): 92.

36. Campochiaro, Peter A., et al. “Gene therapy for neovascular age-related macular degeneration by subretinal delivery of RGX-314: a phase 1/2a dose-escalation study.” The Lancet 403.10436 (2024): 1563-1573.

37. Shen, Ji-kui, et al. “RGX-314, an AAV8 expressing an anti-VEGF protein, strongly suppresses subretinal neovascularization and vascular leakage in mouse models.” Investigative Ophthalmology & Visual Science 58.8 (2017): 199-199.

38. RegenXBio therapeutic pipeline: ABBV-RGX-314 for Retinal Diseases. RegenXBio, https://www.regenxbio.com/therapeutic-programs/rgx-314/.

39. Writer, Staff, and Staff Writer. “Gene Therapy Could Replace Current nAMD Treatments.” Insight, 11 Apr. 2024, www.insightnews.com.au/gene-therapy-could-replace-namd-treatment.

40. REGENXBIO Corporate Presentation “Delivering the promise of gene therapy.”, January 2026, https://ir.regenxbio.com/static-files/a7f4f464-cba3-412b-88b1-02de8bf70faf.

41. Sethi, Supreet, et al. “Approach to highly sensitized kidney transplant candidates and a positive crossmatch.” Advances in Chronic Kidney Disease 28.6 (2021): 587-595.

42. Lonze, Bonnie E., et al. “IdeS (Imlifidase): a novel agent that cleaves human IgG and permits successful kidney transplantation across high-strength donor-specific antibody.” Annals of Surgery 268.3 (2018): 488-496.

43. “Idefirix | European Medicines Agency (EMA).” European Medicines Agency (EMA), 2 July 2025, www.ema.europa.eu/en/medicines/human/EPAR/idefirix.

44. Hansa Biopharma | Clinical Study ConfIdeS NCT04935177. www.hansabiopharma.com/trials-info/nct04935177.

45. Update on ConfIdeS Phase 3 Trial of Imlifidase in Highly Sensitized Kidney Transplant Patients | Hansa Biopharma. www.hansabiopharma.com/media/press-releases/2023/update-on-confides-phase-3-trial-of-imlifidase-in-highly-sensitized-kidney-transplant-patients.