This section highlights FDA-related milestones and regulatory updates for drugs developed by AnaptysBio (ANAB).
Over the past two years, AnaptysBio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
imsidolimab, Rosnilimab, ANB032, and JEMPERLI. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Imsidolimab FDA Regulatory Events
Imsidolimab is a drug developed by AnaptysBio for the following indication: Moderate-to-severe palmoplantar pustulosis (PPP).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- imsidolimab
- Announced Date:
- February 25, 2026
- Indication:
- Moderate-to-severe palmoplantar pustulosis (PPP)
Announcement
Vanda Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP), with a target action date of December 12, 2026.
AI Summary
Vanda Pharmaceuticals announced the U.S. Food and Drug Administration has accepted its Biologics License Application for imsidolimab to treat generalized pustular psoriasis (GPP), with a target action date of December 12, 2026. GPP is a rare, life‑threatening inflammatory skin disease characterized by flares of pustules, redness, fever and fatigue, and is linked to excessive interleukin‑36 (IL‑36) signaling and variants in the IL36RN gene.
Imsidolimab is a fully human IgG4 monoclonal antibody that blocks IL‑36 receptor signaling. In the GEMINI‑1 and GEMINI‑2 trials, a single IV dose led to 53% of patients reaching clear or almost clear skin at Week 4 versus 13% on placebo. Monthly dosing maintained benefit for about two years, with no flares in the active arm, a favorable safety profile, and low anti‑drug antibodies. If approved, imsidolimab could address a major unmet need for people with GPP.
Read Announcement- Drug:
- imsidolimab
- Announced Date:
- December 15, 2025
- Indication:
- Moderate-to-severe palmoplantar pustulosis (PPP)
Announcement
Vanda Pharmaceuticals Inc. announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imsidolimab, a novel IgG4 IL-36 receptor antagonist, to treat generalized pustular psoriasis (GPP).
AI Summary
Vanda Pharmaceuticals has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for imsidolimab, a fully human IgG4 antibody that blocks the IL‑36 receptor. Imsidolimab is designed to treat generalized pustular psoriasis (GPP), a rare, severe inflammatory skin disease often linked to loss‑of‑function IL36RN mutations. The drug aims to correct the overactive IL‑36 signaling that drives GPP symptoms.
The BLA is backed by positive Phase 3 GEMINI‑1 and GEMINI‑2 results. In GEMINI‑1 (45 patients), a single IV dose produced rapid improvements, with 53% of treated patients achieving clear or almost clear skin at Week 4 versus 13% on placebo. In GEMINI‑2, monthly 200 mg maintenance dosing kept responders clear with no flares, while the placebo group had lower maintenance and higher flare rates. Imsidolimab showed a favorable safety profile with no treatment‑related serious adverse events or discontinuations. Vanda has requested priority review for the BLA, which could shorten the FDA review timeline.
Read Announcement
Rosnilimab (formerly ANB030) FDA Regulatory Timeline and Events
Rosnilimab (formerly ANB030) is a drug developed by AnaptysBio for the following indication: Healthy Volunteer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Rosnilimab (formerly ANB030)
- Announced Date:
- November 10, 2025
- Indication:
- Healthy Volunteer
Announcement
AnaptysBio, Inc. announced that investigational rosnilimab was safe and well tolerated but did not meet the primary endpoint of mean change from baseline in modified Mayo Score (mMS) or key secondary endpoints of clinical response and clinical remission at Week 12 in the global Phase 2 trial for moderate-to-severe ulcerative colitis (UC).
AI Summary
AnaptysBio reported that investigational rosnilimab was safe and well tolerated but did not meet the primary endpoint (mean change from baseline in modified Mayo Score) or key secondary endpoints of clinical response and clinical remission at Week 12 in a global Phase 2 trial for moderate-to-severe ulcerative colitis. The randomized study enrolled 136 patients and placebo response rates were within expected historical ranges. Clinical remission at Week 12 occurred in about 7% of rosnilimab-treated patients, with low endoscopic remission rates, and overall efficacy did not support continued development of rosnilimab in UC. As a result, the UC trial will be discontinued, saving at least $10 million.
Pharmacology showed expected effects, including roughly 90% depletion of pathogenic T cells in blood and reductions in PD‑1+ T cells in colon tissue. Safety findings were favorable: most adverse events were mild to moderate, with no treatment-related serious adverse events and similar tolerability to placebo through Week 12.
Read Announcement- Drug:
- Rosnilimab (formerly ANB030)
- Announced Date:
- October 29, 2025
- Indication:
- Healthy Volunteer
Announcement
AnaptysBio, Inc. announced late-breaking data from the robust, global 424-patient Phase 2b trial of rosnilimab, a selective and potent pathogenic T cell depleter, in rheumatoid arthritis (RA) at the American College of Rheumatology (ACR) Convergence 2025 in Chicago.
AI Summary
AnaptysBio announced late-breaking Phase 2b data from its global 424-patient trial of rosnilimab in rheumatoid arthritis at ACR Convergence 2025 in Chicago. Rosnilimab is a novel antibody that selectively depletes disease-driving T cells, aiming to reduce inflammation and restore immune balance.
The study showed that positive responses at Week 12, including DAS28-CRP and ACR20, continued to improve through Week 28 on measures like Clinical Disease Activity Index (CDAI) low disease activity and remission rates. These benefits persisted for at least three months after treatment ended, regardless of patients’ prior advanced therapies, including JAK inhibitors.
Updated safety results through Week 38 revealed rosnilimab was well tolerated with no treatment-related serious adverse events, no deaths, and no malignancies observed in treated patients.
Mechanistic analyses showed rosnilimab reduced peripheral and joint tissue T peripheral helper cells by over 90% by Week 6, confirming its targeted action. These findings support rosnilimab’s potential as a safe, durable treatment for RA.
Read Announcement- Drug:
- Rosnilimab (formerly ANB030)
- Announced Date:
- October 13, 2025
- Indication:
- Healthy Volunteer
Announcement
AnaptysBio, Inc. announced that complete data from the Phase 2b trial of rosnilimab, a pathogenic T cell depleter, in rheumatoid arthritis (RA), was accepted for a late-breaking oral presentation at American College of Rheumatology (ACR) Convergence 2025 in Chicago, IL, Oct. 24 – 29, 2025.
AI Summary
AnaptysBio announced that complete data from its Phase 2b trial of rosnilimab in rheumatoid arthritis were accepted for a late-breaking oral presentation at the American College of Rheumatology Convergence 2025 in Chicago, IL, Oct. 24–29. Rosnilimab is a novel antibody that depletes disease-causing T cells while sparing healthy ones.
Paul Lizzul, AnaptysBio’s chief medical officer, said the selection highlights rosnilimab’s transformational potential. The data showed a strong safety and tolerability profile, JAK-like efficacy through six months of treatment, and durable disease control for at least three months after stopping the drug.
Professor Paul Emery of the University of Leeds will present the findings on Oct. 29 from 8:00–9:30 am CT. The abstract, titled “Rosnilimab, a Selective and Potent Depleter of Pathogenic T Cells,” will be available for download on AnaptysBio’s website after the session.
Read Announcement- Drug:
- Rosnilimab (formerly ANB030)
- Announced Date:
- June 3, 2025
- Indication:
- Healthy Volunteer
Announcement
AnaptysBio, Inc. announced that investigational rosnilimab, a depleter and agonist targeting PD-1+ T cells, demonstrated a best-in-disease profile in patients with moderate-to-severe rheumatoid arthritis (RA).
AI Summary
AnaptysBio announced that its investigational drug rosnilimab, which targets PD-1+ T cells, achieved a best-in-disease profile in patients with moderate-to-severe rheumatoid arthritis (RA) during a global Phase 2b trial. The trial showed that rosnilimab provides JAK-like efficacy, delivering meaningful improvements in low disease activity and remission rates, with many patients experiencing benefits by three months. Notably, the drug’s effects were durable for at least two months after treatment ended, suggesting the possibility of extended maintenance dosing intervals. Additionally, rosnilimab was well tolerated and safe when compared to current biologic therapies and JAK inhibitors. With its potential for once-monthly subcutaneous dosing, these promising results support rosnilimab’s role in addressing the therapeutic needs within the nearly $20 billion RA market, offering hope for improved long-term disease management for patients.
Read Announcement- Drug:
- Rosnilimab (formerly ANB030)
- Announced Date:
- May 27, 2025
- Indication:
- Healthy Volunteer
Announcement
AnaptysBio, Inc. announced that will host an investor call and live webcast to review updated data from the global Phase 2b RENOIR clinical trial of investigational rosnilimab, a depleter and agonist targeting PD-1+ T cells, for moderate-to-severe rheumatoid arthritis on Tuesday, June 3, 2025, at 4:15pm ET / 1:15pm PT.
AI Summary
AnaptysBio, Inc. announced an investor call and live webcast to discuss updated data from its global Phase 2b RENOIR clinical trial evaluating investigational rosnilimab for moderate-to-severe rheumatoid arthritis. This drug, which acts as both a depleter and an agonist targeting PD-1+ T cells, is being studied for its potential to significantly improve treatment options for patients with this condition.
The webcast is scheduled for Tuesday, June 3, 2025, at 4:15pm ET (1:15pm PT). During the session, members of AnaptysBio’s management team will review the latest trial results, providing insights into the efficacy and safety of rosnilimab. This event offers investors a direct look at the clinical progress and future prospects of the company’s therapeutic pipeline.
Read Announcement- Drug:
- Rosnilimab (formerly ANB030)
- Announced Date:
- February 12, 2025
- Indication:
- Healthy Volunteer
Announcement
AnaptysBio, Inc. announced statistically significant Week 12 data from the global 424-patient Phase 2b RENOIR trial of investigational rosnilimab, a depleter and agonist of PD-1+ T cells, for moderate-to-severe rheumatoid arthritis (RA).
AI Summary
AnaptysBio, Inc. announced positive, statistically significant Week 12 results from its global 424-patient Phase 2b RENOIR trial evaluating rosnilimab for moderate-to-severe rheumatoid arthritis (RA). The trial, which targets PD-1+ T cells through a dual mechanism of depletion and agonism, met its primary endpoint by showing a significant improvement in DAS-28 CRP scores compared to placebo. Key secondary endpoints, including ACR20, ACR50, and the Clinical Disease Activity Index (CDAI) low disease activity (LDA) benchmark, also demonstrated statistical significance. In addition, by Week 14, a notably high percentage of patients reached CDAI LDA, and responses appeared to be maintained or even improved through Week 28. Alongside robust immunological effects such as reduced PD-1high T cells and decreased CRP levels, rosnilimab was shown to be safe and well tolerated, supporting its further development in RA treatment.
Read Announcement- Drug:
- Rosnilimab (formerly ANB030)
- Announced Date:
- February 11, 2025
- Indication:
- Healthy Volunteer
Announcement
AnaptysBio, Inc announced will host an investor call and live webcast to review top-line data from the global Phase 2b RENOIR clinical trial of investigational rosnilimab, a depleter and agonist of PD-1+ T cells, for moderate-to-severe rheumatoid arthritis on Wednesday, Feb. 12, 2025, at 8:30am ET / 5:30am PT.
AI Summary
AnaptysBio, Inc. announced that it will host an investor call and live webcast on Wednesday, Feb. 12, 2025, at 8:30am ET / 5:30am PT. The call will focus on sharing top-line data from the global Phase 2b RENOIR clinical trial. This study is evaluating the investigational drug rosnilimab, which functions as both a depleter and agonist of PD-1+ T cells, targeting moderate-to-severe rheumatoid arthritis.
The data will be released in a morning press release and discussed in detail during the webcast, which can be accessed on the company’s website. A replay of the webcast will be available on the site for at least 30 days after the event, ensuring that investors have ample opportunity to review the results and gain insight into the progress of this clinical trial.
Read Announcement
ANB032 FDA Regulatory Events
ANB032 is a drug developed by AnaptysBio for the following indication: for moderate-to-severe atopic dermatitis (AD) or eczema.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ANB032
- Announced Date:
- December 11, 2024
- Indication:
- for moderate-to-severe atopic dermatitis (AD) or eczema.
Announcement
AnaptysBio, Inc announced that investigational ANB032, a BTLA agonist, did not meet the primary and secondary endpoints in any of the doses studied in the global, 201-patient ARISE-AD trial as a monotherapy for moderate-to-severe atopic dermatitis (AD) or eczema. ANB032 was well tolerated with no safety signals observed.
AI Summary
AnaptysBio, Inc. announced that its investigational BTLA agonist, ANB032, did not meet the primary or secondary endpoints in the global ARISE-AD trial. This trial involved 201 patients with moderate-to-severe atopic dermatitis or eczema who received different doses of ANB032 as a monotherapy over 12 weeks. Although the drug was well tolerated across all doses with no safety signals observed, it failed to achieve significant clinical improvements, prompting the company to discontinue further investment in ANB032. Moving forward, AnaptysBio will shift its focus and resources to other projects within its autoimmune portfolio, including advanced trials for rosnilimab targeting rheumatoid arthritis and ulcerative colitis. The company expressed gratitude to the patients and clinicians involved in the trial and remains dedicated to developing innovative immunology therapies.
Read Announcement
JEMPERLI (dostarlimab-gxly) FDA Regulatory Events
JEMPERLI (dostarlimab-gxly) is a drug developed by AnaptysBio for the following indication: Recurrent or Advanced dMMR/MSI-H Endometrial Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- JEMPERLI (dostarlimab-gxly)
- Announced Date:
- June 3, 2024
- Indication:
- Recurrent or Advanced dMMR/MSI-H Endometrial Cancer
Announcement
GSK plc announced updated, longer-term results from the phase II supported collaborative study with Memorial Sloan Kettering Cancer Center (MSK) evaluating Jemperli (dostarlimab-gxly) as a first-line treatment—as an alternative to surgery—for mismatch repair deficient (dMMR) locally advanced rectal cancer.
AI Summary
GSK plc announced promising longer-term results from a phase II study conducted with Memorial Sloan Kettering Cancer Center. This study evaluated dostarlimab-gxly (Jemperli) as a first-line treatment alternative to surgery for patients with mismatch repair deficient (dMMR) locally advanced rectal cancer. In the updated analysis, 42 patients who completed treatment achieved a 100% clinical complete response, with outcomes confirmed via imaging, endoscopy, and digital rectal exams. Notably, an initial subgroup of 24 patients showed sustained tumor regression with a median follow-up of over two years, suggesting lasting benefits. These findings highlight the potential of dostarlimab-gxly to offer a less invasive and quality-of-life–preserving treatment option, bypassing the need for standard surgery and chemoradiotherapy, which can lead to significant long-term adverse effects.
Read Announcement
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