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
ANB032, JEMPERLI, and Rosnilimab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ANB032 - FDA Regulatory Timeline and 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.
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JEMPERLI (dostarlimab-gxly) - FDA Regulatory Timeline and 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.
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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:
- 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
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