This section highlights FDA-related milestones and regulatory updates for drugs developed by Climb Bio (CLYM).
Over the past two years, Climb Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Budoprutug and CLYM116. 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.
Budoprutug FDA Regulatory Events
Budoprutug is a drug developed by Climb Bio for the following indication: Treatment of Primary Membranous Nephropathy.
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:
- Budoprutug
- Announced Date:
- May 14, 2026
- Indication:
- Treatment of Primary Membranous Nephropathy
Announcement
Climb Bio, Inc announced an upcoming presentation on its budoprutug program at the European Hematology Association (EHA) 2026 Congress, which will be held in Stockholm, Sweden June 11-14, 2026.
AI Summary
Climb Bio, Inc. said it will present new data on its budoprutug program at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden, from June 11 to 14, 2026. The company plans to share results from its ongoing Phase 1b/2a study of budoprutug, a low-fucosylated anti-CD19 monoclonal antibody, in adults with primary immune thrombocytopenia (ITP) who were treated before.
The presentation will include safety findings, B-cell depletion data, and early platelet results from the low-dose group receiving 250 mg at 24 weeks. The poster, titled “Budoprutug, a Low-Fucosylated Anti-CD19 Monoclonal Antibody, in Adults With Primary Immune Thrombocytopenia: Initial Phase 1b Study Results,” will be shown in Poster Session 2 on June 13, 2026, from 6:45 to 7:45 p.m. CEST.
Read Announcement- Drug:
- Budoprutug
- Announced Date:
- April 7, 2026
- Indication:
- Treatment of Primary Membranous Nephropathy
Announcement
Climb Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to budoprutug, the company's investigational anti-CD19 monoclonal antibody, for the treatment of primary membranous nephropathy (pMN)—a rare kidney disease for which there are currently no FDA-approved treatments.
AI Summary
Climb Bio, Inc. announced that the U.S. Food and Drug Administration has granted Fast Track Designation to budoprutug, the company’s investigational anti-CD19 monoclonal antibody, for the treatment of primary membranous nephropathy (pMN). pMN is a rare autoimmune kidney disease for which there are currently no FDA-approved treatments. The designation recognizes the therapy’s potential to address an important unmet medical need in this patient population.
Fast Track status allows more frequent communication with the FDA, the possibility of submitting parts of a marketing application on a rolling basis, and the chance to speed development and review if clinical data are positive. Climb Bio will continue clinical studies to evaluate budoprutug’s safety and effectiveness in pMN. If trials succeed, the designation could help shorten the path to approval and bring a new targeted treatment option to patients who now have limited choices.
Read Announcement
CLYM116 FDA Regulatory Events
CLYM116 is a drug developed by Climb Bio for the following indication: for IgAN.
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:
- CLYM116
- Announced Date:
- October 17, 2025
- Indication:
- for IgAN
Announcement
Climb Bio, Inc. announced the upcoming presentation of CLYM116 preclinical data and published budoprutug pMN Phase 1b long-term outcome data at the 2025 American Society of Nephrology (ASN) Kidney Week, which will be held in Houston, TX November 6-9, 2025.
AI Summary
Climb Bio will present preclinical data for CLYM116 and publish long-term Phase 1b outcomes for budoprutug at the 2025 ASN Kidney Week in Houston, Nov 6–9.
CLYM116 is a novel anti-APRIL monoclonal antibody developed for IgA nephropathy. In preclinical models, it promoted APRIL degradation and recycled efficiently to extend half-life, yielding deep and durable reductions in pathogenic IgA. These favorable pharmacokinetic and pharmacodynamic profiles support advancing CLYM116 toward clinical trials.
In addition, Climb Bio released long-term follow-up results for budoprutug, an anti-CD19 antibody tested in primary membranous nephropathy. Four patients showed sustained control of proteinuria up to three years after up to four doses, with no significant treatment-related adverse events. Three patients avoided further immunosuppressive therapy. These findings highlight budoprutug’s potential as a disease-modifying therapy for B-cell mediated kidney diseases.
Both will inform clinical strategies and next steps for these therapies.
Read Announcement- Drug:
- CLYM116
- Announced Date:
- September 29, 2025
- Indication:
- for IgAN
Announcement
Climb Bio, Inc. announced results from a completed nonhuman primate (NHP) study comparing CLYM116 to sibeprenlimab, a first-generation anti-APRIL monoclonal antibody.
AI Summary
Climb Bio, Inc. reported results from a nonhuman primate study comparing its novel anti-APRIL antibody, CLYM116, to sibeprenlimab, a first-generation anti-APRIL antibody. In this head-to-head test, CLYM116 showed a two to three times longer half-life and over 70% maximal reduction in IgA after a single subcutaneous dose at 6 mg/kg. The subcutaneous formulation also reached about 85% bioavailability and was well tolerated. These findings suggest CLYM116 could offer deeper, longer-lasting control of IgA with less frequent dosing than earlier therapies.
The company plans to begin a Phase 1 trial in healthy volunteers in the fourth quarter of 2025, pending regulatory clearance. Early biomarker results and dosing interval data are expected by mid-2026. CLYM116’s design uses a pH-dependent “sweeper” mechanism to block APRIL, promote its degradation, and recycle the antibody, potentially improving treatment for IgA nephropathy.
Climb Bio is hosting an R&D Spotlight Webcast on September 29, 2025, to share these preclinical findings and discuss next steps.
Read Announcement
