Climb Bio's Drug in the FDA Approval Process
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
CLYM116. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- 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
Climb Bio FDA Events - Frequently Asked Questions
As of now, Climb Bio (CLYM) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Climb Bio (CLYM) has reported FDA regulatory activity for CLYM116.
The most recent FDA-related event for Climb Bio occurred on September 29, 2025, involving CLYM116. The update was categorized as "Results," with the company reporting: "Climb Bio, Inc. announced results from a completed nonhuman primate (NHP) study comparing CLYM116 to sibeprenlimab, a first-generation anti-APRIL monoclonal antibody."
Currently, Climb Bio has one therapy (CLYM116) targeting the following condition: for IgAN.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:CLYM) was last updated on 10/1/2025 by MarketBeat.com Staff
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