The data strengthens CLYM116's best-in-class profile for IgAN with Q12W dosing potential. Monitor NAVIGATE-2 Phase 2 initial data in H1 2027 and Phase 3 initiation in 2027 as key catalysts. The favorable safety and efficacy profile could support partnership or licensing interest.
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Executive Summary
Climb Bio announced additional Phase 1 data for CLYM116/MIL116, an anti-APRIL antibody for IgA nephropathy, at ASN Kidney Week 2026. The data showed a ~33-day half-life, >90% free APRIL suppression sustained through 12 weeks, and ~70% Gd-IgA1 reduction at 12 weeks with a single 800 mg dose, supporting Q12W dosing. The NAVIGATE-2 Phase 2 trial is enrolling with initial data expected in H1 2027, and a global Phase 3 trial is planned for 2027.
Key Facts
- CLYM116 showed an estimated half-life of approximately 33 days based on the 800 mg dose and 320 mg MAD cohort.
- A single SC injection of 480 mg or higher produced free APRIL suppression of 90% or more through the full 12-week dosing interval.
- A single SC injection of 800 mg produced reductions of approximately 70% in Gd-IgA1 and approximately 60% in IgA at 12 weeks.
- CLYM116 was generally well tolerated with no serious adverse events, dose-limiting toxicities, or hypogammaglobulinemia across 88 participants.
- NAVIGATE-2 Phase 2 trial is enrolling patients with IgAN; initial data expected in the first half of 2027.
- Global Phase 3 trial expected to initiate in 2027, pending regulatory feedback.
Financial Impact
No financial data provided; clinical-stage biotech with no revenue. Positive Phase 1 data supports pipeline value and potential for accelerated development.
Risk Factors
- Phase 1 data in healthy volunteers may not replicate in IgAN patients in Phase 2/3 trials.
- Competing anti-APRIL therapies (e.g., sibeprenlimab) may achieve similar or better results.
- Regulatory feedback could delay or prevent Phase 3 initiation.
- Company needs substantial additional capital to fund later-stage development.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 10 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (CLYM) — Batch item 1 | 0001193125-26-430681 |
| Document: clym-ex99_1.htm | 0001193125-26-430681 |
| Document: 0001193125-26-430681-index-headers.html | 0001193125-26-430681 |
| Document: 0001193125-26-430681-index.html | 0001193125-26-430681 |
| Document: 0001193125-26-430681.txt | 0001193125-26-430681 |
| 8-K Filing (CLYM) — Batch item 6 | 0001193125-26-430681 |
| Document: clym-ex99_1.htm | 0001193125-26-430681 |
| Document: 0001193125-26-430681-index-headers.html | 0001193125-26-430681 |
| Document: 0001193125-26-430681-index.html | 0001193125-26-430681 |
| Document: 0001193125-26-430681.txt | 0001193125-26-430681 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 26, 2026 today | 8-K | — | awaiting T+1 | — | — |
Oct 23, 2026 3d ago | 8-K | $10.47 | awaiting T+1 | — | $8.81 (−15.85%) |
Oct 23, 2026 3d ago | Press Release | $10.34 | awaiting T+1 | — | $8.81 (−14.80%) |
Sep 22, 2026 4w ago | Institutional Cluster | $14.21 $12.52 | ▼ −11.89% | ▼ −11.17% | $8.81 (−38.00%) |
Sep 3, 2026 7w ago | 8-K | $14.59 $15.52 | ▲ +6.37% | ▲ +6.76% | $8.81 (−39.62%) |
Aug 14, 2026 10w ago | 8-K | $16.33 $17.44 | ▲ +6.80% | ▲ +7.27% | $8.81 (−46.05%) |
Aug 6, 2026 11w ago | 8-K | $14.00 $14.00 | · 0.00% | ▼ −0.61% | $8.81 (−37.07%) |
Jun 30, 2026 16w ago | 144 | $13.29 $12.90 | ▼ −2.93% | ▼ −2.80% | $8.81 (−33.71%) |
Jun 12, 2026 19w ago | 8-K | $11.49 $10.71 | ▲ +6.79% | ▲ +6.19% | $8.81 (+23.32%) |
Jun 12, 2026 19w ago | 424B5 | $11.49 $10.71 | ▲ +6.79% | ▲ +6.19% | $8.81 (+23.32%) |
US Market Status
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