Monitor for initial CR-001 monotherapy data in Q1 2027 and combination data in mid-2027 — these are the first efficacy readouts for the lead asset. CR-002 IND clearance is a procedural milestone; the APOLLO trial initiation in Q4 2026 is the next catalyst to track.
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Executive Summary
Crescent Biopharma provided a clinical pipeline update via an 8-K, announcing that the Phase 1/2 ASCEND trial of CR-001 has completed dose escalation and is enrolling combination chemotherapy cohorts, with initial monotherapy data expected in Q1 2027. The company also disclosed FDA clearance to proceed with CR-002 (a PD-L1-targeting ADC) and plans to initiate the Phase 1/2 APOLLO trial in Q4 2026, with initial data in H2 2027. This is a pre-revenue, clinical-stage biotech filing with no financial data — the update is routine pipeline progress, not a material catalyst.
Key Facts
- CR-001 (PD-1 x VEGF bispecific) Phase 1/2 ASCEND monotherapy dose escalation completed; initial monotherapy data expected Q1 2027.
- Enrollment commenced in chemotherapy combination expansion cohorts of ASCEND; initial combo data expected mid-2027.
- Company plans to initiate first Phase 3 trial of CR-001 in early 2028, pending results and regulatory interactions.
- CR-002 (topoisomerase inhibitor ADC targeting PD-L1) received FDA IND allowance; Phase 1/2 APOLLO trial to start Q4 2026 with initial data in H2 2027.
- Kelun-Biotech is conducting multiple Phase 2 trials of CR-001 (SKB118) combined with sac-TMT in China, with initial data expected mid-2027.
- CR-003 (integrin-beta 6-targeted ADC) Phase 1/2 trial in China ongoing; proof-of-concept data expected Q1 2027.
Financial Impact
No financial data provided in the filing. Company is pre-revenue with no reported revenue, earnings, or cash runway figures.
Risk Factors
- All pipeline candidates are in early-stage clinical development with no approved products or revenue.
- Data readouts are 6-12 months away; binary risk on efficacy and safety results.
- Company has limited operating history and will require additional capital to fund planned trials.
Investment Themes
Documents Analyzed
This report is based on 4 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001628280-26-066006 |
| Document: 0001628280-26-066006-index-headers.html | 0001628280-26-066006 |
| Document: 0001628280-26-066006-index.html | 0001628280-26-066006 |
| Document: 0001628280-26-066006.txt | 0001628280-26-066006 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 15, 2026 11d ago | 8-K | $11.84 | awaiting T+60 | — | $12.94 (+9.33%) |
Oct 15, 2026 11d ago | Press Release | $11.84 | awaiting T+60 | — | $12.94 (+9.33%) |
Oct 5, 2026 22d ago | Press Release | $13.94 | awaiting T+60 | — | $12.94 (−7.14%) |
Sep 18, 2026 5w ago | Insider Cluster | $16.25 | awaiting T+60 | — | $12.94 (−20.34%) |
Jul 30, 2026 12w ago | 8-K | $15.02 $12.82 | ▼ −14.65% | ▼ −17.11% | $12.94 (−13.81%) |
Jul 20, 2026 14w ago | Insider Buy | $16.64 $12.91 | ▼ −22.42% | ▼ −26.39% | $12.94 (−22.21%) |
Jul 15, 2026 14w ago | 8-K / 424B5 | $15.11 $14.91 | ▲ +1.32% | ▲ +5.03% | $12.94 (+14.33%) |
Jul 14, 2026 14w ago | Press Release | $15.67 $14.12 | ▲ +9.89% | ▲ +12.42% | $12.94 (+17.39%) |
Jul 14, 2026 14w ago | 424B5 | $15.67 $14.12 | ▲ +9.89% | ▲ +12.42% | $12.94 (+17.39%) |
Jul 13, 2026 15w ago | EFFECT | $15.69 $13.57 | ▼ −13.51% | ▼ −17.51% | $12.94 (−17.50%) |
US Market Status
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