IND clearance is a procedural milestone with no revenue implications. The APOLLO trial initiation in Q4 2026 and initial data in H2 2027 are the next catalysts. Monitor for enrollment updates and any partnership or financing news given the company's pre-revenue status.
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Executive Summary
Crescent Biopharma announced FDA clearance of its IND application for CR-002, a topoisomerase inhibitor ADC targeting PD-L1 for advanced solid tumors. The Phase 1/2 APOLLO trial is on track to initiate in Q4 2026 with initial clinical data expected in H2 2027.
Key Facts
- FDA cleared IND for CR-002, a topoisomerase inhibitor ADC targeting PD-L1
- Phase 1/2 APOLLO trial to initiate in Q4 2026, enrolling ~200 patients with advanced solid tumors (NSCLC, HNSCC, GI, gynecological)
- Initial clinical data expected in H2 2027
- CR-002 is the third program in Crescent's portfolio to enter the clinic
- Company is pre-revenue clinical-stage biotech with no approved products
Financial Impact
No financial figures disclosed; pre-revenue clinical-stage company
Risk Factors
- Clinical trial failure or safety/efficacy issues could materially impact stock
- Pre-revenue company requires ongoing capital raises, diluting existing shareholders
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3374436 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 15, 2026 11d ago | 8-K | $11.84 | awaiting T+60 | — | $12.76 (+7.77%) |
Oct 15, 2026 11d ago | Press Release | $11.84 | awaiting T+60 | — | $12.76 (+7.77%) |
Oct 5, 2026 21d ago | Press Release | $13.94 | awaiting T+60 | — | $12.76 (−8.46%) |
Sep 18, 2026 5w ago | Insider Cluster | $16.25 | awaiting T+60 | — | $12.76 (−21.48%) |
Jul 30, 2026 12w ago | 8-K | $15.02 $12.82 | ▼ −14.65% | ▼ −17.11% | $12.76 (−15.05%) |
Jul 20, 2026 14w ago | Insider Buy | $16.64 $12.91 | ▼ −22.42% | ▼ −26.39% | $12.76 (−23.32%) |
Jul 15, 2026 14w ago | 8-K / 424B5 | $15.11 $14.91 | ▲ +1.32% | ▲ +5.03% | $12.76 (+15.55%) |
Jul 14, 2026 14w ago | Press Release | $15.67 $14.12 | ▲ +9.89% | ▲ +12.42% | $12.76 (+18.57%) |
Jul 14, 2026 14w ago | 424B5 | $15.67 $14.12 | ▲ +9.89% | ▲ +12.42% | $12.76 (+18.57%) |
Jul 13, 2026 15w ago | EFFECT | $15.69 $13.57 | ▼ −13.51% | ▼ −17.51% | $12.76 (−18.67%) |
US Market Status
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