The data significantly de-risks CRB-701 and validates the OPSCC strategy. With FDA alignment on registration trials, the path to approval is clearer. Key catalysts to watch: initiation of TEMPO-1 (summer 2026), interim ORR readout (fall 2028), and 1L combo data with Keytruda (early 2027). ASCO presentations (May 29-30) may drive near-term volatility.
Price Chart
Executive Summary
Corbus reported updated Phase 1/2 data for CRB-701, a next-generation Nectin-4 ADC, showing a 42.9% confirmed ORR in 2L OPSCC and 34.4% in 2L cervical cancer at the 3.6 mg/kg dose, with manageable safety. The company has FDA alignment on registrational trial designs (TEMPO-1 for OPSCC, summer 2026) and a 250-patient randomized study, positioning CRB-701 for potential accelerated approval in two high-need indications.
Key Facts
- Confirmed ORR of 42.9% in 2L OPSCC at 3.6 mg/kg (9/21 patients) with median DoR of 6.3 months and PFS of 5.6 months
- Confirmed ORR of 34.4% in 2L cervical cancer at 3.6 mg/kg (11/32 patients, including 2 complete responses), median DoR 8.0 months, PFS 4.3 months
- CRB-701 was generally safe and well tolerated; Grade 3 AEs in 19.2%, Grade 4 in 0.9%, no Grade 5 events; discontinuation rate 2.8%
- FDA alignment reached for registrational study TEMPO-1 in 2L OPSCC (n=250) to support potential accelerated approval via ORR endpoint
- Treatment discontinuations remained low at 2.8%, peripheral neuropathy low at 7.3% (all Grade 1-2)
- Cash and investments of $138M as of March 31, 2026, with approximately 17.7M shares outstanding
Financial Impact
Clinical-stage company; no revenue. Success of CRB-701 could open a multibillion-dollar addressable market in 2L OPSCC and cervical cancer. Tivdak (cervical) has annualized global sales of ~$328M, suggesting significant commercial potential if approved.
Risk Factors
- Phase 1/2 data, though strong, is from a non-randomized study with modest sample sizes (n=21 OPSCC, n=32 cervical at 3.6 mg/kg)
- Ocular AEs occurred in 66.2% of patients (Grade 3 in 12.6%), requiring prophylactic management and dose modifications
- Registration trial enrollment and execution risk; TEMPO-1 interim ORR not expected until fall 2028, a long wait
- Competition: Padcev + Keytruda in 1L HNSCC showed 82% cORR in HPV+ patients; tisotumab vedotin (Tivdak) is approved in 2L cervical cancer
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-238059 |
| Document: crbp-ex99_1.htm | 0001193125-26-238059 |
| Document: crbp-ex99_2.htm | 0001193125-26-238059 |
| Document: 0001193125-26-238059-index-headers.html | 0001193125-26-238059 |
| Document: 0001193125-26-238059-index.html | 0001193125-26-238059 |
| Document: 0001193125-26-238059.txt | 0001193125-26-238059 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 15, 2026 12d ago | 8-K | $4.33 | awaiting T+60 | — | $4.07 (−6.00%) |
Sep 30, 2026 26d ago | SC 13G | $6.34 | awaiting T+60 | — | $4.07 (−35.80%) |
Sep 22, 2026 5w ago | Institutional Cluster | $7.88 | awaiting T+60 | — | $4.07 (−48.32%) |
Sep 14, 2026 6w ago | 8-K | $8.08 | awaiting T+60 | — | $4.07 (−49.63%) |
Sep 11, 2026 6w ago | Press Release | $8.08 | awaiting T+60 | — | $4.07 (−49.63%) |
Aug 12, 2026 10w ago | Insider Cluster | $10.08 | awaiting T+60 | — | $4.07 (−59.62%) |
Aug 10, 2026 11w ago | Insider Cluster | $9.51 | awaiting T+60 | — | $4.07 (−57.20%) |
May 26, 2026 22w ago | 8-K | $7.91 $9.99 | ▲ +26.30% | ▲ +23.57% | $4.07 (−48.55%) |
May 21, 2026 22w ago | 8-K | $11.51 $10.49 | ▼ −8.86% | ▼ −13.16% | $4.07 (−64.64%) |
May 14, 2026 23w ago | 8-K | $11.98 $9.46 | ▼ −21.04% | ▼ −24.62% | $4.07 (−66.03%) |
US Market Status
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