CRBP Corbus Pharmaceuticals Holdings, Inc.
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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.
Actionable Insight
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.
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
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.
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May 26, 2026
23d ago
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8-K
| $7.91 $7.75 | ▼ −2.02% | ▼ −3.11% | $8.05 (+1.77%) |
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May 21, 2026
28d ago
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8-K
| $11.51 $7.64 | ▼ −33.62% | ▼ −35.22% | $8.05 (−30.06%) |
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May 14, 2026
5w ago
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| $11.98 $11.51 | ▼ −3.92% | ▼ −3.21% | $8.05 (−32.80%) |
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May 12, 2026
5w ago
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8-K
| $11.43 $9.95 | ▼ −12.95% | ▼ −13.03% | $8.05 (−29.57%) |
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May 12, 2026
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Press Release
| $11.43 $9.95 | ▼ −12.95% | ▼ −13.03% | $8.05 (−29.57%) |
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Apr 16, 2026
9w ago
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8-K
| $10.59 $10.06 | ▼ −5.00% | ▼ −5.56% | $8.05 (−23.98%) |
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Apr 14, 2026
9w ago
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| $10.02 $10.30 | ▲ +2.74% | ▲ +1.35% | $8.05 (−19.66%) |
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Apr 7, 2026
10w ago
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| $9.71 $10.02 | ▲ +3.19% | ▼ −2.14% | $8.05 (−17.10%) |
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Mar 23, 2026
12w ago
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EFFECT
| $8.43 $8.60 | ▲ +2.02% | ▲ +5.58% | $8.05 (−4.51%) |
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Mar 11, 2026
14w ago
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S-3
| $9.59 $8.94 | ▲ +6.78% | ▲ +5.80% | $8.05 (+16.06%) |
US Market Status
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