Corbus Gains FDA Alignment for CRB-701, Completes 240-Patient Obesity Trial

CRBPCRBP

Corbus secured broad FDA alignment on the registrational path for its CRB-701 ADC in second-line head and neck and cervical cancers and will present updated Phase 1/2 data at ASCO 2026, with a registrational study set to start this summer. The company completed enrollment of 240 patients in its 16-week CANYON-1 obesity trial and reported a Q1 net loss of $23.0 million on operating expenses of $24.3 million, with $138.2 million cash runway into 2028.

1. FDA Alignment and Oncology Program Updates

Corbus reached broad alignment with the FDA on the registration path for CRB-701 in second-line head and neck squamous cell carcinoma and cervical cancer, securing Fast Track designations for both indications. The company plans to initiate the registrational study this summer and will present monotherapy and combination data at the upcoming ASCO 2026 meeting.

2. Obesity Program Enrollment

The CANYON-1 Phase 1b trial of CRB-913, a novel oral CB1 inverse agonist, achieved last patient first visit in its 240-patient, 16-week dose-ranging study. Topline data readout is on track for summer 2026, targeting weight loss and long-term management benefits.

3. Q1 Financial Results

For the quarter ended March 31, 2026, Corbus reported a net loss of $23.0 million, or $1.23 per share, compared with a $17.0 million loss the prior year. Operating expenses rose to $24.3 million due to increased clinical development activities.

4. Cash Runway and Outlook

The company held $138.2 million in cash, cash equivalents, and investments at quarter end, funding operations into 2028 under current plans. Management highlighted upcoming inflection points across both oncology and obesity programs as key value drivers for the remainder of the year.

Sources

FF