This section highlights FDA-related milestones and regulatory updates for drugs developed by Crescent Biopharma (CBIO).
Over the past two years, Crescent Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CR-002 and CR-001. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
CR-002 FDA Regulatory Events
CR-002 is a drug developed by Crescent Biopharma for the following indication: To Treat Advanced Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CR-002
- Announced Date:
- October 5, 2026
- Indication:
- To Treat Advanced Solid Tumors
Announcement
Crescent Biopharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CR-002, a topoisomerase inhibitor antibody drug-conjugate (ADC) targeting programmed cell death ligand 1 (PD-L1), being developed for the treatment of advanced solid tumors.
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CR-001 FDA Regulatory Events
CR-001 is a drug developed by Crescent Biopharma for the following indication: Treatment of Advanced Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CR-001
- Announced Date:
- May 21, 2026
- Indication:
- Treatment of Advanced Solid Tumors
Announcement
Crescent Biopharma, Inc. announced a trial in progress poster of the ASCEND study of CR-001, a PD-1 x VEGF bispecific antibody, will be presented during the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 29-June 2, in Chicago.
AI Summary
Crescent Biopharma announced that a trial-in-progress poster for its ASCEND study of CR-001 will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from May 29 to June 2. CR-001 is a PD-1 x VEGF bispecific antibody being studied in a global Phase 1/2 trial across several solid tumors, including non-small cell lung cancer, gastrointestinal cancers, and gynecological cancers. The study includes both first-line and previously treated patients.
The company said it expects multiple CR-001 data readouts starting in the first quarter of 2027. Crescent also noted that, through a strategic collaboration, Sichuan Kelun-Biotech has exclusive rights to develop and commercialize CR-001 in Greater China. Kelun-Biotech plans to begin its own Phase 1/2 trial of CR-001 in China in the first half of 2026.
Read Announcement- Drug:
- CR-001
- Announced Date:
- February 18, 2026
- Indication:
- Treatment of Advanced Solid Tumors
Announcement
Crescent Biopharma, Inc. announced that the first patient has been dosed in its global ASCEND Phase 1/2 clinical trial evaluating CR-001, an investigational PD-1 x VEGF bispecific antibody, for the treatment of advanced solid tumors.
AI Summary
Crescent Biopharma announced the first patient has been dosed in its global ASCEND Phase 1/2 trial testing CR-001, an investigational PD-1 x VEGF bispecific antibody, in advanced solid tumors. The study will evaluate CR-001 in multiple tumor types, including non-small cell lung cancer (NSCLC) and gastrointestinal and gynecological cancers, in both first-line and previously treated patients. ASCEND is the first of four clinical trials Crescent expects to start across its portfolio in 2026.
The company plans to report proof-of-concept data in the first quarter of 2027. Results will include initial safety, pharmacokinetics, pharmacodynamics and preliminary antitumor activity from dose-escalation and backfill cohorts.
CR-001, also known as SKB118, was discovered by Paragon Therapeutics. Under a strategic collaboration, Crescent has granted Sichuan Kelun-Biotech exclusive rights to develop and commercialize CR-001 in Greater China.
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