Crescent Biopharma's Drug in the FDA Approval Process
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-001. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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.
Read Announcement
Crescent Biopharma FDA Events - Frequently Asked Questions
As of now, Crescent Biopharma (CBIO) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Crescent Biopharma (CBIO) has reported FDA regulatory activity for CR-001.
The most recent FDA-related event for Crescent Biopharma occurred on May 21, 2026, involving CR-001. The update was categorized as "Poster Presentation," with the company reporting: "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."
Currently, Crescent Biopharma has one therapy (CR-001) targeting the following condition: Treatment of Advanced Solid Tumors.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:CBIO last updated on 5/22/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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