Crescent Biopharma (CBIO) FDA Approvals $20.74 +0.51 (+2.52%) Closing price 04:00 PM EasternExtended Trading$20.68 -0.06 (-0.31%) As of 04:10 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Crescent Biopharma's Drug in the FDA Approval ProcessThis 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. Poster Presentation - May 21,2026Poster Presentation Drug: CR-001Announced Date: May 21, 2026Indication: Treatment of Advanced Solid TumorsAnnouncementCrescent 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 SummaryCrescent 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 AnnouncementDose Update - February 18,2026Dose Update Phase 1/2Drug: CR-001Announced Date: February 18, 2026Indication: Treatment of Advanced Solid TumorsAnnouncementCrescent 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 SummaryCrescent 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 Has Crescent Biopharma received FDA approval? As of now, Crescent Biopharma (CBIO) has not received any FDA approvals for its therapy in the last two years. What drugs has Crescent Biopharma submitted to the FDA? In the past two years, Crescent Biopharma (CBIO) has reported FDA regulatory activity for CR-001. What is the most recent FDA event for Crescent Biopharma? 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." What conditions do Crescent Biopharma's current drugs treat? Currently, Crescent Biopharma has one therapy (CR-001) targeting the following condition: Treatment of Advanced Solid Tumors. 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FDA EventsAgenus FDA EventsAdagio Medical FDA EventsAktis Oncology FDA EventsAkari Therapeutics FDA Events 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 Related Companies Innoviva FDA Events Novavax FDA Events Zenas BioPharma FDA Events Lexicon Pharmaceuticals FDA Events MannKind FDA Events OPKO Health FDA Events Geron FDA Events Rigel Pharmaceuticals FDA Events Emergent Biosolutions FDA Events Verastem FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:CBIO last updated on 5/22/2026 by MarketBeat.com Staff. 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Poster Presentation - May 21,2026Poster Presentation Drug: CR-001Announced Date: May 21, 2026Indication: Treatment of Advanced Solid TumorsAnnouncementCrescent 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 SummaryCrescent 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
Dose Update - February 18,2026Dose Update Phase 1/2Drug: CR-001Announced Date: February 18, 2026Indication: Treatment of Advanced Solid TumorsAnnouncementCrescent 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 SummaryCrescent 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
