Crescent Biopharma Secures Regulatory Clearances for CR-001 and CR-003
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 05 2026
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Crescent Biopharma announced regulatory clearances of Investigational New Drug applications for CR-001, a PD-1 x VEGF bispecific antibody, and CR-003, an integrin beta-6-targeted antibody drug-conjugate, both being developed for the treatment of advanced solid tumors. The U.S. Food and Drug Administration has cleared Crescent's IND for CR-001, and Crescent's partner Sichuan Kelun-Biotech Biopharmaceutical has received IND approval for CR-003 from the Center for Drug Evaluation of the National Medical Products Administration of China. The Phase 1/2 ASCEND global clinical trial plans to enroll both treatment-naive and previously treated patients with multiple solid tumor types, including non-small cell lung cancer and various gastrointestinal and gynecological tumors. The trial is expected to enroll up to 290 participants in the dose-escalation, back-fill and dose-optimization cohorts designed to enable robust assessment of the clinical profile of CR-001. Crescent anticipates reporting proof-of-concept clinical data from the ASCEND trial in the first quarter of 2027, including safety, pharmacokinetic, pharmacodynamic and early anti-tumor activity in first-line and previously treated patients.
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Analyst Views on CBIO
Wall Street analysts forecast CBIO stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for CBIO is 28.20 USD with a low forecast of 22.00 USD and a high forecast of 35.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 10.730
Low
22.00
Averages
28.20
High
35.00
Current: 10.730
Low
22.00
Averages
28.20
High
35.00
About CBIO
Crescent Biopharma, Inc. is a biotechnology company. The Company is focused on advancing the next wave of therapies for cancer patients. The Company’s pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. The Company’s lead program is CR-001, a tetravalent PD-1 x VEGF bispecific antibody in development for the treatment of solid tumors, and it is also advancing CR-002 and CR-003, antibody drug conjugates (ADCs) with topoisomerase inhibitor payloads. CR-002 and CR-003 are ADCs designed to deliver clinically active cytotoxic drugs known as topoisomerase inhibitors to tumor cells. Each of these programs has the potential to deliver therapeutics with clinical efficacy both as a monotherapy and in combination with CR-001 with significant potential across solid tumor indications.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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Crescent Biopharma Grants 129,626 Stock Options to Attract Talent
- Options Grant: Crescent Biopharma's Board approved the grant of 129,626 stock options to three non-executive employees as part of the 2025 Employment Inducement Incentive Award Plan, aimed at attracting key talent and enhancing team stability.
- Incentive Structure: The options have an exercise price of $13.21 per share, aligning with the closing price on December 15, 2025, ensuring that employees can benefit financially as the company performs well.
- Vesting Schedule: Options will vest one-fourth on the first anniversary of the employee's start date, with one-forty-eighth vesting monthly thereafter, ensuring long-term employee commitment through continuous service with Crescent.
- Strategic Aim: By implementing such incentive measures, Crescent Biopharma aims to build an efficient oncology team to rapidly advance innovative therapies like its PD-1 x VEGF bispecific antibody, further solidifying its market position in the biotechnology sector.
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