This section highlights FDA-related milestones and regulatory updates for drugs developed by Compass Therapeutics (CMPX).
Over the past two years, Compass Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CTX-009, CTX-471, CTX-8371, and tovecimig. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CTX-009 - FDA Regulatory Timeline and Events
CTX-009 is a drug developed by Compass Therapeutics for the following indication: Biliary Tract Cancers (BTC).
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:
- CTX-009
- Announced Date:
- April 1, 2025
- Indication:
- Biliary Tract Cancers (BTC)
Announcement
Compass Therapeutics, Inc. announced statistically significant top-line data on the primary efficacy endpoint for COMPANION-002, the Company's ongoing Phase 2/3 randomized trial of tovecimig (formerly CTX-009) in combination with paclitaxel in patients with advanced BTC.
AI Summary
Compass Therapeutics, Inc. announced positive top‐line results from the COMPANION-002 Phase 2/3 trial evaluating tovecimig (formerly CTX-009) with paclitaxel in advanced biliary tract cancer (BTC) patients. The study met its primary endpoint, showing that the combination achieved a 17.1% overall response rate—including one complete response—compared to 5.3% with paclitaxel alone. This statistically significant improvement (p=0.031) suggests that tovecimig, a bispecific antibody targeting DLL4 and VEGF-A, may offer a promising new treatment option for BTC patients who have limited alternatives in the second-line setting.
The trial, which enrolled patients previously treated with one systemic chemotherapy regimen, confirmed all responses through an independent central radiology review. Additional data on secondary endpoints such as progression-free survival and overall survival are expected to be reported later this year.
Read Announcement- Drug:
- CTX-009
- Announced Date:
- February 27, 2025
- Indication:
- Biliary Tract Cancers (BTC)
Announcement
Compass Therapeutics, Inc provided a business update.
AI Summary
Compass Therapeutics, Inc. provided a business update highlighting several key milestones in its pipeline. The company has completed enrollment of the COMPANION-002 study, a Phase 2/3 trial of tovecimig—a DLL4 x VEGF-A bispecific antibody—in patients with advanced biliary tract cancer (BTC) with a top-line data readout expected at the end of Q1 2025.
In addition, Compass has supported the initiation of an Investigator Sponsored Study at The University of Texas MD Anderson Cancer Center. This study will evaluate tovecimig in a first-line setting for BTC, with patient dosing anticipated to start in the first quarter of 2025.
Along with these clinical progressions, the company remains financially robust, ending 2024 with $127 million in cash and marketable securities, ensuring a cash runway into early 2027.
Read Announcement- Drug:
- CTX-009
- Announced Date:
- August 6, 2024
- Indication:
- Biliary Tract Cancers (BTC)
Announcement
Compass Therapeutics announced that it completed enrollment of the planned 150 patients in COMPANION-002, its randomized Phase 2/3 clinical trial of CTX-009 in patients with BTC.
AI Summary
Compass Therapeutics announced it has completed enrollment of 150 patients in its COMPANION-002 trial. This Phase 2/3 study is testing CTX-009 combined with paclitaxel versus paclitaxel alone in patients with advanced biliary tract cancers who have already received one prior chemotherapy treatment.
The trial is being conducted across 33 sites in the United States and will look at key outcomes such as overall response rate, progression-free survival, overall survival, clinical benefit rate, and duration of response. CTX-009 is a bispecific antibody that targets cancer growth by blocking both DLL4 and VEGF-A, which are crucial for tumor blood vessel formation. Completing enrollment marks an important step in advancing new treatment options for patients dealing with unresectable or recurrent biliary tract cancers.
Read Announcement- Drug:
- CTX-009
- Announced Date:
- April 25, 2024
- Indication:
- Biliary Tract Cancers (BTC)
Announcement
Compass Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CTX-009, the Company's bispecific DLL4/VEGF-A antibody, in combination with paclitaxel for the treatment of patients with metastatic or locally advanced BTC that have been previously treated.
AI Summary
Compass Therapeutics announced that the FDA has granted Fast Track Designation to CTX-009, its bispecific DLL4/VEGF-A antibody, when used in combination with paclitaxel for treating patients with metastatic or locally advanced biliary tract cancer (BTC) who have previously received therapy. This designation highlights the urgent need for effective treatments for BTC, a type of cancer with limited current options and low response rates to existing therapies. In a Phase 2 study, the combination treatment showed promising early results, demonstrating a significant overall response rate and improvements in progression-free and overall survival. The Fast Track status is expected to facilitate closer collaboration with the FDA, potentially speeding up the development and review process to make this innovative treatment available to patients sooner.
Read Announcement- Drug:
- CTX-009
- Announced Date:
- April 25, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- 2024-LATE
- Indication:
- Biliary Tract Cancers (BTC)
Announcement
Compass Therapeutics, Inc. announced that Top-line data readout for COMPANION-002, the Company's randomized Phase 2/3 BTC U.S. study, is expected by the end of 2024
AI Summary
Compass Therapeutics, Inc. announced that top-line data from its COMPANION-002 study, a randomized Phase 2/3 trial in the U.S. for advanced biliary tract cancer (BTC), is expected by the end of 2024. This study is focused on addressing the significant unmet need in BTC, a disease with limited treatment options and generally low response rates. In a preceding Phase 2 study, the company’s bispecific antibody CTX-009, when combined with paclitaxel, showed promising results with partial responses observed in nine out of 24 patients, yielding a 37.5% overall response rate. Additionally, the Phase 2 data indicated a median progression-free survival of 9.4 months and a median overall survival of 12.5 months. The forthcoming readout from COMPANION-002 is highly anticipated as it may further validate the efficacy of this new therapeutic approach for patients with advanced BTC.
Read Announcement
CTX-471 - FDA Regulatory Timeline and Events
CTX-471 is a drug developed by Compass Therapeutics for the following indication: for Cancer.
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:
- CTX-471
- Announced Date:
- April 28, 2025
- Indication:
- for Cancer
Announcement
Compass Therapeutics, Inc. announced its poster presentation entitled "Enhanced Efficacy of CTX-471, A CD137 Agonist Antibody, In Models of Immune Checkpoint Failure Via Simultaneous Blockade of Neo-Angiogenesis" at the American Association for Cancer Research (AACR) Annual Meeting, from April 25–30, 2025, at the McCormick Place Convention Center in Chicago, IL.
AI Summary
Compass Therapeutics, Inc. announced a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting held from April 25–30, 2025, at the McCormick Place Convention Center in Chicago, IL. The presentation, titled “Enhanced Efficacy of CTX-471, A CD137 Agonist Antibody, In Models of Immune Checkpoint Failure Via Simultaneous Blockade of Neo-Angiogenesis,” detailed promising preclinical data. Researchers showed that CTX-471, when used as a monotherapy, induced significant anti-tumor responses in various immune checkpoint-resistant murine models. Moreover, combining CTX-471 with tovecimig, a novel anti-angiogenic agent, further boosted anti-tumor effects by increasing both innate and adaptive immune responses, such as enhanced tumor cell killing and improved antigen presentation. These results point to a potential therapeutic benefit for patients who have not responded to current checkpoint inhibitors, offering a new avenue of treatment in solid tumors.
Read Announcement
CTX-8371 - FDA Regulatory Timeline and Events
CTX-8371 is a drug developed by Compass Therapeutics for the following indication: Bispecific Antibody Checkpoint Inhibitor.
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:
- CTX-8371
- Announced Date:
- April 16, 2024
- Indication:
- Bispecific Antibody Checkpoint Inhibitor
Announcement
Compass Therapeutics y announced that the first patient has been dosed in its Phase 1 dose-escalation clinical trial of CTX-8371, a PD-1 x PD-L1 bispecific antibody, in patients with solid tumors.
AI Summary
Compass Therapeutics has advanced its research by dosing the first patient in a Phase 1 dose-escalation trial for CTX-8371. This novel bispecific antibody uniquely targets both PD-1 and PD-L1, two proteins known to help cancer cells evade the immune system. The trial is being conducted in patients with advanced solid tumors—such as melanoma, non-small cell lung cancer, head and neck cancers, Hodgkin Lymphoma, and triple negative breast cancer—who have already progressed after treatment with a previous checkpoint blocker.
The study is designed to explore five ascending dose levels of CTX-8371 to assess its safety and potential anti-tumor benefits. Early preclinical results indicate that this dual mechanism of action, which includes cleavage of cell surface PD-1, may offer enhanced tumor inhibition compared to existing therapies. This milestone marks a significant step in evaluating a next-generation immunotherapy option for cancer patients.
Read Announcement
tovecimig - FDA Regulatory Timeline and Events
tovecimig is a drug developed by Compass Therapeutics for the following indication: In Patients with Biliary Tract Cancer.
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:
- tovecimig
- Announced Date:
- March 31, 2025
- Indication:
- In Patients with Biliary Tract Cancer
Announcement
Compass Therapeutics, Inc. announced it will host a webcast on Tuesday, April 1, 2025 at 8:00 AM ET to review top-line clinical data from its ongoing Phase 2/3 COMPANION-002 clinical trial assessing tovecimig (a DLL4 x VEGF-A bispecific antibody) in combination with paclitaxel in patients with advanced biliary tract cancer (BTC).
AI Summary
Compass Therapeutics, Inc. announced a webcast scheduled for Tuesday, April 1, 2025, at 8:00 AM ET. During the event, the company will review top-line clinical data from its ongoing Phase 2/3 COMPANION-002 clinical trial. This trial is studying the use of tovecimig, a DLL4 x VEGF-A bispecific antibody, in combination with paclitaxel for patients with advanced biliary tract cancer (BTC). The clinical trial data could provide valuable insights into the treatment of BTC by targeting key pathways involved in tumor growth and angiogenesis.
The webcast is open to interested parties, and a replay will be available on Compass Therapeutics’ Events page for 90 days after the live presentation. This event reflects Compass Therapeutics’ commitment to advancing oncology research and offering new potential treatment options for patients facing tough cancers like BTC.
Read Announcement
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