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
COMPANION-002, tovecimig, CTX-471, and CTX-009. 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.
COMPANION-002 FDA Regulatory Events
COMPANION-002 is a drug developed by Compass Therapeutics for the following indication: 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:
- COMPANION-002
- Announced Date:
- April 27, 2026
- Indication:
- Patients with Biliary Tract Cancer
Announcement
Compass Therapeutics, Inc. announced that it met the key secondary endpoint of PFS and showed additional compelling results in the randomized COMPANION-002 study, which evaluated tovecimig plus paclitaxel versus paclitaxel alone in patients with unresectable advanced, metastatic or recurrent biliary tract cancer (BTC) treated in the second-line setting.
AI Summary
Compass Therapeutics reported that in the randomized COMPANION-002 study, the combination of tovecimig plus paclitaxel met the key secondary endpoint of progression-free survival (PFS) and produced additional compelling results versus paclitaxel alone. The study enrolled patients with unresectable, advanced, metastatic, or recurrent biliary tract cancer who were treated in the second-line setting. These findings suggest the combination may delay disease progression compared with standard paclitaxel.
Tovecimig was generally well tolerated and showed a safety profile consistent with prior studies, with no new safety signals. In the tovecimig combination arm, the most common treatment-emergent adverse events were hypertension (69%) and fatigue (67%). The most common related Grade 3 or higher events were hypertension (44%) and neutropenia (36%).
Compass plans to meet with the U.S. Food and Drug Administration in the coming months to discuss these data ahead of a planned BLA submission. A replay of the company’s webcast will be available on the Compass investors website.
Read Announcement
Tovecimig FDA Regulatory 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:
- April 24, 2026
- Indication:
- In Patients with Biliary Tract Cancer
Announcement
Compass Therapeutics, Inc. announced it will host a webcast on Monday, April 27, 2026 at 8:00am ET to review topline secondary endpoints from its Phase 2/3 COMPANION-002 clinical study 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 will host a webcast on Monday, April 27, 2026 at 8:00am ET to review topline secondary endpoints from its Phase 2/3 COMPANION-002 study. The study evaluates tovecimig, a DLL4 x VEGF-A bispecific antibody, in combination with paclitaxel for patients with advanced biliary tract cancer. The presentation will summarize the key secondary outcome measures and what they may mean for the program.
The event will be available by conference call and webcast. Toll free: 1-877-407-9716; International: 1-201-493-6779; Conference ID: 13760371. A replay of the webcast and the accompanying presentation will be posted for 90 days after the event on the “Events” page under the Investors section of Compass Therapeutics’ website.
Read Announcement- 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
CTX-471 FDA Regulatory 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.
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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
