Compass Therapeutics Provides Regulatory Update on Tovecimig in Biliary Tract Cancer Following FDA Feedback

FDA feedback requests survival data before a BLA for tovecimig, while Compass cites strong PFS and ORR data in advanced biliary tract cancer.

Rhea-AI Summary

Compass Therapeutics (CMPX) reported that the U.S. FDA has recommended conducting an additional trial showing an overall survival benefit before submitting a Biologics License Application (BLA) for tovecimig in previously treated, advanced biliary tract cancer (BTC).

The company does not believe a new trial is warranted before BLA submission, citing the Phase 2/3 COMPANION-002 study, in which tovecimig plus paclitaxel achieved a statistically significant improvement in objective response rate (18.0% vs. 5.3%; p=0.0228) and progression-free survival (median 4.7 vs. 2.6 months; hazard ratio 0.44; p<0.0001) versus paclitaxel alone. Overall survival did not reach statistical significance due to high crossover and prolonged survival in crossover patients. Compass plans further engagement with the FDA while preparing a BLA and states that the safety profile was generally consistent with prior tovecimig studies.

Positive

• Objective response rate 18.0% vs. 5.3% with paclitaxel alone (p=0.0228) in COMPANION-002
• Median PFS 4.7 vs. 2.6 months; hazard ratio 0.44 (p<0.0001), a 56% lower progression risk
• Safety profile generally consistent with prior tovecimig studies in the BTC program

Negative

• FDA recommends a new trial to show an overall survival benefit before BLA submission
• Overall survival endpoint did not meet statistical significance in COMPANION-002

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Details

Market reaction after BLA regulatory update: CMPX -40.65%

-50.6% Trough in 8 min

$0.86 $1.86 Day Range

$194.51M Market Cap

Following this news, CMPX has declined 40.65%, reflecting a significant negative market reaction. Argus tracked a trough of -50.6% from its starting point during tracking. Our momentum scanner has triggered 47 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $1.08. Trading volume is exceptionally heavy at 227.8x the average, suggesting significant selling pressure.

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Market Context

Before publication, CMPX had declined 4.21% from its prior close; that pre-existing move provided ma...

Analysis

Before publication, CMPX had declined 4.21% from its prior close; that pre-existing move provided market context for the FDA recommendation requiring a survival-benefit trial before BLA submission.

Key Figures

Objective response rate: 18.0% vs. 5.3% ORR p-value: p=0.0228 Median PFS: 4.7 vs. 2.6 months +3 more

Objective response rate

18.0% vs. 5.3%

Tovecimig plus paclitaxel vs. paclitaxel alone in COMPANION-002

ORR p-value

p=0.0228

Primary endpoint in COMPANION-002

Median PFS

4.7 vs. 2.6 months

Tovecimig plus paclitaxel vs. paclitaxel alone

PFS hazard ratio

0.44

COMPANION-002 study

PFS p-value

p<0.0001

COMPANION-002 study

Risk reduction

56%

Reduction in risk of disease progression

Historical Context

1 past event · Latest: Aug 06

1 event

1. Aug 06

   2Q26 earnings report

   24h Move

   +5.3%

   Company reported positive COMPANION-002 data while awaiting FDA feedback ahead of potential BLA filing.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

biologics license application, objective response rate, progression-free survival, hazard ratio, +1 more

5 terms

biologics license application regulatory

"before proceeding with a Biologics License Application (BLA) submission"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

objective response rate medical

"primary endpoint of objective response rate (ORR) of 18.0%"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

progression-free survival medical

"a highly significant improvement in progression-free survival (PFS)"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

hazard ratio medical

"with a hazard ratio of 0.44"

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

overall survival medical

"Overall survival (OS) analyses were confounded"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Add on Google Not now

• The FDA recommended that Compass conduct a trial to demonstrate a survival benefit prior to submitting a BLA for tovecimig.
• Compass does not believe that a new trial is warranted prior to submitting a BLA based on the data from the Phase 2/3 COMPANION-002 study and the urgent unmet medical need for patients with BTC.
• Compass intends to further engage with the FDA as we continue to prepare a BLA submission for tovecimig.
• Compass remains confident in tovecimig based on the positive results from COMPANION-002, including the statistically significant improvements in ORR and PFS.

BOSTON, Sept. 22, 2026 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today announced that the U.S. Food and Drug Administration (FDA) recommended that Compass conduct a trial demonstrating a survival benefit before proceeding with a Biologics License Application (BLA) submission for tovecimig in patients with previously treated, advanced biliary tract cancer (BTC).

BTC is an aggressive, life-threatening cancer with poor survival outcomes, and effective options remain limited for patients who have received prior treatment, underscoring the urgent need for new approaches.

As previously disclosed, in the positive Phase 2/3 COMPANION-002 study, tovecimig plus paclitaxel demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) of 18.0% vs. 5.3% with paclitaxel alone (p=0.0228) and a highly significant improvement in progression-free survival (PFS) in patients with BTC who had received prior treatment. Median PFS was 4.7 vs. 2.6 months with a hazard ratio of 0.44 (p<0.0001), representing a compelling 56% reduction in the risk of disease progression. Overall survival (OS) analyses were confounded by both high crossover and notably prolonged survival in crossover patients randomized to the control arm then treated with tovecimig and, therefore, did not meet statistical significance. The safety profile was generally consistent with previously reported data from prior tovecimig studies.

“While this is not the response we expected, we respect the FDA’s feedback and our priority is to work with the Agency to determine the best path forward to support our planned BLA submission and address this pressing unmet need,” said Thomas Schuetz, M.D., Ph.D., Chief Executive Officer of Compass. “We remain confident that the COMPANION-002 findings, including the statistically significant improvements in PFS and ORR combined with subset analyses on survival, demonstrate clinically meaningful activity in patients with previously treated, advanced BTC.”

About Tovecimig
Tovecimig is an investigational DLL4 x VEGF-A bispecific antibody designed to block two angiogenic pathways simultaneously, representing a first-in-class approach to disrupting tumor angiogenesis. In COMPANION-002, tovecimig was evaluated in combination with paclitaxel in patients with previously treated, advanced biliary tract cancer. Tovecimig has received Fast Track and Orphan Drug Designation from the U.S. Food and Drug Administration.

About Compass Therapeutics
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company dedicated to transforming the standard of care for patients with cancer through the discovery and development of innovative antibody-based therapeutics. The company leverages deep expertise in tumor biology and proprietary antibody engineering technologies to develop differentiated therapies that target the intersection of angiogenesis, immune activation, and tumor-driven immunosuppression. Compass has a robust pipeline of novel product candidates designed to address significant unmet needs and improve outcomes for patients with cancer. The Company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics website at https://www.compasstherapeutics.com

Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Compass’s financial position to continue advancing its product candidates, expectations about cash runway, business and development plans, and statements regarding tovecimig, the results of the COMPANION-002 study, and the associated regulatory feedback, plans, and timelines, and the therapeutic potential thereof. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at www.sec.gov, including without limitation Compass’s latest Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC.

Investor Contact
ir@compasstherapeutics.com

Media Contact
Anna Gifford, Chief of Staff
media@compasstherapeutics.com
617-500-8099

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What additional evidence did the FDA recommend before a BLA submission for tovecimig in BTC?

The FDA recommended that Compass conduct a trial demonstrating an overall survival benefit prior to submitting a Biologics License Application for tovecimig in patients with previously treated, advanced biliary tract cancer.

How does Compass view the need for a new survival trial before BLA submission?

Compass does not believe a new trial is warranted before submitting a BLA. The company cites the COMPANION-002 data, including statistically significant improvements in objective response rate and progression-free survival, together with the urgent unmet medical need in BTC.

What were the key efficacy outcomes from the COMPANION-002 study of tovecimig in BTC?

In COMPANION-002, tovecimig plus paclitaxel showed an objective response rate of 18.0% versus 5.3% with paclitaxel alone (p=0.0228) and a highly significant improvement in progression-free survival, with median PFS of 4.7 versus 2.6 months and a hazard ratio of 0.44 (p<0.0001).

Why did overall survival not reach statistical significance in COMPANION-002?

Overall survival analyses were confounded by high crossover and notably prolonged survival in crossover patients who were initially randomized to the control arm and then treated with tovecimig, and overall survival therefore did not meet statistical significance.

How did Compass describe the safety profile of tovecimig in this setting?

The safety profile of tovecimig in COMPANION-002 was described as generally consistent with previously reported data from earlier tovecimig studies.

What are Compass’s next planned regulatory steps for tovecimig in BTC?

Compass intends to further engage with the FDA while continuing to prepare a BLA submission for tovecimig, and the company states that it aims to work with the Agency to determine the best path forward for addressing the unmet need in previously treated, advanced BTC.