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Compass Therapeutics (CMPX)

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Earnings summaries and quarterly performance for Compass Therapeutics.

Recent press releases and 8-K filings for CMPX.

Compass Therapeutics Provides Pipeline Update and Commercialization Plans
CMPX
New Projects/Investments
Product Launch
Management Change
  • Tevesemig, Compass Therapeutics' lead program, achieved its primary endpoint in a randomized study for advanced biliary tract cancer, with progression-free survival (PFS) and overall survival (OS) readouts expected later this quarter (Q1 2026). If positive, this could lead to a biologics license application later this year and a PDUFA date in the first half of 2027, targeting a >$1 billion annual market in the US, which the company plans to commercialize independently.
  • The company's CTX8371 (PD1/PDL1 bispecific antibody) has shown early efficacy with responses in post-checkpoint inhibitor patients across various tumor types, including non-small cell lung cancer, triple-negative breast cancer, and Hodgkin's lymphoma, with cohort expansions currently open.
  • CTX10726 (PD1 VEGF A bispecific antibody) is entering the clinic this quarter (Q1 2026) for renal cell, endometrial, gastric, and hepatocellular cancers, with preclinical data indicating superior PD1 blockade and tumor control compared to other drugs in its class. Clinical data from this Phase 1 study are anticipated in the second half of 2026.
  • Compass Therapeutics also announced additions to its management team, including a new Chief Medical Officer and Chief Commercial Officer, to support its pipeline and commercialization efforts.
1 day ago
Compass Therapeutics Highlights Clinical Progress and Commercial Plans at J.P. Morgan Conference
CMPX
Product Launch
New Projects/Investments
Management Change
  • Tovecimig, a DLL4/VEGF-A bispecific antibody, achieved its primary endpoint (overall response rate) in a randomized study for advanced biliary tract cancer, with secondary endpoints (PFS and OS) expected later this quarter. The company anticipates a potential Biologics License Application (BLA) submission later in 2026, with a PDUFA date in the first half of 2027, targeting a $1 billion+ annual market in the US.
  • CTX-8371, a novel PD-1/PD-L1 bispecific antibody, demonstrated monotherapy responses in post-checkpoint inhibitor patients with non-small cell lung cancer, triple-negative breast cancer, and Hodgkin's lymphoma, with cohort expansions now open.
  • CTX-471, a CD137 agonist antibody, showed responses in post-PD-1 melanoma and a complete response in third-line metastatic small cell lung cancer, with an NCAM-positive basket study planned for the first half of 2026.
  • The fourth drug, CTX-10726, a PD-1/VEGF-A bispecific antibody, is set to enter the clinic this quarter, with initial clinical data expected in the second half of 2026.
  • Compass Therapeutics recently appointed a new Chief Medical Officer and Chief Commercial Officer to support the potential commercialization of tovecimig in the United States.
1 day ago
Compass Therapeutics Updates on Pipeline Progress and Cash Position
CMPX
Guidance Update
New Projects/Investments
Management Change
  • Compass Therapeutics reported an estimated $209 million in cash and marketable securities as of December 31, 2025, which is expected to provide cash runway into 2028.
  • Key analyses of progression-free survival (PFS) and overall survival (OS) for tovecimig in advanced biliary tract cancer are on track for late Q1 2026.
  • The company confirmed a third response for CTX-8371 in a patient with Hodgkin Lymphoma and is investigating accelerated approval pathways for HL, with cohort expansions now open for TNBC and NSCLC.
  • Compass expanded its senior leadership team with the appointment of Arjun Prasad as Chief Commercial Officer and Cynthia Sirard as Chief Medical Officer.
Jan 6, 2026, 1:00 PM
Compass Therapeutics Updates on Pipeline and Financials
CMPX
Guidance Update
New Projects/Investments
Management Change
  • Compass Therapeutics reported an estimated $209 million in cash and marketable securities as of December 31, 2025, which is expected to provide a cash runway into 2028.
  • Analyses of progression-free survival (PFS) and overall survival (OS) for tovecimig in advanced biliary tract cancer are on track for late Q1 2026. Additionally, Phase 2 monotherapy data for colorectal cancer, demonstrating a 5% overall response rate, will be presented on January 9, 2026.
  • A third response for CTX-8371 was confirmed in a Hodgkin Lymphoma patient, and a deep partial response in triple-negative breast cancer remains durable through week 32, with cohort expansions now open for enrollment in TNBC and non-small cell lung cancer (NSCLC). The company is also investigating potential accelerated pathways to approval for Hodgkin Lymphoma.
  • A Phase 1 study for CTX-10726 is expected to initiate in Q1 2026 with initial data anticipated in H2 2026, and a Phase 2 trial for CTX-471 is expected in H1 2026.
  • Compass expanded its senior leadership team with the appointment of Arjun Prasad as Chief Commercial Officer and Cynthia Sirard as Chief Medical Officer.
Jan 6, 2026, 1:00 PM
Compass Therapeutics discusses 2026 pipeline milestones and commercial readiness
CMPX
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
  • Compass Therapeutics expects a readout on secondary endpoints (PFS and OS) for its lead program, Tevesemig, a DLL4 VEGF-A bispecific antibody, at the end of Q1 2026. The company projects a multi-billion dollar commercial opportunity for Tevesemig in second-line biliary tract cancer, with a potential 2027 launch.
  • In its Phase 1 study for the PD-1, PD-L1 bispecific antibody (8371), three responses were observed in the first 15 patients, including near complete responses in metastatic non-small cell lung cancer and refractory triple-negative breast cancer. Cohort expansion readouts are anticipated in the second half of 2026.
  • A novel PD-1 VEGF-A bispecific antibody is scheduled to enter the clinic in early 2026, and a biomarker-driven basket study for the CD137 agonist antibody will commence in the first half of 2026.
Dec 4, 2025, 3:00 PM
Compass Therapeutics Outlines Key 2026 Clinical Milestones and Market Opportunities
CMPX
New Projects/Investments
Product Launch
Guidance Update
  • Compass Therapeutics anticipates an eventful 2026 with several key clinical milestones, including a readout on secondary endpoints (PFS and OS) for its lead program, Tevesemig, a DLL4 VEGF-A bispecific antibody, expected at the end of Q1 2026.
  • Early clinical observations for its PD-1, PD-L1 bispecific antibody (8371) show three responses in the first 15 patients treated in a Phase 1 study, including a near complete response in a patient with triple-negative breast cancer who had relapsed on prior therapies. Cohort expansions are planned for triple-negative breast cancer and non-small cell lung cancer, with a readout expected in the second half of 2026.
  • The company's novel PD-1 VEGF-A bispecific antibody is set to enter the clinic at the beginning of 2026, targeting gastric, hepatocellular, renal cell, and endometrial cancers, and is believed to offer differentiated PD-1 blockade.
  • Tevesemig, which demonstrated a more than tripled response rate in a randomized study for biliary tract cancer (BTC), represents a multi-billion-dollar commercial opportunity in second-line BTC alone, with potential for expansion into first-line and other tumor types. The company is preparing for a potential 2027 launch.
Dec 4, 2025, 3:00 PM
Piper Sandler Healthcare Conference Highlights Compass Therapeutics' and REGENX's Clinical Milestones
CMPX
New Projects/Investments
Product Launch
Guidance Update
  • Compass Therapeutics (CMPX) highlighted a 290% year-to-date stock increase and provided updates on its clinical pipeline.
  • CMPX's Tovecimig program for advanced biliary tract cancer achieved its primary endpoint for overall response rate, with PFS and OS data expected by Q1 2026, and a BLA submission anticipated in H2 2026.
  • CMPX's 8371 program, a PD-1 x PD-L1 bispecific antibody, showed three confirmed responses in 15 post-checkpoint patients in its Phase I study, with potential approval studies for triple-negative breast cancer starting in 2026.
  • REGENX announced upcoming milestones including a February PDUFA date for its RGX-121 Hunter program and top-line data for its RGX-202 Duchenne program in early Q2 2026.
Dec 2, 2025, 1:00 PM
Compass Therapeutics and REGENXBIO Provide Updates on Clinical Programs and Regulatory Timelines
CMPX
Product Launch
New Projects/Investments
Guidance Update
  • Compass Therapeutics expects PFS and OS data for its Tevesemig program in advanced biliary tract cancer by end of Q1 2026, with a potential BLA submission in H2 2026 and PDUFA in H1 2027. The company also highlighted promising Phase 1 data for its 8371 bispecific antibody, showing three confirmed responses in 15 post-checkpoint patients, and plans for two potential approval studies in 2026.
  • REGENXBIO anticipates a PDUFA date in February 2026 for its RGX-121 (Hunter program), following successful manufacturing inspections. Top-line data for its RGX-202 (Duchenne program), which has shown no serious adverse events and functional improvement in older patients, is expected in early Q2 2026.
Dec 2, 2025, 1:00 PM
Compass Therapeutics and REGENXBIO Outline Key Clinical Milestones
CMPX
New Projects/Investments
Guidance Update
Revenue Acceleration/Inflection
  • Compass Therapeutics (CMPX) anticipates PFS and OS data for Tevesemig in advanced biliary tract cancer by the end of Q1 2026, with a potential BLA submission in H2 2026 and launch in H1 2027 targeting an estimated 15,000 eligible US patients annually.
  • CMPX's 8371 (PD-1/PD-L1 bispecific antibody) demonstrated three confirmed responses in 15 post-checkpoint patients in its Phase 1 study, with plans to advance to potential approval studies for triple-negative breast cancer in H1 2026.
  • REGENXBIO anticipates a February PDUFA date for its RGX-121 Hunter program.
  • REGENXBIO also projects top-line data in early Q2 2026 for its RGX-202 Duchenne program, which has shown functional improvement in older patients and no serious adverse events in Phase 1/2.
Dec 2, 2025, 1:00 PM
Compass Therapeutics Outlines Key Clinical Catalysts for 2026 and 2027
CMPX
New Projects/Investments
Product Launch
Guidance Update
  • Compass Therapeutics anticipates a significant year in 2026, with key readouts including Progression-Free Survival (PFS) and Overall Survival (OS) data for tovecimig in advanced biliary tract cancer (BTC) in late Q1 2026. The company projects a potential $3 billion annual market in the U.S. alone for second-line BTC.
  • The company's first-in-class bispecific antibody, CTX-8371, which targets PD-1 and PD-L1, has shown promising early results with three responses out of 15 patients in the post-checkpoint inhibitor setting. Cohort expansions in non-small cell lung cancer and triple-negative breast cancer are underway, with data expected in the first half of 2026.
  • A novel PD-1 VEGF-A bispecific antibody, 10726, is slated to begin its Phase 1 study in early 2026, targeting gastric, hepatocellular, renal cell, and endometrial cancers.
  • Following successful clinical outcomes and an FDA interaction, Compass Therapeutics aims for a potential commercial launch of tovecimig in the first half of 2027.
Nov 20, 2025, 12:30 PM

Quarterly earnings call transcripts for Compass Therapeutics.