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Compass Therapeutics (CMPX) FDA Events

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FDA Events for Compass Therapeutics (CMPX)

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.

Compass Therapeutics' Drugs in FDA Review

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.

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.

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.

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.

Compass Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Compass Therapeutics (CMPX) has reported FDA regulatory activity for the following drugs: CTX-009, CTX-471, tovecimig and CTX-8371.

The most recent FDA-related event for Compass Therapeutics occurred on April 28, 2025, involving CTX-471. The update was categorized as "Poster Presentation," with the company reporting: "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."

Current therapies from Compass Therapeutics in review with the FDA target conditions such as:

  • Biliary Tract Cancers (BTC) - CTX-009
  • for Cancer - CTX-471
  • In Patients with Biliary Tract Cancer - tovecimig
  • Bispecific Antibody Checkpoint Inhibitor - CTX-8371

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:CMPX) was last updated on 7/10/2025 by MarketBeat.com Staff
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