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Kronos Bio (KRON) FDA Events

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FDA Events for Kronos Bio (KRON)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Kronos Bio (KRON). Over the past two years, Kronos Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as KB-0742 and KB-7898. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Kronos Bio's Drugs in FDA Review

KB-0742 - FDA Regulatory Timeline and Events

KB-0742 is a drug developed by Kronos Bio for the following indication: An Oral CDK9 Inhibitor Targeting MYC-amplified Cancers. 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.

KB-7898 - FDA Regulatory Timeline and Events

KB-7898 is a drug developed by Kronos Bio for the following indication: Treatment of Sjögren's disease. 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.

Kronos Bio FDA Events - Frequently Asked Questions

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

In the past two years, Kronos Bio (KRON) has reported FDA regulatory activity for the following drugs: KB-7898 and KB-0742.

The most recent FDA-related event for Kronos Bio occurred on October 7, 2024, involving KB-7898. The update was categorized as "Provided Update," with the company reporting: "Kronos Bio announced that plans to initiate Investigational New Drug (IND)-enabling studies of KB-7898 in the fourth quarter of 2024."

Current therapies from Kronos Bio in review with the FDA target conditions such as:

  • Treatment of Sjögren's disease - KB-7898
  • An Oral CDK9 Inhibitor Targeting MYC-amplified Cancers - KB-0742

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:KRON) was last updated on 7/10/2025 by MarketBeat.com Staff
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