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Keros Therapeutics (KROS) FDA Events

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FDA Events for Keros Therapeutics (KROS)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Keros Therapeutics (KROS). Over the past two years, Keros Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as KER-012, KER-050, and KER-065. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Keros Therapeutics' Drugs in FDA Review

KER-012 - FDA Regulatory Timeline and Events

KER-012 is a drug developed by Keros Therapeutics for the following indication: Healthy Volunteers. 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.

KER-050 - FDA Regulatory Timeline and Events

KER-050 is a drug developed by Keros Therapeutics for the following indication: Myelodysplastic Syndromes. 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.

KER-065 - FDA Regulatory Timeline and Events

KER-065 is a drug developed by Keros Therapeutics for the following indication: To treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ("TGF-ß") family of proteins. 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.

Keros 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, Keros Therapeutics (KROS) has reported FDA regulatory activity for the following drugs: KER-012, KER-050 and KER-065.

The most recent FDA-related event for Keros Therapeutics occurred on May 29, 2025, involving KER-012. The update was categorized as "Top-line data," with the company reporting: "Keros Therapeutics, Inc. announced topline data from the TROPOS trial, a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulmonary arterial hypertension ("PAH"), and provided a corporate update."

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

  • Healthy Volunteers - KER-012
  • Myelodysplastic Syndromes - KER-050
  • To treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ("TGF-ß") family of proteins - KER-065

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