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KALA BIO (KALA) FDA Events

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FDA Events for KALA BIO (KALA)

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

KPI-012 - FDA Regulatory Timeline and Events

KPI-012 is a drug developed by KALA BIO for the following indication: Clinical diagnosis of PCED. 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.

KALA BIO FDA Events - Frequently Asked Questions

As of now, KALA BIO (KALA) has not received any FDA approvals for its therapy in the last two years.

In the past two years, KALA BIO (KALA) has reported FDA regulatory activity for KPI-012.

The most recent FDA-related event for KALA BIO occurred on July 9, 2025, involving KPI-012. The update was categorized as "Enrollment Completion," with the company reporting: "KALA BIO, Inc. announced the completion of patient enrollment in the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial evaluating KPI-012, a human mesenchymal stem cell secretome (MCS-S), for the treatment of persistent corneal epithelial defect (PCED)."

Currently, KALA BIO has one therapy (KPI-012) targeting the following condition: Clinical diagnosis of PCED.

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