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OPKO Health (OPK) FDA Events

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FDA Events for OPKO Health (OPK)

This section highlights FDA-related milestones and regulatory updates for drugs developed by OPKO Health (OPK). Over the past two years, OPKO Health has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as MDX2201 and OPK-88006. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

OPKO Health's Drugs in FDA Review

MDX2201 - FDA Regulatory Timeline and Events

MDX2201 is a drug developed by OPKO Health for the following indication: Epstein-Barr Virus Vaccine Candidate. 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.

OPK-88006 - FDA Regulatory Timeline and Events

OPK-88006 is a drug developed by OPKO Health for the following indication: for patients with obesity, metabolic and fibrotic disorders. 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.

OPKO Health FDA Events - Frequently Asked Questions

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

In the past two years, OPKO Health (OPK) has reported FDA regulatory activity for the following drugs: OPK-88006 and MDX2201.

The most recent FDA-related event for OPKO Health occurred on June 25, 2025, involving OPK-88006. The update was categorized as "Data Presentation," with the company reporting: "OPKO Health, Inc and Entera Bio Ltd. announced that new pharmacologic and pharmacokinetic in vivo data for investigational oral OPK-88006 tablet treatment has been selected for presentation at the ENDO 2025 annual meeting of the Endocrine Society, taking place July 12-15, 2025 in San Francisco, CA, USA."

Current therapies from OPKO Health in review with the FDA target conditions such as:

  • for patients with obesity, metabolic and fibrotic disorders. - OPK-88006
  • Epstein-Barr Virus Vaccine Candidate - MDX2201

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