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Entera Bio (ENTX) FDA Approvals

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Entera Bio's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Entera Bio (ENTX). Over the past two years, Entera Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as EB613 and OPK-88006. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

EB613 FDA Regulatory Timeline and Events

EB613 is a drug developed by Entera Bio for the following indication: Parathyroid hormone (1-34), or PTH for osteoporosis. 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 Events

OPK-88006 is a drug developed by Entera Bio 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.

Entera Bio FDA Events - Frequently Asked Questions

In the past two years, Entera Bio (ENTX) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Entera Bio (ENTX) has reported FDA regulatory activity for the following drugs: EB613 and OPK-88006.

The most recent FDA-related event for Entera Bio occurred on July 28, 2025, involving EB613. The update was categorized as "Provided Update," with the company reporting: "Entera Bio Ltd. announced that in a written response to a Type A meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company's proposal that the NDA marketing application filing for EB613 would be supported by a single multinational, randomized, double-blind, placebo-controlled, 24 month phase 3 study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint."

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

  • Parathyroid hormone (1-34), or PTH for osteoporosis - EB613
  • for patients with obesity, metabolic and fibrotic disorders. - OPK-88006

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:ENTX) was last updated on 8/2/2025 by MarketBeat.com Staff
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