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HOOKIPA Pharma (HOOK) FDA Events

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FDA Events for HOOKIPA Pharma (HOOK)

This section highlights FDA-related milestones and regulatory updates for drugs developed by HOOKIPA Pharma (HOOK). Over the past two years, HOOKIPA Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as HB-200, HB-500, and HB-700. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

HOOKIPA Pharma's Drugs in FDA Review

HB-200 + KEYTRUDA (pembrolizumab) - FDA Regulatory Timeline and Events

HB-200 + KEYTRUDA (pembrolizumab) is a drug developed by HOOKIPA Pharma for the following indication: Advanced head and neck 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.

HB-500 - FDA Regulatory Timeline and Events

HB-500 is a drug developed by HOOKIPA Pharma for the following indication: For the Treatment of Human Immunodeficiency Virus. 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.

HB-700 - FDA Regulatory Timeline and Events

HB-700 is a drug developed by HOOKIPA Pharma for the following indication: for the Treatment of KRAS-Mutated 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.

HOOKIPA Pharma FDA Events - Frequently Asked Questions

In the past two years, HOOKIPA Pharma (HOOK) 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, HOOKIPA Pharma (HOOK) has reported FDA regulatory activity for the following drugs: HB-500, HB-700 and HB-200 + KEYTRUDA (pembrolizumab).

The most recent FDA-related event for HOOKIPA Pharma occurred on January 30, 2025, involving HB-500. The update was categorized as "Enrollment Update," with the company reporting: "HOOKIPA Pharma announced that enrollment is complete in the Phase 1b clinical trial evaluating HB-500 for the treatment of HIV, with 30 participants enrolled across five sites in the United States."

Current therapies from HOOKIPA Pharma in review with the FDA target conditions such as:

  • For the Treatment of Human Immunodeficiency Virus - HB-500
  • for the Treatment of KRAS-Mutated Cancers - HB-700
  • Advanced head and neck cancers - HB-200 + KEYTRUDA (pembrolizumab)

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:HOOK) was last updated on 7/12/2025 by MarketBeat.com Staff
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