Free Trial

Assembly Biosciences (ASMB) FDA Events

Assembly Biosciences logo
$18.36 -0.37 (-1.95%)
As of 01:11 PM Eastern
This is a fair market value price provided by Polygon.io. Learn more.
FDA Events for Assembly Biosciences (ASMB)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Assembly Biosciences (ASMB). Over the past two years, Assembly Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ABI-1179, ABI-4334, ABI-5366, and ABI-6250. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Assembly Biosciences' Drugs in FDA Review

ABI-1179 - FDA Regulatory Timeline and Events

ABI-1179 is a drug developed by Assembly Biosciences for the following indication: For Recurrent Genital Herpes. 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.

ABI-4334 - FDA Regulatory Timeline and Events

ABI-4334 is a drug developed by Assembly Biosciences for the following indication: in Chronic Hepatitis B. 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.

ABI-5366 - FDA Regulatory Timeline and Events

ABI-5366 is a drug developed by Assembly Biosciences for the following indication: For recurrent genital herpes. 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.

ABI-6250 - FDA Regulatory Timeline and Events

ABI-6250 is a drug developed by Assembly Biosciences for the following indication: For Hepatitis Delta 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.

Assembly Biosciences FDA Events - Frequently Asked Questions

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

In the past two years, Assembly Biosciences (ASMB) has reported FDA regulatory activity for the following drugs: ABI-5366, ABI-1179, ABI-4334 and ABI-6250.

The most recent FDA-related event for Assembly Biosciences occurred on June 30, 2025, involving ABI-1179. The update was categorized as "Dosing Update," with the company reporting: "Assembly Biosciences, Inc. announced that the first participant has been dosed in the Phase 1b portion of the Phase 1a/b study of its long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate ABI-1179."

Current therapies from Assembly Biosciences in review with the FDA target conditions such as:

  • For recurrent genital herpes. - ABI-5366
  • For Recurrent Genital Herpes - ABI-1179
  • in Chronic Hepatitis B - ABI-4334
  • For Hepatitis Delta Virus - ABI-6250

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:ASMB) was last updated on 7/10/2025 by MarketBeat.com Staff
From Our Partners