Free Trial

SAB Biotherapeutics (SABS) FDA Events

SAB Biotherapeutics logo
$2.50 -0.05 (-1.96%)
Closing price 07/10/2025 03:59 PM Eastern
Extended Trading
$2.51 +0.01 (+0.36%)
As of 09:01 AM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.
FDA Events for SAB Biotherapeutics (SABS)

This section highlights FDA-related milestones and regulatory updates for drugs developed by SAB Biotherapeutics (SABS). Over the past two years, SAB Biotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SAB and SAB-142. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

SAB Biotherapeutics' Drugs in FDA Review

SAB BIO - FDA Regulatory Timeline and Events

SAB BIO is a drug developed by SAB Biotherapeutics for the following indication: For Type 1 Diabetes Therapies. 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.

SAB-142 - FDA Regulatory Timeline and Events

SAB-142 is a drug developed by SAB Biotherapeutics for the following indication: Anti-thymocyte hpAB therapeutic. 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.

SAB Biotherapeutics FDA Events - Frequently Asked Questions

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

In the past two years, SAB Biotherapeutics (SABS) has reported FDA regulatory activity for the following drugs: SAB-142 and SAB BIO.

The most recent FDA-related event for SAB Biotherapeutics occurred on January 28, 2025, involving SAB-142. The update was categorized as "Top-line data," with the company reporting: "SAB BIO announced positive topline data from a Phase 1 trial of SAB-142 in a single-ascending dose among healthy volunteers."

Current therapies from SAB Biotherapeutics in review with the FDA target conditions such as:

  • Anti-thymocyte hpAB therapeutic - SAB-142
  • For Type 1 Diabetes Therapies - SAB BIO

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:SABS) was last updated on 7/11/2025 by MarketBeat.com Staff
From Our Partners