Free Trial

Spero Therapeutics (SPRO) FDA Events

Spero Therapeutics logo
$3.04 +0.10 (+3.40%)
Closing price 07/9/2025 04:00 PM Eastern
Extended Trading
$3.04 0.00 (0.00%)
As of 07:14 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 Spero Therapeutics (SPRO)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Spero Therapeutics (SPRO). Over the past two years, Spero Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SPR720 and Tebipenem. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Spero Therapeutics' Drugs in FDA Review

SPR720 - FDA Regulatory Timeline and Events

SPR720 is a drug developed by Spero Therapeutics for the following indication: Nontuberculous mycobacterial (NTM) disease. 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.

Tebipenem - FDA Regulatory Timeline and Events

Tebipenem is a drug developed by Spero Therapeutics for the following indication: Adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP). 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.

Spero Therapeutics FDA Events - Frequently Asked Questions

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

In the past two years, Spero Therapeutics (SPRO) has reported FDA regulatory activity for the following drugs: Tebipenem and SPR720.

The most recent FDA-related event for Spero Therapeutics occurred on May 28, 2025, involving Tebipenem. The update was categorized as "Primary endpoint Met," with the company reporting: "Spero Therapeutics, announced that the pivotal Phase 3 PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, met its primary endpoint and will stop early for efficacy (NCT06059846).3"

Current therapies from Spero Therapeutics in review with the FDA target conditions such as:

  • Adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP) - Tebipenem
  • Nontuberculous mycobacterial (NTM) disease - SPR720

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