Free Trial

scPharmaceuticals (SCPH) FDA Events

scPharmaceuticals logo
$4.47 +0.39 (+9.56%)
Closing price 07/10/2025 04:00 PM Eastern
Extended Trading
$4.46 0.00 (-0.11%)
As of 07/10/2025 07:53 PM 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 scPharmaceuticals (SCPH)

This section highlights FDA-related milestones and regulatory updates for drugs developed by scPharmaceuticals (SCPH). Over the past two years, scPharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as FUROSCIX and SCP-111. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

scPharmaceuticals' Drugs in FDA Review

FUROSCIX - FDA Regulatory Timeline and Events

FUROSCIX is a drug developed by scPharmaceuticals for the following indication: Decompensated heart failure. 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.

SCP-111 - FDA Regulatory Timeline and Events

SCP-111 is a drug developed by scPharmaceuticals for the following indication: pH neutral formulation of furosemide administered via an auto-injector. 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.

scPharmaceuticals FDA Events - Frequently Asked Questions

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

In the past two years, scPharmaceuticals (SCPH) has reported FDA regulatory activity for the following drugs: FUROSCIX and SCP-111.

The most recent FDA-related event for scPharmaceuticals occurred on March 6, 2025, involving FUROSCIX. The update was categorized as "FDA Approval," with the company reporting: "scPharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for FUROSCIX® to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD)."

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

  • Decompensated heart failure - FUROSCIX
  • pH neutral formulation of furosemide administered via an auto-injector. - SCP-111

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