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Sorrento Therapeutics (SRNE) FDA Events

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FDA Events for Sorrento Therapeutics (SRNE)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Sorrento Therapeutics (SRNE). Over the past two years, Sorrento Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as SP-102 and ZTlido. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Sorrento Therapeutics' Drugs in FDA Review

SP-102 (SEMDEXA) - FDA Regulatory Timeline and Events

SP-102 (SEMDEXA) is a drug developed by Sorrento Therapeutics for the following indication: Sciatica Pain Management. 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.

ZTlido - FDA Regulatory Timeline and Events

ZTlido is a drug developed by Sorrento Therapeutics for the following indication: Alleviate pain associated with post-herpetic neuralgia. 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.

Sorrento 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, Sorrento Therapeutics (SRNE) has reported FDA regulatory activity for the following drugs: SP-102 (SEMDEXA) and ZTlido.

The most recent FDA-related event for Sorrento Therapeutics occurred on May 1, 2025, involving SP-102 (SEMDEXA). The update was categorized as "Presentation," with the company reporting: "Scilex Holding Company announced an upcoming presentation of post-hoc analysis of the C.L.E.A.R. trial (Corticosteroid Lumbar Epidural Analgesia in Radiculopathy) interpreting clinical meaningfulness of safety and efficacy of SP-102 (SEMDEXA™) for the treatment of lumbosacral radicular pain (LRP) at the 27th Annual Meeting of American Society of Interventional Pain Physicians (ASIPP), May 15-17, 2025 in Orlando, FL."

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

  • Sciatica Pain Management - SP-102 (SEMDEXA)
  • Alleviate pain associated with post-herpetic neuralgia - ZTlido

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:SRNE) was last updated on 7/10/2025 by MarketBeat.com Staff
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