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Soleno Therapeutics (SLNO) FDA Events

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FDA Events for Soleno Therapeutics (SLNO)

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

Soleno Therapeutics' Drugs in FDA Review

DCCR - FDA Regulatory Timeline and Events

DCCR is a drug developed by Soleno Therapeutics for the following indication: For patients with Prader-Willi syndrome (PWS). 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.

Diazoxide Choline Controlled-Release (DCCR- DESTINY PWS) - FDA Regulatory Timeline and Events

Diazoxide Choline Controlled-Release (DCCR- DESTINY PWS) is a drug developed by Soleno Therapeutics for the following indication: Prader-Willi syndrome (PWS). 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.

VYKAT XR - FDA Regulatory Timeline and Events

VYKAT XR is a drug developed by Soleno Therapeutics for the following indication: To Treat Hyperphagia in Prader-Willi Syndrome. 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.

Soleno 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, Soleno Therapeutics (SLNO) has reported FDA regulatory activity for the following drugs: VYKAT XR, Diazoxide Choline Controlled-Release (DCCR- DESTINY PWS) and DCCR.

The most recent FDA-related event for Soleno Therapeutics occurred on July 1, 2025, involving VYKAT XR. The update was categorized as "Abstract Presentation," with the company reporting: "Soleno Therapeutics, announced that two abstracts featuring data on VYKAT™ XR (diazoxide choline) extended-release tablets, previously known as DCCR, have been selected for presentation at the Annual Meeting of the Endocrine Society (ENDO 2025), which is being held July 12-15, 2025, in San Francisco, CA."

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

  • To Treat Hyperphagia in Prader-Willi Syndrome - VYKAT XR
  • Prader-Willi syndrome (PWS) - Diazoxide Choline Controlled-Release (DCCR- DESTINY PWS)
  • For patients with Prader-Willi syndrome (PWS). - DCCR

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