FDA Events for Scinai Immunotherapeutics (SCNI)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Scinai Immunotherapeutics (SCNI).
Over the past two years, Scinai Immunotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
IL-17. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
IL-17 - FDA Regulatory Timeline and Events
IL-17 is a drug developed by Scinai Immunotherapeutics for the following indication: For the treatment of mild to moderate plaque psoriasis.
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.
- Drug:
- IL-17
- Announced Date:
- July 23, 2024
- Indication:
- For the treatment of mild to moderate plaque psoriasis
Announcement
Scinai Immunotherapeutics Ltd. announced the receipt of minutes of meeting from a recent Scientific Advice ("SA") with the Paul Erlich Institute, Federal Institute for Vaccines and Biomedicines (the "PEI"), which is considered acceptable guidance for IMPD filing with the European Medicines Agency (EMA) and is also considered the European comparable to a pre-IND meeting with the FDA in the U.S.
AI Summary
Scinai Immunotherapeutics Ltd. announced that it has received the minutes from a recent Scientific Advice meeting with the Paul Erlich Institute (PEI). This meeting provided important regulatory guidance that the company can use for its Investigational Medicinal Product Dossier (IMPD) filing with the European Medicines Agency (EMA). In Europe, this advice is seen as equivalent to a pre-Investigational New Drug (IND) meeting with the FDA in the United States. The positive feedback from the PEI supports Scinai’s plans to advance its anti-IL-17A/F nanoAb drug for the treatment of mild to moderate plaque psoriasis. According to the guidance, the company can proceed with its strategy of streamlining clinical evaluations, which could result in significant time and cost savings. This clear regulatory pathway provides a strong foundation as Scinai moves forward with its Phase 1/2a clinical trial preparations.
Read Announcement
Scinai Immunotherapeutics FDA Events - Frequently Asked Questions
As of now, Scinai Immunotherapeutics (SCNI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Scinai Immunotherapeutics (SCNI) has reported FDA regulatory activity for IL-17.
The most recent FDA-related event for Scinai Immunotherapeutics occurred on July 23, 2024, involving IL-17. The update was categorized as "Provided Update," with the company reporting: "Scinai Immunotherapeutics Ltd. announced the receipt of minutes of meeting from a recent Scientific Advice ("SA") with the Paul Erlich Institute, Federal Institute for Vaccines and Biomedicines (the "PEI"), which is considered acceptable guidance for IMPD filing with the European Medicines Agency (EMA) and is also considered the European comparable to a pre-IND meeting with the FDA in the U.S."
Currently, Scinai Immunotherapeutics has one therapy (IL-17) targeting the following condition: For the treatment of mild to moderate plaque psoriasis.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- 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:SCNI) was last updated on 7/12/2025 by MarketBeat.com Staff
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