Tiziana Life Sciences Submits 7th Annual Safety Report to FDA
Ticker: TLSA · Form: 6-K · Filed: Dec 29, 2025 · CIK: 1723069
Sentiment: neutral
Topics: regulatory-filing, safety-report, drug-development
TL;DR
Tiziana Life Sciences filed its 7th annual safety report with the FDA, showing no serious drug-related adverse events.
AI Summary
On December 29, 2025, Tiziana Life Sciences LTD announced the submission of its seventh annual Development Safety Update Report (DSUR) to the U.S. Food and Drug Administration (FDA). The DSUR covers the period from September 21, 2024, to September 2, 2025, and reported no drug-related serious adverse events.
Why It Matters
This report is crucial for ongoing drug development as it informs regulatory bodies about the safety profile of Tiziana's investigational drugs.
Risk Assessment
Risk Level: low — The filing is a routine safety update report and does not contain significant new financial or strategic information.
Key Numbers
- 7th — Annual DSUR Submission (Indicates ongoing monitoring and reporting for Tiziana's drug development programs.)
Key Players & Entities
- Tiziana Life Sciences LTD (company) — Filer of the report
- U.S. Food and Drug Administration (FDA) (company) — Recipient of the safety report
- December 29, 2025 (date) — Date of the announcement
- September 21, 2024, to September 2, 2025 (date) — Reporting period for the DSUR
FAQ
What is the primary purpose of the Development Safety Update Report (DSUR)?
The DSUR is submitted to regulatory authorities like the FDA to provide an annual update on the safety of investigational drugs.
What period does the submitted DSUR cover?
The DSUR submitted by Tiziana Life Sciences covers the period from September 21, 2024, to September 2, 2025.
Were there any drug-related serious adverse events reported in the DSUR?
No, the report explicitly states that no drug-related serious adverse events were reported.
Which regulatory body received the DSUR?
The DSUR was submitted to the U.S. Food and Drug Administration (FDA).
What is the filing type and date for this announcement?
This is a Form 6-K filing, announced on December 29, 2025.
Filing Stats: 355 words · 1 min read · ~1 pages · Grade level 13.6 · Accepted 2025-12-29 08:00:16
Filing Documents
- ea0271091-6k_tiziana.htm (6-K) — 15KB
- ea027109101ex99-1_tiziana.htm (EX-99.1) — 15KB
- ex99-1_001.jpg (GRAPHIC) — 4KB
- 0001213900-25-125813.txt ( ) — 38KB
SIGNATURES
SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. TIZIANA LIFE SCIENCES LTD Date: December 29, 2025 By: /s/ Keeren Shah Name: Keeren Shah Title: Chief Financial Officer 2 EXHIBIT INDEX Exhibit No. Description 99.1 Tiziana Life Sciences LTD Press Release, dated December 29, 2025 3