AC Immune Partner LMI Gets FDA Fast Track for Tau PET Diagnostic
Ticker: ACIU · Form: 6-K · Filed: Aug 28, 2024 · CIK: 1651625
| Field | Detail |
|---|---|
| Company | Ac Immune SA (ACIU) |
| Form Type | 6-K |
| Filed Date | Aug 28, 2024 |
| Risk Level | medium |
| Pages | 1 |
| Reading Time | 2 min |
| Sentiment | bullish |
Sentiment: bullish
Topics: FDA, diagnostic, neurodegenerative-disease, partnership
TL;DR
FDA Fast Track for AC Immune's Tau PET diagnostic [18F]PI-2620 in Alzheimer's and other neurodegenerative diseases.
AI Summary
On August 28, 2024, AC Immune SA announced that its partner, Life Molecular Imaging (LMI), received U.S. FDA Fast Track Designation for the Tau PET diagnostic, [18F]PI-2620. This designation is for clinical development in Alzheimer's disease (AD), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD).
Why It Matters
FDA Fast Track designation can expedite the development and review of drugs and diagnostics intended to treat or diagnose serious conditions, potentially bringing new diagnostic tools for neurodegenerative diseases to market sooner.
Risk Assessment
Risk Level: medium — While Fast Track designation is positive, it does not guarantee regulatory approval or commercial success for the diagnostic.
Key Players & Entities
- AC Immune SA (company) — Registrant
- Life Molecular Imaging (LMI) (company) — Partner of AC Immune SA
- [18F]PI-2620 (product) — Tau positron emission tomography (PET) diagnostic
- U.S. Food and Drug Administration (FDA) (company) — Regulatory body granting designation
- Alzheimer's disease (AD) (medical_condition) — Condition for which diagnostic is being developed
- progressive supranuclear palsy (PSP) (medical_condition) — Condition for which diagnostic is being developed
- corticobasal degeneration (CBD) (medical_condition) — Condition for which diagnostic is being developed
FAQ
What is the significance of the FDA Fast Track Designation for [18F]PI-2620?
The Fast Track designation is granted by the U.S. FDA to expedite the development and review of drugs and diagnostics intended to treat or diagnose serious conditions, potentially allowing for earlier market entry.
Which specific neurodegenerative conditions is the [18F]PI-2620 diagnostic intended for?
The [18F]PI-2620 diagnostic is intended for clinical development in Alzheimer's disease (AD), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD).
Who is the partner of AC Immune SA involved in the development of [18F]PI-2620?
Life Molecular Imaging (LMI) is the partner of AC Immune SA that received the Fast Track Designation.
When was this announcement made by AC Immune SA?
AC Immune SA issued the press release announcing this on August 28, 2024.
What type of diagnostic is [18F]PI-2620?
[18F]PI-2620 is a Tau positron emission tomography (PET) diagnostic.
Filing Stats: 390 words · 2 min read · ~1 pages · Grade level 13.2 · Accepted 2024-08-28 09:04:15
Filing Documents
- dp217183_6k.htm (6-K) — 11KB
- dp217183_ex9901.htm (EX-99.1) — 17KB
- image_001.jpg (GRAPHIC) — 52KB
- 0000950103-24-012695.txt ( ) — 101KB
From the Filing
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of August, 2024 Commission file number: 001-37891 AC IMMUNE SA (Exact Name of Registrant as Specified in Its Charter) EPFL Innovation Park Building B 1015 Lausanne, Switzerland (Address of Principal Executive Offices) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F Form 40-F On August 28, 2024, AC Immune SA issued a press release announcing that its partner, Life Molecular Imaging (LMI), has received Fast Track Designation for the Tau positron emission tomography (PET) diagnostic, [18F]PI-2620, from the U.S. Food and Drug Administration (FDA) in three neurodegenerative conditions. Fast Track designation for [18F]PI-2620 has been granted for clinical development in Alzheimer’s disease (AD), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD). PI-2620 is a next-generation PET imaging agent currently in Phase 3 clinical development for detecting Tau pathology in Alzheimer's disease. The compound is also being investigated in other neurodegenerative diseases by many academic researchers and in drug development trials. Tau proteins are a hallmark of several neurodegenerative disorders including AD, PSP, CBD, and frontotemporal lobar dementia (FTLD), and accurately imaging the pathology could significantly enhance disease diagnosis and improve patient care. A copy of the press release is attached as Exhibit 99.1 to this Report on Form 6-K. This Report on Form 6-K (other than Exhibit 99.1 hereto) shall be deemed to be incorporated by reference into the registration statements on Form F-3 (File Nos. 333-227016, 333-249655, 333-255576 and 333-277940) and Form S-8 (File Nos. 333-213865, 333-216539 and 333-233019) of AC Immune SA and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished. EXHIBIT INDEX Exhibit Number Description 99.1 Press Release dated August 28, 2024 SIGNATURE 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. AC IMMUNE SA By: /s/ Andrea Pfeifer Name: Andrea Pfeifer Title: Chief Executive Officer By: /s/ Christopher Roberts Name: Christopher Roberts Title: Chief Financial Officer Date: August 28, 2024