FDA Events for IMAC (IMAC)
This section highlights FDA-related milestones and regulatory updates for drugs developed by IMAC (IMAC).
Over the past two years, IMAC has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AKT–mTOR. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AKT–mTOR - FDA Regulatory Timeline and Events
AKT–mTOR is a drug developed by IMAC for the following indication: In Predicting Breast Cancer Therapy Response.
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:
- AKT–mTOR
- Announced Date:
- February 10, 2025
- Indication:
- In Predicting Breast Cancer Therapy Response
Announcement
Ignite Proteomics LLC, a subsidiary of IMAC Holdings, Inc. announces the publication of a significant study in the British Journal of Cancer titled "Functional activation of the AKT–mTOR signalling axis in a real-world metastatic breast cancer cohort".
AI Summary
Ignite Proteomics LLC, a subsidiary of IMAC Holdings, Inc., has announced the publication of an important study in the British Journal of Cancer titled "Functional activation of the AKT–mTOR signalling axis in a real-world metastatic breast cancer cohort." The research shows that measuring the actual activation of proteins in the AKT–mTOR signaling pathway can better predict how patients might respond to targeted cancer therapies than traditional methods that only look at genetic mutations.
The study found that patients with activated proteins in this pathway tended to have poorer outcomes when treated with standard-first line therapies such as CDK4/6 inhibitors. This evidence supports using proteomic profiling, like Ignite Proteomics’ Reverse Phase Protein Array assay, to personalize and guide treatment decisions, potentially leading to improved outcomes for those with metastatic breast cancer.
Read Announcement
IMAC FDA Events - Frequently Asked Questions
As of now, IMAC (IMAC) has not received any FDA approvals for its therapy in the last two years.
In the past two years, IMAC (IMAC) has reported FDA regulatory activity for AKT–mTOR.
The most recent FDA-related event for IMAC occurred on February 10, 2025, involving AKT–mTOR. The update was categorized as "Publication," with the company reporting: "Ignite Proteomics LLC, a subsidiary of IMAC Holdings, Inc. announces the publication of a significant study in the British Journal of Cancer titled "Functional activation of the AKT–mTOR signalling axis in a real-world metastatic breast cancer cohort"."
Currently, IMAC has one therapy (AKT–mTOR) targeting the following condition: In Predicting Breast Cancer Therapy Response.
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:IMAC) was last updated on 7/13/2025 by MarketBeat.com Staff
