Anixa Biosciences' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Anixa Biosciences (ANIX).
Over the past two years, Anixa Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
alpha-lactalbumin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Alpha-lactalbumin FDA Regulatory Events
Alpha-lactalbumin is a drug developed by Anixa Biosciences for the following indication: In high risk operable triple negative breast cancer.
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:
- alpha-lactalbumin
- Announced Date:
- September 22, 2025
- Indication:
- In high risk operable triple negative breast cancer
Announcement
Anixa Biosciences, Inc announced that final results from the Phase 1 clinical trial of its breast cancer vaccine will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Thursday, December 11, 2025.
AI Summary
Anixa Biosciences will present final Phase 1 breast cancer vaccine results on Thursday, December 11, 2025, at the San Antonio Breast Cancer Symposium (SABCS). This presentation marks the most detailed data release of this first-in-class vaccine.
The trial, funded by the U.S. Department of Defense and conducted at Cleveland Clinic, tested an alpha-lactalbumin (aLA) vaccine to evaluate its safety and ability to trigger an immune response in healthy volunteers at risk for breast cancer.
Justin Johnson, Ph.D., co-inventor of the vaccine technology, will deliver the poster titled “Final Results of a Phase I Trial of Alpha-lactalbumin (aLA) Vaccine for Breast Cancer” at SABCS on December 11 from 5:00–6:30 PM CST.
Anixa plans to share full findings with the Department of Defense and the FDA to inform Phase 2 development. The data could pave the way for new prevention and treatment options in breast cancer.
Read Announcement
Anixa Biosciences FDA Events - Frequently Asked Questions
As of now, Anixa Biosciences (ANIX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Anixa Biosciences (ANIX) has reported FDA regulatory activity for alpha-lactalbumin.
The most recent FDA-related event for Anixa Biosciences occurred on September 22, 2025, involving alpha-lactalbumin. The update was categorized as "Results," with the company reporting: "Anixa Biosciences, Inc announced that final results from the Phase 1 clinical trial of its breast cancer vaccine will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Thursday, December 11, 2025."
Currently, Anixa Biosciences has one therapy (alpha-lactalbumin) targeting the following condition: In high risk operable triple negative breast cancer.
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:ANIX) was last updated on 9/22/2025 by MarketBeat.com Staff
