FDA Events for Greenwich LifeSciences (GLSI)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Greenwich LifeSciences (GLSI).
Over the past two years, Greenwich LifeSciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
GLSI-100. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
GLSI-100 - FDA Regulatory Timeline and Events
GLSI-100 is a drug developed by Greenwich LifeSciences for the following indication: Breast cancer recurrences.
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:
- GLSI-100
- Announced Date:
- April 3, 2025
- Indication:
- Breast cancer recurrences
Announcement
Greenwich Lifesciences Provides Update On Its Phase III Clinical Trial, Flamingo-01, Which Is Evaluating GLSI-100, An Immunotherapy To Prevent Breast Cancer Recurrences
AI Summary
Greenwich LifeSciences provided an update on its Phase III FLAMINGO-01 trial, which studies GLSI-100—an immunotherapy designed to prevent breast cancer recurrences. The trial is examining the treatment in patients with different human leukocyte antigen (HLA) types. So far, preliminary data regarding HLA prevalence, safety, and immune response are trending as expected in both the HLA-A*02 and non-HLA-A*02 arms.
The non-HLA-A*02 arm was expanded to include 250 patients in 2024 with approvals from US and EU regulators. Encouraging immune response data has raised the possibility of converting this arm into a second Phase III trial. This could create several pathways for the marketing approval of GLSI-100 and broaden its market potential. In the first quarter of 2025, the trial reached its highest screening rate of 150 patients per quarter at over 117 active global sites.
Read Announcement- Drug:
- GLSI-100
- Announced Date:
- April 2, 2025
- Indication:
- Breast cancer recurrences
Announcement
Greenwich LifeSciences announced the following update on FLAMINGO-01 open label immune response data.
AI Summary
Greenwich LifeSciences announced preliminary results from its Phase III FLAMINGO-01 trial, which evaluates GLSI-100 as an immunotherapy to prevent breast cancer recurrences. The open label immune response data showed that both HLA-A*02 patients and those with other HLA types experienced increasing immune responses over time. With more vaccinations, a growing number of patients exhibited injection site reactions or GP2 delayed-type hypersensitivity responses, indicating enhanced immune activation.
Interestingly, a baseline immune response to GP2 was observed before treatment, suggesting that GP2 may naturally trigger the immune system, possibly due to earlier treatments. These findings echo the earlier Phase IIb results and are encouraging for the safety and efficacy of GLSI-100. The company is also planning further analysis, including potential expansion of the trial to better understand T cell responses and to extend treatment eligibility.
Read Announcement- Drug:
- GLSI-100
- Announced Date:
- March 17, 2025
- Indication:
- Breast cancer recurrences
Announcement
Greenwich LifeSciences, announced the following update on FLAMINGO-01 open label safety data.
AI Summary
Greenwich LifeSciences recently shared an update on the FLAMINGO-01 open label safety data from its Phase III clinical trial of GLSI-100. The company noted that a preliminary review of safety data in all study arms shows that the GP2 immunotherapy continues to be well-tolerated. No new safety signals for GLSI-100 have been identified, and the most common side effect remains injection site reactions, which are viewed as a sign of an immune response. The Data Safety Monitoring Board (DSMB) has met, reviewed the data, and recommended that the study continue without any modifications. These early findings build confidence in the ongoing trial, as the safety profile of GLSI-100 appears consistent with previous observations. Greenwich LifeSciences plans to further analyze immune response data and potentially share more detailed results at future scientific meetings.
Read Announcement- Drug:
- GLSI-100
- Announced Date:
- February 10, 2025
- Indication:
- Breast cancer recurrences
Announcement
Greenwich LifeSciences, announced the update on FLAMINGO-01 open label HLA data.
AI Summary
Greenwich LifeSciences announced an update on the FLAMINGO-01 open label HLA data. The analysis, conducted while maintaining the study blind, revealed that about 46% of all screened patients have at least one HLA-A*02 allele. This finding meets expectations and supports the trial’s sample size estimates, which anticipated a prevalence of 40–50%.
The open label arm is designed to evaluate the safety and efficacy of the GLSI-100 vaccine in patients who do not carry the HLA-A*02 allele. Researchers believe this group may provide valuable information, as it could be large enough to draw conclusions on immune response and clinical outcomes. In addition, the study plans to investigate how different HLA combinations, including patients with two copies of HLA-A*02, influence the vaccine’s effectiveness.
Read Announcement- Drug:
- GLSI-100
- Announced Date:
- January 22, 2025
- Indication:
- Breast cancer recurrences
Announcement
Greenwich LifeSciences, today provided the following update on the commercial manufacturing of GP2.
AI Summary
Greenwich LifeSciences provided an update on the commercial manufacturing of GP2. The company manufactured the first three commercial lots of GP2 in 2023 at an approved facility, producing enough active ingredient for approximately 200,000 doses. Stability programs for the drug have started, and data from these lots has been submitted to both the FDA and the European Medicines Agency. In 2024, the first commercial lot was filled into vials for either commercial sale or clinical use, with final testing nearly complete. The company is progressing toward filing a Biological License Application (BLA) in the United States by ensuring both clinical and manufacturing data are ready for review. CEO Snehal Patel highlighted plans to manufacture additional lots, finalize packaging and trade names, and work closely with regulators in the US and Europe to meet all requirements before a potential market launch.
Read Announcement- Drug:
- GLSI-100
- Announced Date:
- January 13, 2025
- Indication:
- Breast cancer recurrences
Announcement
Greenwich LifeSciences, announced the activation of clinical sites in France.
AI Summary
Greenwich LifeSciences announced the activation of clinical sites in France for its Phase III FLAMINGO-01 trial. The study is designed to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The trial will now be conducted at approximately 19 sites within the Unicancer breast cancer group, a leading academic network dedicated to fighting cancer in France.
These sites, part of a network of top French cancer centers, were approved by French authorities in early 2024. Initial site initiation visits and trainings were carried out at 15 locations during the latter half of 2024, with the remaining four sites set to start up in early 2025. This expansion is expected to bring innovative treatments to a wide population, as France records a high number of breast cancer cases and related deaths each year.
Read Announcement
Greenwich LifeSciences FDA Events - Frequently Asked Questions
As of now, Greenwich LifeSciences (GLSI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Greenwich LifeSciences (GLSI) has reported FDA regulatory activity for GLSI-100.
The most recent FDA-related event for Greenwich LifeSciences occurred on April 3, 2025, involving GLSI-100. The update was categorized as "Provided Update," with the company reporting: "Greenwich Lifesciences Provides Update On Its Phase III Clinical Trial, Flamingo-01, Which Is Evaluating GLSI-100, An Immunotherapy To Prevent Breast Cancer Recurrences"
Currently, Greenwich LifeSciences has one therapy (GLSI-100) targeting the following condition: Breast cancer recurrences.
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:GLSI) was last updated on 7/11/2025 by MarketBeat.com Staff
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