FDA Events for Estrella Immunopharma (ESLA)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Estrella Immunopharma (ESLA).
Over the past two years, Estrella Immunopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
EB103. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
EB103 - FDA Regulatory Timeline and Events
EB103 is a drug developed by Estrella Immunopharma for the following indication: ARTEMIS® T-Cell Therapy.
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:
- EB103
- Announced Date:
- June 5, 2025
- Indication:
- ARTEMIS® T-Cell Therapy
Announcement
Estrella Immunopharma, Inc announced the activation of a second clinical site for its ongoing STARLIGHT-1 Phase I/II clinical trial evaluating EB103, a CD19-Redirected ARTEMIS® T-cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL).
AI Summary
Estrella Immunopharma, Inc. has expanded its STARLIGHT-1 Phase I/II clinical trial by activating a second clinical site at Baylor Research Institute in Dallas, Texas. This site will enroll patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL) for a study of EB103, a CD19-Redirected ARTEMIS® T-cell therapy. The trial is designed as an open-label, dose escalation study to assess the safety of EB103 and determine the recommended Phase II dose.
By partnering with a well-respected institution like Baylor Research Institute, Estrella aims to broaden the trial’s reach and accelerate patient access to this new treatment option. The company views this expansion as a key step to developing safer and more effective therapies for patients with advanced NHL, thereby furthering its mission to harness the power of the immune system against cancer.
Read Announcement- Drug:
- EB103
- Announced Date:
- September 27, 2024
- Indication:
- ARTEMIS® T-Cell Therapy
Announcement
Estrella Immunopharma, Inc announced that the first patient enrolled in its STARLIGHT-1 Phase I/II clinical trial has achieved a complete response (CR) one month after receiving an infusion of EB103 CD19- Redirected ARTEMIS® T Cells.
AI Summary
Estrella Immunopharma, Inc. announced that the first patient enrolled in its STARLIGHT-1 Phase I/II clinical trial achieved a complete response (CR) just one month after receiving an infusion of EB103 CD19-Redirected ARTEMIS® T Cells. This result means that there are now no detectable signs of disease following the treatment. The patient, diagnosed with follicular lymphoma grade 3A and high-risk symptoms, had relapsed after three previous treatments and was considered high-risk, facing a greater chance of severe side effects from traditional CAR-T therapies. Importantly, the patient experienced no treatment-related serious adverse events such as cytokine release syndrome or neurotoxicity. Estrella is encouraged by these early safety and efficacy results and is focused on developing ARTEMIS® T-cell therapies that could improve on the effectiveness and safety of existing treatments, potentially making these therapies more accessible in a variety of hospital settings.
Read Announcement
Estrella Immunopharma FDA Events - Frequently Asked Questions
As of now, Estrella Immunopharma (ESLA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Estrella Immunopharma (ESLA) has reported FDA regulatory activity for EB103.
The most recent FDA-related event for Estrella Immunopharma occurred on June 5, 2025, involving EB103. The update was categorized as "Provided Update," with the company reporting: "Estrella Immunopharma, Inc announced the activation of a second clinical site for its ongoing STARLIGHT-1 Phase I/II clinical trial evaluating EB103, a CD19-Redirected ARTEMIS® T-cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL)."
Currently, Estrella Immunopharma has one therapy (EB103) targeting the following condition: ARTEMIS® T-Cell Therapy.
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:ESLA) was last updated on 7/12/2025 by MarketBeat.com Staff
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