FDA Events for Orgenesis (ORGS)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Orgenesis (ORGS).
Over the past two years, Orgenesis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ORG-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ORG-101 - FDA Regulatory Timeline and Events
ORG-101 is a drug developed by Orgenesis for the following indication: In patients with CD19+ Acute Lymphoblastic Leukemia (B-cell ALL).
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:
- ORG-101
- Announced Date:
- August 29, 2024
- Indication:
- In patients with CD19+ Acute Lymphoblastic Leukemia (B-cell ALL).
Announcement
Orgenesis Inc. announced positive clinical trial results for a real-world study of CD19 CAR-T therapy, ORG-101, in patients with CD19+ Acute Lymphoblastic Leukemia (B-cell ALL).
AI Summary
Orgenesis Inc. reported very positive results from its real-world study of the CD19 CAR-T therapy, ORG-101, targeting CD19+ Acute Lymphoblastic Leukemia (B-cell ALL). The study showed that 82% of adult patients and 93% of pediatric patients achieved a complete response. Additionally, the occurrence of severe Cytokine Release Syndrome, a common side effect with CAR-T therapies, was low—2% in adults and 6% in children—suggesting a favorable safety profile. These encouraging results support the potential of ORG-101 as an effective and safer treatment for B-cell ALL, laying the groundwork for its further clinical development. The positive data has also spurred a commitment from Harley Street Healthcare Group and its partners to invest in a Global Cancer Initiative aimed at making advanced therapies more accessible worldwide.
Read Announcement
Orgenesis FDA Events - Frequently Asked Questions
As of now, Orgenesis (ORGS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Orgenesis (ORGS) has reported FDA regulatory activity for ORG-101.
The most recent FDA-related event for Orgenesis occurred on August 29, 2024, involving ORG-101. The update was categorized as "Positive Results," with the company reporting: "Orgenesis Inc. announced positive clinical trial results for a real-world study of CD19 CAR-T therapy, ORG-101, in patients with CD19+ Acute Lymphoblastic Leukemia (B-cell ALL)."
Currently, Orgenesis has one therapy (ORG-101) targeting the following condition: In patients with CD19+ Acute Lymphoblastic Leukemia (B-cell ALL)..
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:ORGS) was last updated on 7/9/2025 by MarketBeat.com Staff
