FDA Events for CASI Pharmaceuticals (CASI)
This section highlights FDA-related milestones and regulatory updates for drugs developed by CASI Pharmaceuticals (CASI).
Over the past two years, CASI Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CID-103. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CID-103 - FDA Regulatory Timeline and Events
CID-103 is a drug developed by CASI Pharmaceuticals for the following indication: Relapsed Or Refractory Multiple Myeloma.
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:
- CID-103
- Announced Date:
- January 6, 2025
- Indication:
- Relapsed Or Refractory Multiple Myeloma
Announcement
CASI Pharmaceuticals, Inc. announced that the first patient has been dosed in the Phase 1/2 trial to evaluate the safety and tolerability of CID-103 in adult patients with chronic Immune Thrombocytopenia (ITP) in China.
AI Summary
CASI Pharmaceuticals, Inc. announced that it has dosed the first patient in its Phase 1/2 trial in China. This study is designed to evaluate the safety and tolerability of CID-103 in adult patients with chronic Immune Thrombocytopenia (ITP), a condition where patients have limited treatment options.
CID-103, a fully human IgG1 anti-CD38 monoclonal antibody, is being tested to collect important safety and dose-response data. Dr. Wei-Wu He, Chairman and CEO of CASI, stated that dosing the first patient is a major milestone for the program. The trial underscores the company’s commitment to swiftly advancing clinical development and aims to provide insights that could benefit future studies in treating other autoimmune conditions with significant unmet needs.
Read Announcement- Drug:
- CID-103
- Announced Date:
- June 26, 2024
- Indication:
- Relapsed Or Refractory Multiple Myeloma
Announcement
CASI Pharmaceuticals, Inc. announced that the Company is planning to submit an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration ("FDA") for CID-103 for the treatment of antibody-mediated rejection ("AMR") in kidney transplant recipients by the end of 2024.
AI Summary
CASI Pharmaceuticals, Inc. announced plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) by the end of 2024. The company will seek approval for CID-103, a fully human IgG1 anti-CD38 monoclonal antibody, as a treatment for antibody-mediated rejection (AMR) in kidney transplant recipients. Early preclinical studies of CID-103 have shown promising safety and efficacy profiles when compared to similar drugs, highlighting its potential as a beneficial therapy for patients facing transplant complications. CASI Pharmaceuticals plans to use proceeds from recent private placement financing along with its existing cash reserves to complete a Phase II clinical trial for AMR. This step reflects the company’s commitment to addressing unmet medical needs in kidney transplant care and advancing innovative treatment options through rigorous clinical evaluation.
Read Announcement- Drug:
- CID-103
- Announced Date:
- May 15, 2024
- Indication:
- Relapsed Or Refractory Multiple Myeloma
Announcement
CASI Pharmaceuticals, Inc. announced the following: On April 12, 2024 CASI submitted the IND application to the FDA for CID-103 to support a phase 1/2 study of CID-103 in adults with chronic Immune Thrombocytopenia (ITP).
Read Announcement
CASI Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, CASI Pharmaceuticals (CASI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, CASI Pharmaceuticals (CASI) has reported FDA regulatory activity for CID-103.
The most recent FDA-related event for CASI Pharmaceuticals occurred on January 6, 2025, involving CID-103. The update was categorized as "Dosing Update," with the company reporting: "CASI Pharmaceuticals, Inc. announced that the first patient has been dosed in the Phase 1/2 trial to evaluate the safety and tolerability of CID-103 in adult patients with chronic Immune Thrombocytopenia (ITP) in China."
Currently, CASI Pharmaceuticals has one therapy (CID-103) targeting the following condition: Relapsed Or Refractory Multiple Myeloma.
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:CASI) was last updated on 7/11/2025 by MarketBeat.com Staff
