FDA Events for Marker Therapeutics (MRKR)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Marker Therapeutics (MRKR).
Over the past two years, Marker Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
MT-601. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
MT-601 - FDA Regulatory Timeline and Events
MT-601 is a drug developed by Marker Therapeutics for the following indication: Pancreatic 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:
- MT-601
- Announced Date:
- December 19, 2024
- Indication:
- Pancreatic cancer
Announcement
Marker Therapeutics, Inc. provided an update on the progress and clinical observations from the Phase 1 APOLLO study, with a data cutoff date of September 10.
AI Summary
Marker Therapeutics, Inc. provided an update on the Phase 1 APOLLO study for MT-601, a multi-antigen recognizing T cell therapy for patients with relapsed lymphoma. The study, with data cut off on September 10, showed promising early results. Out of 9 patients treated at 5 clinical sites in the United States, 78% achieved objective responses and 44.4% experienced complete responses at the initial assessment. MT-601 was well tolerated, with no reports of immune-effector cell associated neurotoxicity syndrome and only one case of Grade 1 cytokine release syndrome. The data suggests that lymphodepletion might enhance the expansion and persistence of the therapy’s T cell clones. These early clinical observations have provided hope that MT-601 could offer a new treatment option for patients who have relapsed after prior therapies, including anti-CD19 CAR-T cells.
Read Announcement
Marker Therapeutics FDA Events - Frequently Asked Questions
As of now, Marker Therapeutics (MRKR) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Marker Therapeutics (MRKR) has reported FDA regulatory activity for MT-601.
The most recent FDA-related event for Marker Therapeutics occurred on December 19, 2024, involving MT-601. The update was categorized as "Provided Update," with the company reporting: "Marker Therapeutics, Inc. provided an update on the progress and clinical observations from the Phase 1 APOLLO study, with a data cutoff date of September 10."
Currently, Marker Therapeutics has one therapy (MT-601) targeting the following condition: Pancreatic 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:MRKR) was last updated on 7/12/2025 by MarketBeat.com Staff
