FDA Events for LAVA Therapeutics (LVTX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by LAVA Therapeutics (LVTX).
Over the past two years, LAVA Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LAVA-1266. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
LAVA-1266 - FDA Regulatory Timeline and Events
LAVA-1266 is a drug developed by LAVA Therapeutics for the following indication: In Hematological Cancers.
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:
- LAVA-1266
- Announced Date:
- January 10, 2025
- Indication:
- In Hematological Cancers
Announcement
LAVA Therapeutics N.V. announced dosing of the first patient in the Phase 1, first-in-human study of the CD123-targeted Gammabody®, LAVA-1266, an investigational agent in development for the treatment of hematologic cancers including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
AI Summary
LAVA Therapeutics N.V. has begun dosing the first patient in a Phase 1, first-in-human study of its CD123-targeted Gammabody®, LAVA-1266. This investigational agent is designed to treat hematologic cancers, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), by using a bispecific approach that engages Vγ9Vδ2-T cells to kill CD123-positive tumor cells. Preclinical studies of LAVA-1266 showed strong tumor cell lysis with limited off-target effects, suggesting a wide therapeutic window compared to previous CD123 therapies known for their toxicity issues. The open-label, multi-center study based in Australia will review safety, tolerability, pharmacokinetics, pharmacodynamics, and initial signs of anti-tumor activity. Results from this dose escalation study are expected by the end of 2025, offering hope for more effective treatment options for patients battling these challenging blood cancers.
Read Announcement
LAVA Therapeutics FDA Events - Frequently Asked Questions
As of now, LAVA Therapeutics (LVTX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, LAVA Therapeutics (LVTX) has reported FDA regulatory activity for LAVA-1266.
The most recent FDA-related event for LAVA Therapeutics occurred on January 10, 2025, involving LAVA-1266. The update was categorized as "Dose Update," with the company reporting: "LAVA Therapeutics N.V. announced dosing of the first patient in the Phase 1, first-in-human study of the CD123-targeted Gammabody®, LAVA-1266, an investigational agent in development for the treatment of hematologic cancers including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)."
Currently, LAVA Therapeutics has one therapy (LAVA-1266) targeting the following condition: In Hematological Cancers.
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:LVTX) was last updated on 7/12/2025 by MarketBeat.com Staff
Free LVTX Stock Alerts