Kalaris Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Kalaris Therapeutics (KLRS).
Over the past two years, Kalaris Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TH103. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TH103 FDA Regulatory Events
TH103 is a drug developed by Kalaris Therapeutics for the following indication: in Neovascular Age-Related Macular Degeneration.
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:
- TH103
- Announced Date:
- September 15, 2025
- Indication:
- in Neovascular Age-Related Macular Degeneration
Announcement
Kalaris Therapeutics, Inc. announced that it is now enrolling a Phase 1b/2 multiple ascending dose (MAD) study of TH103 in patients with neovascular age-related macular degeneration (nAMD).
AI Summary
Kalaris Therapeutics, a clinical-stage biopharmaceutical company focused on retinal diseases, has started enrolling patients in a Phase 1b/2 multiple ascending dose (MAD) study of its investigational drug TH103 for neovascular age-related macular degeneration (nAMD). This study builds on an earlier single ascending dose trial and marks a key step toward possible Phase 3 development.
In the MAD study, up to 80 nAMD patients will receive as many as four monthly injections of TH103 directly into the eye. Researchers will track safety and early signs of benefit, such as changes in vision and retinal structure. The main analysis will occur one month after the last injection, and patients will continue in an extension phase to assess longer-term effects.
Data from this dose-finding trial will help choose the best dose for future tests, with initial results expected in the second half of 2026. The ongoing Phase 1a study remains on track to report data in late 2025.
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Kalaris Therapeutics FDA Events - Frequently Asked Questions
As of now, Kalaris Therapeutics (KLRS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Kalaris Therapeutics (KLRS) has reported FDA regulatory activity for TH103.
The most recent FDA-related event for Kalaris Therapeutics occurred on September 15, 2025, involving TH103. The update was categorized as "Enrollment Update," with the company reporting: "Kalaris Therapeutics, Inc. announced that it is now enrolling a Phase 1b/2 multiple ascending dose (MAD) study of TH103 in patients with neovascular age-related macular degeneration (nAMD)."
Currently, Kalaris Therapeutics has one therapy (TH103) targeting the following condition: in Neovascular Age-Related Macular Degeneration.
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:KLRS) was last updated on 9/16/2025 by MarketBeat.com Staff
