FDA Events for Rein Therapeutics (RNTX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Rein Therapeutics (RNTX).
Over the past two years, Rein Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LTI-2355. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
LTI-2355 - FDA Regulatory Timeline and Events
LTI-2355 is a drug developed by Rein Therapeutics for the following indication: In Idiopathic Pulmonary Fibrosis (IPF) and Post-Acute Sequelae of COVID Fibrosis (PASC-F).
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:
- LTI-2355
- Announced Date:
- April 15, 2025
- Indication:
- In Idiopathic Pulmonary Fibrosis (IPF) and Post-Acute Sequelae of COVID Fibrosis (PASC-F)
Announcement
Rein Therapeutics announced a publication highlighting the therapeutic potential of Caveolin-1-related peptide LTI-2355 in Idiopathic Pulmonary Fibrosis (IPF) and Post-Acute Sequelae of COVID Fibrosis (PASC-F) in the peer-reviewed journal, Biomedicines.
AI Summary
Rein Therapeutics recently published a study in the peer-reviewed journal Biomedicines that highlights the potential of their Caveolin-1-related peptide, LTI-2355, for treating lung fibrosis. The study focused on two serious conditions: Idiopathic Pulmonary Fibrosis (IPF) and Post-Acute Sequelae of COVID Fibrosis (PASC-F).
The research showed that LTI-2355, a stable 13-amino acid peptide, improved the phagocytic ability of lung myeloid cells, allowing them to better fight infections. At the same time, the peptide reduced the inflammatory and fibrotic responses of these key cells, which are linked to the worsening of lung fibrosis. Authored by Rein Therapeutics’ scientists along with collaborators from Cedars-Sinai Medical Center and Duke University, the study supports the promise of LTI-2355 as a therapeutic option for lung fibrosis patients.
Read Announcement
Rein Therapeutics FDA Events - Frequently Asked Questions
As of now, Rein Therapeutics (RNTX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Rein Therapeutics (RNTX) has reported FDA regulatory activity for LTI-2355.
The most recent FDA-related event for Rein Therapeutics occurred on April 15, 2025, involving LTI-2355. The update was categorized as "Publication," with the company reporting: "Rein Therapeutics announced a publication highlighting the therapeutic potential of Caveolin-1-related peptide LTI-2355 in Idiopathic Pulmonary Fibrosis (IPF) and Post-Acute Sequelae of COVID Fibrosis (PASC-F) in the peer-reviewed journal, Biomedicines."
Currently, Rein Therapeutics has one therapy (LTI-2355) targeting the following condition: In Idiopathic Pulmonary Fibrosis (IPF) and Post-Acute Sequelae of COVID Fibrosis (PASC-F).
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:RNTX) was last updated on 7/13/2025 by MarketBeat.com Staff
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