Rein Therapeutics Receives FDA Clearance to Resume U.S. Phase 2 Trial of LTI-03 in Idiopathic Pulmonary Fibrosis
Rein Therapeutics, Inc. (RNTX)
Company Research
Source: GlobeNewswire
FDA lifts clinical hold following review of Company’s Complete Response submission.Company expects to restart U.S. enrollment in late 2025 or early 2026 across 20 clinical sites.Early data suggests that LTI-03 may not only slow fibrosis but also promote lung healing. AUSTIN, Texas, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced that the U.S. Food and Drug Administration (FDA) has lifted the full clinical hold on the Company’s Phase 2 “RENEW” trial evaluating LTI-03 in patients with idiopathic pulmonary fibrosis (IPF). The FDA’s decision follows a review of Rein’s submission, which addressed all of the agency’s concerns. In its correspondence, the FDA confirmed that Study LTI-03-2001 may proceed and that any prior Full Clinical Hold concerns have been fully resolved.
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News
- Rein Therapeutics Announces New Scientific Publication Demonstrating LTI-03 May Reduce Lung Scarring and Protect Cells Needed for Lung Repair in IPFGlobeNewswire
- Rein Therapeutics (NASDAQ:RNTX) was given a new $6.00 price target on by analysts at Loop Capital.MarketBeat
- Rein Therapeutics (NASDAQ:RNTX) was upgraded by analysts at Brookline Capital Management to a "buy" rating.MarketBeat
- Rein Therapeutics Receives European Regulatory Approval to Initiate Phase 2 Trial of LTI-03 in Idiopathic Pulmonary Fibrosis [Yahoo! Finance]Yahoo! Finance
- Rein Therapeutics Receives European Regulatory Approval to Initiate Phase 2 Trial of LTI-03 in Idiopathic Pulmonary FibrosisGlobeNewswire
RNTX
Sec Filings
- 11/18/25 - Form 4
- 11/14/25 - Form 10-Q
- 11/3/25 - Form 8-K
- RNTX's page on the SEC website