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AUSTIN, Texas - Rein Therapeutics (NASDAQ:RNTX), whose shares have surged nearly 20% over the past week according to InvestingPro data, has received authorization from the European Medicines Agency (EMA) to begin its Phase 2 RENEW clinical trial for LTI-03 in idiopathic pulmonary fibrosis (IPF) patients at sites in Germany and Poland, the company announced Thursday.
The approval expands the global reach of the trial, which had previously received clearance from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
The RENEW trial is designed as a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability, and efficacy of LTI-03 in up to 120 IPF patients globally. The treatment duration will be 24 weeks across two dosing groups, with secondary endpoints including changes in lung function and imaging-based assessments of fibrosis progression.
LTI-03 is described as a Caveolin-1 derived peptide designed to both inhibit fibrosis and support regeneration of healthy lung tissue.
"These new authorizations mark another important milestone in our global RENEW trial," said Brian Windsor, Chief Executive Officer of Rein Therapeutics, according to the company’s press release. The clinical-stage biotech company, currently valued at $32.39 million, maintains a FAIR financial health score according to InvestingPro analysis.
IPF is a chronic, progressive lung disease characterized by irreversible scarring that makes breathing increasingly difficult. The condition has a median survival of 3-5 years after diagnosis even with currently approved therapies. According to data cited in the announcement, approximately 100,000 people in the United States have IPF, with 30,000 to 40,000 new cases diagnosed annually.
LTI-03 has received Orphan Drug Designation in the U.S. The company is also developing a second product candidate, LTI-01, for the treatment of loculated pleural effusions. While currently trading at $1.39, analysts have set an ambitious $10 price target for the stock, though InvestingPro subscribers can access additional insights, including more than 6 key ProTips and detailed financial metrics to better evaluate the company’s potential.
In other recent news, Rein Therapeutics reported promising data for its lead drug candidate, LTI-03, in a study published in the journal iScience. The study demonstrated anti-fibrotic activity in lung tissue from patients with idiopathic pulmonary fibrosis (IPF), showing reduced scarring pathways and decreased collagen production. Additionally, the UK Medicines and Healthcare products Regulatory Agency approved the initiation of Rein Therapeutics’ Phase 2 RENEW clinical trial for LTI-03, which will assess safety and efficacy in up to 120 patients.
H.C. Wainwright has reiterated its Buy rating for Rein Therapeutics, maintaining a $10.00 price target, expressing optimism about developments that may lift the pause on U.S. clinical trial sites. The firm also initiated coverage on Rein Therapeutics with a Buy rating, citing the company’s promising pipeline targeting significant market opportunities. However, Brookline Capital Markets downgraded the stock to Hold, pointing to concerns over clinical trial delays and funding challenges. Rein Therapeutics is still awaiting a meeting with the FDA regarding the clinical hold on its Phase 2 RENEW trial.
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