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AUSTIN - Rein Therapeutics (NASDAQ:RNTX), a $26.8 million market cap biotech company whose shares have declined 60% over the past year, announced Wednesday the publication of new data on its lead drug candidate LTI-03 in the peer-reviewed journal iScience, showing promising anti-fibrotic activity in lung tissue from patients with idiopathic pulmonary fibrosis (IPF).
The study tested LTI-03 directly on lung tissue donated by IPF patients who underwent lung transplants. Results showed the drug reduced multiple scarring pathways while lowering collagen production and inflammatory signals in the diseased tissue.
Unlike nintedanib, an FDA-approved standard treatment, LTI-03 achieved these effects without causing cell damage or death in the patient samples, according to the company’s press release.
"Using a highly relevant translational model, this peer-reviewed publication provides further validation of LTI-03’s broad anti-fibrotic effects in IPF lung tissue," said Brian Windsor, CEO of Rein Therapeutics.
IPF affects approximately 100,000 people in the U.S. and more than 70,000 in the U.K., with a median survival of 3-5 years from diagnosis even with current therapies.
The biopharmaceutical company recently received regulatory approval from the U.K.’s Medicines and Healthcare products Regulatory Agency to initiate the Phase 2 RENEW trial of LTI-03. The trial will evaluate safety, tolerability, and changes in lung function in up to 120 patients, with initial data expected in 2026.
LTI-03 has received Orphan Drug Designation in the U.S. and is being developed to address what the company describes as significant unmet medical needs in IPF treatment. With analysts setting a $7 price target and InvestingPro data revealing 5 additional key insights about the company’s financial health and market position, investors seeking deeper analysis can access comprehensive metrics and expert tools through the Pro platform.
In other recent news, Rein Therapeutics has received approval from the UK Medicines and Healthcare products Regulatory Agency to begin its Phase 2 RENEW clinical trial for LTI-03, targeting idiopathic pulmonary fibrosis. This trial will involve up to 120 patients and will focus on assessing the safety and tolerability of the drug, as well as its effects on lung function and fibrosis progression. Meanwhile, Brookline Capital Markets has downgraded Rein Therapeutics from Buy to Hold, citing concerns over delays in clinical trials and funding challenges. The downgrade comes after a second-quarter update that Brookline found disappointing, with the company still awaiting a meeting with the FDA regarding a clinical hold on the RENEW trial.
In a separate development, Rein Therapeutics has secured up to $21 million in strategic financing through agreements with Yorkville Advisors Global. This financing includes a $6 million pre-paid advance agreement, with an initial $1 million already funded, and a $15 million standby equity purchase agreement available over 36 months. These funds are intended to support the company’s clinical development programs. These recent developments highlight both the progress and challenges faced by Rein Therapeutics in advancing its drug development efforts.
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