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Rein Therapeutics’s LTI-03 Gains Momentum with FDA Clearance and Promising Trial Developments

Rein Therapeutics’s LTI-03 Gains Momentum with FDA Clearance and Promising Trial Developments

Analyst Brandon Folkes from H.C. Wainwright reiterated a Buy rating on Rein Therapeutics and keeping the price target at $10.00.

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Brandon Folkes has given his Buy rating due to a combination of factors surrounding Rein Therapeutics’s recent developments. The FDA’s decision to lift the clinical hold on the Phase 2 RENEW trial for LTI-03 in idiopathic pulmonary fibrosis (IPF) marks a significant milestone, reducing uncertainty and validating the science behind LTI-03. This clearance allows U.S. trial enrollment to resume, which is expected to accelerate the trial’s progress and lead to topline data by the third quarter of 2026.
Furthermore, the FDA’s action suggests that the market had previously undervalued RNTX due to the clinical hold, despite its strong scientific foundation and promising early biomarker data. The expansion of trial sites in the U.S. enhances the patient pool and data quality, aligning with global regulatory standards. The dual mechanism of LTI-03, offering both anti-fibrotic and regenerative benefits, sets it apart from existing treatments, supporting a favorable risk-reward profile. Recent findings also highlight its effective target engagement and safety, reinforcing the potential for LTI-03 to impact disease biology positively.

In another report released on November 3, Brookline Capital Markets also upgraded the stock to a Buy with a $6.00 price target.

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