Rein Therapeutics says FDA grants Fast Track status to LTI-03 in idiopathic pulmonary fibrosis

Enrollment continues in the Phase 2 RENEW trial across five countries, positioning the program for a key clinical readout.

Interim results have not been presented yet; data are expected in the second half of 2026.

Rein Therapeutics says the FDA has granted Fast Track designation for LTI-03 in idiopathic pulmonary fibrosis, a move that could accelerate development timelines.

The designation signals regulatory support for a potential therapy aimed at slowing progression while supporting lung repair in a high-mortality disease. LTI-03 previously received FDA Orphan Drug designation in the same indication, strengthening its regulatory profile ahead of later-stage decisions.