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LTR Pharma Limited ( (AU:LTP) ) has shared an update.
LTR Pharma Limited has received ethics approval for its SPONTAN® Phase II clinical study, which will focus on pharmacokinetics and multiple-dose administration in men aged 65 and older. This study is designed to meet FDA guidelines and generate valuable data for prescribing decisions, with recruitment starting in early 2026 and initial data expected by mid-2026. The study is a crucial step in LTR Pharma’s FDA 505(b)(2) development pathway, supporting future FDA and TGA guidance for older men. This progress aligns with LTR Pharma’s multi-market commercial strategy, as it continues to expand its product offerings and market presence.
More about LTR Pharma Limited
LTR Pharma is a commercial-stage pharmaceutical company focused on delivering innovative therapies through its proprietary intranasal drug-delivery platform. The company has commercialized its rapid-acting treatment technology in Australia and is expanding its regulatory pathways in the US and other key markets. Its lead products, SPONTAN® and ROXUS®, are fast-acting intranasal sprays for erectile dysfunction, and it is developing OROFLOW® for Oesophageal Motility Disorders.
Average Trading Volume: 594,843
Technical Sentiment Signal: Sell
Current Market Cap: A$83.56M
See more data about LTP stock on TipRanks’ Stock Analysis page.