FDA Gives Green Light to Lantern Pharma's LP-300 Phase 2 Trial Amendments
LTRN has more than doubled off its 52-week low of $1.11.
Summary
Lantern Pharma announced a successful outcome from its FDA Type C meeting regarding the HARMONIC Phase 2 trial for LP-300 in never-smokers with NSCLC. The FDA raised no objections to key proposed amendments, which include focusing enrollment on EGFR Exon 21 L858R mutation patients, increasing treatment cycles to eight, and transitioning to a single-arm design. This positive regulatory feedback provides a clearer and potentially more efficient path forward for a critical pipeline asset. This development is particularly significant for Lantern Pharma, which recently reported a going concern warning and limited cash runway in its Q1 earnings, making progress on its drug development crucial for its long-term viability. Investors will now watch for the execution of these trial amendments and subsequent data readouts.
At the time of this announcement, LTRN was trading at $3.12 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $33.9M. The 52-week trading range was $1.11 to $5.74. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Reuters.