Palatin Technologies PL9643 Drug Setback

Palatin Technologies witnessed a significant decline in share value, nearly 40%, during premarket trading on Wednesday following the release of mixed late-stage study results for its PL9643 drug candidate aimed at dry-eye disease treatment.

Study Results Overview

The pivotal Phase 3 study assessing the safety and effectiveness of PL9643 by Palatin fell short of meeting its co-primary endpoint, along with a secondary endpoint linked to clinical observations. However, the study did achieve its other co-primary endpoint associated with pain, as well as various secondary symptom endpoints. Furthermore, Palatin highlighted the excellent safety and tolerability profile exhibited by the drug throughout the trial.

Future Plans

Palatin intends to engage with the U.S. Food and Drug Administration (FDA) to explore potential pathways for regulatory approval of PL9643. Additionally, the company seeks feedback regarding the design of its upcoming pivotal Phase 3 trial.

Market Response

Following the disappointing study results, Palatin's shares experienced a significant drop, moving from $3.97 at the close of trading on Tuesday to $2.47 in premarket trading.