Definium Therapeutics said it reported positive topline results from its second phase 3 study of DT120, an orally disintegrating tablet in adults with generalized anxiety disorder.

This is its third positive phase 3 readout for DT120 ODT, following positive results in major depressive disorder announced in June and in generalized anxiety disorder announced in August.

Shares were halted earlier in premarket trading and have resumed, gaining 18.7% and trading at $38.89 on Monday.

The company said the latest study met the primary endpoint along with key secondary efficacy endpoints. This demonstrates a statistically-significant and clinically-meaningful improvement from baseline compared with a placebo, as measured by the change in Hamilton Anxiety Rating Scale total score at Week 12, it said.

The drug was generally well-tolerated, with a safety profile consistent with prior clinical experience, the company said.

"Building on this momentum, we are advancing toward an NDA submission and look forward to aligning with the FDA at our upcoming pre-NDA meeting," Chief Executive Rob Barrow said.

An initial meeting for a new drug application is scheduled for the fourth quarter and a filing is anticipated sometime in the first half of next year.