On Monday, Neurocrine Biosciences, Inc ( NBIX ). amended its agreement with Takeda Pharmaceutical Co Ltd ( TAK ) to develop and commercialize osavampator (NBI-1065845/TAK-653).

Under the amended agreement, Neurocrine will obtain exclusive rights for all indications to develop and commercialize osavampator for patients with inadequate response to treatment of major depressive disorder (MDD) in all territories worldwide except Japan, where Takeda will reacquire exclusive rights.

Also Read: Neurocrine’s Drug Gains FDA Nod As First Targeted Treatment For Certain Type Of Inherited Disorder, Analyst Highlights Blockbuster Potential

Under the terms of the updated agreement, each company is responsible for development costs in their respective region, and both companies are eligible to receive royalty payments.

“With the recent successful completion of our End-of-Phase 2 meeting with FDA for osavampator, we look forward to beginning the Phase 3 program in the first half of this year,” said Kyle Gano, Chief Executive Officer at Neurocrine Biosciences ( NBIX ).

In 2020, Neurocrine Biosciences ( NBIX ) and Takeda entered into a strategic collaboration to develop and commercialize compounds in depression and schizophrenia, including an exclusive license to both osavampator and NBI-1070770, which are being studied for the treatment of major depressive disorder, as well as a preclinical GPR139 antagonist development program.

Concurrently, Neurocrine Biosciences ( NBIX ) initiated a Phase 3 registrational study to evaluate the efficacy, safety and tolerability of osavampator as an adjunctive treatment to antidepressants for major depressive disorder.

In April 2024, Neurocrine announced topline data for its Phase 2 SAVITRI study in adult subjects with MDD.

The study met its primary and key secondary endpoints, demonstrating that once-daily, oral administration of NBI-1065845 produced a statistically significant change from baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total score at both Day 28 (primary) and Day 56 (secondary). 

Price Action: NBIX stock is up 1.38% at $150.23 at the last check on Tuesday.

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