Anupam Rama

Ashwani Verma

Cory Kasimov

David Amsellem

Laura Chico

Marc Goodman

Myles Minter

Paul Matteis

Tazeen Ahmad

Akash Tewari

Brian Abrahams

Brian Skorney

Evan Seigerman

Jay Olson

Mohit Bansal

Philip Nadeau

Ami Fadia

Chris Shibutani

Sumant Kulkarni

Uy Ear

Yatin Suneja

Carter L. Gould

Corinne Johnson

Danielle Brill

David Huang

Jeff Hung

Jeffrey Hung

Joshua Schimmer

Leonid Timashev

Michael Riad

Phil Nadeau

Sean Laaman

- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced the presentation of **positive new data** from its Phase 2 SAVITRI™ study of **1 mg osavampator** (NBI-1065845) for major depressive disorder (MDD) at the 38th annual Psych Congress.  **[914475_20250922LA79580:0]** 
- The study showed **statistically significant and clinically meaningful improvement in depression severity** at Day 28 and Day 56, meeting its primary efficacy endpoint.  **[914475_20250922LA79580:0]**  Osavampator was also **generally well tolerated**.  **[914475_20250922LA79580:0]** 
- Osavampator is an investigational potential **first-in-class selective positive allosteric modulator** of the AMPA receptor (AMPA-PAM) in development as an adjunctive treatment for adults with MDD who have an inadequate response to oral antidepressant treatment.  **[914475_20250922LA79580:0]** **[914475_20250922LA79580:1]** 
- Following the positive Phase 2 results, Neurocrine **initiated a Phase 3 registrational program** for osavampator in **January 2025**, which currently includes five active and enrolling studies.  **[914475_20250922LA79580:1]**

Neurocrine Biosciences Presents Positive Phase 2 Data for Osavampator in Major Depressive Disorder

- Neurocrine Biosciences is evolving its R&D strategy to include internal discovery and diverse modalities, with a focus on validated targets. The company aims to initiate **four new Phase 1, two new Phase 2, and three Phase 3 programs annually** at steady state, targeting **one new medicine every other year**.  **[914475_2146295_1]**  The portfolio is expected to reweight over time, with **40-50% in neurology**.  **[914475_2146295_2]** 
- Key pipeline updates include **NBI-770** (MDD), with Phase 2 data expected in the **October-November timeframe** from a **72-patient study**.  **[914475_2146295_2]**  **Osavampator** (MDD) Phase 3 trials are ongoing, with high-level data expected in **2027**, following Phase 2 results that showed an effect size of **0.55 to 0.75** in MADRS improvement.  **[914475_2146295_4]**  **NBI-568** (Schizophrenia) Phase 3 studies are also ongoing, with data earmarked for **2027**, after Phase 2 demonstrated a **7.5-point placebo-corrected PANSS improvement** and an effect size of **0.61** at the **20 mg once-daily dose**.  **[914475_2146295_6]** 
- The company reported strong commercial performance in Q2 2025, with total revenue of **$682 million**, representing **17% year-over-year growth**.  **[914475_2146295_9]**  This was driven by **Ingrezza's $624 million** and **CRENESITY's $53 million** in Q2, with Ingrezza achieving record back-to-back NRX and a record TRX quarter.  **[914475_2146295_9]**

Neurocrine Biosciences Provides Updates on R&D Strategy, Pipeline Progress, and Commercial Performance

- Neurocrine Biosciences expects **INGREZZA sales to reach $2.5 billion** in 2025.  **[914475_tx_379747_0]** 
- The launch of **Chrinesity** has been strong, marking the first new medicine for congenital adrenal hyperplasia in over seventy years.  **[914475_tx_379747_0]** 
- The company has initiated two major Phase 3 programs: **osavampitur for major depressive disorder** and a **muscarinic program for schizophrenia**, with plans to initiate a trial for bipolar mania later in 2025.  **[914475_tx_379747_0]** 
- Neurocrine has increased INGREZZA's Medicare coverage to **north of 70%** of the TD market, which has led to record new patient starts in Q1 and Q2 2025, despite a **5% net price impact** for the year.  **[914475_tx_379747_1]** 
- Under the IRA, INGREZZA's potential negotiated price range is **25-34%**, expected to be implemented in **2029**.  **[914475_tx_379747_3]**

Neurocrine Biosciences Provides 2025 Outlook and Pipeline Updates

NEUROCRINE BIOSCIENCES (NBIX)