Keep Factually independent
Whether you agree or disagree with our analysis, these conversations matter for democracy. We don't take money from political groups - even a $5 donation helps us keep it that way.
Which Neurocept product candidates have completed Phase 2 or Phase 3 trials and what were the outcomes?
Executive summary
Neurocrine Biosciences’ publicly reported pipeline shows multiple candidates that reached Phase 2 or Phase 3 by mid‑2025, with mixed outcomes: at least one Phase 2 failure (NBI‑1070770 in MDD did not meet its primary endpoint) and at least one Phase 3 initiation or readout activity (NBI‑568 and osavampator moved into Phase 3 programs during 1H–2H 2025) [1] [2] [3]. Corporate filings and investor decks emphasize upcoming Phase 3 readouts (valbenazine for dyskinetic cerebral palsy, osavampator in MDD) and note some Phase 3 misses reported earlier (adjunctive valbenazine in schizophrenia failed its primary endpoint) [4] [5].
1. What Neurocrine says publicly about Phase‑2 and Phase‑3 activity
Neurocrine’s investor materials and press releases list several candidates transitioning through Phase 2 to Phase 3 in 2025: osavampator (an NMDA‑related candidate) advanced into a Phase 3 program for major depressive disorder with a milestone reflected in R&D expense, and NBI‑568 (a muscarinic M4 agonist) moved into or initiated Phase 3 development for schizophrenia during the first half of 2025 [2] [3]. The company’s Q2 slide set also flagged expected top‑line Phase 3 and Phase 2 data later in 2025, including valbenazine in dyskinetic cerebral palsy and NBI‑770 in MDD [4].
2. Known Phase‑2 outcomes reported in the materials
Neurocrine explicitly reported that NBI‑1070770 (also referenced as NBI‑1070770 / NBI‑1070xx series in releases) failed to meet the primary endpoint in a Phase 2 study in adults with major depressive disorder; the company said it would continue to analyze the data and consider next steps [1]. Investor slides and summaries also describe Phase 2 efficacy/safety readouts for other candidates (for example, NBI‑568 showed Phase 2 efficacy signals that supported further development), but detailed numerical results and full datasets were not published in the provided excerpts and are said to be shared later [4] [3].
3. Phase‑3 initiations and readouts — what advanced and what missed
Neurocrine recorded milestone expenses tied to initiating Phase 3 programs for osavampator in MDD and for NBI‑568 in schizophrenia, signaling formal Phase 3 starts in 2025 [2] [3]. The company also noted that a Phase 3 study of valbenazine as adjunctive therapy in schizophrenia did not meet its primary endpoint — an explicit Phase 3 miss reported in its Q2 materials — while a separate Phase 3 study of valbenazine for dyskinetic cerebral palsy was expected to report top‑line data in Q4 2025 [5] [4].
4. How Neurocrine frames the mixed results and next steps
In the NBI‑1070770 Phase 2 update Neurocrine stated disappointment that the trial did not meet its primary endpoint but emphasized aspects of the data that “warrant further exploration” and said additional analysis would determine next steps [1]. Across investor decks the company repeatedly frames individual trial outcomes as one input in an expanding portfolio strategy—citing both setbacks (failed endpoints) and forward commitments (Phase 3 initiations, upcoming readouts) and referencing milestone charges tied to program starts [2] [3].
5. What the documentation does NOT provide (limitations)
The provided materials do not include full numeric efficacy or safety data tables for the Phase 2 or Phase 3 trials; where slides and releases reference “efficacy, safety, and tolerability results” they promise more detail later, and they frequently say full results will be published or presented at meetings rather than included in the press materials [2] [6] [4]. Available sources do not mention complete statistical outcomes (p‑values, effect sizes) or independent peer‑reviewed publications for these specific Neurocrine trials within the provided set [4] [3].
6. Competing perspectives and implicit agendas to watch
Investor decks and press releases serve corporate objectives: they highlight pipeline progress and upcoming catalysts while acknowledging failures succinctly; milestone‑related R&D expenses are presented to signal seriousness of advancement [2] [3]. Independent clinical reports or peer‑reviewed publications are not in the provided set, so outside verification of numerical efficacy/safety claims is not available here — readers should watch for conference presentations and journal articles promised by the company [4] [6]. When Neurocrine frames a failed study as “warranting further exploration,” that phrasing can reflect an agenda to preserve optionality for a program while managing investor reaction [1].
Bottom line: company materials confirm Phase 2 failures (NBI‑1070770 in MDD) and active Phase‑3 starts/readouts (osavampator, NBI‑568, valbenazine programs) in 2025, but detailed outcome data and independent analyses are not included in the documents provided and are described as forthcoming [1] [2] [5].