Neurocrine Biosciences Files 8-K

Ticker: NBIX · Form: 8-K · Filed: 2024-08-28T00:00:00.000Z

Sentiment: neutral

Topics: disclosure, regulation-fd, other-event

Related Tickers: NBI

TL;DR

NBI filed an 8-K, something important happened.

AI Summary

Neurocrine Biosciences, Inc. filed an 8-K on August 28, 2024, to report an Other Event and Regulation FD Disclosure. The filing does not contain specific financial figures or details about the event itself, but it indicates a material event requiring disclosure.

Why It Matters

This filing signals a significant event or disclosure by Neurocrine Biosciences that could impact investors' understanding of the company's current status.

Risk Assessment

Risk Level: medium — The filing indicates a material event, but the lack of specific details makes it difficult to assess the immediate impact or risk.

Key Players & Entities

FAQ

What is the primary purpose of this 8-K filing?

The primary purpose of this 8-K filing is to report an Other Event and a Regulation FD Disclosure, as of August 28, 2024.

What is the exact date of the earliest event reported in this filing?

The date of the earliest event reported in this filing is August 28, 2024.

In which state is Neurocrine Biosciences, Inc. incorporated?

Neurocrine Biosciences, Inc. is incorporated in Delaware.

What is the IRS Employer Identification Number for Neurocrine Biosciences, Inc.?

The IRS Employer Identification Number for Neurocrine Biosciences, Inc. is 33-0525145.

What is the principal executive office address for Neurocrine Biosciences, Inc.?

The principal executive office address for Neurocrine Biosciences, Inc. is 6027 Edgewood Bend Court, San Diego, California 92130.

Filing Stats: 1,446 words · 6 min read · ~5 pages · Grade level 11.5 · Accepted 2024-08-28 07:00:59

Key Financial Figures

Filing Documents

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On August 28, 2024, Neurocrine Biosciences, Inc. ("Neurocrine" or the "Company") issued a press release announcing positive top-line data for its Phase 2 clinical study of NBI-1117568 in adults with schizophrenia, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The Company will hold a live conference call and webcast to discuss the clinical data on August 28, 2024 at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time). The Company will make available a slide presentation to accompany the call, a copy of which is furnished as Exhibit 99.2 to this Current Report on Form 8-K. The information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2 attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

01. Other Events

Item 8.01. Other Events. On August 28, 2024, Neurocrine announced positive top-line data for its Phase 2 clinical study of NBI-1117568 ("NBI-'568") in adults with schizophrenia. NBI-'568 is the first investigational, oral, muscarinic M4 selective agonist in development for the treatment of schizophrenia. The NBI-'568-SCZ2028 dose-finding study met its primary endpoint for the once-daily 20 mg dose. It demonstrated a clinically meaningful and statistically significant reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6 with a placebo-adjusted mean reduction of 7.5 points (p=0.011 and effect size of 0.61) and an 18.2-point reduction from baseline. The once-daily 20 mg dose also demonstrated a statistically significant improvement for additional endpoints, including improvement in the Clinical Global Impression of Severity (CGI-S) scale, Marder Factor Score – Positive Symptom Change, and Marder Factor Score – Negative Symptom Change. NBI-'568 was generally safe and well-tolerated at all doses studied in the Phase 2 clinical trial. Treatment discontinuation rates due to adverse events were similar between NBI-'568 and placebo. Adverse events with the highest incidence were somnolence, dizziness, and headache. Gastrointestinal adverse events including nausea and constipation were low in frequency and similar to placebo. Cardiovascular-related events were also low in frequency and were not deemed to have clinical relevance at any dose tested. NBI-'568 was not associated with a greater increase in weight than placebo. Few extrapyramidal symptoms adverse events were reported. Neurocrine currently expects to advance NBI-'568 into Phase 3 development in early 2025. Primary Endpoint Results Summary Week 6 (Day 42) Placebo (N=68) 20 mg QD (N=35) 40 mg QD (N=38) 60 mg QD (N=34) 30 mg BID (N=26) PANSS Total Score LS Mean Change from Baseline* -10.8 -18.2 -12.6 -13.7 -15.8 LS Mean Difference vs. Placebo* - -7.5 (p=0.011) -1.9

Forward-Looking Statements

Forward-Looking Statements In addition to historical facts, this Current Report on Form 8-K and certain of the materials furnished herewith contain forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding the clinical results from, and our future development plans with respect to, NBI-1117568, as well as the therapeutic potential and clinical benefits or safety profile of NBI-1117568. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: top-line data that we report may change following a more comprehensive review of the data related to the clinical study and such data may not accurately reflect the complete results of the clinical study; risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that regulatory submissions for our product candidates may not occur or be submitted in a timely manner; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, ad

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release issued by Neurocrine Biosciences, Inc. on August 28, 2024 99.2 Slide Presentation dated August 28, 2024 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. NEUROCRINE BIOSCIENCES, INC. Dated: August 28, 2024 /s/ Darin M. Lippoldt Darin M. Lippoldt Chief Legal Officer

View on Read The Filing