NBIX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-07-31

• •On May 18, 2026, we completed our acquisition of Soleno in an all-cash transaction representing a total equity value of approximately $2.9 billion, adding VYKAT XR, the first and only FDA-approved treatment for hyperphagia in PWS, to our rare disease commercial portfolio.

• •In May 2026, we entered into a $1.0 billion senior secured revolving credit facility (the 2026 Credit Facility). In June 2026, we repaid $600.0 million of principal that was borrowed under the 2026 Credit Facility in May 2026. As of June 30, 2026, we had $1.0 billion of available borrowing capacity…

• •Promoted Samir Siddhanti to the executive management team as Chief Business Officer where he will lead the Company’s business development, corporate strategy, and R&D portfolio management functions helping guide Neurocrine’s continued evolution into a leading, global biotechnology company.

• •Initiated Phase 2 clinical study to assess the safety and tolerability of crinecerfont in children aged 3 months to under 4 years with CAH.

• •Initiated Phase 1 first-in-human clinical study evaluating the safety and tolerability of NBIP-2118 in adult participants. NBIP-2118 is an investigational corticotropin-releasing factor 2 receptor (CRF2) peptide agonist and a potential first-in-class therapy for obesity.

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• •In April 2026, we entered into an Agreement and Plan of Merger (the Merger Agreement) to acquire all of the outstanding shares of common stock of Soleno Therapeutics, Inc. (Soleno) for approximately $2.9 billion. Pursuant to the Merger Agreement, we commenced a tender offer to purchase all of the o…

• •Presented new real-world evidence demonstrating that adult patients with tardive dyskinesia receiving INGREZZA (valbenazine) capsules showed higher treatment persistence compared to those on AUSTEDO XR (deutetrabenazine). The findings were presented at the Academy of Managed Care Pharmacy 2026 Annu…

• •Presented the first expert consensus recommendations focused on screening, diagnosis and treatment of tardive dyskinesia among older adults in long-term care settings. The recommendations address persistent gaps in recognizing and managing tardive dyskinesia in this higher-risk population. Findings…

• •Presented new two-year CRENESSITY data demonstrating durable hormonal control, reduced glucocorticoid exposure and meaningful clinical improvements in pediatric patients with classic congenital adrenal hyperplasia. The findings were presented at the Pediatric Endocrine Society 2026 Annual Meeting i…

• Results of Operations for the Three Months Ended March 31, 2026 and 2025

相对上期新增的文字 · 来源:10-Q · 2026-07-31

• •If healthcare providers and patients do not continue to accept our commercial products, or our sales and marketing efforts are not effective, we may not generate sufficient revenue.

• •We may not successfully integrate Soleno Therapeutics. Inc. (Soleno) or realize the anticipated benefits of the acquisition. which could adversely affect our business and financial condition.

• •Because the development of our product candidates is subject to a substantial degree of technological uncertainty, we may not succeed in developing any of our product candidates, which could adversely affect our business and financial condition.

• •Our credit facility imposes operating and financial restrictions, and our failure to comply with its covenants or satisfy our obligations under the facility could adversely affect our business and financial condition.

• In December 2024, we announced FDA approval and launched CRENESSITY capsules and oral solution as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years of age and older with classic CAH. We have also established our commercial team and …

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• •We may not be able to successfully launch and commercialize CRENESSITY.

• •If physicians and patients do not continue to accept INGREZZA or do not accept CRENESSITY, or our sales and marketing efforts are not effective, we may not generate sufficient revenue.

• •Because the development of our product candidates is subject to a substantial degree of technological uncertainty, we may not succeed in developing any of our product candidates.

• In December 2024, we announced FDA approval and launched CRENESSITY capsules and oral solution as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years of age and older with classic CAH. We have also established our commercial team and …

• If physicians and patients do not continue to accept INGREZZA or do not accept CRENESSITY, or our sales and marketing efforts are not effective, we may not generate sufficient revenue.

相对上期新增的文字 · 来源:10-Q · 2026-07-31

• Name and TitleActionDateTrading ArrangementTotal Shares Authorized

相对上期删除的文字 · 来源:10-Q · 2026-05-05

• * The Rule 10b5-1 trading arrangements reflected in the termination rows dated January 20, 2026 were sell-to-cover arrangements authorizing the pre-arranged sale of shares to satisfy employee tax withholding obligations arising exclusively from the vesting of restricted stock units (RSUs) and perfor…