NUVB 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• In April 2026, we amended the existing exclusive license agreement for safusidenib with Daiichi Sankyo to include Japan in the territory rights licensed to us, effectively securing exclusive global safusidenib development and commercialization rights for the Company.

• In May 2026, we announced the FDA had accepted a supplemental New Drug Application with updated data for IBTROZI in both TKI-naïve and TKI-pretreated advanced ROS1+ NSCLC with a target action date of January 4, 2027.

• In June 2026, we announced that the MHRA in the United Kingdom had validated the Marketing Authorisation Application submitted by our partner Eisai for taletrectinib for the treatment of advanced ROS1+ NSCLC.

• In July 2026, we completed our registered underwritten public offering of $287.5 million aggregate principal amount of 0.75% Convertible Senior Notes due 2032 (the “Notes”), including $37.5 million aggregate principal amount of Notes issued pursuant to the exercise in full of the overallotment optio…

• In July 2026, we announced we will initiate two new studies to evaluate safusidenib across the broader landscape of IDH1-mutant glioma: a pivotal Phase 3 study in patients with grade 2 IDH1-mutant glioma outside the U.S, and a Phase 2 study in patients with grade 2 or 3 IDH1-mutant glioma who have p…

相对上期删除的文字 · 来源:10-Q · 2026-05-04

• European Medicines Agency had validated the Marketing Authorisation Application (“MAA”) for taletrectinib for the treatment of advanced ROS1+ NSCLC.

• In January 2026, we announced entry into an exclusive license agreement for taletrectinib in Europe and additional countries with Eisai.

• On February 10, 2026, the outstanding warrants to purchase Class A Common stock expired and were delisted pursuant to a Form 25 filed by The New York Stock Exchange.

• In February 2026, we announced a protocol amendment to SIGMA study for safusidenib in IDH1-mutant glioma, which converted the study from a Phase 2 to a Phase 3 study.

• In March 2026, the Company announced that new data will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2026 taking place April 17–22, 2026, in San Diego, California.

相对上期删除的文字 · 来源:10-Q · 2026-05-04

• effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rule 13a–15(e) and 15d-15(e)) as of March 31, 2026. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures were effective as …

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• including comparable foreign healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

• We may not have the ability to raise the funds necessary to settle conversions of the Notes in cash, to repay the Notes at maturity or to repurchase the Notes upon a fundamental change, and our future debt may contain limitations on our ability to pay cash upon conversion or repurchase of the Notes.

• is mostly dependent on our ability to successfully commercialize IBTROZI in the U.S. We may not be able to successfully commercialize IBTROZI for a number of reasons, including:

• As a company, we have limited experience in selling and marketing or commercializing an approved drug product in the U.S., and no such experience outside of the U.S. The success of our U.S. commercialization efforts is subject to, among other things, managing our internal sales, marketing, and distr…

• If we enter into arrangements with third parties to perform sales, marketing and distribution services, our product revenue or the profitability of these product revenue to us are likely to be lower than if we were to market and sell any products that we develop

相对上期删除的文字 · 来源:10-Q · 2026-05-04

• parties with whom we conduct business, including our contract manufacturing organizations ("CMOs"), contract research organizations ("CROs"), shippers and others.

• As a company, we have limited experience in selling and marketing or commercializing an approved drug product in the U.S., and no such experience outside of the U.S. The success of our U.S. commercialization efforts is subject to, among other things, managing our internal sales, marketing, and distr…

• the management of such capabilities. For example, our commercial launch of IBTROZI in the U.S. may not continue as planned or anticipated, which may require us to, among others, adjust or amend our commercialization plan and incur significant expenses. If we are unsuccessful in accomplishing our obj…

• or are available only to limited levels, we may not be able to successfully commercialize IBTROZI and our product candidates that we develop, which could have an adverse effect on our operating results and our overall financial condition.

• If we enter into arrangements with third parties to perform sales, marketing and distribution services, our product revenue or the profitability of these product revenue to us are likely to be lower than if we were to market and sell any products that we develop ourselves. In addition, we may not be…

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• On May 27, 2026, David Hung, the Company’s Chief Executive Officer, entered into a trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act, providing for the sale of up to 2,000,000 shares of the Company's Class A Common Stock. Pursuant to this pl…

相对上期删除的文字 · 来源:10-Q · 2026-05-04

• During the three months ended March 31, 2026, no director or Section 16 officer adopted or terminated any Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements (in each case, as defined in Item 408(a) of Regulation S-K).