PLX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-12

• ●risks associated with global conditions and developments such as new or increased tariffs, treaties, trade policies, taxes, and other limitations on cross-border operations, which may adversely impact our business, results of operations, and financial condition;

• ●risks associated with other global conditions and developments such as new or changed trade restrictions, supply chain challenges, the inflationary environment, and tight labor market, and instability in the banking industry, which may adversely impact our business, results of operations, and finan…

• ●On May 4, 2026, the U.S. Patent and Trademark Office (USPTO) issued a Patent Term Extension for U.S. Patent No. 9,194,011, covering Elfabrio. The extension adds five years to the patent term, moving the expiration date of the U.S. patent to November 17, 2035.

• ●In May 2026, the South Korean Ministry of Food and Drug Safety (MFDS) granted orphan drug marketing authorization for Elfabrio for adult patients with Fabry disease. Kwang Dong Pharm. Co., Ltd., will be Chiesi’s distributor in South Korea and, accordingly, is the market authorization holder in Sout…

• The Brazil Agreement provides for a staged technology transfer that is intended to transfer to Fiocruz the capacity and skills required for the Brazilian government to construct its own manufacturing facility, at its sole expense, and to produce a sustainable, high-quality, and cost-effective supply…

相对上期删除的文字 · 来源:10-Q · 2026-05-13

• ●risks associated with global conditions and developments such as new or increased tariffs, new or changed trade restrictions, supply chain challenges, the inflationary environment and tight labor market, and instability in the banking industry, which may adversely impact our business, operations, a…

• ●On March 5, 2026, the EC approved, in the EU, the 2 mg/kg E4W dosing regimen for pegunigalsidase alfa in Fabry disease adult patients stable with an ERT treatment. The approval is the result of an appeal submitted after a negative opinion issued in October 2025.

• ●On March 31, 2026, we received a $25.0 million milestone payment from Chiesi in connection with the approval by the EC of the 2 mg/kg E4W dosing regimen for pegunigalsidase alfa in the EU.

• The Brazil Agreement provides for a staged technology transfer that is intended to transfer to Fiocruz the capacity and skills required for the Brazilian government to construct its own manufacturing facility, at its sole expense, and to produce a sustainable, high-

• quality, and cost-effective supply of BioManguinhos alfataliglicerase. Fiocruz has not satisfied certain purchase commitments under the Brazil Agreement. We continue to sell BioManguinhos alfataliglicerase for a fixed price through purchase orders and we continue to discuss with Fiocruz potential st…

相对上期新增的文字 · 来源:10-Q · 2026-08-12

• Changes in tariffs and other governmental trade policies in the United States could have an adverse effect on our business, results of operations, and financial condition.

• There is currently significant uncertainty about the future relationship between the U.S. and various other countries and jurisdictions, including Israel and the EU, with respect to tariffs, treaties, trade policies, taxes, and other limitations on cross-border operations. For example, the current U…

• There is no guarantee that the Israeli Government will award to us any grants under the Israeli Law for the Encouragement and Incentivization of Research and Development, 2026.

• Under the Israeli R&D Law, we are entitled to apply for a number of grants related to research and development efforts as well as capital investments. We have begun to apply for such grants and intend to continue to apply for grants, as relevant and applicable. Ultimately, grants awarded under the R…

相对上期删除的文字 · 来源:10-Q · 2026-05-13

• On May 12, 2026, upon the approval of our Board of Directors, we entered into a new employment agreement with Yaron Naos, our Sr. Vice President and Chief Operating Officer. Pursuant to the new Employment Agreement, Mr. Naos will continue to receive his current monthly base salary of 70,000 New Isra…