KRYS 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-03

• VYJUVEK is a non-invasive, topical, redosable gene therapy approved in the United States, the EU, the UK, and Japan for the treatment of DEB, a rare and severe monogenic disease that affects the skin and mucosal tissues and is caused by one or more mutations in a gene called COL7A1. VYJUVEK is desig…

• VYJUVEK was first approved by the United States Food and Drug Administration (“FDA”) in May 2023 for the treatment of wounds in patients, six months of age or older, suffering from DEB, making it the first and only corrective medicine approved by the FDA for the treatment of both recessive and domin…

• VYJUVEK was approved in Japan and the EU in 2025 and, in May 2026, received approval in the UK, making it the first and only corrective therapy approved for the treatment of DEB in each of those markets. All three approvals include flexible dosing options with the potential for patient or caregiver …

• We possess exclusive rights to develop, manufacture, and commercialize VYJUVEK throughout the world. We are commercializing VYJUVEK directly in the United States, major European markets, and Japan, and are building a specialty distributor network to support the commercialization of VYJUVEK outside o…

• We launched VYJUVEK in the United States in 2023, in Germany in August 2025, and in France and Japan in October 2025. The launch in France is under the post-marketing authorization early reimbursed access Accès Précoce program.

相对上期删除的文字 · 来源:10-Q · 2026-05-04

• administration at a healthcare professional’s office or in the patient’s home. Our innovative technology platform is supported by two in-house, commercial scale CGMP manufacturing facilities.

• VYJUVEK is a non-invasive, topical, redosable gene therapy approved in the United States, European Union (“EU”), and Japan for the treatment of DEB, a rare and severe monogenic disease that affects the skin and mucosal tissues and is caused by one or more mutations in a gene called COL7A1. VYJUVEK i…

• VYJUVEK was first approved by the FDA in May 2023 for the treatment of wounds in patients, six months of age or older, suffering from DEB, making it the first and only corrective medicine approved by the FDA for the treatment of both recessive and dominant subtypes of DEB. In September 2025, the FDA…

• VYJUVEK was also approved in Japan and the EU in 2025, making it the first and only corrective therapy approved for the treatment of DEB in each of those respective markets. Both approvals include flexible dosing options with the potential for patient or caregiver administration in the home setting.

• We possess exclusive rights to develop, manufacture, and commercialize VYJUVEK throughout the world. We are commercializing VYJUVEK directly in the United States, major European markets, and Japan. We launched VYJUVEK in the United States in 2023, in Germany in August 2025, and in France and Japan i…

相对上期新增的文字 · 来源:10-Q · 2026-08-03

• We had cash, cash equivalents and short-term investments of $845.6 million as of June 30, 2026, which consisted primarily of money market funds, commercial paper, corporate bonds and U.S. government agency securities. The investments in these financial instruments are made in accordance with an inve…

• We also have established operations in Europe and Japan and hold cash in Swiss Francs, Euros, Japanese Yen, and Great British Pounds. We are subject to foreign exchange rate risk arising from transactions conducted in the aforementioned foreign currencies. Future movements in foreign exchange rates …

相对上期删除的文字 · 来源:10-Q · 2026-05-04

• We had cash, cash equivalents and short-term investments of $823.4 million as of March 31, 2026, which consisted primarily of money market funds, commercial paper, corporate bonds and U.S. government agency securities. The investments

• in these financial instruments are made in accordance with an investment policy which specifies the categories, allocations and ratings of securities we may consider for investment. The primary objective of our investment activities is to preserve principal while at the same time maximizing the inco…

• We also have established operations in Europe and Japan and hold cash in Swiss Francs, Euros and Japanese Yen. We are subject to foreign exchange rate risk arising from transactions conducted in the aforementioned foreign currencies, however, our foreign operations are not currently material to our …

相对上期新增的文字 · 来源:10-Q · 2026-08-03

• During the three months ended June 30, 2026, no director or officer (as that term is defined by the SEC in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation S-K…

相对上期删除的文字 · 来源:10-Q · 2026-05-04

• On February 3, 2026, John Thomas, our Executive Vice President, General Counsel, and Corporate Secretary, adopted a Rule 10b5-1 trading arrangement (the “Trading Plan”) that is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act for the sale of up to 1,903…

• On March 9, 2026, Daniel Janney, one of our directors, terminated a Rule 10b5-1 trading arrangement that was originally adopted on November 25, 2025. The Rule 10b5-1 trading arrangement was terminated during the Company’s unrestricted trading window and at a time when Mr. Janney was not in possessio…

• During the three months ended March 31, 2026, other than as set forth above, no other director or officer (as that term is defined by the SEC in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as each term is…