บันทึกจากแหล่งปฐมภูมิ
The FDA set a PDUFA target action date of December 15, 2025 for the zoliflodacin NDA under Priority Review. The agency indicated in its Day-74 letter that it does not plan to hold an Advisory Committee meeting.
EX-99.1 2 tm2530226d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Innoviva Reports Third Quarter 2025 Financial Results; Highlights Recent Company Progress Generated $63.4 million in revenue from durable royalties portfolio IST achieved U.S. net product sales of $29.9 million, representing 52% year-over-year growth Strengthened product portfolio with U.S. launch of ZEVTERA ® Announced $125 million share repurchase program BURLINGAME, Calif. – November 5, 2025 – Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today reported financial results for the