Record mula sa primary source

Decision-gradeNaitakda ang petsa ng PDUFA

Innoviva: Ang target na petsa ng aksyon ng PDUFA para sa zoliflodacin ay Disyembre 15, 2025

Itinakda ng FDA ang PDUFA target action date na December 15, 2025 para sa zoliflodacin NDA sa ilalim ng Priority Review. Ipinahiwatig ng ahensya sa Day-74 letter nito na hindi ito nagbabalak na magdaos ng Advisory Committee meeting.

Mahahalagang fact

Na-file
Nob 5, 2025, 09:18 PM
Kaganapan
Naitakda ang petsa ng PDUFA
Direksyon
Neutral
Pinagmulan
SEC 8-K
Kumpiyansa
May source
Kalendaryo
Desisyon ng FDA (PDUFA) · Dis 15, 2025 · Walang naitalang resulta

Sipi mula sa source

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

SEC 8-K