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.
Desisyon ng FDA (PDUFA) · Dis 15, 2025 · Walang naitalang resulta
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EX-99.1
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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