Gilead Sciences

Gilead secured three FDA approvals in the past four months, most recently for Bixlenvo for virologically suppressed adults with HIV, adding to approvals for Trodelvy and Hepcludex. Near-term catalysts include PDUFA target dates for anito-cel (Dec. 23) and once-weekly oral Yeztugo for PrEP (Feb. 2), plus a planned 2027 launch of a weekly lenacapavir-islatravir combo. The company reported Q2 revenue of $7.6 billion (up 8% y/y), raised its quarterly dividend to $0.82, executed buybacks, and posted gross margins near 87%, supporting management’s case for durable cash generation despite HIV-related concentration risks. » Altro su finance.yahoo.com

The U.S. FDA approved Gilead Sciences' once-daily oral combination pill Bixlenvo for adults whose HIV infection is already reduced to very low levels. Bixlenvo combines bictegravir, the core of Biktarvy, with capsid inhibitor lenacapavir, which is also marketed as Sunlenca and Yeztugo. The approval expands oral treatment options for virally suppressed patients. » Altro su yahoo.com

The European Commission has approved Trodelvy (sacituzumab govitecan) in combination with Keytruda (pembrolizumab) for adult women with inoperable or metastatic, PD‑L1‑positive (CPS≥10) triple‑negative breast cancer. The decision applies to the 27 EU member states as well as Norway, Iceland and Liechtenstein and is based on data from the phase‑III ASCENT‑04/KEYNOTE‑D19 study. The combination reduced the risk of disease progression or death by 35% versus standard chemotherapy plus Keytruda. » Altro su de.investing.com