Gilead (GILD) Wins FDA Approval for First HDV Treatment Hepcludex

The excerpt argues that institutional investors increasingly influence pharma CEOs, shifting priorities toward shareholder returns. A 2021 US House Oversight report on 14 major drug companies found 2016–2020 spending of $577B on buybacks/dividends versus $56B more than R&D, with executive pay over $3.2B. It also cites AbbVie’s Humira-related “anticompetitive R&D” and merger-driven declines in innovation.

Civil society groups urged President Cyril Ramaphosa to push Gilead to expand access to lenacapavir, a twice-yearly HIV prevention shot, ahead of its launch in Secunda, Mpumalanga. They said South Africa will receive under 975,000 doses in two years (38,000 arrived by April) versus HE2RO modelling of ~2 million annual doses needed. They criticized delayed rollout tied to Sahpra testing and limited generic licensing.

In May 2026, the FDA approved new therapies for rare/underserved patients. On May 8, Partner Therapeutics’ Bizengri won approval for NRG1 fusion-positive cholangiocarcinoma under the CNPV pilot. On May 22, Gilead’s Hepcludex was approved for chronic HDV in adults without or with compensated cirrhosis. The article says 20 novel drugs were approved through end-May, and highlights biotech stocks facing FDA decisions in June 2026.

Gilead Sciences said it and its subsidiary Kite will present 25+ cancer abstracts at the 2026 ASCO meeting (May 29–June 2) and EHA Congress (June 11–14). ASCO includes new Phase 3 Trodelvy first-line metastatic triple-negative breast cancer analyses on long-term progression-free survival, plus anito-cel manufacturing consistency data. EHA will cover durability and safety for KITE-753. Separately, Gilead reported Phase 3 interim data that Livdelzi achieved high, sustained ALP normalization in pri

Gilead Sciences said the FDA approved Hepcludex (bulevirtide) injection to treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis, calling it the first FDA-approved HDV therapy. Separately, Gilead completed its Tubulis acquisition for $3.15B upfront plus up to $1.85B milestones. Maxim upgraded Gilead to Buy, setting a $165 target.

The article is largely promotional and does not provide verifiable details about Gilead Sciences’ planned acquisition of Tubulis. It claims Gilead will buy Tubulis for $3.15 billion to expand its oncology portfolio, but offers no supporting financial terms or investor impact analysis beyond marketing language.