Lenacapavir Sodium

Gilead Sciences has axed half a dozen programmes from its portfolio, including candidates partnered with Novo Nordisk and Arcus Biosciences. The pipeline cull was disclosed in the company's second-quarter financial report on Thursday, when it also announced encouraging early uptake for its HIV prevention shot Yeztugo (lenacapavir) (see – Spotlight On: With Yeztugo's launch off to the races, Gilead ups HIV guidance).The pipeline prioritisation hit four cancer programmes, an experimental infectious disease asset, and Gilead's final metabolic dysfunction-associated steatohepatitis (MASH) hopeful. The drugmaker had been developing a triple-combination MASH treatment in collaboration with Novo Nordisk since at least 2020. The cocktail, comprising the Danish pharma's GLP-1 blockbuster semaglutide along with Gilead's experimental drugs cilofexor and firsocostat, was studied in the Phase II WAYFIND study.The discontinued candidates from Arcus also date back to a 2020 partnership pegged to last a decade. At the time, Gilead paid $175 million upfront and made a $200-million equity investment to co-develop and co-commercialise cancer immunotherapies from Arcus' pipeline — notably, the PD-1 inhibitor zimberelimab and several anti-TIGIT programmes, although the allure of TIGIT has since faded drastically following a number of high-profile setbacks within the class (see – Spotlight On: AstraZeneca leads TIGIT charge as another one bites the dust).In 2021, Gilead exercised options for several additional assets including etrumadenant, a dual adenosine A2a/A2b receptor antagonist, and the small-molecule CD73 inhibitor quemliclustat; both were pruned from the drugmaker's pipeline on Thursday.  The partners had been studying etrumadenant in combination with zimberelimab in the Phase II ARC-9 study for metastatic colorectal cancer, while quemliclustat was being evaluated in the Phase II ARC-8 trial in patients with metastatic pancreatic ductal adenocarcinoma, with or without the PD-1 inhibitor. Separate from the Arcus partnership, Gilead also cut two Phase I oncology programmes from its portfolio: MCL1 inhibitor GS-9716 and DGKα inhibitor GS-9911.The sixth asset to get the axe was the oral antiviral obeldesivir, specifically as a treatment for respiratory syncytial virus (RSV) in both children and adults. Gilead's decision to end development in RSV doesn't come as a surprise, as two trials were terminated in June due to "lower than expected" RSV infection incident rates. At the time, Gilead told FirstWord that a 400-person Phase II study of obeldesivir in Marburg virus disease was continuing as planned. The antiviral also failed the Phase III OAKTREE trial last year after it didn't improve time to symptom alleviation versus placebo in non-hospitalised COVID-19 patients without risk factors for severe disease.

iStock, Sundry Photography The U.S. Preventive Services Task Force makes recommendations for preventive services—including Gilead’s twice-yearly HIV PrEP Yeztugo—that insurers must cover. A recently postponed meeting has raised concerns that Health Secretary RFK Jr. could abolish or overhaul the group. Gilead executives are confident that the pharma can “work through” any potential access difficulties that could arise from the recent uncertainties surrounding the U.S. Preventive Services Task Force. The company had its first earnings call since the landmark FDA approval of its long-acting HIV PrEP drug Yeztugo in June. And PrEP was the undoubted star of Gilead’s Q2, with almost all analysts congratulating the pharma on the strong launch of Yeztugo, opening up a twice-yearly injection option for the prevention of HIV. Gilead did not provide sales figures for the PrEP product and chief commercial officer Johanna Mercier declined to reveal specific uptake figures on the call. She did, however, commend the company’s launch teams. “The hour we got the approval, everything was basically ready to turn key and get going,” Mercier told investors. Gilead’s teams have so far executed around 25,000 customer calls since approval. Many potential customers “have seen . . . a medical sales representative more than once,” Mercier added. Analysts on the call raised the possibility that uptake of the drug might be affected by changes made to the Preventive Services Task Force. The USPSTF was established in 1984 and consists of independent scientific experts in preventive medicine. The group makes recommendations on certain preventive services, such as screenings and counseling, which insurance providers need to cover. In June, the Supreme Court ruled that the Health Secretary has power over the panel’s composition and recommendations. Weeks after the ruling, Robert F. Kennedy Jr. postponed a scheduled meeting of the USPSTF, raising concerns that he could abolish or overhaul the group, and subsequently affect a recommendation it would make on covering Yeztugo. Having the Task Force’s recommendation for Yeztugo would be “ideal,” Mercier told investors during the company’s Q2 call, but in case that falls through, she also noted that “these guidelines didn’t really have legs until probably less than a year ago, probably about two, three quarters ago.” Before that, even without the USPSTF’s endorsement, the prevention market was “growing very strong,” she added. If the Task Force guidelines were to change in any way, Mercier said Gilead can “just work closer with our payers to make sure that people have access to HIV prevention moving forward, just as they do today.” In the second quarter, Gilead’s total revenue hit $7.1 billion, a 1% beat versus consensus estimates. The company’s HIV portfolio drove its topline beat, surging 7% year-on-year to bring in $5.1 billion. The daily HIV-1 antiretroviral pill Biktarvy emerged as Gilead’s best-selling product, with $3.53 billion in sales worldwide. Gilead on Thursday also slightly lifted its full-year outlook. The company now expects to make $28.3 billion to $28.7 billion in 2025, versus its prior guidance of $28.2 billion to $28.6 billion.