Some of the biggest news and trends captured in PharmaVoice’s newsletter this week. Sign up here to receive the newsletter daily.
Gilead’s expanding footprint in HIV
Gilead is growing its HIV franchise with a fresh FDA nod.
The agency OK’d a novel medication last week that combines two Gilead HIV treatments into a single pill as an option for patients who want to “simplify their treatment regimen,” the company’s CEO, Daniel O’Day, said in a statement.
One of the ingredients in the new pill, lenacapavir, is also the backbone in Gilead’s twice-yearly shot Yeztugo, which won a landmark approval last year. To bolster Yeztugo’s ongoing rollout, Gilead is targeting populations that are traditionally tough to reach, including the Black community — an effort we’re looked at this week.
Cell therapy deals plummet
Licensing deals for cell therapies have cratered. The sector recorded $583 million in upfront cash and equity deals in 2024, according to a J.P. Morgan analysis. In the first half of this year? That total failed to hit a million.
The cell therapy sector has fared better when it comes to seed or series A funding, notching $383 million in the first half of 2026 — outpacing its total of $339 million last year.
But CAR-T remains in a kind of limbo as researchers chase the next breakthroughs. Developers are testing CAR-Ts in autoimmune diseases for the first time, while other approaches that aim to overcome long-standing manufacturing challenges are still in the clinic. This week, we dug into the nitty gritty of those production hurdles and which breakthroughs could turn the tide.
FDA’s warm embrace of psychedelics
The FDA has become friendly territory for psychedelic drug developers. After issuing priority review vouchers to three psychedelic-based candidates earlier this year, the agency is now planning a public hearing that could further buoy the sector.
On Sept. 14 the FDA is convening a meeting on the future therapeutic use of psychedelic drugs to better align the industry with the agency’s ongoing development of regulatory guidance for the drugs.
More large pharmas are also embracing the space. Most recently, Eli Lilly picked up AtaiBeckly and its suite of psychedelic candidates for mental health conditions for $2.8 billion up front. This week, we looked at the impact Lilly and AtaiBeckley could have on social anxiety in particular, which has proved a difficult indication for drug R&D.
