Gilead is buying CAR-T therapy partner Arcellx

The acquisition that was nearly inevitable finally happened. Gilead Sciences is buying Arcellx for $7.8 billion, merging two biotech companies already co-developing a CAR-T therapy for multiple myeloma.

The transaction values Arcellx at $115 per share, or a 79% premium to the stock's Friday close.

The centerpiece of the deal is an experimental CAR-T therapy called anito-cel that was initially developed by Arcellx. Since 2023, the therapy has been co-developed by Kite Pharma, Gilead's cell therapy division, as part of a collaboration and co-marketing agreement.

Investors have long surmised that the intertwined relationship between the two companies meant an outright acquisition of Arcellx by Gilead, its much larger partner, was only a matter of time.

Read more about the deal in a story written by my colleague Adam Feuerstein.

influence

Pharma lobbyists see new room to maneuver

Health secretary Robert F. Kennedy Jr. has vowed to purge industry influence from the FDA, but as political control over the agency tightens, drugmakers are increasingly stepping up their lobbying efforts, STAT's Daniel Payne and Lizzy Lawrence write.

Lobbyists, advisers, and officials describe a marked shift around the conversation about the FDA. Discussions that once would have been taboo — explicitly trying to influence agency decisions through political channels, including through the White House — are now routine, and companies are now framing approvals as potential wins for the Trump administration. Pharma lobbying spending hit a record $452 million in 2025, with firms tied to President Trump's inner circle reaping a surge in contracts.

"It was always the case: if it's FDA, leave it alone," one of the lobbyists, granted anonymity to discuss confidential meetings, told STAT. "There's been a swing. … Now the conversations are: Can we influence the process? I had never had that conversation before."

Daniel and Lizzy also take a closer look at three firms, in particular: Checkmate Government Relations, Miller Strategies, and Ballard Partners, all of which saw a boom in business in the first year of Trump's second term.

obesity

Novo's next-gen obesity drug stumbles in Lilly comparison study

From my colleague Andrew Joseph: Novo Nordisk's next-generation weight loss drug CagriSema, one of the company's key hopes to help it regain its footing in the increasingly competitive obesity market, failed in a key study that compared it to rival Eli Lilly's tirzepatide, Novo said.

The open-label REDEFINE 4 study was designed to test whether CagriSema could help patients lose the same amount of weight as those who received Lilly's tirzepatide, which is sold as Zepbound and Mounjaro.

It did not. The disappointing details can be read here, but simply put, CagriSema did not perform equivalently to Lilly's drug — failing to achieve a statistical test of non-inferiority.

Novo shares were down 15% in early trading this morning.

rare disease

Gossamer's lung disease drug comes up short but company still plans to seek approval

Gossamer Bio said this morning that its Phase 3 trial of seralutinib, an experimental drug for pulmonary arterial hypertension, failed to meet its primary endpoint. Treated patients walked 13 meters farther than placebo over six minutes — a difference that favored the drug but wasn't statistically significant, STAT's Adam Feuerstein writes.

The therapy also raised tolerability questions, as 37% of patients experienced cough and 13% had elevated liver enzymes. Still, the company plans to file for FDA approval, arguing that a post-hoc subgroup comprising roughly two-thirds of participants showed a 20-meter placebo-adjusted improvement, even as the remaining third derived little benefit.

CEO Faheem Hasnain told STAT he sees a "reasonable chance for approval."

health tech

AI petition tests FDA's bent toward deregulation

An Australian AI developer, Harrison.ai, is asking the FDA to let companies with existing clearances in certain radiology categories roll out new imaging algorithms without premarket review — effectively swapping early regulatory scrutiny for post-market monitoring. If the agency doesn't deny the petition by mid-April, it could take effect automatically, STAT's Mario Aguilar and Katie Palmer write.

The proposal, which would touch more than 200 cleared devices, comes as the FDA signals greater comfort with a "commonsense" AI framework emphasizing real-world surveillance. Notably, a former Harrison.ai subsidiary executive now leads the agency's digital health policy arm.

The argument at play: Some say the current 510(k) churn is stifling innovation and patient access. But post-market oversight is currently quite weak, and the concern is that exempting higher-risk tools like computer-aided diagnosis could create regulatory blind spots.

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