Genmab to acquire Merus for $8 billion

The Danish company Genmab said this morning that it planned to buy Merus, the maker of a promising head and neck cancer drug, in a deal worth roughly $8 billion. Genmab will pay $97 per share in cash for Merus, a 41% premium over the latter's closing price on Friday.

Merus reported in May that its experimental drug petosemtamab, when used with the checkpoint inhibitor Keytruda, showed a preliminary survival benefit in a Phase 2 trial in patients with metastatic head and neck cancer. The Dutch biotech has been enrolling patients in Phase 3 trials that could prove the drug's efficacy

Genmab said it could potentially launch petosemtamab in 2027, pending clinical results and regulatory approvals.

Read more from my colleague Andrew Joseph.

Pharma

GSK names a new CEO

It is Luke Miels, currently the U.K. pharma giant's chief commercial officer, who will take over as CEO on Jan. 1. He is replacing Emma Walmsley, who has led the company since 2017.

Walmsley's tenure included the spinoff of GSK's consumer health care business into a new firm called Haleon and focusing the company on innovative medicines that could fuel its growth, specifically specialty drugs and certain vaccines.

The company said that Miels had been "instrumental" in growing GSK's specialty medicines portfolio, including the respiratory and oncology drugs that it's been prioritizing.

Read more from, again, STAT's Andrew Joseph.

adam's take

MoonLake's drug candidate fails in Phase 3 trials

MoonLake Immunotherapeutics suffered a crushing blow yesterday as its only drug candidate, sonelokimab, failed twin Phase 3 trials in the inflammatory skin condition hidradenitis suppurativa. While one study technically beat placebo by 17 percentage points, it fell short of the 23-point margin needed to compete with an approved antibody called Bimzelx from Belgium-based UCB.

A second trial was worse, STAT's Adam Feuerstein notes, showing that MoonLake's previous attempts to spin the data — including pooling results and blaming "intercurrent events" — now only highlight the drug's weakness.

With its $4 billion valuation built on shaky hype, MoonLake's stock price is plunging in early Monday trading.

drug pricing

Firms scramble as Trump's drug pricing deadline hits

Today is the deadline for pharmaceutical companies to respond to President Trump's demand that U.S. drug prices match those in other advanced economies, or "most-favored nations." While a number of companies have made last-minute announcements that appear designed to curry Trump's favor, they seem to have have fallen short, STAT's Elaine Chen and Daniel Payne write.

Some firms, including AstraZeneca and Bristol Myers Squibb, have rolled out new direct-to-consumer sales models and U.S. manufacturing investments. Others have pledged to raise prices overseas to narrow the gap with the U.S. But a White House officials suggested such steps may not be enough.

Industry executives and investors remain on edge as the White House signals it may pursue regulatory action if voluntary moves don't deliver.

"The tariffs are, I think, becoming less of a headwind just because of ways to navigate around it," said Mizuho analyst Jared Holz said, pointing to the announcements that pharma companies have already made to invest in U.S. manufacturing. However, the most-favored nation policy "is a little bit more important as far as investors look at it, because we still don't know mechanistically how it's going to work."

OPINION

FDA PreCheck aims to speed U.S. drug manufacturing

The Trump administration's new FDA PreCheck program, which was unveiled Aug. 7 and which will be the subject of an public agency meeting on Tuesday, promises to streamline U.S. drug manufacturing by fostering earlier, more frequent engagement between regulators and industry. The hope is that the initiative could shave up to a year off the four- to five-year timeline to build new pharmaceutical facilities by coordinating reviews, inspections, and permitting.

Two executives at Eli Lilly, which recently announced it would spend more than $11 billion on new U.S. plants, opine for STAT that PreCheck could accelerate patient access to medicines, strengthen the domestic supply chain, and reinforce America's global leadership in drug innovation — if paired with broader regulatory reforms and alignment across federal and local agencies.

"Acceleration is the theme of this moment," they write. "This is not simply about responding to current challenges but about seizing a once-in-a-generation opportunity to propel American innovation forward."