In this week’s edition of InnovationRx, we look at the battle for Metsera, the departure of FDA’s top drug regulator, Kimberly-Clark’s $40 billion Kenvue deal, and more. To get it in your inbox, subscribe here.
The battle between Novo Nordisk and Pfizer over Metsera, a three-year-old company working on treatments for obesity and diabetes, escalated this week.
Last Thursday, Novo Nordisk made an unsolicited bid for Metsera valued at up to $9 billion–nearly 25% higher than Pfizer’s earlier bid for the company, valued at up to $7.3 billion.
A legal battle commenced on Friday, with Pfizer suing both companies in an effort to block the deal. On Monday, Pfizer filed a second lawsuit alleging that the Novo bid is anticompetitive. Metsera issued a statement calling Pfizer’s arguments “nonsense. Then, on Tuesday, just hours before a court hearing on a temporary restraining order, Novo increased its bid to as much as $10 billion. Pfizer, meanwhile, had upped its own bid to as much as $8.1 billion.
The fight shows just how cutthroat the booming market for popular weight loss drugs has become. Metsera’s stock is up 40% since the deal was announced, and 187% year-to-date. Pfizer does not have any weight loss drugs in its portfolio after abandoning one potential medication last April over safety concerns, and has wanted to get them. Novo’s bid is substantially higher, but Pfizer may be able to play the Trump card because it is a U.S. company while Novo is not, as Reuters reported last week.
Metsera doesn’t have any drugs on the market yet, but its lead candidate is in phase 2 clinical trials and its pipeline spans seven other drugs beyond that. Only a handful of other companies, including Kailera (which we profiled earlier this year) and Viking Therapeutics have drug candidates this close to approval that Big Pharma could plug into their pipelines. Leerink Partners analyst David Risinger has projected that the drugs in Metsera’s pipeline could top more than $5 billion in combined peak sales.
However it plays out, the biggest winners may be investors Arch Venture Partners and Population Health Partners, which founded the company in 2022. Metsera CEO Whit Bernard is among those investors: He cofounded Population Health after working as an executive at The Medicines Co., which was acquired by Novartis for $9.7 billion in January 2022. Arch, led by Midas Lister Bob Nelsen, and Population Health organization Validae Health (whose sole general partner is Population Health Partners GP) own a combined stake of 37.7%, according to its latest 10-K securities filing.
Trump Spurs SNAP Confusion, Saying The Government Won’t Pay Recipients, Despite The Court Order
President Donald Trump said the federal government would withhold Supplemental Nutrition Assistance Program funding from recipients for the duration of the shutdown, contradicting statements from his administration that it would make half of November’s payments.The USDA stopped distributing SNAP funding to states on November 1. A group of 25 states, plus Washington, D.C., filed lawsuits, arguing it was illegal for the federal government not to pay SNAP recipients and demanding the USDA continue making the payments. Two judges, one in the district court of Massachusetts and the other in the district court of Rhode Island ruled Friday that the agency should do so.
The USDA said Monday that it would only partially fund November payments after refusing to tap the $5 billion contingency fund to distribute the benefits in full. The plaintiffs in the case before the district court of Rhode Island have asked the judge to require the Trump administration to provide the funding in full. A hearing will be held Thursday.
Around 42 million Americans rely on SNAP to cover at least part of their food budget every month, including about 25% of the nation’s children. Cutting all or part of those benefits risks harming the health of the people who rely on them, according to experts. People with chronic conditions such as diabetes, which need to be managed with specific diets, are most at risk.
The FDA’s Top Drug Regulator Is Out
George Tidmarsh, the FDA’s top drug regulator, resigned over the weekend after an explosive lawsuit from Aurinia Pharmaceuticals accused him of abusing his position to carry out a “personal vendetta.” Tidmarsh had been in the role less than four months.
His departure comes as the agency is already reeling from Trump’s staff cuts, which have culled more than 20% of workers and well over half of senior leadership, as well as pressure from the Administration on the agency’s scientific evaluations. Tidmarsh told The New York Times that his ouster may have been related to concerns he raised over the legality of proposed changes to the FDA’s regulatory process.
Deal of the Week
Kimberly-Clark agreed to buy Kenvue, the embattled maker of Tylenol and other consumer health brands, for more than $40 billion in cash and stock. The deal—one of the largest this year—will create a consumer health giant with brands that include Kimberly-Clark’s Huggies and Kleenex and Kenvue’s Band-Aid and Tylenol. The acquisition came together despite the litigation risk for two of Kenvue’s brands.
Kenvue has been in President Trump’s crosshairs because of unfounded claims linking acetaminophen, the active ingredient in Tylenol, with increased risk of autism during pregnancy. Texas sued Kenvue in October alleging that the company had deceived mothers about the risks of autism. Kenvue is fighting the claims, citing “the perpetuation of misinformation” about acetaminophen’s safety. The company also faces a lawsuit in the U.K. over allegations that talc in its Johnson’s Baby Powder caused cancer. The company denied the claims, but its liability costs are an open question. Kenvue now uses cornstarch instead of talc in the powder.
It’s unclear how Kimberly-Clark accounted for the litigation risk in pricing the deal. Kenvue’s shares have fallen some 35% since it was spun out of Johnson & Johnson in May 2023. Kenvue’s $15 billion (2024 sales) portfolio includes Listerine mouthwash, Aveeno skincare and Motrin pain relief.
WHAT WE’RE READING
Stat goes inside Moderna’s fall, detailing the missteps and misfortunes that have caused its market cap to plummet more than 90% from its peak.
Sarepta Therapeutics’ confirmatory trials for its Duchenne muscular dystrophy drug failed, but the company plans to seek FDA approval anyway, arguing the study showed “encouraging trends.”
Trump is negotiating a deal with Novo Nordisk and Eli Lilly to sell the lowest doses of their weight loss drugs for $149 a month on TrumpRx–and to give them Medicare and Medicaid coverage for those GLP-1s for weight loss.
A shuttered factory in Louisiana that used to manufacture generic drugs, shows how hard reviving that manufacturing in the U.S. will be.
MIT researchers developed a patch that can be applied to the heart after a heart attack to deliver drugs–and regenerate tissue.
The Trump Administration ordered state Medicaid programs to investigate whether certain recipients are undocumented.
Recursion founder Chris Gibson out as CEO after 12 years as the company repositions its efforts to use AI in drug discovery.
