Madrigal Pharmaceuticals, Inc.

These days, if you ask the CEO of Roivant if he’s open to selling another late-stage drug to a larger company, he refers you to a spoof video clip. It’s the scene from “Toy Story” where the alien toys are watching the arcade claw descend upon them, and Woody and Buzz Lightyear are trying to escape the machine. In the video, the aliens are labeled as biotechs ripe for a buyout, the claw is big pharma and Woody is Roivant. Matt Gline’s point? Roivant isn’t begging for a buyer. “Building businesses sitting around waiting for some other mercurial master to come around and decide whether you’re good enough for their appeal or not is, in addition to being a bad way to build businesses, it’s just boring,” the CEO said in an interview at the company’s Manhattan headquarters. Roivant, of course, has gladly succumbed to the claw in the past, to its benefit. Roche snapped up the company’s anti-TL1A antibody for more than $7 billion in 2023 and Organon bought Dermavant for effectively $250 million plus $950 million in additional potential milestones. This time around, the potentially prized product is brepocitinib, an oral dual JAK-TYK2 inhibitor that is expecting its first approval this year to treat a rare, autoimmune condition called dermatomyositis. Gline acknowledged it’s his responsibility to take any meeting from an interested party, but he thinks Roivant can and should take it alone. About 40,000 to 70,000 patients in the US would be eligible for treatment if the FDA approves brepocitinib later this year. Two other autoimmune indications in development, if clinically successful, would open the door to almost 100,000 additional patients, according to Roivant’s latest earnings presentation . Gline called brepocitinib “the cleanest shot on goal we’ve ever had.” His confidence in Roivant commercializing the drug on its own can be attributed to the success of other biotechs in orphan markets that didn’t first find a large pharma buyer. At an investor conference earlier this week, Gline cited Horizon, Madrigal, Verona, Insmed, BridgeBio and argenx as companies that have laid the groundwork. One of their strategies, called a bridge program, is effectively giving patients the drug at no cost so long as they and their doctor commit to pulling every lever to obtain insurance coverage. The belief is that patients will be more willing to fight the claims denial process if they’re able to access the treatment. “These payers are really trying to make sure you’re arriving at the right answer for the patient, and they’re willing to make you do a ton of work to show it,” Gline said. Gline has emphatically brushed off business development as Roivant’s only pathway to increasing value. The existing pipeline, he says, holds plenty of potential. “The path for us to get from where we are to even two to three times our current value, we only need the stuff we’ve got,” Gline said, citing sell-side analysts’ consensus on sales for brepocitinib and two other clinical-stage programs in mid- to late-stage development. Roivant currently has more than $4.5 billion in cash and equivalents. And that was before a recent settlement with Moderna that netted at least $950 million (though a good chunk will go to Arbutus). Even more could come if Roivant and Arbutus reach a similar settlement with Pfizer, though Gline declined to comment on pending litigation. The healthy cash total, which includes no debt on the balance sheet, would suggest that Roivant could actually be a buyer of assets, not a seller. But again, referring to the pipeline, Gline said “the ‘do we need to grow?’ question is a little bit obviated.” “If we are successful at everything, if we are a $55 billion company with good commercial launches in two and a half, three years, everyone will be asking, OK, how do you get from 55 to 100 [billion dollars],” he said. “Somebody will say to me, ‘You’re the claw now.’” Editor’s note: This story was updated to correct that Roivant’s settlement with Moderna was at least $950 million, not $900 million.

iStock, Pikovit44 Servier will pick up Ojemda, which received FDA approval in 2024 to treat pediatric glioma. The drug clocked sales of $155 million for Day One Biopharmaceuticals in 2025. France’s Servier is spending $2.5 billion to acquire Day One Biopharmaceuticals, a commercial-stage oncology company that launched six years ago with a goal of filling treatment gaps for adults and children. The deal will support Servier’s 2030 goal to target high unmet needs in oncology, with Day One’s programs spanning all clinical stages. In particular, Servier will pick up Ojemda, which received FDA approval in 2024 to treat pediatric glioma. The drug clocked sales of $155.4 million in 2025, according to the biotech’s February earnings call . The pharma has offered $21.50 per share in cash, which represents a total equity value of $2.5 billion, according to the Friday release . After the deal announcement, Day One’s shares spiked 65% to $21.14 on Friday morning. Around since the 1950s, Servier has three focus areas: oncology, neurology and cardiometabolic. The company’s cancer portfolio includes chemotherapy drugs as well as targeted therapies for blood cancers and solid tumors. Voranigo was also approved by the FDA in 2024 for glioma in pediatric and adult patients with a IDH1 or IDH2 mutation. Drug Development 100 Dedicated Employees Answer the Clarion Call for Kids’ Cancer Drugs Day One Biopharmaceuticals aims to provide a business solution to a moral problem: the inequity in pediatric oncology drug development. August 31, 2022 · 7 min read · Heather McKenzie Read more “Servier’s successful track record in rare cancers and its commitment to advancing targeted therapies makes it the ideal home for our portfolio as part of Day One’s mission to bring medicines to patients of all ages with life threatening diseases,” Day One CEO Jeremy Bender said in a statement. Day One launched in May 2020 with a $60 million series A. While the company’s broad remit is to create cancer therapies for people of all ages , the company has focused on tackling tough questions in pediatric oncology. The biotech was built around a program acquired from Takeda that eventually became Ojemda. After becoming a commercial company in 2024, Day One struck a deal to acquire Mersana Therapeutics for up to $285 million in November 2025. This brought in a pipeline of antibody-drug conjugates (ADCs) focused on adult patients with rare cancers. At the heart of the deal was emiltatug ledadotin (Emi-Le), for which updated Phase 1 data in adenoid cystic carcinoma are expected in the middle of this year. Regulatory 5 Companies That Celebrated First Approvals in 2024 Madrigal Pharmaceuticals, X4 Pharmaceuticals and Day One Biopharmaceuticals secured their maiden approvals this year in metabolic dysfunction-associated steatohepatitis, WHIM syndrome and pediatric low-grade glioma. Geron Corporation and ImmunityBio also notched wins. December 23, 2024 · 6 min read · Heather McKenzie Read more

“Midsize biotechs are the lifeline to make sure we maintain being the world leader in healthcare innovation,” says Midsized Biotech Alliance of America spokesperson Alanna Temme. \n In an effort to battle against what members feel is an existential threat to their businesses, a group of 10 domestic biotech companies has launched the Midsized Biotech Alliance of America (MBAA) with a focus on contesting the Trump administration’s most-favored-nation (MFN) drug pricing policy.MBAA members, which consist of companies like Acadia Pharmaceuticals, Madrigal Pharmaceuticals and Travere Therapeutics, feel vulnerable to MFN, which seeks to lower U.S. drug prices by aligning them with the lowest prices paid by comparable nations. The midsized members are fearful if MFN targets their drugs, the resulting loss in profits could spell the end of their enterprises.“MFN would destroy biotech innovation in this country,” MBAA spokesperson Alanna Temme told Fierce Biotech. Temme is also the founder of healthcare advisory firm LMH Strategic Solutions. Introduced in May 2025 by way of executive order, President Donald Trump\'s MFN push has so far secured drug pricing pledges from more than a dozen of the world\'s biggest pharmaceutical companies, with those drugmakers often winning immunity from the administration\'s import tariff threats in the process. While large drugmakers have taken the threat in stride, the pricing policy could introduce more severe implications for smaller-scale biopharmas.The new coalition consists of members that have already invested years in R&D and have marketed products to show for it, but that at the same time, lack the wide commercial portfolios of large-cap pharmas.. MBAA didn\'t share specific criteria for inclusion, but other members include Alkermes, Alnylam, Ardelyx, BioMarin, Exelixis, Incyte and Neurocrine Biosciences.Temme explained that midsize biotechs often target unmet needs and have significant risk capital requirements and that their limited reach makes them particularly vulnerable to MFN policies. According to the MBAA, its member companies represent $7 billion in annual U.S. R&D investment, employ 12,000 people and have brought 30 therapies to market, with nearly 100 more in the pipeline.But the road to profitability is a slow one. The organization says it takes an average of 25 years for its members to turn a profit on their drug candidates. R&D costs, multi-phased clinical trials, attaining market share and scaling manufacturing all factor into the extended timeline that it typically takes to get out of the red.With long timelines and narrow windows for success, Temme didn’t mince words when discussing the logical impacts of MFN on medium-sized biotechs: “MFN could wipe them off the map,” she said. MFN carries a higher risk for midsize American biopharma jobs and organizations than smaller biotechs and larger pharmas, Temme explained. Smaller startups are years away from having to worry about profit loss from the MFN policy, while Big Pharma companies can make up for lower prices on some drugs by making more on others. But midsize biotechs don’t have that kind of flexibility, Temme said. Often boasting just one marketed product, members felt they needed more protection and formed the MBAA to advocate for themselves. With PhRMA representing larger organizations and BIO undertaking advocacy for the industry at large, the MBAA aims to fill that midsized advocacy gap.The MBAA aims to educate the public and policymakers and encourage a free-market solution to drug development, Temme says. Members believe MFN is a destructive policy, but their efforts have been hampered by industry giants like AstraZeneca, Eli Lilly, Novo Nordisk and Pfizer signing MFN agreements with the Trump administration in recent months. While individual pharma companies haven’t been too publicly negative about MFN, the MBAA’s arguments against the policy echo those shared by the Coalition Opposing the Codification of Most-Favored-Nation Prescription Drug Pricing, which released a letter earlier this month warning that the policy would hamper innovation and American competitiveness. “MFN would reduce access to new cures and reduce U.S. global competitiveness, ceding ground to China,” the coalition wrote.The division between the companies that have signed MFN deals and MBAA members will make the organization’s advocacy efforts more difficult and damage the overall industry, Temme said.“One size does not fit all,” MBAA spokesperson Alanna Temme explained. “Midsize biotechs can’t survive a change like that. MFN has fractured the industry, which is never good.”The MBAA’s fears may already be coming to fruition. Though analysts have said the MFN order is more bark than bite and subject to future legal challenges, American biotechs have become increasingly wary of licensing products to European partners, fearing they may run afoul of MFN. While the group is “laser-focused on MFN,” Temme also noted the impact that MBAA members and their peers have on American industry at large. Calling the midsized biotechs “the heart of American innovation,” she said safeguarding a strong U.S. biotech ecosystem could help bolster an industry that has seen turmoil domestically, while China continues its strong biotech growth and Europe reprioritizes to make itself more competitive. “Midsize biotechs are the lifeline to make sure we maintain being the world leader in healthcare innovation,” Temme says.