Lumateperone Tosylate

Dive Brief:Johnson & Johnson on Wednesday reported modestly higher-than-expected earnings for the fourth quarter, while cautioning that unfavorable currency exchange rates would temper sales growth this year.Adjusted earnings per share reached $2.04 in the fourth quarter, higher than the Wall Street consensus of $2.01 and Leerink Partners estimate of $1.96, Leerink analyst David Risinger wrote in a note to clients. The companys sales rose 5.3% to $22.5 billion during the quarter, in line with estimatesFull-year 2024 revenue increased to $88.8 billion from $85.2 billion in 2023. For this year, J&J expects revenue to climb to between $89.2 billion and $90 billion, with a mid-point of $89.6 billion, less than the consensus estimate of $91.1 billion. Shares of the company dropped about 3% in early trading Wednesday, even as the overall market rose.Dive Insight:CEO Joaquin Duato is looking to newer medicines to drive J&Js sales growth as the company fights through generic competition for its second-best selling drug, Stelara. Worldwide sales of Stelara dropped 15% to $2.3 billion in the fourth quarter, with most of the decline coming from overseas, where copycat competition already has a toehold. In the U.S., Amgen recently launched the first biosimilar of Stelara and more are on the way.Even so, J&J is poised for sustained growth through this decade, Duato said. I cannot think of any other company that would be able to deliver growth through the first year of losing exclusivity of a multibillion-dollar product, Duato told analysts on a conference call.That growth will depend in large part on the continued success of the companys cancer medicines, led by Darzalex. Sales of the drug jumped 21% to $3.1 billion in the fourth quarter. At the same time, J&Js Carvykti, a CAR-T treatment for multiple myeloma, came close to breaking $1 billion in sales for the year. J&J will also be looking for growth from newer medicines including Tecvayli and Talvey.Outside of oncology, J&Js depression treatment Spravato brought in sales of $1.1 billion for the year, a 56% increase from the previous year. And the drug will benefit in 2025 from an expanded Food and Drug Administration approval in people with treatment-resistant depression.J&J also plans to expand its psychiatric offerings with the $14.6 billion acquisition of Intra-Cellular Therapies announced last week. Intra-Cellular sells a drug called Caplyta for schizophrenia and bipolar disorder and is looking to expand its use for patients with major depressive disorder. '

Welcome back to the new and improved Endpoints Weekly! This week we’ll be recapping the JP Morgan Healthcare Conference, IRA price negotiations, Pfizer’s plans to get back on track, and more. Thanks to everyone who attended our JPM events in San Francisco this week, and we hope everyone had safe flights back to wherever you call home. Now to dive into the week’s biggest stories. JPM kicked off with an M&A bang, with three of the biggest biopharma companies — J&J, GSK and Eli Lilly — all swooping in with buyouts on Monday morning. As the week progressed, Lilly continued to make headlines in lowering its revenue guidance, and Moderna again disappointed Wall Street in announcing yet another round of cost cuts. We wrapped up the week with the news that the Biden administration selected semaglutide (Ozempic, Wegovy, Rybelsus) to be on the next list of drugs selected for Medicare negotiations. We’ll have more below on what this means for President-elect Donald Trump and his pick to lead CMS, Mehmet Oz. A quick programming note before we jump to the headlines: we’re off for MLK Day on Monday, but will return to your inboxes on Tuesday morning at the usual time. We wish you all a relaxing long weekend! — Max Gelman 🤝 An M&A Monday for the books. J&J took home the crown for biggest buyout at JPM, snapping up Intra-Cellular Therapies and its depression and schizophrenia drug Caplyta for $14.6 billion. Meanwhile, Lilly nabbed cancer drug startup Scorpion Therapeutics in an up to $2.5 billion bolt-on, buying a company that shares the same founder as Loxo. Finally, GSK kicked things off with an overnight acquisition of IDRx for up to $1.15 billion, adding its rare cancer drug to the “careful” momentum it’s aiming to build. And this all happened before 7 a.m. Monday in California! Why did J&J pay so much money? The opportunity comes as psychiatry is making a comeback at the top of the industry: the deal comes in the backdrop of Bristol Myers Squibb’s $14 billion buyout of Karuna, which led to a recent historic approval in schizophrenia, and AbbVie’s $8.7 billion takeout of Cerevel (though that deal has, effectively, already imploded). J&J projects Caplyta as a potential $5 billion-per-year drug, and it also gets a suite of other pipeline programs for other psychiatric and neurodegenerative conditions. What about Lilly and GSK? For Lilly, it continues the ongoing bolt-on strategy seen under chief scientific officer Dan Skovronsky with a face it’s familiar with in founder Keith Flaherty. Scorpion’s lead program, for which it released new data at ESMO last year, comes in a space dominated by Novartis and Roche. Meanwhile, GSK execs likened their buyout of IDRx to the 2022 acquisition of Sierra Oncology, finding an area with approved drugs that it can build upon and offer new options with different tumor mutations. Do these deals brighten the morose M&A sentiment? Well, it’s probably too early to say. A lackluster dealmaking environment has left the industry anxious for more in 2025, and the Intra-Cellular buyout did come at a decent size. But as founding editor John Carroll writes in his column from JPM, there’s still a lot left unsettled . 💊What else is on the list? GSK’s Trelegy Ellipta and Breo Ellipta inhalers, Pfizer and Astellas’ cancer drug Xtandi, and Teva’s Austedo treatment for movement disorders have also been selected to participate in negotiations, among others. Together, the 15 drugs cost Medicare Part D about $41 billion from November 2023 through October 2024, according to HHS. Wegovy and Rybelsus were notably included on the list, as they share the same active molecule as Ozempic. Some drugmakers — including Teva — have criticized guidance that allows CMS to group drugs together, arguing that it deviates from the statute. What comes next? Drugmakers have until the end of February to decide if they are participating in negotiations. The negotiation process is set to end Nov. 1, and negotiated prices will take effect on Jan. 1, 2027. How will the change of administration affect negotiations? Senior Biden officials said Thursday that core parts of the negotiation process are established by law, including much of the timeline. But there could be some changes to the government’s tactics, including “the degree to which they play hardball with manufacturers,” according to Anna Kaltenboeck, who co-authored the IRA’s drug-negotiation section. Read more here . 🔽Moderna cut its 2025 revenue estimate by $1 billion this week and said it would expand and accelerate cost-cutting measures. Executives say they expect $1.5 billion to $2.5 billion in 2025 sales, down from the company’s September projections of $2.5 billion to $3.5 billion. Moderna had previously laid out plans to reduce annual spending on R&D by $1.1 billion by 2027. But now the company plans to cut costs across a range of areas by $1 billion in 2025, plus an additional $500 million in 2026. Meanwhile, Eli Lilly said it expects to miss its revenue estimate for 2024 by about $400 million. Executives are saying the actual figure will be around $45 billion, which is below the low end of its third-quarter projection. The company predicts 2025 sales will come in between $58 billion and $61 billion. 🚂Pfizer has brought on two new board members and promoted cancer scientist Chris Boshoff to run R&D. “There is no one like the Pfizer machine in getting things done,” Bourla told journalists. The company highlighted its focus on four therapeutic categories for R&D: cancer, vaccines, internal medicine, and inflammation and immunology. Will it be enough to keep Starboard Value at bay? Bourla suggested he wants to work with the activist investor, adding that he’s in “constant contact” with them. Jaimy Lee has the details . 👨‍⚖️The lawsuit is under seal, given Delaware’s chancery court rules. But in a separate, public filing, Sage said it’s seeking an injunction against its largest shareholder “to enforce a standstill agreement and a trial on a paper record on an expedited basis.” Last week, Biogen offered to buy Sage for $469 million and, unusually, had to disclose the offer because it’s the biotech’s largest shareholder. Read more here from Max Bayer. DON’T MISS