Xanomeline Tartrate/Trospium Chloride

Bristol Myers Squibb’s CEO Chris Boerner, Ph.D., described the company's discussions with the Trump administration as “frequent and, while not always fully aligned, they’re always constructive and thought-provoking on both sides.” Bristol Myers Squibb’s highly anticipated Cobenfy just finished its first trip around the sun as an approved drug, posting results in line with expectations that leave investors wondering when an inflection point might arrive.Approved by the FDA to treat schizophrenia in September 2024 and officially launched the following month, Cobenfy generated third-quarter sales of $43 million, compared with $35 million in the second quarter. The quarterly number largely met Wall Street’s expectations of $44 million, according to Citi.Cobenfy’s performance looks relatively underwhelming compared to the company’s overall 3% revenue beat, driven by above-consensus sales from several other new medicines, such as anemia drug Reblozyl and CAR-T therapy Breyanzi.During BMS’s earnings call Thursday, CEO Chris Boerner, Ph.D., described Cobenfy as “delivering steady growth.” But the first-in-class drug still has a long way to go to fulfill its promise as a potential multibillion-dollar product.“We’re establishing a new treatment paradigm in what we knew was going to be a highly entrenched market,” Adam Lenkowsky, chief commercialization officer of BMS, said on the call.Cobenfy is entering a disease field where dopamine D2 receptor antagonists have been the mainstay of treatment for three decades. The new med’s progress is tracking ahead of all recently launched analogs in schizophrenia, Lenkowsky said, as the drug has surpassed 2,400 weekly total scripts.“There’s clearly more work to do,” the BMS exec acknowledged. “In year two, we need to continue to increase both breadth and depth of prescribing […] We’ve onboarded our expanded field force now in the community and in the hospital setting.”BMS is working hard to get more doctors to try out Cobenfy. To help build physician confidence, the company is resorting to peer education for new prescribers, introducing real-world data and running a phase 4 study to address the key question of how to switch from a D2 drug to Cobenfy.“Based on the leading indicators that we’re seeing, Cobenfy is going to deliver continued, steady growth in schizophrenia, and longer-term growth is going to be fueled by additional indications,” Lenkowsky said, adding that “we are confident that Cobenfy will be a big drug over time.”But as one analyst pointed out on Thursday’s call, investors have grown nervous around a key potential Cobenfy expansion opportunity in Alzheimer’s disease psychosis following some recent management comments. During the company’s second-quarter earnings call in July, BMS’ then-chief medical officer Samit Hirawat, M.D., mentioned that as part of a bigger project to improve success for all BMS clinical programs, the New Jersey pharma was conducting clinical trial site reviews of the Adept-2 trial, which is slated to read out this year as the first of three Cobenfy phase 3 studies in Alzheimer’s disease psychosis. BMS has said it’ll need positive readouts from two of the three trials to be able to file with the FDA.“I wouldn’t read too much into it, other than to say that there’s a lot of focus on us being able to deliver on each of the stages of our strategy,” Boerner said Thursday.“If I step back from the specific studies, remember the work that we’re doing in development fits with the focus that we have on execution, really across the company,” the CEO added. “And given the importance of the late-stage studies, I think it’s prudent that we take whatever learnings we can and pull whatever appropriate levers we can to ensure that we deliver these studies with the highest [probability of technical success] and on time.”Hirawat was recently succeeded by Cristian Massacesi, M.D., who came over from AstraZeneca. On Thursday’s call, Massacesi said that the Cobenfy development program is “progressing really at a rapid pace.” The new CMO counted 14 studies that are either ongoing or in the process of being activated, including 10 pivotal studies. Zooming out of specific products, Boerner highlighted a “very dynamic” policy environment inside and outside the U.S. Three Big Pharma companies—Pfizer, AZ and Merck KGaA’s EMD Serono—have signed “most favored nation” drug pricing deals with the Trump administration.Pfizer’s deal was announced Sept. 30, and since EMD Serono struck the third pact Oct. 16, no new agreement with the U.S. government has emerged.“We continue to actively engage with the administration,” Boerner said. “I would characterize those discussions as frequent and, while not always fully aligned, they’re always constructive and thought-provoking on both sides.”“We agree with the President on the need for equalization of prices,” he continued. “U.S. prices need to come down. We’re sharing ideas to do that. Ex-U.S. prices need to come up. We’ve seen some good progress—for example, in the U.K.—but more needs to be done. And accomplishing those objectives while preserving the ecosystem for innovation that we have in the U.S. is what we’re focused on.”

Bristol Myers Squibb didn’t reveal anything earth-shattering in its third-quarter earnings report on Thursday, but rather a handful of smaller updates on its pipeline and negotiations with the Trump administration. And analysts appeared most interested in an upcoming readout for Cobenfy in Alzheimer’s disease psychosis — expected before the end of the year — and expressed a growing level of anxiety. Earlier this year, Cobenfy failed a Phase 3 study as an adjunctive treatment for schizophrenia, and former CMO Samit Hirawat last quarter said the company would be conducting trial site reviews for the upcoming psychosis data. On Thursday’s call, CEO Chris Boerner tried to assuage concerns, reiterating that the data are on track for the end of 2025. When asked, he declined to provide specifics on why the data haven’t come out yet and whether or not Bristol Myers is seeing any irregularities at the trial sites under review. “We obviously understand there’s a lot of focus on individual programs, including the ones that are going to be reading out most near-term,” Boerner said. “So I wouldn’t read too much into it, other than to say that there’s a lot of focus on us being able to deliver on each of the stages of our strategy.” Although Cobenfy was approved for schizophrenia last year, Bristol Myers is hoping to expand its label to a number of Alzheimer’s-adjacent indications, including psychosis, agitation and cognition. In addition to this year’s readout, BMS is expecting two other Alzheimer’s psychosis trials to have data next year. The company has said two of the three studies need to be positive in order to seek approval. Executives have previously portrayed these as key to growing Cobenfy into a megablockbuster. BMS is also studying Cobenfy in multiple bipolar disorder settings. Bristol Myers also revealed a number of new trials where it would be testing its PD-1xVEGF bispecific pumitamig. Working with BioNTech, the companies are launching studies in triple-negative breast cancer, colorectal cancer and gastric cancer. Notably, the colorectal cancer study is in the microsatellite-stable setting, an area where industry experts have thought bispecifics could make a big impact and where PD-1 checkpoint inhibitors previously proved ineffective. Chief commercialization officer Adam Lenkowsky said the company’s strategy is to be the “first or second” bispecific approved. Bristol Myers’ main competition is Summit Therapeutics, which earlier this month announced its first trial outside lung cancer — and also in microsatellite-stable colorectal cancer. “Our focus is on speed to market,” Lenkowsky said. “We feel very good about combining our industry-leading commercial and operational capabilities with BioNTech’s scientific expertise. We plan to maximize the potential of this asset.” Here’s the full outline for BMS’ pumitamig studies, all of which are in the first-line setting: Also during Thursday’s Q&A with analysts, Boerner provided perhaps the most in-depth commentary so far on how negotiations with the Trump administration are going. Boerner said that while BMS and the administration don’t agree on every minute detail, the conversations have been constructive and frequent on issues like most favored nation pricing. “While not always fully aligned, they’re always constructive and thought-provoking on both sides,” Boerner said. “Clearly, MFN and tariffs are front and center, but we continue to monitor a host of other issues, including the shutdown and what potential impact that could have downstream. “All of that for us, though, is that we agree with the president on the need for equalization of prices. US prices need to come down,” he continued. “Ex-US prices need to come up. We’ve seen some good progress, for example, in the UK. But more needs to be done. And accomplishing those objectives while preserving the ecosystem for innovation that we have in the US is what we’re focused on. “So there’s a lot going on. It’s manageable.”