Asundexian

Following a spate of large-scale pharma investments in the U.S. last year, German conglomerate Bayer is advancing its own plans to expand in America, in a move the company is framing as the culmination of a multi-year strategy, rather than an acute policy response. Bayer has selected New Albany, Ohio, as the location where it will invest $2.2 billion to stand up a new high-tech manufacturing site. The “flexible” and “modular” campus is expected to come online in stages, with a drug substance module slated to open in 2031 and a second for drug product manufacturing planned to debut in 2034. Work will initially center on the production of oncology, cardiovascular and renal products, the company said in an Oct. 2 release, adding that the site will be equipped with digital and automation technologies. The project, which is expected to create some 1,500 construction jobs during the build-out process, will eventually open up 600 new full-time roles at the site in the New Albany International Business Park once complete. The outlay comes “against the backdrop of a very deliberate and strategic move to strengthen our presence in the United States,” Sebastian Guth, global chief operating officer for Bayer Pharmaceuticals and president of Bayer U.S., said in an interview. He pointed out that this is not a new trajectory for Bayer, which started work to amplify its American operations back in late 2018 and early 2019. It was around that time that Guth came to the States, originally as the president of Bayer’s U.S. business. Guth now holds that title and also oversees Bayer’s global pharma business as COO. Back then, however, sales from the U.S. made up just 20% of the German drugmaker’s pharmaceutical revenues—a number that has subsequently risen to around 35% today, Guth said. Framed another way, when Guth arrived, Bayer was spending less than half-a-billion dollars on local R&D annually, whereas the company is now spending “well above $1.2 billion” on U.S. research and development each year, he said. “Part of that strategy was always to also expand our manufacturing presence in the U.S. commensurate with the growth of our business in the U.S.,” Guth added. “Because at the end, we’re looking at supply chains that must be resilient, and [we] are convinced that there is value in moving our manufacturing capacity, or in having substantial manufacturing capacity close to where our biggest markets are.” Once complete, the site will add to Bayer’s U.S. network, which also includes outposts in Pittsburgh, Berkeley, San Diego and Research Triangle Park in North Carolina. As for how Bayer homed in on Ohio, Guth said that following a “comprehensive vetting process,” the company was especially attracted to New Albany because of a “very strong talent base.” He flagged that the site will be in the vicinity of “seven leading academic centers and universities,” as part of a region rich in companies making investments, both in biopharma and other industries like tech. “We’re looking at a growing and vibrant life science ecosystem that is being built, and we’ve experienced a state that is very committed to growing its presence in our industry, and that attracted us,” Guth added. The company is purchasing some 200 acres for the project and expects to break ground around the middle of next year. Reflecting on Bayer’s growth in recent years, Guth said he feels the drugmaker’s U.S. pharmaceutical business “historically was under-indexed.” “We had out-licensed many of our key products, such as Xarelto, to Johnson & Johnson, and had a relatively—at least for the size of our company—small presence, which we started to scale very substantially,” Guth said. The shift in Bayer’s U.S. positioning, meanwhile, comes courtesy of a doubling down on oncology, and especially prostate cancer, with Guth pointing to the success of the company’s androgen receptor inhibitor, Nubeqa. He also cited a return to the cardiovascular and renal business through such products as Kerendia, plus the strengthening of Bayer’s pre-existing women’s health foothold with new meds like nonhormonal menopause symptoms treatment, Lynkuet . And on the clinical front, the company is buzzing about the opportunity it could have in experimental stroke asset asundexian , an oral FXIa inhibitor. The new $2.2 billion pledge comes on top of some $7 billion that Bayer has spread across R&D and manufacturing in the U.S. over the past five years, Guth added. Overall, he framed the investment as a “testament not only to our strategy to date, but also our conviction as to what’s to come, and clearly the conviction that the best is yet to come.” Bayer did not directly tie its investment plan to the ongoing policy shifts involving tariffs in the U.S. The company is notably absent from the list of 26 drugmakers who’ve struck “most favored nation” deals with the White House, in which companies have swapped drug pricing and investment concessions in exchange for a period of immunity from the Trump administration’s drug import duties. The exact terms of those deals remain murky, and the administration has laid out routes for other companies who haven’t signed MFN deals to blunt the tariff impact , too.

iStock, Afry Harvy BMS is barreling toward a clinical trial readout that an H.C. Wainwright analyst believes could contribute to the return of mergers between mega-cap drugmakers. The collapse of AstraZeneca’s reported merger talks with Bristol Myers Squibb extended the long wait for a deal between two major drugmakers and deprived BMS of one possible solution to growth problems that could be compounded soon if a key upcoming readout does not meet expectations. Analysts saw merging with AstraZeneca as a way for BMS to manage its patent cliff. About 80% of the company’s revenue base will face generic or biosimilar competition by 2031, Raghuram Selvaraju, senior healthcare equity research analyst at H.C. Wainwright & Co., told BioSpace via email. Unless the oral FXIa inhibitor milvexian succeeds in the clinic and offsets lost sales, Selvaraju believes BMS may face challenges that could have implications across the Big Pharma landscape. “We think that consolidation among the weaker large-cap companies is inevitable. If BMS blows up with milvexian, there may be a feeding frenzy once the carnage is over and the dust settles,” Selvaraju said. “Other companies that could be the subject of takeover speculation include the weakest of the traditional large-caps, namely GSK and Pfizer.” M&A No deal between AstraZeneca and BMS, senior source insists: Reuters Reuters has deflated rumors that AstraZeneca and Bristol Myers Squibb are discussing a possible merger, letting the air out of industry-wide speculation over what could have been the largest deal in pharma history. August 5, 2026 · 1 min read · Gabrielle Masson Read more BMS’ binary event Selvaraju sees LIBREXIA AF, a Phase 3 trial of milvexian in atrial fibrillation, as the key readout for BMS’ future, regardless of whether the company delivers positive results elsewhere in its portfolio. BMS expects to report LIBREXIA AF data next year. Milvexian has become a risky prospect, given the previous failure of the LIBREXIA ACS pivotal program for reducing cardiovascular risk and prior setbacks in stroke, Selvaraju said. Bayer’s rival oral FXIa inhibitor, asundexian, also failed to reduce the risk of stroke in atrial fibrillation, leading the German drugmaker to end the trial in 2023. Noting the readthrough from Bayer’s failure, Selvaraju said it is “not totally clear” why there remains “significant faith in milvexian.” In an email to BioSpace , Seamus Fernandez, senior managing director at Guggenheim Securities, put milvexian’s chances of success in the atrial fibrillation trial at 60%. Milvexian has a 70% chance of succeeding in a secondary stroke prevention study, Fernandez said. BMS does not currently have sufficient backup programs to weather the possibility of milvexian failing in Phase 3, Selvaraju said. If milvexian is totally written off, BMS’ share price could fall 40% to 50% from its current levels, the analyst added. “If milvexian fails in atrial fibrillation, that leaves a gaping hole in the portfolio and a revenue base void that could prove impossible to fill, with significant top-line sales attrition likely to occur in 2029 through the early 2030s,” Selvaraju said. BMS reported Eliquis and Opdivo revenues of $8.6 billion and $4.6 billion, respectively, in the first half of 2026. The drugs accounted for more than half of BMS’ sales. Selvaraju predicts the entire Eliquis revenue base could be erased by 2030, reflecting expectations that generics will start to erode sales quickly when the patent expires later this year. The company is working to hold on to a larger share of Opdivo sales for longer. Not only does Opdivo have a couple extra years of exclusivity, going off patent in 2028, but biosimilars typically take longer to win market share than generics. BMS aims to further dull the impact of biosimilars by driving uptake of its subcutaneous product, Opdivo Qvantig. H.C. Wainwright analysts model Opdivo sales falling from about $11 billion in 2027 to less than $5 billion by 2030. Biosimilars “are likely to eat into Opdivo sales relatively quickly,” Selvaraju said, because BMS lacks “a clear life cycle management strategy” and Qvantig will only partly cushion the blow. Selvaraju added that “Opdivo has been getting creamed by Keytruda in the checkpoint inhibitor wars for years.” Life beyond milvexian BMS’ LPA1 antagonist admilparant is widely seen as another important R&D program. The pulmonary fibrosis drug candidate is “probably the most exciting and high-probability prospect” in the company’s clinical pipeline, Selvaraju said. BMS aims to publish Phase 3 data for the asset in idiopathic pulmonary fibrosis this year, with results in progressive pulmonary fibrosis due in 2027. Boehringer Ingelheim’s Jascayd has set the bar in these indications. Selvaraju predicts that BMS can dominate the markets if admilparant matches Jascayd’s “relatively low” efficacy benchmark and meets the “readily achievable” goal of improving on the drug’s safety and tolerability. In that scenario, peak annual sales of admilparant could exceed $3 billion. Fernandez is bullish on the drug candidate, telling investors to “watch the extraordinary launch of Jascayd as a benchmark for just how poorly served the market is.” The Guggenheim analyst sees the U.S. market growing to “well over” $30 billion at peak and values the admilparant opportunity at more than $5 billion. Admilparant could join Camzyos and Breyanzi among BMS’ key commercial products. Heart disease drug Camzyos “has particularly strong long-term sales potential given its first-in-class status and favorable positioning following recent label expansions,” Selvaraju said. The H.C. Wainwright analyst said the cell therapy Breyanzi is an underappreciated asset and an “eminently defensible” franchise. Selvaraju is more downbeat on Cobenfy, the schizophrenia treatment that BMS acquired in its $14 billion takeover of Karuna Therapeutics. Turning Cobenfy into a blockbuster will be challenging, the analyst said, and “label expansion into the elderly Alzheimer’s disease population shall be difficult due to the well-documented side effects of the drug.” BMS’ struggles to grow Cobenfy, sales of which totaled $119 million in the first half of 2026, are dialing up the pressure on the rest of the business. Drug candidates such as lymphoma prospect golcadomide and PD-L1/VEGF-A bispecific antibody pumitamig could take some of the slack. Yet the magnitude of the patent cliff means Selvaraju believes milvexian will be key to securing BMS’ future. Its failure, Selvaraju said, could leave BMS “hanging by a thread.” Neurodegenerative disease BMS’ neuro renaissance was built on back of Celgene mega-merger Well-known for its oncology efforts and making recent headlines for a rumored mega merger with AstraZeneca, Bristol Myers Squibb is also dedicating considerable resources to neurological and psychiatric diseases, with a “continuum of care” mindset. August 31, 2026 · 7 min read · Heather McKenzie Read more