Admilparant

iStock, JHVEPhoto Bristol Myers Squibb beat analyst and consensus estimates for the third quarter with $12.2 billion in sales, but executives on the company’s investor call faced questions about a sluggish uptake for schizophrenia drug Cobenfy as well as a highly anticipated Alzheimer’s psychosis readout for the product. Bristol Myers Squibb exceeded analyst expectations for third quarter earnings, driven largely by its growth portfolio, but all eyes were on recently approved schizophrenia drug Cobenfy, which came in slightly below estimates. On the company’s Q3 call on Thursday, BMS executives emphasized challenges in breaking into the market with a new mechanism—Cobenfy was approved by the FDA in September 2024 as the first novel drug for schizophrenia in 35 years. In its presentation, BMS said the continued focus will be on changing the “deeply ingrained D2 [dopamine] prescribing habits through education.” Cobenfy brought in $43 million for the quarter, falling below William Blair’s estimate of $46 million and consensus estimate of $45 million, according to a Thursday morning note from the firm. The drug has brought in $105 million to date, BMS CFO David Elkins said on the call. Despite this, CEO Chris Boerner struck an optimistic tone. “Cobenfy is delivering steady growth as we continue to receive positive feedback from physicians on key indicators, supporting our expectation that this is a meaningful first indication for Cobenfy,” he said. Beyond schizophrenia, BMS is studying Cobenfy in Alzheimer’s disease—the drug’s initial target in early development—and analysts had speculated that a readout for the Phase III ADEPT-2 trial, which pits Cobenfy against placebo in treating patients with moderate to severe psychosis attributed to the disease, would arrive Thursday along with the Q3 results. “We await updates on the delayed Cobenfy ADEPT-2 Alzheimer’s Disease Psychosis (ADP) trial, which management is scrutinizing due to concerns about trial execution,” Leerink wrote in a note to investors Thursday morning. In June, Leerink analysts said that Alzheimer’s patients are more sensitive to side effects in the digestive system, Fierce Pharma reported at the time. Two other studies of Cobenfy in Alzheimer’s—ADEPT-4 and ADEPT-1 in Alzheimer’s disease psychosis—are expected to read out next year. “We anticipate needing two of these three studies to read out positively to support regulatory approval,” Boerner said. Boerner emphasized that BMS is “entering a data-rich period,” with the pace of pivotal readouts accelerating in 2026. The CEO specifically highlighted readouts for admilparant in idiopathic pulmonary fibrosis, mezigdomide in multiple myeloma and Sotyktu in Sjögren’s disease. Overall, BMS’ growth portfolio performed well, thanks to strong sales from cancer blockbuster Opdivo ($2.5 billion), CAR T therapy Breyanzi ($359 million, up 58% year over year) and Camzyos ($296 million, an increase of 88%), leading to a total of $6.9 billion in revenue for the quarter. This made up more than half of BMS’ total Q3 revenue of $12.2 billion. BMS raised its full year 2025 revenue guidance from $46.5 billion to $47.5 billion to a new range of $47.5 billion to $48 billion. ‘Constructive’ Conversations on MFN As with its peers this earnings season, BMS also faced questions on drug pricing—specifically whether the company is in the process of negotiating an agreement with the White House. “We continue to actively engage with the administration,” Boerner said in response to an analyst’s question. “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,” Boerner continued, echoing peers who have said the same in recent days, including Novartis CEO Vas Narasimhan . “U.S. prices need to come down. We’re sharing ideas to do that. We’ve seen some good progress, for example, in the U.K., but more needs to be done in accomplishing those objectives while preserving the ecosystem for innovation that we have in the U.S.” While Boerner said that Most Favored Nation drug pricing and tariffs are “always front and center,” BMS continues to monitor a host of other issues, including the current federal government shutdown and what potential impact that could have downstream.

German pharma Boehringer Ingelheim has obtained FDA approval for its disease-modifying therapy, Jascayd (nerandomalist) in IPF, making it the first treatment to be approved in this indication in more than a decade. Image credit: Fagreia via ShutterStock.com. Boehringer Ingelheim’s Jascayd (nerandomalist) has got the US Food and Drug Administration (FDA) nod in idiopathic pulmonary fibrosis (IPF), making it the first drug to be approved in this indication in more than a decade. The preferential phosphodiesterase 4B (PDE4B) inhibitor is a first in its class that acts by exerting immunomodulatory and antifibrotic effects. These contribute to the slowing of lung function decline in patients. The drug obtained the FDA go-ahead after two positive Phase III readouts, including the FIBRONEER-ILD (NCT05321082) and FIBRONEER-IPF (NCT05321069) studies. During these trials, Jascayd was found to boost lung function by slowing forced vital capacity (FVC) decline. Following its market debut, Scott Staszak, president and CEO of the Pulmonary Fibrosis Foundation, noted that Jascayd could fulfil the “long-standing need for new treatment options in IPF”. According to Staszak, the drug will also provide an important addition to IPF’s treatment landscape , which has lain dormant since the approval of anti-fibrotics pirfenidone and Boehringer’s Ofev (nintedanib), for which generics are now marketed. Jascayd could set a new standard in IPF Since the respective approvals of pirfenidone and nintedanib in IPF, these two drugs have been the standard of care (SoC) for patients, though they are commonly associated with strong side effects. This includes severe liver damage, meaning patients with compromised liver function may not be able to take this combination. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence According to analysts in GlobalData’s Immunology team, Jascayd approval will be a positive development for patients. “Jascayd is a new, effective treatment with a similar side effect profile to placebo,” which they note will be a welcome advance for those unable to tolerate currently approved therapies. Over time, analysts forecast that the drug will obtain patient share from pirfenidone-nintedanib, allowing the drug to “further penetrate the IPF market”. They also predict the drug’s clinical uptake to be swift, citing its “strong clinical backing and favourable safety profile,” as well as the “flexibility to use Jascayd alone or alongside existing treatment.” IPF market set for future growth Though the IPF market had not seen new blood since 2014, the indication’s dynamic appears to be shifting , as a big pharma and biotech push has seen a range of hopefuls reach late-stage trials. This includes Bristol Myers Squibb’s (BMS) admilparant, which is in a Phase III trial for IPF. In September 2025, United Therapeutics’ Tyvaso (inhaled treprostinil) showed benefit in the Phase III TETON-2 study (NCT05255991), with a significant 95.6mL increase in FVC from baseline. This data will tee the company up to apply for approval of the therapy in the US once it receives data from the TETON-1 trial (NCT04708782). EmphyCorp’s antioxidant, sodium pyruvate, is also in the registrational phase for IPF. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now