Durcabtagene autoleucel

Just five months after closing its $2.9 billion deal for MorphoSys, Novartis has recorded an $800 million impairment on the acquisition after a review of “certain clinical trial data,” the company said in its third-quarter earnings report . A company spokesperson confirmed that the review was triggered by pelabresib, an oncology candidate at the center of the MorphoSys buyout. Novartis shared Tuesday that it’s expecting a delayed regulatory submission for pelabresib, as it needs to follow patients longer to assess concerns about emergent malignancies. The company had initially hoped to file for approval in myelofibrosis this year. Emergent malignancies in patients treated with pelabresib were first reported by STAT earlier this year. Novartis will “look at the data over the course of next year,” and assess the potential need for additional studies, CEO Vas Narasimhan said during its Q3 earnings call with the media. Novartis also disclosed three Phase 2 pipeline cuts Tuesday: a BCMA cell therapy called durcabtagene autoleucel or PHE885 in multiple myeloma; XXB750 in hypertension and heart failure; and an IL-17 inhibitor subbed CMK389 in pulmonary sarcoidosis. Overall, Barclays analysts said Novartis had a “strong” quarter. The company raised its end-of-year guidance, with Narasimhan saying its “pure-play” strategy is starting to pay off. While executives previously expected net sales growth in the high single digits to low double digits, Novartis now says the low end of that range will be in the double digits. “The changes we’ve made to become a focused, pure-play company focused on key therapeutic areas, focused on key geographies, is really working,” Narasimhan told reporters. Elsewhere, Narasimhan also fielded a variety of questions about Novartis’ new structure, legal strategy and manufacturing capacity: On the company’s reorganization: It’s been roughly two years since Novartis announced a global restructuring that impacted thousands of positions and involved the spinout of generics unit Sandoz. The company said it completed its transformation in November 2023, though “additional streamlining” this year brought some cuts on the development side. Narasimhan said Novartis is “always going to be fine-tuning at a low level, but we don’t foresee any other large changes at this time.” On radioligand supply: Novartis applied for a label expansion last quarter to bring Pluvicto into the pre-taxane setting for patients with metastatic castration-resistant prostate cancer. But despite recent shortage concerns across the radiopharma space, Narasimhan said Novartis’ manufacturing plans will enable not only the supply of Pluvicto, but also “a very large pipeline of radioligand therapies moving forward.” He added that Novartis’ supply has been “unconstrained for most of this year,” with the ability to produce volumes that support $7 billion to $8 billion-plus in sales. The company has plans to expand its Indianapolis site, and is putting up new sites in California, China and Japan. On the Inflation Reduction Act and a recent court loss: A New Jersey federal court recently rejected Novartis’ legal challenge to the IRA. The company has appealed, though Narasimhan said it’s “difficult to say” whether Novartis’ case or cases brought by other drugmakers will conclude before negotiated prices take effect in 2026. For now, the CEO said Novartis is pushing for legislative changes, including around a provision that calls for negotiations to occur sooner for small molecule drugs than for biologics. “We are operating under the assumption that we need to work under the rules of the law and rather focus on trying to educate policymakers,” he said. On generic entry: Novartis said it expects generic rivals to Tasigna, Promacta and Entresto to hit the US market in mid-2025. “That will certainly be a headwind we’ll face in the second half of 2025,” Narasimhan said. “We still expect good growth next year, both on the top and bottom line.” Editor’s note: This story has been updated to include comment from Novartis on the MorphoSys impairment.