Obrixtamig

Boehringer Ingelheim\'s chief medical officer told Fierce that the FDA’s decision on zongertinib could come at “any moment.”\n It\'s shaping up to be a big year for Boehringer Ingelheim—at least if the FDA plays ball. The German drugmaker is awaiting the agency\'s decision on approving key therapies for lung cancer and idiopathic pulmonary fibrosis (IPF) with the aim of launching both meds before the end of 2025.The privately owned company’s top oncology prospect is zongertinib, a HER2-selective tyrosine kinase inhibitor that earlier this year was tied to an objective response rate of 71% among patients with advanced non-small cell lung cancer.If the FDA gives zongertinib the green light in the coming months, the drug would be the first orally administered targeted therapy available for patients with previously treated HER2-mutated lung cancer.“Zongertinib selectively inhibits HER2 while sparing EGFR, which is critical,” Boehringer Chief Medical Officer Lykke Hinsch Gylvin, M.D., told Fierce Biotech in an interview ahead of the company’s first-half earnings results. “So it has the potential to be the first oral and also, as far as we can see, potential to be a best-in-class treatment with a very benign safety and tolerability profile.”For now, the company is “really excited” and “crossing fingers” while it waits for the FDA’s verdict, which could come at “any moment,” Hinsch Gylvin said. Another FDA decision Boehringer is “eagerly waiting” this year is for its PDE4B inhibitor nerandomilast in IPF. Phase 3 data posted in May were considered by analysts to be a step up from Boehringer’s approved IPF drug Ofev, but not a game changer.Still, Hinsch Gylvin argued that nerandomilast has “got the potential to really revolutionize care” for the chronic lung disease.Just days after the nerandomilast readout, PureTech reaffirmed a phase 2b trial success for its own IPF candidate deupirfenidone. Hinsch Gylvin wouldn’t be drawn on whether this meant nerandomilast could soon have a tough battle on its hands, instead pointing out that the aim of Boehringer’s option is to create “a solution for patients that hopefully will change this condition, which is actually fatal.”The CMO also didn’t commit herself to a ballpark figure for sales of Boehringer’s two prospective approvals, but did point out that more than one million patients worldwide have the condition.Another late-stage asset that Hinsch Gylvin is keen to raise awareness of is a DPP1/CatC inhibitor called verducatib, which Boehringer is now evaluating in a late-stage study of non-cystic fibrosis bronchiectasis.“This is part of our maturing pipeline,” she said. “We have over 10 more late-stage trials coming within the next 12 to 18 months.”It seems like any Big Pharma worth the name has a contestant in the obesity race, and Boehringer is no exception. The company’s glucagon/GLP-1 receptor dual agonist survodutide is in late-stage development for both weight loss and metabolic dysfunction-associated steatohepatitis (MASH). Phase 2 readouts for the Zealand Pharma-partnered drug have already demonstrated a placebo-adjusted 64.8% improvement in the fatty liver disease as well as almost 19% weight loss at 46 weeks.But with everyone from Novo Nordisk’s weight loss mainstay Wegovy to up-and-comer candidates from the likes of Rivus Pharmaceuticals showing promise in both obesity and MASH, does Boehringer still think it can stand out in such a crowded space?“We expect a lot from survodutide,” said Hinsch Gylvin, who pointed to the fact that weight loss hadn’t plateaued in the phase 2 trial by the 46-week readout. “In MASH, we had very strong data in phase 2 that helped us to really accelerate.”The company’s MASH ambitions aren’t limited to survodutide, however. There’s also a SIRPα antagonist in a midstage trial that Boehringer “expects a lot from.” Another red-hot space Boehringer has been dabbling in is T-cell engagers. The DLL3/CD3 T-cell engager obrixtamig is being evaluated in midstage trials in both extrapulmonary neuroendocrine carcinoma and small-cell lung cancer.“That\'s definitely also one to look out for,” Hinsch Gylvin said.Further back in development, Boehringer has a B7-H6/CD3 T-cell engager that is tasked with “turn[ing] cold tumors hot.” Another phase 1-stage cancer drug name-checked by Hinsch Gylvin is a CD137/FAP bispecific agonist being aimed at head and neck cancer.In April, Boehringer committed more than $30 million to a new R&D facility specifically focused on antibody-drug conjugates. The site is run by the company’s Swiss subsidiary NBE Therapeutics, which Boehringer bought for $1.5 billion in 2020 in a deal centered around a ROR1-directed ADC. More recently, Boehringer has continued to seek out partners in the ADC arena, kicking off 2025 with a $1.3 billion biobucks licensing deal with Synaffix.Announcing the site in Basel in April, Boehringer said the location will “contribute to building a broad pipeline of ADCs, addressing novel tumor target space to develop next-generation cancer treatments.”Hinsch Gylvin placed this ADC work in the broader context of the company’s “very robust oncology pipeline.”“Apart from small molecule inhibitors, we\'re also exploring T cell engagers, protein degraders, ADCs, cancer vaccines [and] oncolytic viruses,” she continued. “So we really do have a robust pipeline, and we continue to look to strengthen it even further.”One disease area for which Boehringer is less well known is eye health, but the company has been working to change that in recent years—including by licensing a bispecific antibody from Surrozen and a geographic-atrophy-focused pact with RetinAI.Hinsch Glyvin said this ophthalmology work is “fairly new for Boehringer” but has already been “recognized by clinicians as something to look out for.” Boehringer’s Human Pharma business grew 5.7% in the first half of 2025, reaching 11.3 billion euros ($13.2 million) in net sales. This growth was credited to the likes of Jardiance for diabetes, heart failure and kidney disease as well as IPF drug Ofev.According to Hinsch Glyvin, Boehringer invests around 28% of this Human Pharma revenue back into its innovation pipeline—a ratio at the top end of its Big Pharma peers.So, is the company eyeing some of this cash to seek out new drugs to plug any remaining gaps in its portfolio?“About 50% of our pipeline is already anchored in partnerships, and so we continue to always look outside, whether it is for actual partnerships on our current pipeline, or anywhere else to invest,” Hinsch Glyvin said.“I would say we are very fortunate also with this maturing pipeline and the outlook we have to potentially launch up to 20 indications in the coming years,” she added.