Baricitinib

The launches reportedly represent a potential $1bn in incremental revenues for Incyte by 2029. Credit: SOPA Images / Getty Images. Incyte CEO Hervé Hoppenot has promised investors that 2025 will be “a year that will be full of many defining catalysts” for the company. Speaking at the 2025 JP Morgan Healthcare Conference, Hoppenot shared plans for the US pharma company to launch four new products in 2025, beginning with its third-line chronic graft-versus-host disease (GvHD) treatment Niktimvo (axatilimab-csfr). The drug was approved by the FDA in August 2024 and is expected to reach the US market in the first quarter of 2025. The company hopes that three other pipeline drugs will be approved in the second half of the year. These are Zynyz ( retifanlimab ) for the treatment of squamous cell anal carcinoma (SCAC), Monjuvi (tafasitamab) for follicular lymphoma, and Opzelura (ruxolitinib) cream. A supplemental NDA has been submitted for Incyte’s Opzelura cream, which has the potential to be the first topical JAK inhibitor approved for paediatric patients in the US for the treatment of atopic dermatitis (AD). Meanwhile, supplemental BLAs have been submitted for Monjuvi and Zynyz, which Incyte hopes could become the new standard of care for SCAC. The four launches reportedly represent a potential $1bn in incremental revenues for the company by 2029. Hoppenot also used the JP Morgan conference as an opportunity to highlight other anticipated milestones for Incyte this year. The company expects to announce four pivotal trial readouts, at least three Phase III study initiations and seven proof-of-concept data readouts. He highlighted three “high-impact” pipeline programmes in particular, namely povorcitinib, mCALR and CDK2 inhibitors. Oral small-molecule JAK1 inhibitor povorcitinib “is coming soon, and it could be very big”, Hoppenot said. The drug is in pivotal studies for three indications: hidradenitis suppurativa, vitiligo and prugrigo nodularis. The data for the Phase III hidradenitis suppurativa trial is expected in the first half of 2025 while vitiligo and prugrigo nodularis data is expected next year. The share price of the company increased 2.59% on 13 January, suggesting some optimism for pipeline products. Looking at the broader picture, Hoppenot explained that the business was adopting a focused, specific approach to R&D: “Our pipeline has been reduced a little bit – some projects have been stopped – and we are trying to direct our resources to what is novel biology – what is first in class or best in class.” However, he also credited diversification within the portfolio as the reason behind Incyte’s $3.1bn revenue in the first nine months of 2024, which represented a 14% year-on-year increase. Hoppenot noted that “revenue at Incyte is growing because of diversification of the portfolio and also because of international expansion”.

Is the frenzy of JPM dealmaking finally underway? GSK announced Monday morning that it will acquire the privately-held biotech IDRx for $1 billion upfront, bringing a rare cancer treatment into the British drugmaker’s fold. If all milestones are met, GSK will pay up to another $150 million. It’s the first big deal to be announced at the annual JP Morgan Healthcare Conference, which begins Monday. The buyout gives GSK a bolt-on oncology program called IDRX-42. It also shares similarities to the company’s 2022 acquisition of Sierra Oncology, according to Luke Miels, GSK’s chief commercial officer. Through that deal, GSK gained Ojjaara, a JAK inhibitor also known as momelotinib that was approved in 2023. “The way I would look at it is it’s further building our portfolio,” Miels said in an interview. GSK CSO Tony Wood previously told Endpoints News that it’s aiming to build “careful” momentum for its oncology pipeline. Both the IDRx buyout and a recent licensing agreement with Rgenta to develop splice modulators for different cancers appear to fall into that strategy. Miels said that the deal started coming together last month, when the IDRx team gave a presentation to GSK executives. “The IDRx molecule, when the team presented it, certainly got Tony’s and my attention,” Miels said. IDRx chair Ben Auspitz said the startup had run a dual-track process looking at both an IPO and an M&A deal. It was “highly competitive” with “multiple suitors” in the mix, he told Endpoints on the sidelines of JPM on Monday. If approved, the market for IDRX-42 also has parallels to Miels’ past work at AstraZeneca, where he helped shepherd the lung cancer drug Tagrisso across the finish line, he said. There were already approved drugs on the market, but Tagrisso helped fill in some treatment gaps because it targeted specific tumor mutations — in that case, EGFR. In the case of IDRX-42, the program is designed to treat GIST, a type of cancer that grows in the digestive tract lining, and goes after tumors with a mutation called KIT that’s found in over 80% of GIST tumors. This is where GSK believes it can improve on already-approved treatment options like Novartis’ Gleevec, which was first approved in 2008 for GIST, according to Miels. There are about 6,000 GIST patients in the US and 5,000 in the EU, Miels added, though global estimates range between 80,000 and 120,000 because of how individuals are diagnosed. Durability will be a key question for IDRX-42 since GIST patients typically survive for at least five years. GSK intends to start a study in second-line patients this year. A study in first-line patients is expected to follow relatively quickly, though there’s no timeline yet. “We won’t wait for the second-line study to conclude,” Miels said. IDRx had been targeting a pivotal study sometime in the middle of 2025. At the annual ASCO meeting in June, the company shared Phase 1 data that showed IDRX-42 shrank tumors in 23% of patients regardless of how many prior regimens they had tried and in 43% of second-line patients. IDRx last raised money in August, putting together a $120 million Series B from a syndicate that included RA Capital, Commodore Capital and Blackstone. The company licensed IDRX-42 from Merck KGaA prior to its de-stealthing in 2022. The Financial Times first reported last week that a deal was close. (Endpoints is part of FT Specialist, a unit of the Financial Times.) Editor’s note: This story was updated to include information from an interview with IDRx chair Ben Auspitz.