Galapagos believed so strongly in its work developing new cancer cell therapies that it pinned its future on them. This past winter, the Belgian drugmaker unveiled a plan to spin out the rest of the company as a standalone business, leaving legacy Galapagos to focus exclusively on its new approach to manufacturing and supplying CAR T-cell therapies. Now it’s halting the spinoff plans and is instead exploring strategic alternatives for everything — including cell therapy.
The re-evaluation of the planned business separation follows unspecified “regulatory and market developments,” Galapagos said Tuesday. The company is not winding down. But by exploring business deals for its existing business assets, the Galapagos board of directors aims to maximize the financial resources the company can deploy toward “transformative business development transactions.”
Galapagos, founded in 1999, initially focused on developing small molecule drugs for inflammatory disorders. The company changed course in recent years with deals that gave it access to cell therapy technologies. These technologies enabled the company to bring cell therapy manufacturing at or near the point of care, a decentralized approach that stands in contrast to current manufacturing practices in which a patient’s cells are engineered and expanded in a distant lab, a multi-step process that can take a month or more.
The most advanced Galapagos cell therapy program is GLPG5101. Though Galapagos generated encouraging early clinical data for this therapy in non-Hodgkin lymphoma, the company later selected mantle cell lymphoma (MCL) as the lead indication; a potentially pivotal clinical study was planned to start 2026.
MCL is a competitive indication that earlier this year welcomed AstraZeneca BTK inhibitor Calquence as a new first-line treatment for this rare blood cancer. Eli Lilly’s Jaypirca, also a BTK inhibitor, has accelerated FDA approval as a third-line MCL treatment. As for cell therapies, the FDA’s 2020 approval of Tecartus made that Gilead Sciences cell therapy the first CAR T-treatment for MCL. Nearly a year ago, Bristol Myers Squibb’s Breyanzi expanded its label to include third-line treatment of MCL.
SpinCo was not envisioned as a way to develop and commercialize the non-cell therapy pieces of the Galapagos pipeline. When the spinoff plan was announced, Galapagos said it would seek partners or deals for its clinical-stage immunology drug as well as its preclinical assets. SpinCo would combine cash from those transactions with €2.45 billion (about $2.5 billion) in capital from Galapagos to acquire or license clinical-stage drugs in oncology, immunology, and virology.
Weeks ago, the spinoff appeared to be proceeding as planned. Galapagos announced its CEO, Paul Stoffels, would retire upon the appointment of a successor in the next year and biopharma industry veteran Henry Gosebruch was named the new CEO of the SpinCo. In its report of first quarter 2025 financial results, the company said the spinoff was still on track to happen in mid-2025.
Galapagos said Tuesday that its board of directors has appointed Gosebruch to serve as CEO of the company effective immediately, succeeding Stoffels, who has retired. Gosebruch now takes on the responsibility for pursuing strategic alternatives for Galapagos’s assets and for striking deals to build a new drug pipeline. As of the end of the first quarter of this year, Galapagos reported its cash position was €3.3 billion (about $3.7 billion).
To Leerink Partners analyst Faisal Khurshid, Galapagos’s change in course is a recognition that its CAR T-platform alone was unlikely to sustain an independent company. Leerink had a cautious view of the cell therapy platform, given the logistical challenges and limited evidence of clinical differentiation from already available cell therapies.
“While we await additional details on next steps we think this may enable [Galapagos] to pursue further [business development] and build out an innovative pipeline which may be of interest to investors,” Khurshid wrote in a note sent to investors. “We see this move as tacit acknowledgement that an independent company focused on this platform would not be sustainable from an investor interest and financing capability perspective.”
Photo: Yuriko Nakao, Getty Images
