Belumosudil Mesilate

Sanofi’s first-quarter earnings call with the media on Thursday was an exercise in redirecting the narrative before its new CEO steps in next week. CFO François-Xavier Roger defended the company’s appointment of Merck KGaA’s Belén Garijo as its new CEO after ousting Paul Hudson. “Belén is a scientist by training and a longstanding industry leader with deep experience across R&D and global operations, and a track record of driving focus and transformation in complex environments,” Roger said. He added that Sanofi is “fully committed” to its four priority therapeutic areas, including immunology. That commitment comes in spite of a slew of clinical setbacks in this space last year. Garijo is set to start on Wednesday. The leadership change, announced in February, triggered a dip in Sanofi’s shares. Jefferies analysts noted at the time that some onlookers may have been concerned by Garijo’s lack of “credible R&D record” at Merck KGaA. However, the analysts did also note that R&D was not the full picture of her capabilities, which also includes experience of managing an aging pharma portfolio and a group of diverse businesses at the German conglomerate. Roger also countered suggestions that Sanofi’s R&D strategy had failed under Hudson during his tenure. “We would not phrase it [as a failure],” he said. “The company, during [Hudson’s] leadership, moved from, to simplify, €30 billion in sales to almost €45 billion.” Much of that growth was buoyed by Sanofi and Regeneron’s megablockbuster immunology drug Dupixent. Hudson joined the company as CEO in late 2019, and Dupixent’s annual sales rocketed from about €3.5 billion in 2020 to €15.7 billion last year. Roger said the drug is on track to become the fourth-largest medicine in history by 2030. But Dupixent is due to lose its patent protection in the early 2030s, and Sanofi’s efforts to find another megablockbuster have come up short. The company’s anti-OX40L antibody, called amlitelimab, was unable to match Dupixent’s efficacy in atopic dermatitis when comparing results across studies. Another candidate called balinatunfib failed two mid-stage studies in rheumatoid arthritis and psoriasis last year. Jefferies analyst Michael Leuchten previously told Endpoints News that staying all-in on immunology likely isn’t viable for Sanofi going forward. The company’s CFO argued otherwise on Thursday. “Last year, we had a certain number of setbacks, but that happened in the industry [more broadly], so you need to look at that over time,” Roger said. The company secured five regulatory approvals from the start of the year through April, all of which were in immunology. These included pediatric label expansions for Dupixent and diabetes treatment Tzield , and a first European approval for Rezurock in chronic graft-versus-host disease. Rezurock and Tzield generated €133 million and €14 million in the quarter, respectively, representing increases of 11.5% and 36.4% at constant exchange rates. Sanofi’s total first-quarter sales were up 13.6% at €10.5 billion. The company’s vaccine sales crept up 2.1% to €1.29 billion. Sanofi is up by as much as 4% on the Paris exchange Thursday morning. Editor’s note: This article was updated to add information about Sanofi’s share price.

Orca Bio has announced that the US FDA extended the review timeline for its Biologics License Application (BLA) for Orca-T, an investigational allogeneic T-cell immunotherapy targeting hematologic malignancies including acute leukemias and myelodysplastic syndromes. The revised PDUFA target action date is July 6, 2026, three months beyond the original deadline, following the FDA’s classification of a recent company submission as a Major Amendment to the BLA. The extension was triggered by Orca Bio’s submission of updated chemistry, manufacturing and controls (CMC) information provided in response to FDA requests during the standard review process, the company said. The agency has not requested additional clinical data, and Orca Bio stated it believes the updated CMC information does not affect the benefit-risk conclusions of the BLA. The filing carries Priority Review designation, and Orca-T has previously received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft-versus-host disease (GVHD) or death in patients eligible for hematopoietic stem cell transplant (HSCT). Orca-T is composed of highly purified hematopoietic stem cells, regulatory T-cells, and conventional T-cells derived from matched related or unrelated donors. The inclusion of regulatory T-cells is central to the product’s design rationale: by modulating the post-transplant alloreactive immune response, the approach aims to reduce GVHD without eliminating the graft-versus-leukemia effect that makes allogeneic transplantation therapeutically relevant. This positions Orca-T not as an adjunctive drug but as a redefined graft — intended to replace conventional unmanipulated cell products at the transplant step itself. The clinical program supporting the BLA includes the Phase III Precision-T trial (NCT05316701), which enrolled patients with hematologic malignancies and used moderate or severe chronic GVHD-free survival at 12 months as its primary endpoint, assessed by an independent Endpoint Adjudication Committee. An earlier Phase Ib study (NCT04013685) focused on safety endpoints including the incidence of grade 3 or 4 acute GVHD and primary graft failure. The filing enters review at a time when GVHD remains a substantial source of morbidity and non-relapse mortality in the allogeneic transplant setting. Approved prophylactic agents include abatacept, which received FDA approval in 2021 for use in unrelated-donor transplants, while treatment options for established GVHD include ruxolitinib, belumosudil, and axatilimab, the latter approved in 2024 for recurrent or refractory chronic GVHD. Despite these additions, no approved intervention has demonstrated the capacity to simultaneously reduce GVHD and preserve the graft-versus-leukemia effect — the core biological tension that precision graft engineering approaches such as Orca-T are designed to address. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website