Sanofi (NASDAQ:SNY) is reviewing its late-stage pipeline, broadening its business-development lens and working to rebuild early research output under new leadership, Chief Scientific Officer and Global Head of Research Mike Quigley said at a Bank of America event.
Quigley said Chief Executive Officer Belén has reaffirmed the company’s core focus areas of immunology and inflammation, rare diseases and vaccines. Paul, who joined as head of research and development three weeks before the event, is conducting an additional assessment of the late-stage development portfolio after Sanofi previously terminated amlitelimab, itepekimab and belantamab.
Pipeline Review and Business Development
Quigley said the outcomes of the late-stage review have not been determined. The effort is examining scientific rigor, portfolio risk and capital allocation, rather than representing a predetermined plan to discontinue additional programs. Phase III-start decisions have generally continued, although new R&D leadership has been given an opportunity to weigh in on significant investments.
Sanofi is now “phase agnostic” in evaluating external opportunities, Quigley said, after its prior focus had been more concentrated on bolt-on Phase I and Phase II assets. The company will consider deals across development stages if they meet standards for strategic fit, scientific merit, unmet medical need and financial return.
The company’s R&D organization is involved in diligence for both early- and late-stage opportunities. Business development and mergers and acquisitions now sit under the chief financial officer, alongside Sanofi Ventures, while R&D remains central to scientific evaluation, Quigley said.
Near-term external opportunities are likely to be closest to Sanofi’s existing development and commercial expertise, including rare diseases and immunology and inflammation, particularly dermatology and respiratory disease. Quigley also cited internal research efforts in oncology, neurology and ophthalmology, while emphasizing that these programs do not necessarily represent a broader commitment to those therapeutic areas.
- Sanofi aims for a roughly 50/50 balance between internal and external innovation in its research and early-development portfolio.
- Quigley said the company expects to announce more platform-oriented partnerships, involving larger portions of a portfolio, rather than solely individual assets.
- The company is also using its corporate venture arm to monitor and invest in emerging biology that may be too early for internal development.
Regeneron Alliance Discussions
Sanofi is holding discussions with Regeneron regarding how to maximize their alliance in dermatology, respiratory disease and potentially gastroenterology, Quigley said. He identified lunsekimig, a TSLP and IL-13 nanobody being studied in respiratory disease, as an example of a Sanofi asset that could potentially be included, though no decision has been made.
Revekimab is not currently part of those discussions, he said. Sanofi is developing that program for hidradenitis suppurativa.
The companies are also discussing the potential positioning of long-acting IL-13 approaches and other assets. Quigley said questions surrounding whether IL-4 receptor assets are included in the alliance remain part of ongoing negotiations and clarifications. While external assets could ultimately be brought into the collaboration, he said the first priority is understanding the current assets held by both companies.
Research Output and Early Pipeline
Quigley, who joined Sanofi about two years ago, said his goal has been to make the research organization more resilient and able to generate sustained, high-quality output. He said frequent changes in R&D and strategy leadership during the prior eight to nine years had affected long research timelines.
According to Quigley, the company’s recent first-in-human starts have been “abysmal,” but Sanofi expects its Phase I pipeline to begin rebuilding with programs starting this year and continuing through 2026, 2027 and 2028. He noted that research initiatives can take more than four years to reach the clinic and about 14 years, in a successful case, to reach the market.
Sanofi is also using technology obtained through its Translate Bio acquisition. Quigley cited in vivo CAR-T efforts that combine the mRNA platform with lipid nanoparticle and nanobody technologies. The company is considering how mRNA cancer-vaccine approaches could fit into a broader assessment of oncology and other therapeutic-area priorities.
Updates on Selected Development Programs
Quigley said Sanofi remains confident enough in lunsekimig’s Phase IIb asthma data to project a Phase III program, while cautioning against cross-trial comparisons with other medicines. He said the company saw statistically significant results for exacerbation and FEV1 endpoints in an all-comer population and potentially stronger outcomes in a prespecified subgroup more similar to a potential Phase III population.
For revekimab in hidradenitis suppurativa, Sanofi expects Phase IIb data next year. The company will evaluate both hidradenitis suppurativa scores and tunnel outcomes in determining whether the program has sufficient differentiation to advance to Phase III, Quigley said.
Sanofi is in regulatory discussions on frexalimab in multiple sclerosis. The company is considering changing the primary readout in its study from superiority to non-inferiority on annualized relapse rate against teriflunomide. Disability progression at six months remains a key secondary endpoint and an important factor in judging the program’s potential, Quigley said.
For riliprubart, Quigley said the VITALIZE study remains on track for a 2027 readout after an independent data monitoring committee recommended ending the MOBILIZE study for futility. He said the studies involve different patient populations, with VITALIZE enrolling a more homogeneous group dependent on IVIG treatment.
Sanofi is also continuing regulatory discussions for duvakitug alfa in alpha-1 antitrypsin deficiency. The company remains on track for a potential filing by year-end based on an accelerated-approval pathway, although Quigley said the key issue is correlation between biomarker levels and clinical outcomes rather than safety. A Phase III study would be required for a European filing.
Looking ahead, Quigley highlighted planned ESMO data for Sanofi’s Phase II PD-1/IL-15 asset in solid tumors, including colorectal and lung cancer. He also cited two ophthalmology gene-therapy programs entering or in Phase II, targeting neovascular age-related macular degeneration and geographic atrophy. Sanofi has not guided to material data releases for its early STAT6 programs before 2028.
Quigley said Sanofi plans to provide further updates as strategic decisions are made, with third-quarter earnings in October representing the next expected opportunity for communication.
About Sanofi (NASDAQ:SNY)
Sanofi is a global healthcare company headquartered in France that develops, manufactures and markets prescription medicines and vaccines. Its portfolio serves patients across areas including immunology, rare diseases, rare blood disorders, neurology, oncology and inflammatory conditions, as well as other specialty-care and general-medicine categories.
The company is also a major vaccine producer through its vaccines business, which supplies products for diseases such as influenza, polio, pertussis, meningitis and dengue.
