Sanofi’s new CEO wants more ‘realistic view’ of Phase 3 go/no-go decisions

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Sanofi is going to “look very deeply” at its late-stage pipeline as part of a portfolio prioritization initiative, though new CEO Belén Garijo didn’t commit to shelving a specific number of assets.

Sanofi will be more judicious in moving assets into late-stage development under new CEO Belén Garijo, first making sure that only the candidates worth investing in go into Phase 3.

“I want to make sure that the data that we have coming from Phase 2 studies—or Phase 1b, depending on the therapeutic area—will justify the significant commitment of capital,” Garijo told reporters Thursday morning during a press call to present the pharma’s second quarter earnings results.

Sanofi “will have a realistic view of the potential of the asset in order to make a fact-based decision” of whether to advance into late-stage studies, she added.

As part of this new, more prudent approach to pipeline stewardship, Garijo has also put in motion a “very rigorous portfolio prioritization process,” though it’s not clear if this will mean the discontinuation of programs.

“We don’t have a target number of products to discontinue,” she said, however noting that “we are going to look very deeply at our current late-stage portfolio and we will decide on scientific merit, potential to create long-term value and, obviously, ensuring the right risk profile of our pipeline moving forward.”

Last week, Sanofi announced the end of all but one ongoing clinical study of amlitelimab, an investigational antibody that had been in development for a slew of atopic dermatitis trials. Following this move, only a celiac disease study will remain, with data expected later this year.

Sanofi had hoped the acquisition of Kymab would fill a major hole that will be left as autoimmune juggernaut Dupixent heads toward a patent cliff. Now, another therapy has failed to meet expectations.

As a result of this decision, the pharma reported a €952 million ($1.1 billion) impairment loss for the second quarter.

Sanofi on Thursday also announced that it would no longer advance the IL-33 blocker itepekimab and the oral TNFR inhibitor balinatunfib. The former showed mixed data in a Phase 3 study of chronic obstructive pulmonary disease, while the latter failed to significantly ease disease severity in a Phase 2 trial of psoriasis.

For the period, Sanofi recorded a 17.8% year-on-year increase in net sales, bringing in €11.6 billion ($13.3 billion).

The immunology powerhouse Dupixent, which the pharma shares with Regeneron, remained Sanofi’s best-selling product, surging 37.6% to nearly €5.2 billion ($6 billion). On the call, CFO François Roger projected that the drug’s sales could hit €25 billion ($28.6 billion) by 2030.

Dupixent accounted for about half of the company’s Q2 revenue, but is expected to lose key patent protections in 2031, threatening a major contributor to Sanofi’s income stream. On the call, Garijo was asked if the pharma had plans for striking any big M&A deals soon to help buttress the Dupixent cliff.

The CEO remained noncommittal, saying only that the pharma will be “looking for opportunities that fit our strategic imperatives,” but that the company will be “very disciplined” with dealmaking.

The rest of Sanofi’s products lag far behind Dupixent. The pharma’s second-largest franchise in Q2 was its polio/pertussis/influenza B primary and booster vaccines, which together made €700 million ($802 million), followed by the long-acting insulin Lantus at €394 million ($451 million).

Still, the pharma was optimistic after its performance in the first half of the year and increased its 2026 guidance. Sanofi now expects sales to grow around 10% at constant currencies, up from its prior projection of a high-single-digit increase.

The new CEO has at least five years and a large M&A war chest to position Sanofi for life after the loss of exclusivity on its cornerstone immunology product.

Editor’s note (July 30): This story has been changed to add details regarding two other assets that Sanofi discontinued.

Tristan is BioSpace‘s senior staff writer. Based in Metro Manila, Tristan has more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.
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