Sanofi Advances Mid-to-Late-Stage Pipeline in Respiratory Indications

Sanofi SNY announced preliminary data from the phase II TIDE-Asthma study, which evaluated its anti-OX40L mAb, amlitelimab, for treating adults with moderate-to-severe asthma. The company also provided updates on other pipeline candidates, which are in mid- to late-stage studies for treating various respiratory indications.

Preliminary Data From SNY's Asthma Study on Amlitelimab

Preliminary data from the TIDE-Asthma study showed that treatment with the highest dose level of amlitelimab failed to meet the primary endpoint of the annualized exacerbation rate at week 48 while demonstrating nominal significance at the medium dose level.

At week 60, treatment with the medium dose of amlitelimab demonstrated nominally significant and clinically meaningful reductions in asthma exacerbations, while a numerically greater reduction in exacerbations was observed at the high dose level.

Treatment with amlitelimab led to nominally significant and clinically meaningful improvements in lung function and asthma control – the secondary endpoints of the TIDE-Asthma study.

The phase III studies on the candidate are currently in the planning stage.

Year to date, shares of Sanofi have risen 4.9% against the industry’s decline of 4.9%.

SNY's Progress With Other Respiratory Pipelines

Sanofi is developing itepekimab in partnership with Regeneron Pharmaceuticals REGN. The candidate is currently being evaluated in two phase III studies — CEREN 1 and CEREN 2 — for treating patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

A phase II study is evaluating itepekimab in patients with chronic rhinosinusitis without nasal polyps.

Itepekimab is also being investigated in separate mid-to-late-stage studies for the treatment of patients with chronic obstructive pulmonary disease (COPD). Data from these studies are expected to be announced in the second half of 2025.

SNY markets blockbuster asthma drug Dupixent (dupilumab) in collaboration with REGN.

While Sanofi records global net product sales of Dupixent, Regeneron records its share of profit in connection with the global sales of the drug.

Meanwhile, a phase II study is evaluating itepekimab for treating bronchiectasis, with data from the same expected in 2026.

Sanofi is also exploring another candidate, lunsekimig, in separate phase II studies for high-risk asthma and moderate-to-severe asthma. A phase II/III study evaluating lunsekimig in COPD patients is expected to begin later in 2025.

Lunsekimig is also being evaluated in a phase II study for the treatment of CRSwNP. Data from the CRSwNP and asthma studies are expected in 2026.

SNY's Zacks Rank & Stocks to Consider

Sanofi currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Jazz Pharmaceuticals, Inc. JAZZ and Krystal Biotech, Inc. KRYS, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Jazz Pharmaceuticals’ earnings per share have increased from $22.11 to $23.33 for 2025. During the same time, earnings per share estimates for 2026 have increased from $23.23 to $23.35. Year to date, shares of JAZZ have lost 16.4%.

JAZZ’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.20%.

In the past 60 days, estimates for Krystal Biotech’s earnings per share have increased from $5.52 to $7.00 for 2025. During the same time, earnings per share estimates for 2026 have increased from $9.15 to $10.84. Year to date, shares of KRYS have gained 8%.

KRYS’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.29%.

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