We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
SNY's Lunsekimig Succeeds in Asthma & CRSwNP Studies, Fails in Eczema
Read MoreHide Full Article
Key Takeaways
Sanofi reported positive phase II AIRCULES and DUET data, meeting key endpoints in asthma and CRSwNP.
SNY's lunsekimig improved lung function, reduced exacerbations and eased nasal polyp severity vs. placebo.
Sanofi's VELVET study missed its primary endpoint in atopic dermatitis despite some secondary gains.
Sanofi (SNY - Free Report) announced positive data from two separate mid-stage studies (AIRCULES and DUET) evaluating the safety and efficacy of its investigational candidate, lunsekimig, in patients with moderate-to-severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), respectively. Both studies met their primary and key secondary endpoints. However, SNY faced a setback in the VELVET study in atopic dermatitis, as it failed to achieve the primary endpoint.
Year to date, SNY’s shares have lost 1.7% compared with the industry’s 0.9% decline.
Image Source: Zacks Investment Research
Key Highlights of SNY’s AIRCULES & DUET Studies on Lunsekimig
The phase IIb AIRCULES study enrolled adult patients with moderate-to-severe asthma, despite being on standard of care. In the study, treatment with lunsekimig led to statistically significant and clinically meaningful reductions in exacerbation rates, as well as improvements in lung function, as measured by pre-bronchodilator forced expiratory volume in one second (pre-BD FEV1), regardless of biomarker status. Pre-BD FEV1 is the amount of air a person can forcefully exhale in the first second of a breath, measured before using any bronchodilator medication.
Similarly, the phase IIa DUET proof-of-concept study evaluating lunsekimig in patients with CRSwNP successfully met its primary endpoint, demonstrating a significant improvement in nasal polyp score from baseline. The study achieved its key secondary endpoints, including reductions in patient-reported nasal congestion/obstruction and improvements in Lund-Mackay Computed Tomography scores (a measure used to quantify the severity of the disease) compared with placebo at week 24.
Overall, lunsekimig was well tolerated in both studies.
Sanofi’s Lunsekimig Missed VELVET Study Primary Endpoint
Sanofi also announced data from a separate exploratory phase IIb VELVET study in moderate-to-severe atopic dermatitis patients. The study failed to meet its primary endpoint of percentage improvement in the Eczema Area and Severity Index score from baseline. The study demonstrated encouraging data across key secondary endpoints, including measures of skin clearance such as EASI-75 and vIGA-AD 0/1.
Several other studies are also ongoing on lunsekimig, including the phase II AIRLYMPUS study in high-risk asthma and the phase III PERSEPHONE and THESEUS studies in chronic obstructive pulmonary disease.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. CPRX shares have gained 7% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. INDV shares have lost 15.2% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.14 to $8.99. Year to date, shares of ANIP have declined 2.2%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Zacks' 7 Best Strong Buy Stocks (New Research Report)
Valued at $99, click below to receive our just-released report
predicting the 7 stocks that will soar highest in the coming month.
View the Zacks #1 Rank List
Image: Bigstock
SNY's Lunsekimig Succeeds in Asthma & CRSwNP Studies, Fails in Eczema
Key Takeaways
Sanofi (SNY - Free Report) announced positive data from two separate mid-stage studies (AIRCULES and DUET) evaluating the safety and efficacy of its investigational candidate, lunsekimig, in patients with moderate-to-severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), respectively. Both studies met their primary and key secondary endpoints. However, SNY faced a setback in the VELVET study in atopic dermatitis, as it failed to achieve the primary endpoint.
Year to date, SNY’s shares have lost 1.7% compared with the industry’s 0.9% decline.
Image Source: Zacks Investment Research
Key Highlights of SNY’s AIRCULES & DUET Studies on Lunsekimig
The phase IIb AIRCULES study enrolled adult patients with moderate-to-severe asthma, despite being on standard of care. In the study, treatment with lunsekimig led to statistically significant and clinically meaningful reductions in exacerbation rates, as well as improvements in lung function, as measured by pre-bronchodilator forced expiratory volume in one second (pre-BD FEV1), regardless of biomarker status. Pre-BD FEV1 is the amount of air a person can forcefully exhale in the first second of a breath, measured before using any bronchodilator medication.
Similarly, the phase IIa DUET proof-of-concept study evaluating lunsekimig in patients with CRSwNP successfully met its primary endpoint, demonstrating a significant improvement in nasal polyp score from baseline. The study achieved its key secondary endpoints, including reductions in patient-reported nasal congestion/obstruction and improvements in Lund-Mackay Computed Tomography scores (a measure used to quantify the severity of the disease) compared with placebo at week 24.
Overall, lunsekimig was well tolerated in both studies.
Sanofi’s Lunsekimig Missed VELVET Study Primary Endpoint
Sanofi also announced data from a separate exploratory phase IIb VELVET study in moderate-to-severe atopic dermatitis patients. The study failed to meet its primary endpoint of percentage improvement in the Eczema Area and Severity Index score from baseline. The study demonstrated encouraging data across key secondary endpoints, including measures of skin clearance such as EASI-75 and vIGA-AD 0/1.
Several other studies are also ongoing on lunsekimig, including the phase II AIRLYMPUS study in high-risk asthma and the phase III PERSEPHONE and THESEUS studies in chronic obstructive pulmonary disease.
SNY’s Zacks Rank & Stocks to Consider
SNY currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy), and ANI Pharmaceuticals (ANIP - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. CPRX shares have gained 7% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. INDV shares have lost 15.2% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.14 to $8.99. Year to date, shares of ANIP have declined 2.2%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.