Sanofi SNY announced that the phase III Baby-COMET study evaluating Nexviazyme (avalglucosidase alfa) in patients with infantile-onset Pompe disease (IOPD) has met all primary and secondary endpoints.
The study met its primary endpoint by showing the proportion of treatment-naïve pediatric participants aged six months and younger with IOPD remained alive and free of invasive ventilator support following 52 weeks of treatment with Nexviazyme.
The study also met all secondary endpoints, including the proportion of participants who remained alive and free of invasive ventilation at 12 and 18 months of age, as well as improvements in other measures of disease progression after 52 weeks of treatment.
Based on this data, Sanofi is planning to submit a regulatory filing in the United States seeking approval for Nexviazyme in IOPD in the second half of 2026.
Nexviazyme is currently approved in the United States for the treatment of late-onset Pompe disease (LOPD) in patients aged one year and above.
SNY’s Price Performance
Year to date, shares of Sanofi have declined 8.3% against the industry’s increase of 14.6%.
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More on Sanofi’s Nexviazyme
Nexviazyme is marketed as Nexviadyme in Europe and is approved to treat both LOPD and IOPD. The drug is also approved in several other countries for treating Pompe disease, although its approved use varies by country.
Besides Nexviazyme, Sanofi also markets Myozyme/Lumizyme for Pompe disease. The company's Pompe disease franchise generated €320 million in sales in the first quarter of 2026, up 2.4% year over year.
Sales of Nexviazyme/Nexviadyme rose 13.3% year over year to €208 million in the first quarter, driven by continued patient switching from Myozyme/Lumizyme.
Meanwhile, Myozyme/Lumizyme sales declined 13.3% year over year to €112 million during the same time.
A potential FDA approval of Nexviazyme for IOPD could further expand the drug's eligible patient population and boost sales. At the same time, sales of Myozyme/Lumizyme are likely to continue declining as more patients transition to Nexviazyme.
SNY’s Zacks Rank & Stocks to Consider
Sanofi currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Amarin ( AMRN), Immunocore IMCR and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Amarin’s 2026 loss per share have narrowed from $15.72 to $1.14. Over the same period, loss per share estimates for 2027 have narrowed from $13.59 to 89 cents. AMRN shares have risen 14.2% year to date.
Amarin’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 97.18%.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 97 cents per share to earnings of 6 cents. Over the same time, estimates for 2027 bottom line have improved from a loss of 39 cents per share to earnings of 87 cents. IMCR stock has lost 8.5% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.75 to $3.02, while estimates for 2027 have increased from $2.91 to $4.92 during the same time. LQDA shares have surged 131.2% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
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This article originally published on Zacks Investment Research (zacks.com).