Sanofi SNY and companion Regeneron REGN introduced that the FDA has authorised their blockbuster drug, Dupixent, for its sixth indication — continual obstructive pulmonary illness (COPD) — in the USA. The authorised indication is as an add-on upkeep therapy of adults with inadequately managed COPD and an eosinophilic phenotype. With this approval, Dupixent grew to become the primary biologic therapy authorised for COPD in the USA.
Dupixent was authorised for treating COPD with raised blood eosinophils within the EU in July 2024. Dupixent was additionally authorised for the COPD indication in China final week.
Sanofi’s inventory has gained 16.0% to this point this yr in contrast with a rise of 20.2% for the big cap pharmaceutical industry.
Picture Supply: Zacks Funding Analysis
The approval for COPD, a respiratory illness that causes progressive lung operate decline, was based mostly on information from two research. The NOTUS and BOREAS research met their main endpoint by exhibiting that Dupixent considerably diminished reasonable or extreme acute COPD exacerbations by 30% and 34%, respectively. Dupixent additionally confirmed enhancements in lung operate and health-related high quality of life in comparison with placebo.
Earlier this yr, the FDA prolonged its determination on a supplemental biologics license software in search of approval of Dupixent for COPD from June 27 to Sept. 27.
Dupixent – Key Prime-Line Driver For SNY, REGN
Dupixent is presently authorised in a number of nations, together with the USA and EU, for 5 different kind II inflammatory ailments, specifically extreme continual rhinosinusitis with nasal polyposis, extreme bronchial asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
Dupixent is being collectively marketed by Regeneron and Sanofi below a world collaboration settlement. Sanofi data international web product gross sales of Dupixent, whereas Regeneron data its share of earnings/losses in reference to the worldwide gross sales of the drug. The approval for the COPD indication can considerably increase gross sales of Dupixent. Some analysts count on complete gross sales of Dupixent for COPD to be round $6 billion.
Dupixent is a key top-line driver for each Sanofi and Regeneron on robust demand tendencies. Within the first half of 2024, Dupixent generated international product gross sales of $€6.1 billion, which had been recorded by Sanofi, representing progress of 27.1% at a continuing alternate fee. Sanofi expects Dupixent to realize greater than €13 billion in gross sales in 2024.
For Regeneron, Dupixent generated collaboration revenues of $2.06 billion within the first half, up 18% yr over yr.
SNY Zacks Rank and Different Shares to Take into account
Sanofi presently has a Zacks Rank #2 (Purchase).
Another top-ranked drug/biotech firms are Eli Lilly LLY and Pfizer PFE. Whereas Lilly sports activities a Zacks Rank #1 (Sturdy Purchase), Pfizer has a Zacks Rank #2. You’ll be able to see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Lilly’s 2024 earnings have risen from $13.79 to $16.49 per share over the previous 60 days. For 2025, earnings estimates have risen from $19.44 to $23.97 per share over the identical timeframe. Yr thus far, Lilly’s inventory has risen 50.5%.
Lilly beat estimates in every of the final 4 quarters, delivering a four-quarter common earnings shock of 69.07%.
The Zacks Consensus Estimate for Pfizer’s earnings has risen from $2.38 to $2.62 per share for 2024 over the previous 60 days, whereas that for 2025 has risen from $2.74 per share to $2.85 per share. Pfizer’s shares have risen 1.0% yr thus far.
Pfizer beat estimates in every of the final 4 quarters, delivering a four-quarter common earnings shock of 69.82%.
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