Sanofi SNY and partner Regeneron REGN announced positive top-line data from the second pivotal phase III study on their blockbuster medicine Dupixent (dupilumab) for treating adult patients with uncontrolled prurigo nodularis, a chronic inflammatory skin disease. The phase III PRIME study met its primary and all key secondary endpoints. In the study, Dupixent significantly reduced itch and skin lesions compared to placebo at 24 weeks.
Top-line data from the study showed that 60% of the patients treated with Dupixent experienced a clinically meaningful reduction in itch from baseline compared with 18% of the patients in the placebo arm — the primary endpoint.
Also, 48% of the patients treated with Dupixent achieved clear or almost clear skin compared to 18% of placebo patients at week 24.
Treatment with Dupixent led to significantly greater improvements in health-related quality of life, skin pain, as well as symptoms of anxiety and depression. In fact, Dupixent is the only medicine that has shown the potential benefit of targeting IL-4 and IL-13, central drivers of type 2 inflammation, to reduce itch and skin lesions associated with prurigo nodularis disease.
PRIME is the second successful study on Dupixent for the prurigo nodularis indication. Positive top-line data from the first pivotal study were announced in October last year. Data from the studies will be submitted to global regulatory authorities, starting in the first half of 2022.
Sanofi stock has risen 7.2% in the past year compared with the industry’s rally of 17.5%.
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Regeneron’s stock has risen 14% in the past year against the industry’s decrease of 37%
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Dupixent is being jointly marketed by Regeneron and Sanofi under a global collaboration agreement. Sanofi records global net product sales of Dupixent while Regeneron records its share of profits/losses in connection with global sales of the drug.
Dupixent is now approved in the United States, the EU and some other countries for three type II inflammatory diseases, namely uncontrolled chronic rhinosinusitis with nasal polyposis, moderate-to-severe asthma and moderate-to-severe atopic dermatitis. The frequent label expansion approvals are driving the drug’s sales higher.
Dupixent has become the key driver of the top line for Sanofi and profits for Regeneron. Dupixent generated third-quarter global product sales of $1.66 billion, which were recorded by Sanofi. Sanofi and Regeneron are also studying dupilumab in late-stage studies in a broad range of diseases driven by type 2 inflammation like chronic obstructive pulmonary disease, eosinophilic esophagitis, bullous pemphigoid, chronic spontaneous urticaria and some more.
With outside U.S. revenues accelerating and multiple approvals for new indications expected in the near future, Dupixent’s sales are expected to be higher.
Sanofi currently has a Zacks Rank #5 (Strong Sell). Regeneron presently carries a Zacks Rank #2 (Buy).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stocks to Consider
Some large drug/biotech stocks worth considering are Pfizer PFE and BioNTech BNTX, which have a Zacks Rank of 1 (Strong Buy),
Pfizer’s stock has risen 52.3% in the past year. Estimates for Pfizer’s 2022 earnings have gone up from $3.86 to $5.80 over the past 60 days.
Pfizer’s earnings performance has been mixed, with the company exceeding earnings expectations in three of the last four quarters while missing in one. PFE has a four-quarter earnings surprise of 10.85%, on average.
BioNTech’s stock has surged 64% in the past year. Estimates for BioNTech’s 2022 earnings have gone up from $31.14 to $32.52 over the past 60 days.
BioNTech topped earnings estimates in each of the last four quarters. BioNTech has a four-quarter earnings surprise of 132.44%, on average.
(We are reissuing this article to correct a mistake. The original article, issued on January 20, 2022, should no longer be relied upon.)
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