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Sanofi (SNY), Regeneron Dupixent sBLA Accepted for FDA Review
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Sanofi (SNY - Free Report) announced that the supplemental biologics license application (sBLA) for the label expansion of asthma drug Dupixent (dupilumab) has been accepted for review by the FDA.
The sBLA is seeking approval for the drug to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU), which is not adequately controlled with the current standard of treatment — H1 antihistamine medication.
The regulatory body has set a target action date of Oct 22, 2023.
CSU is an inflammatory skin condition, primarily occurring due to type 2 inflammation. This causes sudden and debilitating hives and swelling on the skin.
The sBLA was supported by positive data from two phase III trials (LIBERTY-CUPID Studies A and B), evaluating Dupixent in two patients with uncontrolled CSU. Study A was conducted in CSU patients who were uncontrolled on standard-of-care antihistamines, with efficacy and safety data supporting the submission. Study B was conducted in CSU patients who were uncontrolled on standard-of-care antihistamines and refractory to omalizumab, with results providing additional supporting data.
Dupilumab was developed by Sanofi, in collaboration with its partner Regeneron (REGN - Free Report) . We note that Dupixent is approved in the United States and EU for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and eosinophilic esophagitis (EoE).
Sanofi markets Dupixent and Kevzara in partnership with Regeneron. While Sanofi records sales of drugs, REGN records its share of profits/losses in connection with the global sales of Dupixent and Kevzara.
Sanofi’s shares have lost 8.4% in the past year against the industry’s 6.4% gain.
Image Source: Zacks Investment Research
The drug is also being evaluated in a broad range of diseases driven by type 2 inflammation or other allergic processes, including pediatric EoE, atopic hand and foot dermatitis, chronic inducible urticaria-cold, CSU, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid.
Allogene Therapeutics’ loss per share estimates have narrowed from $2.84 to $2.56 for 2023 and from $2.79 to $2.47 for 2024, in the past 60 days. The stock has plunged 26.9% in the past year.
ALLO’s earnings beat estimates in all the last four quarters, the average surprise being 8.33%.
CRISPR Therapeutics' loss per share estimates for 2023 have narrowed from $8.21 to $7.39 in the past 60 days.
CRSP's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 3.19%. The stock has declined 20.8% in the past year.
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Sanofi (SNY), Regeneron Dupixent sBLA Accepted for FDA Review
Sanofi (SNY - Free Report) announced that the supplemental biologics license application (sBLA) for the label expansion of asthma drug Dupixent (dupilumab) has been accepted for review by the FDA.
The sBLA is seeking approval for the drug to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU), which is not adequately controlled with the current standard of treatment — H1 antihistamine medication.
The regulatory body has set a target action date of Oct 22, 2023.
CSU is an inflammatory skin condition, primarily occurring due to type 2 inflammation. This causes sudden and debilitating hives and swelling on the skin.
The sBLA was supported by positive data from two phase III trials (LIBERTY-CUPID Studies A and B), evaluating Dupixent in two patients with uncontrolled CSU. Study A was conducted in CSU patients who were uncontrolled on standard-of-care antihistamines, with efficacy and safety data supporting the submission. Study B was conducted in CSU patients who were uncontrolled on standard-of-care antihistamines and refractory to omalizumab, with results providing additional supporting data.
Dupilumab was developed by Sanofi, in collaboration with its partner Regeneron (REGN - Free Report) . We note that Dupixent is approved in the United States and EU for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and eosinophilic esophagitis (EoE).
Sanofi markets Dupixent and Kevzara in partnership with Regeneron. While Sanofi records sales of drugs, REGN records its share of profits/losses in connection with the global sales of Dupixent and Kevzara.
Sanofi’s shares have lost 8.4% in the past year against the industry’s 6.4% gain.
Image Source: Zacks Investment Research
The drug is also being evaluated in a broad range of diseases driven by type 2 inflammation or other allergic processes, including pediatric EoE, atopic hand and foot dermatitis, chronic inducible urticaria-cold, CSU, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid.
Sanofi Price and Consensus
Sanofi price-consensus-chart | Sanofi Quote
Zacks Rank & Other Stocks to Consider
Sanofi currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same sector include Allogene Therapeutics (ALLO - Free Report) and CRISPR Therapeutics (CRSP - Free Report) both holding a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Allogene Therapeutics’ loss per share estimates have narrowed from $2.84 to $2.56 for 2023 and from $2.79 to $2.47 for 2024, in the past 60 days. The stock has plunged 26.9% in the past year.
ALLO’s earnings beat estimates in all the last four quarters, the average surprise being 8.33%.
CRISPR Therapeutics' loss per share estimates for 2023 have narrowed from $8.21 to $7.39 in the past 60 days.
CRSP's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 3.19%. The stock has declined 20.8% in the past year.