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Sanofi's (SNY) Sarclisa sBLA Gets FDA's Priority Review Tag
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Sanofi (SNY - Free Report) announced that the FDA has accepted the supplemental biologics license application (sBLA), seeking expanded use of its multiple myeloma drug, Sarclisa (isatuximab).
The sBLA seeks approval for Sarclisa in combination with Velcade (bortezomib), Bristol-Myers’ (BMY - Free Report) Revlimid (lenalidomide) and dexamethasone (VRd) for the treatment of patients with newly diagnosed multiple myeloma (NDMM) who are transplant-ineligible.
With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected on Sep 27, 2024.
A similar regulatory application is also currently under review in the European Union.
The sBLA and the application in the EU were based on positive data from the phase III IMROZ study, which evaluated the investigational use of Sarclisa in combination with standard-of-care VRd in transplant-ineligible patients with NDMM. The study met its primary endpoint at a planned interim analysis for efficacy.
Data from the IMROZ study showed that treatment with the combination of Sarclisa plus VRd led to a statistically significant improvement in progression-free survival (PFS) compared with VRd alone in the given patient population.
If approved, Sarclisa would become the first anti-CD38 therapy in combination with standard-of-care VRd for treating newly diagnosed multiple myeloma patients who are not eligible for transplant.
Shares of Sanofi have declined 2.4% year to date against the industry’s increase of 16%.
Image Source: Zacks Investment Research
Sarclisa, in combination with BMY’s Pomalyst (pomalidomide) and dexamethasone, is presently approved for the treatment of certain patients with relapsed refractory MM (RRMM) who have received at least two prior therapies, including Revlimid (lenalidomide) and a proteasome inhibitor.
We note that Bristol-Myers’ Pomalyst and Revlimid are both approved for treating MM.
Sarclisa, in combination with Kyprolis (carfilzomib) and dexamethasone, is also approved for treating patients with RRMM who have received 1–3 prior lines of therapy.
Sarclisa generated sales worth €106 million in the first quarter of 2024, reflecting an increase of 28.7% year over year. Its approval for expanded use in newly diagnosed patients is expected to boost sales of the drug in future quarters.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have improved from $1.61 to $2.06. Earnings per share estimates for 2025 have improved from $3.69 to $4.33. Year to date, shares of KRYS have surged 31.3%.
KRYS’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average negative surprise being 21.46%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have narrowed from $2.44 to $1.87, while loss per share estimates for 2025 have narrowed from $1.97 to 90 cents. Year to date, shares of MRNS have plunged 87.3%.
MRNS’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same once, the average surprise being 3.27%.
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Sanofi's (SNY) Sarclisa sBLA Gets FDA's Priority Review Tag
Sanofi (SNY - Free Report) announced that the FDA has accepted the supplemental biologics license application (sBLA), seeking expanded use of its multiple myeloma drug, Sarclisa (isatuximab).
The sBLA seeks approval for Sarclisa in combination with Velcade (bortezomib), Bristol-Myers’ (BMY - Free Report) Revlimid (lenalidomide) and dexamethasone (VRd) for the treatment of patients with newly diagnosed multiple myeloma (NDMM) who are transplant-ineligible.
With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected on Sep 27, 2024.
A similar regulatory application is also currently under review in the European Union.
The sBLA and the application in the EU were based on positive data from the phase III IMROZ study, which evaluated the investigational use of Sarclisa in combination with standard-of-care VRd in transplant-ineligible patients with NDMM. The study met its primary endpoint at a planned interim analysis for efficacy.
Data from the IMROZ study showed that treatment with the combination of Sarclisa plus VRd led to a statistically significant improvement in progression-free survival (PFS) compared with VRd alone in the given patient population.
If approved, Sarclisa would become the first anti-CD38 therapy in combination with standard-of-care VRd for treating newly diagnosed multiple myeloma patients who are not eligible for transplant.
Shares of Sanofi have declined 2.4% year to date against the industry’s increase of 16%.
Image Source: Zacks Investment Research
Sarclisa, in combination with BMY’s Pomalyst (pomalidomide) and dexamethasone, is presently approved for the treatment of certain patients with relapsed refractory MM (RRMM) who have received at least two prior therapies, including Revlimid (lenalidomide) and a proteasome inhibitor.
We note that Bristol-Myers’ Pomalyst and Revlimid are both approved for treating MM.
Sarclisa, in combination with Kyprolis (carfilzomib) and dexamethasone, is also approved for treating patients with RRMM who have received 1–3 prior lines of therapy.
Sarclisa generated sales worth €106 million in the first quarter of 2024, reflecting an increase of 28.7% year over year. Its approval for expanded use in newly diagnosed patients is expected to boost sales of the drug in future quarters.
Zacks Rank & Stocks to Consider
Sanofi currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Krystal Biotech, Inc. (KRYS - Free Report) and Marinus Pharmaceuticals, Inc. (MRNS - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have improved from $1.61 to $2.06. Earnings per share estimates for 2025 have improved from $3.69 to $4.33. Year to date, shares of KRYS have surged 31.3%.
KRYS’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average negative surprise being 21.46%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have narrowed from $2.44 to $1.87, while loss per share estimates for 2025 have narrowed from $1.97 to 90 cents. Year to date, shares of MRNS have plunged 87.3%.
MRNS’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same once, the average surprise being 3.27%.