We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Sanofi (SNY) Rilzabrutinib Shows Benefit in Blood Disorder Study
Read MoreHide Full Article
Sanofi (SNY - Free Report) announced positive data from the phase III LUNA 3 study, which evaluated its covalent BTK inhibitor, rilzabrutinib, for treating patients with immune thrombocytopenia (ITP), an autoimmune blood disorder.
The LUNA 3 study evaluated the safety and efficacy of rilzabrutinib versus placebo in adult and adolescent patients with persistent or chronic ITP.
Data from the study showed that treatment with twice-daily oral rilzabrutinib (400 mg) led to durable platelet response, the primary endpoint of the LUNA 3 study, in significantly higher proportion of adult patients with persistent or chronic ITP as compared to placebo.
The data underscore the potential of rilzabrutinib to provide a clinically meaningful benefit to patients living with ITP. Moreover, the safety profile of rilzabrutinib was similar to that seen in previous clinical studies.
Building on the success of the LUNA 3 study, SNY plans to make regulatory filings for rilzabrutinib in ITP in the United States and in the European Union by 2024-end.
Shares of Sanofi have declined 5.2% so far this year against the industry’s rise of 8.7%.
Image Source: Zacks Investment Research
The FDA has already granted a Fast Track designation and an Orphan Drug designation to rilzabrutinib for the treatment of ITP.
Apart from ITP, rilzabrutinib is being studied in various mid to late-stage studies for treating several immune-mediated diseases. The candidate is being evaluated in a phase II study for treating asthma.
Two different phase IIb studies are investigating rilzabrutinib in IgG4-related disease and warm autoimmune hemolytic anemia. Data from both these studies are expected in the second half of 2024.
Meanwhile, SNY plans to begin separate phase III studies evaluating rilzabrutinib for the treatment of chronic spontaneous urticaria and prurigo nodularis later in 2024.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Year to date, shares of ADMA have rallied 37.2%.
ADMA’s earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 85.00%.
In the past 60 days, estimates for Ligand’s 2024 earnings per share have improved from $4.42 to $4.56. Year to date, shares of LGND have decreased 4%.
Earnings of LGND beat estimates in each of the trailing four quarters, the average surprise being 84.81%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.12 to $4.43. Year to date, shares of ANIP have jumped 19%.
Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Sanofi (SNY) Rilzabrutinib Shows Benefit in Blood Disorder Study
Sanofi (SNY - Free Report) announced positive data from the phase III LUNA 3 study, which evaluated its covalent BTK inhibitor, rilzabrutinib, for treating patients with immune thrombocytopenia (ITP), an autoimmune blood disorder.
The LUNA 3 study evaluated the safety and efficacy of rilzabrutinib versus placebo in adult and adolescent patients with persistent or chronic ITP.
Data from the study showed that treatment with twice-daily oral rilzabrutinib (400 mg) led to durable platelet response, the primary endpoint of the LUNA 3 study, in significantly higher proportion of adult patients with persistent or chronic ITP as compared to placebo.
The data underscore the potential of rilzabrutinib to provide a clinically meaningful benefit to patients living with ITP. Moreover, the safety profile of rilzabrutinib was similar to that seen in previous clinical studies.
Building on the success of the LUNA 3 study, SNY plans to make regulatory filings for rilzabrutinib in ITP in the United States and in the European Union by 2024-end.
Shares of Sanofi have declined 5.2% so far this year against the industry’s rise of 8.7%.
Image Source: Zacks Investment Research
The FDA has already granted a Fast Track designation and an Orphan Drug designation to rilzabrutinib for the treatment of ITP.
Apart from ITP, rilzabrutinib is being studied in various mid to late-stage studies for treating several immune-mediated diseases. The candidate is being evaluated in a phase II study for treating asthma.
Two different phase IIb studies are investigating rilzabrutinib in IgG4-related disease and warm autoimmune hemolytic anemia. Data from both these studies are expected in the second half of 2024.
Meanwhile, SNY plans to begin separate phase III studies evaluating rilzabrutinib for the treatment of chronic spontaneous urticaria and prurigo nodularis later in 2024.
Zacks Rank & Stocks to Consider
Sanofi currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the healthcare sector are ADMA Biologics, Inc. (ADMA - Free Report) , Ligand Pharmaceuticals Incorporated (LGND - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Year to date, shares of ADMA have rallied 37.2%.
ADMA’s earnings beat estimates in three of the trailing four quarters and met the same once, the average surprise being 85.00%.
In the past 60 days, estimates for Ligand’s 2024 earnings per share have improved from $4.42 to $4.56. Year to date, shares of LGND have decreased 4%.
Earnings of LGND beat estimates in each of the trailing four quarters, the average surprise being 84.81%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.12 to $4.43. Year to date, shares of ANIP have jumped 19%.
Earnings of ANIP beat estimates in each of the trailing four quarters, the average surprise being 109.06%.