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.
Horizon (HZNP) Dazodalibep Meets Goal in Sjogren's Syndrome Study
Read MoreHide Full Article
Horizon Therapeutics Plc announced that a phase II study on its candidate, dazodalibep, for the treatment of Sjögren’s syndrome met the primary endpoint for the second population.
The phase II study comprised two patient populations with positive results in the first population announced by Horizon in September 2022. Dazodalibep currently stands as the only candidate to have achieved the primary endpoint in both patient populations in a phase II study.
Sjögren’ssyndrome is a chronic, systemic autoimmune disease affecting exocrine glands, primarily the salivary and tear glands, with severe cases affecting multiple organs. The disease increases the risk of non-Hodgkin’s B-cell lymphoma and there are currently no approved therapies to treat or to slow the course of the disease.
Dazodalibep, being developed by Horizon, disrupts the overactivation of the T-cell interaction with CD40-expressing B cells. There are several other autoimmune diseases that are associated with the same pathway and Horizon expects dazodalibep to be an effective treatment in this forte.
In the past year, shares of Horizon have risen 30.5% against the industry’s decline of 7.8%.
Image Source: Zacks Investment Research
The second patient population in the phase II study included those with moderate-to-severe symptomatology including dryness, pain, and fatigue despite lacking additional organ involvement. The company reported that on Day 169, patients treated with dazodalibep achieved a 1.8-point reduction in their Sjögren’s Syndrome Patient Reported Index (ESSPRI) scores as against 0.53-point reduction in patients treated with a placebo.
The ESSPRI is a composite endpoint that measures dryness, pain, and fatigue severity. A significant improvement in certain secondary quality-of-life measures, including fatigue, was observed. Dazodalibep was very well tolerated by patients with the most common adverse events through Day 169, like COVID-19 infection, nasopharyngitis, and anemia.
The absence of any disease-modifying FDA-approved treatments for Sjögren’s syndrome suggests a clear unmet clinical need and forms a lucrative market opportunity for Horizon Therapeutics.
HZNP previously announced that the phase II study of dazodalibep for the first population of patients with moderate-to-high systemic disease activity met its primary endpoint in September 2022. At Week 24, patients treated with dazodalibep achieved a 6.3-point reduction in their ESSDAI score against patients treated with a placebo achieved a 4.1-point reduction.
Horizon Therapeutics is set to be acquired by biotech giant Amgen (AMGN - Free Report) for $116.5 per share in cash or $27.8 billion per a definitive agreement announced in December 2022. This acquisition will add Horizon’s portfolio of rare disease drugs like Tepezza, Krystexxa and Uplizna to Amgen’s broad and diversified portfolio and should be accretive to the bottom line by 2024.
Tepezza is approved for the treatment of thyroid eye disease. Krystexxa is used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments. Uplizna is a prescription medicine used to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.
Zacks Rank and Other Stocks to Consider
Horizon Therapeutics currently has a Zacks Rank #2 (Buy).
In the past 60 days, the estimate for Celularity’s 2022 loss per share has narrowed from 44 cents to $34 cents. During the same period, the loss estimate per share for 2023 has narrowed from 97 cents to 86 cents. In the past year, the shares of Celularity have decreased by 71.0%.
CELU’s earnings witnessed an average earnings surprise of 51.01%, beating three out of four estimates, in the trailing four reported quarters.
In the past 60 days, the estimate for LianBio’s 2022 loss per share has narrowed from $1.30 to $1.23. In the past year, the shares of LianBio have decreased by 48.8%.
LIAN’s earnings witnessed an average earnings surprise of 7.06%, beating three out of the four surprise estimates in the trailing four quarters.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Horizon (HZNP) Dazodalibep Meets Goal in Sjogren's Syndrome Study
Horizon Therapeutics Plc announced that a phase II study on its candidate, dazodalibep, for the treatment of Sjögren’s syndrome met the primary endpoint for the second population.
The phase II study comprised two patient populations with positive results in the first population announced by Horizon in September 2022. Dazodalibep currently stands as the only candidate to have achieved the primary endpoint in both patient populations in a phase II study.
Sjögren’ssyndrome is a chronic, systemic autoimmune disease affecting exocrine glands, primarily the salivary and tear glands, with severe cases affecting multiple organs. The disease increases the risk of non-Hodgkin’s B-cell lymphoma and there are currently no approved therapies to treat or to slow the course of the disease.
Dazodalibep, being developed by Horizon, disrupts the overactivation of the T-cell interaction with CD40-expressing B cells. There are several other autoimmune diseases that are associated with the same pathway and Horizon expects dazodalibep to be an effective treatment in this forte.
In the past year, shares of Horizon have risen 30.5% against the industry’s decline of 7.8%.
Image Source: Zacks Investment Research
The second patient population in the phase II study included those with moderate-to-severe symptomatology including dryness, pain, and fatigue despite lacking additional organ involvement. The company reported that on Day 169, patients treated with dazodalibep achieved a 1.8-point reduction in their Sjögren’s Syndrome Patient Reported Index (ESSPRI) scores as against 0.53-point reduction in patients treated with a placebo.
The ESSPRI is a composite endpoint that measures dryness, pain, and fatigue severity. A significant improvement in certain secondary quality-of-life measures, including fatigue, was observed. Dazodalibep was very well tolerated by patients with the most common adverse events through Day 169, like COVID-19 infection, nasopharyngitis, and anemia.
The absence of any disease-modifying FDA-approved treatments for Sjögren’s syndrome suggests a clear unmet clinical need and forms a lucrative market opportunity for Horizon Therapeutics.
HZNP previously announced that the phase II study of dazodalibep for the first population of patients with moderate-to-high systemic disease activity met its primary endpoint in September 2022. At Week 24, patients treated with dazodalibep achieved a 6.3-point reduction in their ESSDAI score against patients treated with a placebo achieved a 4.1-point reduction.
Horizon Therapeutics is set to be acquired by biotech giant Amgen (AMGN - Free Report) for $116.5 per share in cash or $27.8 billion per a definitive agreement announced in December 2022. This acquisition will add Horizon’s portfolio of rare disease drugs like Tepezza, Krystexxa and Uplizna to Amgen’s broad and diversified portfolio and should be accretive to the bottom line by 2024.
Tepezza is approved for the treatment of thyroid eye disease. Krystexxa is used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments. Uplizna is a prescription medicine used to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.
Zacks Rank and Other Stocks to Consider
Horizon Therapeutics currently has a Zacks Rank #2 (Buy).
Some better-ranked stocks in the biotech sector are Celularity, Inc. (CELU - Free Report) and LianBio LLC , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, the estimate for Celularity’s 2022 loss per share has narrowed from 44 cents to $34 cents. During the same period, the loss estimate per share for 2023 has narrowed from 97 cents to 86 cents. In the past year, the shares of Celularity have decreased by 71.0%.
CELU’s earnings witnessed an average earnings surprise of 51.01%, beating three out of four estimates, in the trailing four reported quarters.
In the past 60 days, the estimate for LianBio’s 2022 loss per share has narrowed from $1.30 to $1.23. In the past year, the shares of LianBio have decreased by 48.8%.
LIAN’s earnings witnessed an average earnings surprise of 7.06%, beating three out of the four surprise estimates in the trailing four quarters.