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Horizon's (HZNP) Phase II Sjogren's Syndrome Study Meets Goal
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Horizon Therapeutics plc announced that the phase II study evaluating its pipeline candidate, dazodalibep, for the treatment of Sjögren’s syndrome has met the primary endpoint in patients with moderate-to-high systemic disease activity. This was evident from the European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) score of ≥ 5.
Data from the study showed that treatment with dazodalibep led to a 6.3-point reduction in patients’ ESSDAI scores compared to a 4.1-point reduction in patients who received a placebo at 24 weeks.
Treatment with dazodalibep was generally well-tolerated.
Currently, there is no FDA-approved treatment available for Sjögren’s syndrome, a devastating autoimmune disease.
The above-mentioned phase II study is also evaluating dazodalibep in a separate set of patient populations with moderate-to-severe subjective symptoms, as defined by EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score of ≥ 5.
Shares of Horizon have plunged 38.1% in the year compared with the industry’s decline of 21.1%.
Image Source: Zacks Investment Research
Apart from Sjögren’s syndrome, dazodalibep, a CD40 ligand antagonist, is also being developed for various other autoimmune diseases.
A phase II study is evaluating dazodalibep in patients with rheumatoid arthritis (RA). In May 2022, HZNP announced positive top-line data from the same. The study met its primary endpoint and treatment with dazodalibep was generally well-tolerated.
Another phase II study is currently underway, investigating dazodalibep in kidney transplant rejection patients.
Horizon plans to evaluate dazodalibep in a phase II study for treating patients with focal segmental glomerulosclerosis, a rare kidney disorder characterized by scarring of glomeruli.
Investors must note that Horizon reports financial results under two segments, Orphan and Inflammation. HZNP’s portfolio of marketed drugs has been witnessing a solid uptake to date.
In the first six months of 2022, the Orphan segment generated sales worth $1.67 billion, reflecting an increase of 67% on a year-over-year basis.
Sales in the Orphan segment are being driven by strong sales growth in Krystexxa and continued growth of drugs like Uplizna, Ravicti, Actimmune and Tepezza.
Successful development and potential approval of its pipeline candidates are likely to diversify Horizon’s portfolio of drugs and drive growth in the days ahead.
Zacks Rank & Stocks to Consider
Horizon currently carries a Zacks Rank #5 (Strong Sell).
Aptose Biosciences’ loss per share estimates have narrowed 15.8% for 2022 and 16% for 2023 in the past 60 days.
Earnings of Aptose Biosciences surpassed estimates in three of the trailing four quarters and missed the mark on the remaining occasion. APTO delivered an earnings surprise of 2.23%, on average.
Atara Biotherapeutics’ loss per share estimates have narrowed 43.2% for 2022 and 31.8% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed the same on a single occasion. ATRA delivered an earnings surprise of 4.83%, on average.
ORIC Pharmaceuticals’ loss per share estimates have narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed the mark on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.
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Horizon's (HZNP) Phase II Sjogren's Syndrome Study Meets Goal
Horizon Therapeutics plc announced that the phase II study evaluating its pipeline candidate, dazodalibep, for the treatment of Sjögren’s syndrome has met the primary endpoint in patients with moderate-to-high systemic disease activity. This was evident from the European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) score of ≥ 5.
Data from the study showed that treatment with dazodalibep led to a 6.3-point reduction in patients’ ESSDAI scores compared to a 4.1-point reduction in patients who received a placebo at 24 weeks.
Treatment with dazodalibep was generally well-tolerated.
Currently, there is no FDA-approved treatment available for Sjögren’s syndrome, a devastating autoimmune disease.
The above-mentioned phase II study is also evaluating dazodalibep in a separate set of patient populations with moderate-to-severe subjective symptoms, as defined by EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score of ≥ 5.
Shares of Horizon have plunged 38.1% in the year compared with the industry’s decline of 21.1%.
Image Source: Zacks Investment Research
Apart from Sjögren’s syndrome, dazodalibep, a CD40 ligand antagonist, is also being developed for various other autoimmune diseases.
A phase II study is evaluating dazodalibep in patients with rheumatoid arthritis (RA). In May 2022, HZNP announced positive top-line data from the same. The study met its primary endpoint and treatment with dazodalibep was generally well-tolerated.
Another phase II study is currently underway, investigating dazodalibep in kidney transplant rejection patients.
Horizon plans to evaluate dazodalibep in a phase II study for treating patients with focal segmental glomerulosclerosis, a rare kidney disorder characterized by scarring of glomeruli.
Investors must note that Horizon reports financial results under two segments, Orphan and Inflammation. HZNP’s portfolio of marketed drugs has been witnessing a solid uptake to date.
In the first six months of 2022, the Orphan segment generated sales worth $1.67 billion, reflecting an increase of 67% on a year-over-year basis.
Sales in the Orphan segment are being driven by strong sales growth in Krystexxa and continued growth of drugs like Uplizna, Ravicti, Actimmune and Tepezza.
Successful development and potential approval of its pipeline candidates are likely to diversify Horizon’s portfolio of drugs and drive growth in the days ahead.
Zacks Rank & Stocks to Consider
Horizon currently carries a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks in the biotech sector are Aptose Biosciences Inc. (APTO - Free Report) , Atara Biotherapeutics, Inc. (ATRA - Free Report) and ORIC Pharmaceuticals, Inc. (ORIC - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aptose Biosciences’ loss per share estimates have narrowed 15.8% for 2022 and 16% for 2023 in the past 60 days.
Earnings of Aptose Biosciences surpassed estimates in three of the trailing four quarters and missed the mark on the remaining occasion. APTO delivered an earnings surprise of 2.23%, on average.
Atara Biotherapeutics’ loss per share estimates have narrowed 43.2% for 2022 and 31.8% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed the same on a single occasion. ATRA delivered an earnings surprise of 4.83%, on average.
ORIC Pharmaceuticals’ loss per share estimates have narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed the mark on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.