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AMGN's Dazodalibep Meets Goal in Systemic Sjogren's Disease Study
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Key Takeaways
Amgen's dazodalibep delivered significant improvement in systemic Sjogren's disease activity at week 48.
Dazodalibep's ESSDAI improvements emerged by week four and sustained through week 48.
AMGN plans to present detailed OASIZ 301 data. The OASIZ 303 study is expected to finish in Q4 2026.
Amgen (AMGN - Free Report) announced positive top-line data from the phase III OASIZ 301 study evaluating dazodalibep in adults with Sjögren’s disease and moderate-to-severe systemic disease activity.
Sjögren’s disease is a systemic autoimmune disease that can cause extensive dryness, fatigue, chronic pain, major organ involvement and neuropathy. Currently, there are no FDA-approved therapies for the given indication, highlighting a significant unmet need.
More on AMGN’s OASIZ 301 Study Data
Data from the OASIZ 301 study showed that treatment with dazodalibep led to statistically significant and clinically meaningful improvement as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 48 – the study’s primary endpoint.
ESSDAI is a validated clinical tool used to check systemic disease activity across organ systems in patients with Sjögren’s disease.
Importantly, improvements in ESSDAI were observed as early as week four following treatment with dazodalibep and were sustained through week 48.
AMGN’s Price Performance
Year to date, shares of Amgen have rallied 27.9% compared with the industry’s rise of 8%.
Image Source: Zacks Investment Research
Per the company, the above data underscores the potential of dazodalibep as an emerging treatment for improving systemic disease activity in patients with Sjögren’s disease.
Amgen plans to present detailed data from the OASIZ 301 study at an upcoming medical conference.
Besides the OASIZ 301 study, dazodalibep is also being evaluated in the phase III OASIZ 303 study in patients with moderate-to-severe symptomatic Sjögren's disease. The study is expected to be completed in the fourth quarter of 2026.
AMGN’s Key Pipeline Development Activities
Amgen has several interesting candidates in its pipeline, which represent significant commercial opportunity. The company’s main area of focus remains general medicine, obesity, inflammation, rare disease and oncology.
Besides dazodalibep, important pipeline candidates include olpasiran for atherosclerotic cardiovascular disease in a phase III study, xaluritamig for metastatic castration-resistant prostate cancer in a phase III study and daxdilimab for primary discoid lupus erythematosus in a phase II study.
Amgen is developing MariTide, a GIPR/GLP-1 receptor for monthly and maybe less frequent dosing, which may help reduce treatment burden and improve persistence on treatment over time. MariTide is being studied for type II diabetes, obesity and obesity-related conditions.
Amgen believes that progress across its late-stage pipeline assets and biosimilars pipeline can support sustainable long-term growth beyond its established portfolio of marketed drugs.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 14% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time frame. ANIK’s shares have surged 11% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents. Earnings estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 84.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 88.8%.
View the Zacks #1 Rank List
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AMGN's Dazodalibep Meets Goal in Systemic Sjogren's Disease Study
Key Takeaways
Amgen (AMGN - Free Report) announced positive top-line data from the phase III OASIZ 301 study evaluating dazodalibep in adults with Sjögren’s disease and moderate-to-severe systemic disease activity.
Sjögren’s disease is a systemic autoimmune disease that can cause extensive dryness, fatigue, chronic pain, major organ involvement and neuropathy. Currently, there are no FDA-approved therapies for the given indication, highlighting a significant unmet need.
More on AMGN’s OASIZ 301 Study Data
Data from the OASIZ 301 study showed that treatment with dazodalibep led to statistically significant and clinically meaningful improvement as measured by the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 48 – the study’s primary endpoint.
ESSDAI is a validated clinical tool used to check systemic disease activity across organ systems in patients with Sjögren’s disease.
Importantly, improvements in ESSDAI were observed as early as week four following treatment with dazodalibep and were sustained through week 48.
AMGN’s Price Performance
Year to date, shares of Amgen have rallied 27.9% compared with the industry’s rise of 8%.
Image Source: Zacks Investment Research
Per the company, the above data underscores the potential of dazodalibep as an emerging treatment for improving systemic disease activity in patients with Sjögren’s disease.
Amgen plans to present detailed data from the OASIZ 301 study at an upcoming medical conference.
Besides the OASIZ 301 study, dazodalibep is also being evaluated in the phase III OASIZ 303 study in patients with moderate-to-severe symptomatic Sjögren's disease. The study is expected to be completed in the fourth quarter of 2026.
AMGN’s Key Pipeline Development Activities
Amgen has several interesting candidates in its pipeline, which represent significant commercial opportunity. The company’s main area of focus remains general medicine, obesity, inflammation, rare disease and oncology.
Besides dazodalibep, important pipeline candidates include olpasiran for atherosclerotic cardiovascular disease in a phase III study, xaluritamig for metastatic castration-resistant prostate cancer in a phase III study and daxdilimab for primary discoid lupus erythematosus in a phase II study.
Amgen is developing MariTide, a GIPR/GLP-1 receptor for monthly and maybe less frequent dosing, which may help reduce treatment burden and improve persistence on treatment over time. MariTide is being studied for type II diabetes, obesity and obesity-related conditions.
Amgen believes that progress across its late-stage pipeline assets and biosimilars pipeline can support sustainable long-term growth beyond its established portfolio of marketed drugs.
AMGN’s Zacks Rank & Stocks to Consider
Amgen currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) , Anika Therapeutics (ANIK - Free Report) and Precigen (PGEN - 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.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 14% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time frame. ANIK’s shares have surged 11% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents. Earnings estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 84.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 88.8%.