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SAGE Rides on Zurzuvae Sales, Pipeline Setbacks a Concern
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Sage Therapeutics, Inc. (SAGE - Free Report) is focused on developing life-changing brain health medicines.
The company’s first marketed drug, Zulresso (brexanolone), was approved by the FDA in 2019 as the first-ever FDA-approved treatment for adults with postpartum depression (PPD).
SAGE’s second marketed drug, Zurzuvae (zuranolone) was approved by the FDA last August and commercially launched in December 2023. Zurzuvae is the first and only oral medicine indicated for adults with PPD.
SAGE markets Zurzuvae in partnership with drug giant Biogen (BIIB - Free Report) .
Sage and Biogen, equally share profits and losses for the commercialization of Zurzuvae in the United States. In ex-U.S. markets, Biogen records product sales (excluding Japan, Taiwan and South Korea) and pays royalties to Sage.
Sage and BIIB are focused on establishing Zurzuvae as a first-line therapy and the standard of care for women with PPD.
Shares of Sage Therapeutics have plunged 43.9% so far this year compared with the industry’s decline of 4%.
Image Source: Zacks Investment Research
SAGE is also developing its lead neuropsychiatric and neurology candidates, dalzanemdor and SAGE-324.
Last month, the company reported that the phase II SURVEYOR study evaluating dalzanemdor as a potential treatment for patients with cognition dysfunction caused by Huntington's disease (“HD”) met its primary endpoint.
SAGE is also investigating dalzanemdor in the larger phase II DIMENSION study, which is designed to evaluate the efficacy of dalzanemdor dosed over 12 weeks in people with cognitive impairment associated with HD. Data from this study is expected in late 2024.
Dalzanemdor is also being evaluated in the phase II LIGHTWAVE study for treating mild cognitive impairment and mild dementia associated with Alzheimer’s disease. Top-line data from this study is expected later this year.
Meanwhile, Sage is evaluating SAGE-324 in the phase IIb KINETIC 2 study as a potential treatment for patients with essential tremors. Top-line data from this study is expected shortly. The candidate is also being developed in collaboration with Biogen.
Being the only company with two FDA-approved drugs for PPD, Sage is well-placed to exploit the target market. However, the recent pipeline and regulatory setbacks have been an area of concern.
Though the company sought approval for Zurzuvae in major depressive disorder (MDD) indication, the FDA issued a complete response letter requesting management to conduct more clinical studies. This was a major setback as the MDD indication provided a much larger and more lucrative market opportunity.
In April 2024, SAGE reported that the phase II PRECEDENT study on dalzanemdor in Parkinson’s disease (PD) failed to achieve its primary endpoint. Based on this outcome, the company decided not to pursue the development of the drug in the PD indication going forward.
Similar setbacks in the future will hinder the company’s growth prospects.
In the past 60 days, estimates for Aclaris Therapeutics’ 2024 loss per share have narrowed from 81 cents to 78 cents, while loss per share estimates for 2025 have narrowed from 73 cents to 69 cents. Year to date, shares of ACRS have rallied 24.8%.
ACRS’ earnings beat estimates in each of the trailing four quarters, the average surprise being 13.62%.
In the past 60 days, estimates for Neurocrine Biosciences’ 2024 earnings per share have improved from $4.02 to $4.20. Earnings per share estimates for 2025 have improved from $6.51 to $6.73. Year to date, shares of NBIX have jumped 9.4%.
NBIX’s earnings beat estimates in two of the trailing four quarters while missing on the remaining two occasions, the average negative surprise being 4.68%.
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SAGE Rides on Zurzuvae Sales, Pipeline Setbacks a Concern
Sage Therapeutics, Inc. (SAGE - Free Report) is focused on developing life-changing brain health medicines.
The company’s first marketed drug, Zulresso (brexanolone), was approved by the FDA in 2019 as the first-ever FDA-approved treatment for adults with postpartum depression (PPD).
SAGE’s second marketed drug, Zurzuvae (zuranolone) was approved by the FDA last August and commercially launched in December 2023. Zurzuvae is the first and only oral medicine indicated for adults with PPD.
SAGE markets Zurzuvae in partnership with drug giant Biogen (BIIB - Free Report) .
Sage and Biogen, equally share profits and losses for the commercialization of Zurzuvae in the United States. In ex-U.S. markets, Biogen records product sales (excluding Japan, Taiwan and South Korea) and pays royalties to Sage.
Sage and BIIB are focused on establishing Zurzuvae as a first-line therapy and the standard of care for women with PPD.
Shares of Sage Therapeutics have plunged 43.9% so far this year compared with the industry’s decline of 4%.
Image Source: Zacks Investment Research
SAGE is also developing its lead neuropsychiatric and neurology candidates, dalzanemdor and SAGE-324.
Last month, the company reported that the phase II SURVEYOR study evaluating dalzanemdor as a potential treatment for patients with cognition dysfunction caused by Huntington's disease (“HD”) met its primary endpoint.
SAGE is also investigating dalzanemdor in the larger phase II DIMENSION study, which is designed to evaluate the efficacy of dalzanemdor dosed over 12 weeks in people with cognitive impairment associated with HD. Data from this study is expected in late 2024.
Dalzanemdor is also being evaluated in the phase II LIGHTWAVE study for treating mild cognitive impairment and mild dementia associated with Alzheimer’s disease. Top-line data from this study is expected later this year.
Meanwhile, Sage is evaluating SAGE-324 in the phase IIb KINETIC 2 study as a potential treatment for patients with essential tremors. Top-line data from this study is expected shortly. The candidate is also being developed in collaboration with Biogen.
Being the only company with two FDA-approved drugs for PPD, Sage is well-placed to exploit the target market. However, the recent pipeline and regulatory setbacks have been an area of concern.
Though the company sought approval for Zurzuvae in major depressive disorder (MDD) indication, the FDA issued a complete response letter requesting management to conduct more clinical studies. This was a major setback as the MDD indication provided a much larger and more lucrative market opportunity.
In April 2024, SAGE reported that the phase II PRECEDENT study on dalzanemdor in Parkinson’s disease (PD) failed to achieve its primary endpoint. Based on this outcome, the company decided not to pursue the development of the drug in the PD indication going forward.
Similar setbacks in the future will hinder the company’s growth prospects.
Sage Therapeutics, Inc. Price and Consensus
Sage Therapeutics, Inc. price-consensus-chart | Sage Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Sage currently carries a Zacks Rank #3 (Hold).
Some top-ranked stocks in the biotech sector are Aclaris Therapeutics, Inc. (ACRS - Free Report) and Neurocrine Biosciences, Inc. (NBIX - 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 Aclaris Therapeutics’ 2024 loss per share have narrowed from 81 cents to 78 cents, while loss per share estimates for 2025 have narrowed from 73 cents to 69 cents. Year to date, shares of ACRS have rallied 24.8%.
ACRS’ earnings beat estimates in each of the trailing four quarters, the average surprise being 13.62%.
In the past 60 days, estimates for Neurocrine Biosciences’ 2024 earnings per share have improved from $4.02 to $4.20. Earnings per share estimates for 2025 have improved from $6.51 to $6.73. Year to date, shares of NBIX have jumped 9.4%.
NBIX’s earnings beat estimates in two of the trailing four quarters while missing on the remaining two occasions, the average negative surprise being 4.68%.