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Aclaris (ACRS) Down 21% on Mixed Results From Eczema Study
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Shares of Aclaris (ACRS - Free Report) lost 21.5% on Jan 10 after management announced top-line results from a phase IIb study (ATI-1777-AD-202) on its investigational topical ‘soft’ JAK 1/3 inhibitor ATI-1777 in patients with mild to severe atopic dermatitis (AD or eczema).
The ATI-1777-AD-202 study evaluated ATI-1777 as a spray at concentrations of 0.5%, 1% or 2% administered twice daily, or a once-daily treatment of ATI-1777 at 2% concentration, compared with vehicle, in AD patients aged 12 years and older.
This study met its primary endpoint of statistically significant change in the Eczema Area and Severity Index (EASI) score following four weeks of treatment with ATI-1777 2% administered twice daily. The EASI score was 69.7% for patients who received the spray at 2% concentration twice daily compared with 58.7% in the pooled vehicle group.
Yet, patients administered the 2% concentration of ATI-1777 once daily exhibited only a ‘trend toward significance,’ showing a 68.3% change in EASI score compared with 59.5% in the vehicle-receiving group. Per management, this difference failed to achieve statistical superiority.
Although the phase IIb study lacked statistical power for a response measured by the Investigator Global Assessment Treatment Success (ING-TS), recognized as the FDA's regulatory endpoint, Aclaris reported that the drug demonstrated improvement in this aspect. The once-daily and twice-daily 2% concentrations showed changes of 37.2% and 36.6%, respectively, compared with 27.1% and 26.3% in the corresponding vehicle cohorts.
This close proximity of ATI-1777 results with the vehicle did not sit well with the investors, which is likely the reason for the fall in share price. In the past year, shares of Aclaris have plunged 93.9% compared with the industry’s 0.5% decline.
Image Source: Zacks Investment Research
Aclaris did not share any numerical data on the 0.5% and 1% concentrations. It intends to submit the full results at a future medical meeting.
The mixed results could also prove detrimental for the company in its search for a partner to develop and market ATI-1777. Management expects the drug to be potentially effective for treating additional indications like vitiligo.
This is one of the multiple clinical setbacks faced by management in the past year. Last November, Aclaris reported top-line data from a phase IIb study on zunsemetinib in rheumatoid arthritis (RA) indication, which failed to achieve its primary or secondary efficacy endpoints. Previously, in March, Aclaris reported top-line data from a phase IIa study on zunsemetinib in hidradenitis suppurativa (HS) indication, which also failed to achieve its primary or secondary efficacy endpoints.
Following the above setbacks, the company had previously announced its decision to discontinue the development of zunsemetinib. However, it recently decided to revive the candidate, with plans for use as a potential treatment for pancreatic cancer and metastatic breast cancer indications.
Aclaris is also undergoing a restructuring plan, implemented last month, wherein management plans to reduce its workforce by nearly 46%. It expects to achieve this reduction by June substantially.
Aclaris currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the overall healthcare sector include CytomX Therapeutics (CTMX - Free Report) , Novo Nordisk (NVO - Free Report) and Sarepta Therapeutics (SRPT - Free Report) . While CytomX sports a Zacks Rank #1 (Strong Buy), Novo Nordisk and Sarepta carry a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CytomX Therapeutics for 2023 have swung from a loss of 10 cents per share to earnings of 2 cents. During the same period, estimates for 2024 have narrowed from a loss of 22 cents to a loss of 6 cents. Shares of CytomX have lost 39.1% in the past year.
CytomX Therapeutics’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 45.44%. In the last reported quarter, CytomX Therapeutics’ earnings beat estimates by 123.53%.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.62 to $2.42. During the same period, the earnings estimates for 2024 have risen from $3.07 to $3.16. Shares of NVO have surged 63.9% in the past year.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.
In the past 60 days, Sarepta’s loss estimates for 2023 have improved from a loss of $7.53 per share to $6.79 per share. During the same period, earnings estimates per share for 2024 have risen from 46 cents to $1.72. Sarepta’s shares have lost 0.8% in the past year.
Sarepta’s earnings beat estimates in each of the last four quarters, delivering an average surprise of 48.67%. In the last reported quarter, Sarepta’s earnings beat estimates by 72.29%.
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Aclaris (ACRS) Down 21% on Mixed Results From Eczema Study
Shares of Aclaris (ACRS - Free Report) lost 21.5% on Jan 10 after management announced top-line results from a phase IIb study (ATI-1777-AD-202) on its investigational topical ‘soft’ JAK 1/3 inhibitor ATI-1777 in patients with mild to severe atopic dermatitis (AD or eczema).
The ATI-1777-AD-202 study evaluated ATI-1777 as a spray at concentrations of 0.5%, 1% or 2% administered twice daily, or a once-daily treatment of ATI-1777 at 2% concentration, compared with vehicle, in AD patients aged 12 years and older.
This study met its primary endpoint of statistically significant change in the Eczema Area and Severity Index (EASI) score following four weeks of treatment with ATI-1777 2% administered twice daily. The EASI score was 69.7% for patients who received the spray at 2% concentration twice daily compared with 58.7% in the pooled vehicle group.
Yet, patients administered the 2% concentration of ATI-1777 once daily exhibited only a ‘trend toward significance,’ showing a 68.3% change in EASI score compared with 59.5% in the vehicle-receiving group. Per management, this difference failed to achieve statistical superiority.
Although the phase IIb study lacked statistical power for a response measured by the Investigator Global Assessment Treatment Success (ING-TS), recognized as the FDA's regulatory endpoint, Aclaris reported that the drug demonstrated improvement in this aspect. The once-daily and twice-daily 2% concentrations showed changes of 37.2% and 36.6%, respectively, compared with 27.1% and 26.3% in the corresponding vehicle cohorts.
This close proximity of ATI-1777 results with the vehicle did not sit well with the investors, which is likely the reason for the fall in share price. In the past year, shares of Aclaris have plunged 93.9% compared with the industry’s 0.5% decline.
Image Source: Zacks Investment Research
Aclaris did not share any numerical data on the 0.5% and 1% concentrations. It intends to submit the full results at a future medical meeting.
The mixed results could also prove detrimental for the company in its search for a partner to develop and market ATI-1777. Management expects the drug to be potentially effective for treating additional indications like vitiligo.
This is one of the multiple clinical setbacks faced by management in the past year. Last November, Aclaris reported top-line data from a phase IIb study on zunsemetinib in rheumatoid arthritis (RA) indication, which failed to achieve its primary or secondary efficacy endpoints. Previously, in March, Aclaris reported top-line data from a phase IIa study on zunsemetinib in hidradenitis suppurativa (HS) indication, which also failed to achieve its primary or secondary efficacy endpoints.
Following the above setbacks, the company had previously announced its decision to discontinue the development of zunsemetinib. However, it recently decided to revive the candidate, with plans for use as a potential treatment for pancreatic cancer and metastatic breast cancer indications.
Aclaris is also undergoing a restructuring plan, implemented last month, wherein management plans to reduce its workforce by nearly 46%. It expects to achieve this reduction by June substantially.
Aclaris Therapeutics, Inc. Price
Aclaris Therapeutics, Inc. price | Aclaris Therapeutics, Inc. Quote
Zacks Rank & Other Key Picks
Aclaris currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the overall healthcare sector include CytomX Therapeutics (CTMX - Free Report) , Novo Nordisk (NVO - Free Report) and Sarepta Therapeutics (SRPT - Free Report) . While CytomX sports a Zacks Rank #1 (Strong Buy), Novo Nordisk and Sarepta carry a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CytomX Therapeutics for 2023 have swung from a loss of 10 cents per share to earnings of 2 cents. During the same period, estimates for 2024 have narrowed from a loss of 22 cents to a loss of 6 cents. Shares of CytomX have lost 39.1% in the past year.
CytomX Therapeutics’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 45.44%. In the last reported quarter, CytomX Therapeutics’ earnings beat estimates by 123.53%.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.62 to $2.42. During the same period, the earnings estimates for 2024 have risen from $3.07 to $3.16. Shares of NVO have surged 63.9% in the past year.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.
In the past 60 days, Sarepta’s loss estimates for 2023 have improved from a loss of $7.53 per share to $6.79 per share. During the same period, earnings estimates per share for 2024 have risen from 46 cents to $1.72. Sarepta’s shares have lost 0.8% in the past year.
Sarepta’s earnings beat estimates in each of the last four quarters, delivering an average surprise of 48.67%. In the last reported quarter, Sarepta’s earnings beat estimates by 72.29%.