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Endo (ENDP) Phase II Study for Frozen Shoulder Disappoints
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Endo International plc has announced disappointing top-line results from its phase II study of collagenase clostridium histolyticum (CCH) in participants with adhesive capsulitis (AC) of the shoulder.
The condition is commonly known as "frozen shoulder."
The phase II study enrolled 198 participants with unilateral idiopathic AC of the shoulder with restricted range of motion (ROM) and function in the affected shoulder. Participants were randomized equally to receive CCH or placebo administered by ultrasound-guided injection. Participants received up to three injections, separated by a minimum of 21 days. Participants completed standard home exercises and received physical therapy at designated time points during the study.
The primary endpoint was the change from baseline in the adapted American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Form composite score for the affected shoulder at the day 95 visit. This adapted scale measures pain and function parameters of the shoulder. Secondary endpoints included measures of passive and active range of motion improvement (PROM and AROM, respectively).
The study participants receiving up to three doses of CCH showed some improvement in the change from baseline in the adapted ASES Standardized Shoulder Form composite score for the affected shoulder at the day 95 visit. But, the difference compared to those study participants receiving placebo was not statistically significant.
However, the safety profile was consistent with the known safety profile from other studies.
Consequently, Endo will be reevaluating the path forward for CCH to treat adhesive capsulitis of the shoulder.
In March 2021, Endo launched collagenase clostridium histolyticum-aaes under the brand name QWO for the treatment of moderate to severe cellulite in the buttocks of adult women.
Endo has lost 86.7% in the year so far compared with the industry's 29.6% decline.
Image Source: Zacks Investment Research
We note that shares tanked significantly earlier after a Wall Street report stated that the company has started negotiations with its lenders and senior bondholders about a possible restructuring of more than $8 billion of debt.
Please note that Endo is already in deep trouble with several litigation suits over opioid sales, which has been an overhang on its shares for quite some time now.
Per a recent Bloomberg article, Endo’s senior leaders have advised the company to file a bankruptcy to survive this turmoil. They have also suggested that Endo skip paying the upcoming interests to shareholders to preserve company cash.
Endo reported first-quarter earnings of 66 cents per share, beating the Zacks Consensus Estimate of 44 cents but declining from 73 cents in the year-ago quarter. A significant increase in litigation expenses and selling, general and administrative expenses hurt the bottom line.
As of March 2022, the company had $1.4 billion of cash and equivalents and long-term debt of $8.0 billion.
Loss estimates for SESN for 2022 have narrowed to 44 cents from a loss of 46 cents in the past 60 days. Sesen surpassed estimates in all of the trailing four quarters, the average surprise being 69.94%.
Loss estimates for Bolt for 2022 have narrowed to $2.87 from $2.99 in the past 60 days. Bolt surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average surprise being a negative 17.29%.
Loss estimates for GERN for 2022 have narrowed by 6 cents in the past 60 days. Geron surpassed estimates in three of the trailing four quarters, the average surprise being 1.07%.
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Endo (ENDP) Phase II Study for Frozen Shoulder Disappoints
Endo International plc has announced disappointing top-line results from its phase II study of collagenase clostridium histolyticum (CCH) in participants with adhesive capsulitis (AC) of the shoulder.
The condition is commonly known as "frozen shoulder."
The phase II study enrolled 198 participants with unilateral idiopathic AC of the shoulder with restricted range of motion (ROM) and function in the affected shoulder. Participants were randomized equally to receive CCH or placebo administered by ultrasound-guided injection. Participants received up to three injections, separated by a minimum of 21 days. Participants completed standard home exercises and received physical therapy at designated time points during the study.
The primary endpoint was the change from baseline in the adapted American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Form composite score for the affected shoulder at the day 95 visit. This adapted scale measures pain and function parameters of the shoulder. Secondary endpoints included measures of passive and active range of motion improvement (PROM and AROM, respectively).
The study participants receiving up to three doses of CCH showed some improvement in the change from baseline in the adapted ASES Standardized Shoulder Form composite score for the affected shoulder at the day 95 visit. But, the difference compared to those study participants receiving placebo was not statistically significant.
However, the safety profile was consistent with the known safety profile from other studies.
Consequently, Endo will be reevaluating the path forward for CCH to treat adhesive capsulitis of the shoulder.
In March 2021, Endo launched collagenase clostridium histolyticum-aaes under the brand name QWO for the treatment of moderate to severe cellulite in the buttocks of adult women.
Endo has lost 86.7% in the year so far compared with the industry's 29.6% decline.
Image Source: Zacks Investment Research
We note that shares tanked significantly earlier after a Wall Street report stated that the company has started negotiations with its lenders and senior bondholders about a possible restructuring of more than $8 billion of debt.
Please note that Endo is already in deep trouble with several litigation suits over opioid sales, which has been an overhang on its shares for quite some time now.
Per a recent Bloomberg article, Endo’s senior leaders have advised the company to file a bankruptcy to survive this turmoil. They have also suggested that Endo skip paying the upcoming interests to shareholders to preserve company cash.
Endo reported first-quarter earnings of 66 cents per share, beating the Zacks Consensus Estimate of 44 cents but declining from 73 cents in the year-ago quarter. A significant increase in litigation expenses and selling, general and administrative expenses hurt the bottom line.
As of March 2022, the company had $1.4 billion of cash and equivalents and long-term debt of $8.0 billion.
Zacks Rank & Stocks to Consider
Endo currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks are Sesen Bio , Bolt Therapeutics (BOLT - Free Report) and Geron Corporation (GERN - Free Report) . While Sesen sports a Zacks Rank #1 (Strong Buy), Geron and Bolt have a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss estimates for SESN for 2022 have narrowed to 44 cents from a loss of 46 cents in the past 60 days. Sesen surpassed estimates in all of the trailing four quarters, the average surprise being 69.94%.
Loss estimates for Bolt for 2022 have narrowed to $2.87 from $2.99 in the past 60 days. Bolt surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average surprise being a negative 17.29%.
Loss estimates for GERN for 2022 have narrowed by 6 cents in the past 60 days. Geron surpassed estimates in three of the trailing four quarters, the average surprise being 1.07%.