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Endo Files BLA for CCH With the FDA for Cellulite Candidate (Revised)
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Recently, Endo International plc (announced that it has submitted a Biologics License Application (BLA) to the FDA for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks. The FDA has a 60-day filing review period to determine whether the BLA is complete and acceptable for filing.
The latest submission is based on positive results from two identical phase III RELEASE studies presented at the 2019 Annual Meeting of the American Academy of Dermatology (AAD) in Washington, DC, and subsequently at the Aesthetic Meeting 2019 in New Orleans, LA. The studies showed that a greater percentage of the 843 women treated during the studies met the primary endpoint of response, with CCH versus placebo in both RELEASE-1 and RELEASE-2 studies.
Further, statistically significant improvements with the CCH versus placebo were observed for 8 of 8 (RELEASE-1) and 7 of 8 (RELEASE-2) secondary endpoints. All patient-centric endpoints displayed statistically significant improvement in the CCH group compared with the placebo group.
Notably, CCH for the treatment of cellulite will be a new product for the company and it will be marketed under a new brand name.We note that CCH is currently marketed by the company under the brand name of Xiaflex for the treatment of Peyronie's disease (PD) and Dupuytren's contracture. The drug’s performance was strong in the first half of 2019. The company is developing Xiaflex in partnership with BioSpecifics Technologies Corp. .
Shares of the company have plunged 58% year to date against the industry’s growth of 6.6%. However, the stock got a boost last week after it announced the finalization of a settlement agreement with two Ohio counties, County of Cuyahoga and the County of Summit,in an opioid-related litigation. Endo agreed to pay a total of $10 million to Cuyahoga and Summit counties. The company will also provide up to $1 million of its Vasostrict and Adrenalin products free of charge to these counties.
FibroGen’s loss per share estimates for 2019 narrowed from 87 cents to 37 cents in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, the average being 346.59%.
VAXART’s loss per share estimates for the current year narrowed from $1.67 to $1.45, in the past 60 days. The company delivered a positive earnings surprise in one of the trailing four quarters, the average being 22%.
(We are reissuing this article to correct a mistake. The original article, issued on September 9, 2019, should no longer be relied upon.)
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Endo Files BLA for CCH With the FDA for Cellulite Candidate (Revised)
Recently, Endo International plc ( announced that it has submitted a Biologics License Application (BLA) to the FDA for collagenase clostridium histolyticum (CCH) for the treatment of cellulite in the buttocks. The FDA has a 60-day filing review period to determine whether the BLA is complete and acceptable for filing.
The latest submission is based on positive results from two identical phase III RELEASE studies presented at the 2019 Annual Meeting of the American Academy of Dermatology (AAD) in Washington, DC, and subsequently at the Aesthetic Meeting 2019 in New Orleans, LA. The studies showed that a greater percentage of the 843 women treated during the studies met the primary endpoint of response, with CCH versus placebo in both RELEASE-1 and RELEASE-2 studies.
Further, statistically significant improvements with the CCH versus placebo were observed for 8 of 8 (RELEASE-1) and 7 of 8 (RELEASE-2) secondary endpoints. All patient-centric endpoints displayed statistically significant improvement in the CCH group compared with the placebo group.
Notably, CCH for the treatment of cellulite will be a new product for the company and it will be marketed under a new brand name.We note that CCH is currently marketed by the company under the brand name of Xiaflex for the treatment of Peyronie's disease (PD) and Dupuytren's contracture. The drug’s performance was strong in the first half of 2019. The company is developing Xiaflex in partnership with BioSpecifics Technologies Corp. .
Shares of the company have plunged 58% year to date against the industry’s growth of 6.6%. However, the stock got a boost last week after it announced the finalization of a settlement agreement with two Ohio counties, County of Cuyahoga and the County of Summit,in an opioid-related litigation. Endo agreed to pay a total of $10 million to Cuyahoga and Summit counties. The company will also provide up to $1 million of its Vasostrict and Adrenalin products free of charge to these counties.
Endo International plc Price
Endo International plc price | Endo International plc Quote
Zacks Rank & Other Stocks to Consider
Endo currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks are FibroGen Inc. (FGEN - Free Report) and VAXART INC. (VXRT - Free Report) . While FibroGen carries a Zacks Rank #1 (Strong Buy), VAXART carries a Zacks Rank#2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
FibroGen’s loss per share estimates for 2019 narrowed from 87 cents to 37 cents in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, the average being 346.59%.
VAXART’s loss per share estimates for the current year narrowed from $1.67 to $1.45, in the past 60 days. The company delivered a positive earnings surprise in one of the trailing four quarters, the average being 22%.
(We are reissuing this article to correct a mistake. The original article, issued on September 9, 2019, should no longer be relied upon.)