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Ironwood (IRWD) Gets FDA Priority Tag for Linzess sNDA
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Ironwood Pharmaceuticals (IRWD - Free Report) announced that the FDA has accepted and granted priority review to a supplemental new drug application (sNDA), seeking expanded use of Linzess (linaclotide) for children and adolescents with functional constipation (“FC”). The FDA has assigned a PDUFA date of Jun 14, 2023.
Ironwood had filed the sNDA in December last year. Linzess, developed by Ironwood and its partner AbbVie (ABBV - Free Report) , is the sole commercial product in Ironwood’s portfolio. Linzess is currently indicated for the treatment of irritable bowel syndrome with constipation (“IBS-C”) and chronic idiopathic constipation in adults above 18 years of age. Presently, it is not approved for use in patients below 18 years.
Functional constipation is one of the most common gastrointestinal issues in pediatric patients and currently has no FDA-approved treatments for children.
Shares of Ironwood have risen 5% in the past year against the industry’s decline of 14.7%.
Image Source: Zacks Investment Research
The sNDA was based on data from a phase III study, which evaluated Linzess in pediatric FC patients six to 17 years of age. The study met its primary and secondary end points. The top-line data from the study showed that Linzess led to a statistically significant and clinically meaningful improvement from baseline in 12-week spontaneous bowel movement (SBM) frequency rate. SBM frequency was the study’s primary endpoint.
With no FDA-approved prescription pediatric therapies for FC, the indication represents a significant opportunity. Approximately 6 million kids in the age bracket of 6-17 suffer from FC in the United States. Ironwood is also evaluating linaclotide in IBS-C for pediatric patients between six to 17 years.
Ironwood and partner AbbVie co-develop and co-commercialize Linzess and equally share Linzess' U.S. collaboration profits or losses as well as all development costs. Linzess is marketed by AbbVie for IBS-C in Europe and Canada under the brand name Constella. Ironwood receives royalties on sales of Constella in Europe and Canada from AbbVie. As reported by partner AbbVie, Linzess generated net sales of $1.0 billion in the United States in 2022. Ironwood reports its share of net profits from the sales of Linzess in the United States, which is included in collaborative revenues. It will report this number for 2022 when it announces its full-year results later this month.
Ironwood also has agreements with two other partners — Astellas Pharma and AstraZeneca (AZN - Free Report) — related to the development and commercialization of Linzess in Japan and China, respectively. Ironwood records royalties on sales of Linzess from Astellas and AstraZeneca in their respective territories.
Catalyst’s earnings per share estimates for 2023 have improved from 88 cents to $1.13 in the past 60 days.
Earnings of Catalyst missed estimates in two of the trailing four quarters and beat the same twice. The average negative earnings surprise for CPRX is 4.10%.
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Ironwood (IRWD) Gets FDA Priority Tag for Linzess sNDA
Ironwood Pharmaceuticals (IRWD - Free Report) announced that the FDA has accepted and granted priority review to a supplemental new drug application (sNDA), seeking expanded use of Linzess (linaclotide) for children and adolescents with functional constipation (“FC”). The FDA has assigned a PDUFA date of Jun 14, 2023.
Ironwood had filed the sNDA in December last year. Linzess, developed by Ironwood and its partner AbbVie (ABBV - Free Report) , is the sole commercial product in Ironwood’s portfolio. Linzess is currently indicated for the treatment of irritable bowel syndrome with constipation (“IBS-C”) and chronic idiopathic constipation in adults above 18 years of age. Presently, it is not approved for use in patients below 18 years.
Functional constipation is one of the most common gastrointestinal issues in pediatric patients and currently has no FDA-approved treatments for children.
Shares of Ironwood have risen 5% in the past year against the industry’s decline of 14.7%.
Image Source: Zacks Investment Research
The sNDA was based on data from a phase III study, which evaluated Linzess in pediatric FC patients six to 17 years of age. The study met its primary and secondary end points. The top-line data from the study showed that Linzess led to a statistically significant and clinically meaningful improvement from baseline in 12-week spontaneous bowel movement (SBM) frequency rate. SBM frequency was the study’s primary endpoint.
With no FDA-approved prescription pediatric therapies for FC, the indication represents a significant opportunity. Approximately 6 million kids in the age bracket of 6-17 suffer from FC in the United States. Ironwood is also evaluating linaclotide in IBS-C for pediatric patients between six to 17 years.
Ironwood and partner AbbVie co-develop and co-commercialize Linzess and equally share Linzess' U.S. collaboration profits or losses as well as all development costs. Linzess is marketed by AbbVie for IBS-C in Europe and Canada under the brand name Constella. Ironwood receives royalties on sales of Constella in Europe and Canada from AbbVie. As reported by partner AbbVie, Linzess generated net sales of $1.0 billion in the United States in 2022. Ironwood reports its share of net profits from the sales of Linzess in the United States, which is included in collaborative revenues. It will report this number for 2022 when it announces its full-year results later this month.
Ironwood also has agreements with two other partners — Astellas Pharma and AstraZeneca (AZN - Free Report) — related to the development and commercialization of Linzess in Japan and China, respectively. Ironwood records royalties on sales of Linzess from Astellas and AstraZeneca in their respective territories.
Zacks Rank & Stock to Consider
Currently, Ironwood carries a Zacks Rank #4 (Sell). A better stock in the same sector is Catalyst Pharmaceuticals (CPRX - Free Report) , which has a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Catalyst’s earnings per share estimates for 2023 have improved from 88 cents to $1.13 in the past 60 days.
Earnings of Catalyst missed estimates in two of the trailing four quarters and beat the same twice. The average negative earnings surprise for CPRX is 4.10%.