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Horizon (HZNP) Gets FDA Nod for Krystexxa's Label Expansion
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Horizon Therapeutics plc announced that the FDA has approved its supplemental biologics license application (“BLA”) for combination use of its marketed drug, Krystexxa. The FDA has now approved Krystexxa injection plus methotrexate to help more people with uncontrolled gout achieve a complete response to therapy.
Krystexxa, until now, was approved as a monotherapy for the treatment of adult patients with chronic gout refractory to conventional therapies, also called uncontrolled gout.
The latest FDA approval was based on data from the MIRROR randomized clinical study, which evaluated Krystexxa plus methotrexate in patients with uncontrolled gout. Data from the same showed that treatment with Krystexxa plus methotrexate led to a significant improvement and sustained patient response compared to Krystexxa alone.
The data also demonstrated a more than 30%-point increase in patient response rate during month six — 71% of patients who received treatment with Krystexxa plus methotrexate achieved the primary endpoint, which is defined as sUA<6 mg/dL, at least 80% of the time during month six.
No new safety concerns were identified from the study.
Shares of Horizon have lost 22.4% in the year so far compared with the industry’s decline of 18.3%.
Image Source: Zacks Investment Research
Per the company, immunomodulatory therapies like methotrexate are often used with biologic therapies to reduce the development of anti-drug antibodies. The latest approval for Krystexxa plus methotrexate will allow more physicians to recommend the combo to help people with uncontrolled gout.
In March 2022, the FDA granted priority review to the above-mentioned sBLA for Krystexxa. Horizon submitted the sBLA for the label expansion of Krystexxa to the FDA in January.
Krystexxa remains an important top-line driver for Horizon. The drug generated sales worth $140.7 million in the first quarter of 2022, reflecting an increase of 32% year over year. The label expansion of the drug in combination with methotrexate will make it eligible to serve a broader patient population and boost sales further in 2022 and beyond.
The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 in the past 60 days.
Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.
Aptose Biosciences’ loss per share estimates narrowed 16.1% for 2022 and 13% for 2023 in the past 60 days.
Earnings of Aptose Biosciences have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. APTO delivered an earnings surprise of 2.55%, on average.
Precision BioSciences’ loss per share estimates narrowed 26.2% for 2022 and 42.6% for 2023 in the past 60 days.
Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters. DTIL delivered an earnings surprise of 76.15%, on average.
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Horizon (HZNP) Gets FDA Nod for Krystexxa's Label Expansion
Horizon Therapeutics plc announced that the FDA has approved its supplemental biologics license application (“BLA”) for combination use of its marketed drug, Krystexxa. The FDA has now approved Krystexxa injection plus methotrexate to help more people with uncontrolled gout achieve a complete response to therapy.
Krystexxa, until now, was approved as a monotherapy for the treatment of adult patients with chronic gout refractory to conventional therapies, also called uncontrolled gout.
The latest FDA approval was based on data from the MIRROR randomized clinical study, which evaluated Krystexxa plus methotrexate in patients with uncontrolled gout. Data from the same showed that treatment with Krystexxa plus methotrexate led to a significant improvement and sustained patient response compared to Krystexxa alone.
The data also demonstrated a more than 30%-point increase in patient response rate during month six — 71% of patients who received treatment with Krystexxa plus methotrexate achieved the primary endpoint, which is defined as sUA<6 mg/dL, at least 80% of the time during month six.
No new safety concerns were identified from the study.
Shares of Horizon have lost 22.4% in the year so far compared with the industry’s decline of 18.3%.
Image Source: Zacks Investment Research
Per the company, immunomodulatory therapies like methotrexate are often used with biologic therapies to reduce the development of anti-drug antibodies. The latest approval for Krystexxa plus methotrexate will allow more physicians to recommend the combo to help people with uncontrolled gout.
In March 2022, the FDA granted priority review to the above-mentioned sBLA for Krystexxa. Horizon submitted the sBLA for the label expansion of Krystexxa to the FDA in January.
Krystexxa remains an important top-line driver for Horizon. The drug generated sales worth $140.7 million in the first quarter of 2022, reflecting an increase of 32% year over year. The label expansion of the drug in combination with methotrexate will make it eligible to serve a broader patient population and boost sales further in 2022 and beyond.
Zacks Rank & Stocks to Consider
Horizon currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector are Leap Therapeutics, Inc. (LPTX - Free Report) , Aptose Biosciences Inc. (APTO - Free Report) and Precision BioSciences, Inc. (DTIL - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 in the past 60 days.
Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.
Aptose Biosciences’ loss per share estimates narrowed 16.1% for 2022 and 13% for 2023 in the past 60 days.
Earnings of Aptose Biosciences have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. APTO delivered an earnings surprise of 2.55%, on average.
Precision BioSciences’ loss per share estimates narrowed 26.2% for 2022 and 42.6% for 2023 in the past 60 days.
Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters. DTIL delivered an earnings surprise of 76.15%, on average.