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Lilly's (LLY) Olumiant Gets CHMP Nod for Alopecia Areata
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Eli Lilly and Company (LLY - Free Report) and partner Incyte Corporation (INCY - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) recommended approval of its JAK inhibitor drug, Olumiant (baricitinib). The drug will be used for treating adults with severe alopecia areata (“AA”), an autoimmune disorder that results in non-scarring hair loss.
A decision from the European Commission is expected in the next couple of months. If approved, Olumiant will become the first centrally-authorized oral treatment of its kind in Europe for patients with severe AA.
The CHMP opinion was based on data from the phase III BRAVE-AA1 and BRAVE-AA2 studies, which evaluated the safety and efficacy of Olumiant in patients with severe AA. The study’s primary endpoint is to see the proportion of patients achieving the Severity of Alopecia Tool or SALT score at week 36.
Olumiant is under review in the United States for severe AA. In February 2022, the FDA granted priority review to Olumiant for treating adults with severe AA. Additional regulatory decisions are expected later in 2022 in the United States and Japan.
Shares of Lilly have moved up 8.2% so far this year compared with the industry’s rise of 4.5%.
Image Source: Zacks Investment Research
Olumiant is currently approved for treating rheumatoid arthritis in several countries. It is also authorized to treat hospitalized COVID-19 patients in various countries. Olumiant is approved in Europe and Japan for atopic dermatitis while under review in the United States for the same indication. Olumiant is also under review for juvenile idiopathic arthritis.
Earlier this month, the FDA granted full approval to Lilly and Incyte’s Olumiant for treating COVID-19 in certain hospitalized adults requiring various degrees of oxygen support.
Olumiant generated sales of $255.6 million for Lilly in first-quarter 2022, up 32% on a year-over-year basis. A potential label expansion in other indications is likely to drive the drug’s sales in the days ahead.
The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 over 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.
AegleaBio Therapeutics’ loss per share estimates have narrowed 23.2% for 2022 and 30.6% for 2023 IN the past 60 days.
Earnings of AegleaBio Therapeutics have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. AGLE delivered an earnings surprise of 9.47%, on average.
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Lilly's (LLY) Olumiant Gets CHMP Nod for Alopecia Areata
Eli Lilly and Company (LLY - Free Report) and partner Incyte Corporation (INCY - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) recommended approval of its JAK inhibitor drug, Olumiant (baricitinib). The drug will be used for treating adults with severe alopecia areata (“AA”), an autoimmune disorder that results in non-scarring hair loss.
A decision from the European Commission is expected in the next couple of months. If approved, Olumiant will become the first centrally-authorized oral treatment of its kind in Europe for patients with severe AA.
The CHMP opinion was based on data from the phase III BRAVE-AA1 and BRAVE-AA2 studies, which evaluated the safety and efficacy of Olumiant in patients with severe AA. The study’s primary endpoint is to see the proportion of patients achieving the Severity of Alopecia Tool or SALT score at week 36.
Olumiant is under review in the United States for severe AA. In February 2022, the FDA granted priority review to Olumiant for treating adults with severe AA. Additional regulatory decisions are expected later in 2022 in the United States and Japan.
Shares of Lilly have moved up 8.2% so far this year compared with the industry’s rise of 4.5%.
Image Source: Zacks Investment Research
Olumiant is currently approved for treating rheumatoid arthritis in several countries. It is also authorized to treat hospitalized COVID-19 patients in various countries. Olumiant is approved in Europe and Japan for atopic dermatitis while under review in the United States for the same indication. Olumiant is also under review for juvenile idiopathic arthritis.
Earlier this month, the FDA granted full approval to Lilly and Incyte’s Olumiant for treating COVID-19 in certain hospitalized adults requiring various degrees of oxygen support.
Olumiant generated sales of $255.6 million for Lilly in first-quarter 2022, up 32% on a year-over-year basis. A potential label expansion in other indications is likely to drive the drug’s sales in the days ahead.
Zacks Rank & Stocks to Consider
Lilly currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Leap Therapeutics, Inc. (LPTX - Free Report) and Aeglea BioTherapeutics, Inc. , both 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 over 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.
AegleaBio Therapeutics’ loss per share estimates have narrowed 23.2% for 2022 and 30.6% for 2023 IN the past 60 days.
Earnings of AegleaBio Therapeutics have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. AGLE delivered an earnings surprise of 9.47%, on average.