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Pfizer's (PFE) Alopecia Areata Drug Litfulo Receives EU Nod
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Pfizer Inc. (PFE - Free Report) announced that the European Commission (EC) has granted marketing authorization for Litfulo (ritlecitinib), a once-daily oral capsule, to treat adults and adolescents aged 12 years and older with severe alopecia areata.
The marketing authorization grant by the EC was based on Pfizer’s ALLEGRO clinical program. The program included the phase IIb/III ALLEGRO study, evaluating Litfulo in patients aged 12 years and older with alopecia areata with 50% or more scalp hair loss, including patients with alopecia totalis (total scalp hair loss) and alopecia universalis (total body hair loss).
Per the data from the pivotal study, it was observed that 13.4% of adults and adolescents saw 90% or more scalp hair coverage after 24 weeks of treatment with Litfulo 50 mg compared to 1.5% with placebo. The study also met its key secondary endpoint of moderate-to-great improvement (49.2%) in alopecia areata patients, as measured by the Patient Global Impression of Change, at week 24, compared with placebo (9.2%).
Year to date, shares of Pfizer have plunged 34.3% against the industry’s 7.5% rise.
Image Source: Zacks Investment Research
Eli Lilly’s (LLY) Olumiant (baricitinib) is currently approved in the EU to treat adult patients with severe alopecia areata and moderate-to-severe rheumatoid arthritis. Lilly’s Olumiant is also a JAK inhibitor but is indicated only for adult patients in the treatment of severe alopecia areata. With the approval of Litfulo in the EU, the drug becomes the first EC-approved medicine to be indicated for adolescent patients, as young as 12 years of age, with severe alopecia areata.
Eligible patients, approved for Pfizer’s Litfulo, are greater than Lilly’s Olumiant, which could help PFE capture a greater share of the alopecia areata market.
Ritlecitinib was approved in the United States and Japan in June 2023.
We would like to remind the investors that the authorization by the EC follows the positive opinion adopted by the advisory committee of the European Medicines Agency in July 2023, recommending marketing authorization for Litfulo for patients aged 12 years and older, with severe alopecia areata.
PFE is currently evaluating Litfulo in an ongoing long-term phase III ALLEGRO-LT study, collecting the safety and efficacy data for adults with alopecia areata with 25% or greater scalp hair loss and adolescents from 12 years and older with alopecia areata with 50% or greater scalp hair loss. The regulatory filing with the EC comprised such long-term efficacy and safety data to support the approval.
Besides alopecia areata, Pfizer is also currently evaluating ritlecitinib in other potential indications. The company’s ongoing phase III Tranquillo study is evaluating the efficacy, safety and tolerability of ritlecitinib in adults and adolescents with non-segmental vitiligo.
A couple of better-ranked stocks in the drug/biotech sector are Dynavax Technologies (DVAX - Free Report) and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has remained constant at 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Year to date, shares of DVAX have risen by 27.5%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. The estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have climbed 59.1%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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Pfizer's (PFE) Alopecia Areata Drug Litfulo Receives EU Nod
Pfizer Inc. (PFE - Free Report) announced that the European Commission (EC) has granted marketing authorization for Litfulo (ritlecitinib), a once-daily oral capsule, to treat adults and adolescents aged 12 years and older with severe alopecia areata.
The marketing authorization grant by the EC was based on Pfizer’s ALLEGRO clinical program. The program included the phase IIb/III ALLEGRO study, evaluating Litfulo in patients aged 12 years and older with alopecia areata with 50% or more scalp hair loss, including patients with alopecia totalis (total scalp hair loss) and alopecia universalis (total body hair loss).
Per the data from the pivotal study, it was observed that 13.4% of adults and adolescents saw 90% or more scalp hair coverage after 24 weeks of treatment with Litfulo 50 mg compared to 1.5% with placebo. The study also met its key secondary endpoint of moderate-to-great improvement (49.2%) in alopecia areata patients, as measured by the Patient Global Impression of Change, at week 24, compared with placebo (9.2%).
Year to date, shares of Pfizer have plunged 34.3% against the industry’s 7.5% rise.
Image Source: Zacks Investment Research
Eli Lilly’s (LLY) Olumiant (baricitinib) is currently approved in the EU to treat adult patients with severe alopecia areata and moderate-to-severe rheumatoid arthritis. Lilly’s Olumiant is also a JAK inhibitor but is indicated only for adult patients in the treatment of severe alopecia areata. With the approval of Litfulo in the EU, the drug becomes the first EC-approved medicine to be indicated for adolescent patients, as young as 12 years of age, with severe alopecia areata.
Eligible patients, approved for Pfizer’s Litfulo, are greater than Lilly’s Olumiant, which could help PFE capture a greater share of the alopecia areata market.
Ritlecitinib was approved in the United States and Japan in June 2023.
We would like to remind the investors that the authorization by the EC follows the positive opinion adopted by the advisory committee of the European Medicines Agency in July 2023, recommending marketing authorization for Litfulo for patients aged 12 years and older, with severe alopecia areata.
PFE is currently evaluating Litfulo in an ongoing long-term phase III ALLEGRO-LT study, collecting the safety and efficacy data for adults with alopecia areata with 25% or greater scalp hair loss and adolescents from 12 years and older with alopecia areata with 50% or greater scalp hair loss. The regulatory filing with the EC comprised such long-term efficacy and safety data to support the approval.
Besides alopecia areata, Pfizer is also currently evaluating ritlecitinib in other potential indications. The company’s ongoing phase III Tranquillo study is evaluating the efficacy, safety and tolerability of ritlecitinib in adults and adolescents with non-segmental vitiligo.
Pfizer Inc. Price and Consensus
Pfizer Inc. price-consensus-chart | Pfizer Inc. Quote
Zacks Rank and Stocks to Consider
Pfizer currently has a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the drug/biotech sector are Dynavax Technologies (DVAX - Free Report) and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has remained constant at 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Year to date, shares of DVAX have risen by 27.5%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. The estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have climbed 59.1%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.