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AbbVie Gets FDA Nod for Oriahnn to Control Menstrual Bleeding
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AbbVie Inc. (ABBV - Free Report) along with partner Neurocrine Biosciences, Inc. (NBIX - Free Report) announced that the FDA has approved its pipeline candidate elagolix for treating heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women.
The candidate to be marketed by the trade name Oriahnn is expected to hit the retail markets in the United States by this June-end.
Following the nod, Oriahnn became the first FDA-approved non-surgical, oral drug for managing heavy menstrual bleeding associated with uterine fibroids with the treatment duration of up to 24 months.
Per the company, Oriahnn met the primary endpoint of clinically meaningful reduction in bleeding compared to placebo with seven of 10 women no longer experiencing heavy menstrual bleeding versus one out of 10 on placebo in the two randomized phase III studies namely, ELARIS UF-I and ELARIS UF-II.
Notably, elagolix is already marketed by the trade name of Orilissa for the management of pain associated with endometriosis, a common gynecologic disorder.
Orilissa recorded sales worth $31 million in the first quarter of 2020, down 8.8% sequentially. The sales uptick of the drug was slower than expected.
Shares of AbbVie have increased 4.6% so far this year against the industry’s decrease of 0.5%.
In a separate press release, AbbVie announced that it has entered into a strategic collaboration with small biotech Jacobio Pharmaceuticals to develop and commercialize SHP2 inhibitors, which target a key node in cancer and immune cells. SHP2 is an important protein mediator of cellular signaling through RAS/MAP kinase pathway.
The financial terms of the deal have been kept under the wraps. The transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
Per the agreement, AbbVie will get an exclusive license to the SHP2 portfolio while Jacobio will continue to conduct early global clinical studies of JAB-3068 and JAB-3312 with the former covering the R&D expenses. Upon completion of the deal, AbbVie will assume global development and commercialization responsibilities.
Eli Lilly’s earnings have been revised 0.6% upward for 2020 and 1% for 2021 over the past 60 days. The stock has gained 16.4% year to date.
Innoviva’s earnings have been revised 37.9% upward for 2021 over the past 60 days.
Zacks’ Single Best Pick to Double
From thousands of stocks, 5 Zacks experts each picked their favorite to gain +100% or more in months to come. From those 5, Zacks Director of Research, Sheraz Mian hand-picks one to have the most explosive upside of all.
This young company’s gigantic growth was hidden by low-volume trading, then cut short by the coronavirus. But its digital products stand out in a region where the internet economy has tripled since 2015 and looks to triple again by 2025.
Its stock price is already starting to resume its upward arc. The sky’s the limit! And the earlier you get in, the greater your potential gain.
Image: Shutterstock
AbbVie Gets FDA Nod for Oriahnn to Control Menstrual Bleeding
AbbVie Inc. (ABBV - Free Report) along with partner Neurocrine Biosciences, Inc. (NBIX - Free Report) announced that the FDA has approved its pipeline candidate elagolix for treating heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women.
The candidate to be marketed by the trade name Oriahnn is expected to hit the retail markets in the United States by this June-end.
Following the nod, Oriahnn became the first FDA-approved non-surgical, oral drug for managing heavy menstrual bleeding associated with uterine fibroids with the treatment duration of up to 24 months.
Per the company, Oriahnn met the primary endpoint of clinically meaningful reduction in bleeding compared to placebo with seven of 10 women no longer experiencing heavy menstrual bleeding versus one out of 10 on placebo in the two randomized phase III studies namely, ELARIS UF-I and ELARIS UF-II.
Notably, elagolix is already marketed by the trade name of Orilissa for the management of pain associated with endometriosis, a common gynecologic disorder.
Orilissa recorded sales worth $31 million in the first quarter of 2020, down 8.8% sequentially. The sales uptick of the drug was slower than expected.
Shares of AbbVie have increased 4.6% so far this year against the industry’s decrease of 0.5%.
In a separate press release, AbbVie announced that it has entered into a strategic collaboration with small biotech Jacobio Pharmaceuticals to develop and commercialize SHP2 inhibitors, which target a key node in cancer and immune cells. SHP2 is an important protein mediator of cellular signaling through RAS/MAP kinase pathway.
The financial terms of the deal have been kept under the wraps. The transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
Per the agreement, AbbVie will get an exclusive license to the SHP2 portfolio while Jacobio will continue to conduct early global clinical studies of JAB-3068 and JAB-3312 with the former covering the R&D expenses. Upon completion of the deal, AbbVie will assume global development and commercialization responsibilities.
Zacks Rank & Stocks to Consider
AbbVie currently sports a Zacks Rank #1 (Strong Buy). Other top-ranked stocks in the large cap pharma sector include Eli Lilly and Company (LLY - Free Report) and Innoviva, Inc. (INVA - Free Report) , both flaunting the same Zacks Rank as AbbVie. You can see the complete list of today’s Zacks #1 Rank stocks here.
Eli Lilly’s earnings have been revised 0.6% upward for 2020 and 1% for 2021 over the past 60 days. The stock has gained 16.4% year to date.
Innoviva’s earnings have been revised 37.9% upward for 2021 over the past 60 days.
Zacks’ Single Best Pick to Double
From thousands of stocks, 5 Zacks experts each picked their favorite to gain +100% or more in months to come. From those 5, Zacks Director of Research, Sheraz Mian hand-picks one to have the most explosive upside of all.
This young company’s gigantic growth was hidden by low-volume trading, then cut short by the coronavirus. But its digital products stand out in a region where the internet economy has tripled since 2015 and looks to triple again by 2025.
Its stock price is already starting to resume its upward arc. The sky’s the limit! And the earlier you get in, the greater your potential gain.
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