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FDA Accepts Neurocrine's NDA for Parkinson's Disease Drug
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Neurocrine Biosciences, Inc. (NBIX - Free Report) announced that the FDA has accepted its new drug application (NDA) for opicapone as an adjunct therapy to levodopa/carbidopa to treat patients with Parkinson's disease (PD), who are experiencing OFF episodes.
The FDA is expected to notify its decision on Apr 26, 2020.
The NDA was based on data from 38 clinical studies including two phase III programs (BIPARK-1 and BIPARK-2), which evaluated more than 1,000 patients with PD. In both evaluations, the primary endpoint was to see a change from the baseline in absolute time during the OFF periods when the effects of levodopa have worn off.
Shares of Neurocrine have rallied 22% so far this year, outperforming the industry’s increase of 9.7%.
In 2017, Neurocrine in-licensed the exclusive development/commercialization rights to opicapone in the United States and in Canada from BIAL, a Portugal-based pharmaceutical company. Following this FDA acceptance of the NDA, Neurocrine is entitled to pay a $10-million milestone fee to BIAL.
Notably, opicapone — an investigational once-daily, oral COMT inhibitor — is already approved in the EU where it is marketed under the trade name of Ongentys. In June 2016, BIAL received the European Commission’s nod for Ongentys.
Another recently approved drug in Neurocrine’s portfolio is Orilissa (elagolix), which is marketed by Neurocrine’s partner, AbbVie, Inc. (ABBV - Free Report) . Last July, the FDA approved Orilissa for managing moderate to severe endometriosis pain in women. The drug is also approved in Canada. Notably, another drug Elagolix has also been developed for the treatment of uterine fibroids in women.
We remind investors that opicapone, if approved in the United States, is likely to face competition from Acorda’s PD drug, Inbrija (levodopa inhalation powder), which received the FDA nod last December. Following the same, Inbrija became the first and the only approved inhaled levodopa for treating OFF periods in patients suffering Parkinson’s and receiving a carbidopa / levodopa regimen.
In February this year, Inbrija was officially launched in the United States. The drug is also under review in the EU with a decision awaited anytime soon.
Soleno’s loss per share estimates have been narrowed 30% for 2019 and 26.1% for 2020 over the past 60 days. The stock has soared 73.1% year to date.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Image: Bigstock
FDA Accepts Neurocrine's NDA for Parkinson's Disease Drug
Neurocrine Biosciences, Inc. (NBIX - Free Report) announced that the FDA has accepted its new drug application (NDA) for opicapone as an adjunct therapy to levodopa/carbidopa to treat patients with Parkinson's disease (PD), who are experiencing OFF episodes.
The FDA is expected to notify its decision on Apr 26, 2020.
The NDA was based on data from 38 clinical studies including two phase III programs (BIPARK-1 and BIPARK-2), which evaluated more than 1,000 patients with PD. In both evaluations, the primary endpoint was to see a change from the baseline in absolute time during the OFF periods when the effects of levodopa have worn off.
Shares of Neurocrine have rallied 22% so far this year, outperforming the industry’s increase of 9.7%.
In 2017, Neurocrine in-licensed the exclusive development/commercialization rights to opicapone in the United States and in Canada from BIAL, a Portugal-based pharmaceutical company. Following this FDA acceptance of the NDA, Neurocrine is entitled to pay a $10-million milestone fee to BIAL.
Notably, opicapone — an investigational once-daily, oral COMT inhibitor — is already approved in the EU where it is marketed under the trade name of Ongentys. In June 2016, BIAL received the European Commission’s nod for Ongentys.
Another recently approved drug in Neurocrine’s portfolio is Orilissa (elagolix), which is marketed by Neurocrine’s partner, AbbVie, Inc. (ABBV - Free Report) . Last July, the FDA approved Orilissa for managing moderate to severe endometriosis pain in women. The drug is also approved in Canada. Notably, another drug Elagolix has also been developed for the treatment of uterine fibroids in women.
We remind investors that opicapone, if approved in the United States, is likely to face competition from Acorda’s PD drug, Inbrija (levodopa inhalation powder), which received the FDA nod last December. Following the same, Inbrija became the first and the only approved inhaled levodopa for treating OFF periods in patients suffering Parkinson’s and receiving a carbidopa / levodopa regimen.
In February this year, Inbrija was officially launched in the United States. The drug is also under review in the EU with a decision awaited anytime soon.
Zacks Rank & Key Pick
Neurocrine currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Soleno Therapeutics, Inc. (SLNO - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Soleno’s loss per share estimates have been narrowed 30% for 2019 and 26.1% for 2020 over the past 60 days. The stock has soared 73.1% year to date.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Click here for the 6 trades >>