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ACADIA to Merge Two Phase III Studies on Nuplazid for MDD
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ACADIA Pharmaceuticals Inc. (ACAD - Free Report) announced that it plans to combine the two-phase III studies namely, CLARITY-2 and CLARITY-3 on its marketed drug Nuplazid (pimavanserin) for the adjunctive treatment of major depressive disorder (MDD). Following a positive feedback from the FDA, the company decided to combine the two above-mentioned identically-designed studies into one with a pre-specified statistical analysis plan.
Per the company, no new patients will be enrolled in the two-phase III studies, each of which is likely to be concluded with slightly above 50% enrolment.
Top-line data from the combined study is expected in the third quarter of 2020.
If positive, the results from the combined study along with the previously announced favorable outcomes from the pivotal CLARITY study will form the basis of a supplemental new drug application (sNDA) for Nuplazid as an adjunctive treatment of MDD.
Nuplazid is already marketed for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. The drug is the first and the only FDA-approved treatment for the given indication.
Shares of ACADIA have rallied 19.6% so far this year compared with the industry’s increase of 7.9%.
We note that ACADIA’s sole marketed drug Nuplazid witnessed strong sales since its launch. The drug recorded sales worth $90.1 million in the first quarter of 2020, reflecting an increase of 43% year over year.
Other than MDD, several additional studies on Nuplazid targeting different central nervous system (CNS) indications are currently underway. Nuplazid is being evaluated in the phase III HARMONY study for treating dementia-related psychosis (DRP). ACADIA plans to file an sNDA later in the summer of 2020 seeking approval for Nuplazid to treat DRP. A potential label expansion will boost the sales of the drug in future quarters.
Other studies on Nuplazid include the phase II ADVANCE study for addressing schizophrenia’s negative symptoms. The company plans to initiate a second pivotal study, ADVANCE-2, on Nuplazid in the second half of 2020 for treating negative symptoms of schizophrenia.
The company expects total net sales from the drug in the range of $420-$450 million for 2020.
Zacks Rank & Stocks to Consider
ACADIA currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Akcea Therapeutics, Inc. , Halozyme Therapeutics, Inc. (HALO - Free Report) and Xenon Pharmaceuticals Inc. (XENE - Free Report) , all currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Akcea Therapeutics’ loss per share estimates have narrowed 33.8% for 2020 and 24.8% for 2021 over the past 60 days.
Halozyme’s earnings have been revised 17.2% upward for 2020 and 9.8% for 2021 over the past 60 days. The stock has surged 37.1% year to date.
Xenon Pharmaceuticals’ loss per share estimates have narrowed 0.7% for 2020 and 3.8% for 2021 over the past 60 days. The stock has gained 5.1% 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.
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ACADIA to Merge Two Phase III Studies on Nuplazid for MDD
ACADIA Pharmaceuticals Inc. (ACAD - Free Report) announced that it plans to combine the two-phase III studies namely, CLARITY-2 and CLARITY-3 on its marketed drug Nuplazid (pimavanserin) for the adjunctive treatment of major depressive disorder (MDD). Following a positive feedback from the FDA, the company decided to combine the two above-mentioned identically-designed studies into one with a pre-specified statistical analysis plan.
Per the company, no new patients will be enrolled in the two-phase III studies, each of which is likely to be concluded with slightly above 50% enrolment.
Top-line data from the combined study is expected in the third quarter of 2020.
If positive, the results from the combined study along with the previously announced favorable outcomes from the pivotal CLARITY study will form the basis of a supplemental new drug application (sNDA) for Nuplazid as an adjunctive treatment of MDD.
Nuplazid is already marketed for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. The drug is the first and the only FDA-approved treatment for the given indication.
Shares of ACADIA have rallied 19.6% so far this year compared with the industry’s increase of 7.9%.
We note that ACADIA’s sole marketed drug Nuplazid witnessed strong sales since its launch. The drug recorded sales worth $90.1 million in the first quarter of 2020, reflecting an increase of 43% year over year.
Other than MDD, several additional studies on Nuplazid targeting different central nervous system (CNS) indications are currently underway. Nuplazid is being evaluated in the phase III HARMONY study for treating dementia-related psychosis (DRP). ACADIA plans to file an sNDA later in the summer of 2020 seeking approval for Nuplazid to treat DRP. A potential label expansion will boost the sales of the drug in future quarters.
Other studies on Nuplazid include the phase II ADVANCE study for addressing schizophrenia’s negative symptoms. The company plans to initiate a second pivotal study, ADVANCE-2, on Nuplazid in the second half of 2020 for treating negative symptoms of schizophrenia.
The company expects total net sales from the drug in the range of $420-$450 million for 2020.
Zacks Rank & Stocks to Consider
ACADIA currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Akcea Therapeutics, Inc. , Halozyme Therapeutics, Inc. (HALO - Free Report) and Xenon Pharmaceuticals Inc. (XENE - Free Report) , all currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Akcea Therapeutics’ loss per share estimates have narrowed 33.8% for 2020 and 24.8% for 2021 over the past 60 days.
Halozyme’s earnings have been revised 17.2% upward for 2020 and 9.8% for 2021 over the past 60 days. The stock has surged 37.1% year to date.
Xenon Pharmaceuticals’ loss per share estimates have narrowed 0.7% for 2020 and 3.8% for 2021 over the past 60 days. The stock has gained 5.1% 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 2021.
Click here for the 6 trades >>