Shares of ACADIA Pharmaceuticals Inc. (ACAD - Free Report) have skyrocketed 111.4% in the past year versus the industry’s decrease of 2.8%.
The company’s sole marketed drug Nuplazid (pimavanserin) is the first and the only FDA-approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis.
In the first nine months of 2019, Nuplazid recorded sales of $240.8 million, reflecting a surge of 46.6% year over year.
Following a strong performance during the third quarter of 2019, ACADIA raised its full-year 2019 net sales guidance for Nuplazid to $330-$340 million from the earlier projection of $320-$330 million.
Several additional studies on Nuplazid targeting different types of neurological and psychiatric disorders are currently ongoing. The drug is being evaluated in the phase III HARMONY study for treating dementia-related psychosis (DRP). Other studies include the phase III ENHANCE study for schizophrenia inadequate response, the phase II ADVANCE study for addressing schizophrenia negative symptoms and the phase III CLARITY study as an adjunctive treatment of major depressive disorder.
Notably, in September 2019, Nuplazid met the primary endpoint in the phase III HARMONY study by showing statistically significant superiority over placebo in increasing the time-to-relapse of dementia-related psychosis. ACADIA is planning to meet the FDA authorities for discussing a possible submission of a supplemental new drug application for Nupalzid to treat DRP in the first half of 2020.
In November 2019, ACADIA announced positive top-line results from the phase II ADVANCE study, which met its primary goal.
A potential approval for any of the above indications will be a significant boost to the company.
Meanwhile, ACADIA initiated a phase III study on its investigational candidate trofinetide in October 2019 for the treatment of Rett syndrome, a rare neurodevelopmental congenital CNS disorder for treating girls aged between five and 20 years.
Currently, ACADIA has no approved product in its portfolio other than Nupalzid. Therefore, the company’s sole dependence on a single drug is a concern. Thus, any regulatory setback for Nupalzid could hurt sales significantly for ACADIA. Moreover, competition from other companies, such as Axsome Therapeutics (AXSM - Free Report) which has four CNS product candidates, is a headwind.
ACADIA Pharmaceuticals Inc. Price
Zacks Rank & Stocks to Consider
ACADIA currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Repligen Corporation (RGEN - Free Report) and Epizyme, Inc. (EPZM - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Repligen’s earnings estimates have moved 0.9% north for 2020 over the past 60 days. The stock has soared 71.2% in the past year.
Epizyme’s loss per share estimates have narrowed 1% for 2020 over the past 60 days. The stock has surged 167.1% in the past year.
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