Acadia Pharmaceuticals Inc. ACAD announced that the FDA has accepted for review its new drug application (NDA) seeking approval of its pipeline candidate, trofinetide, for the treatment of patients with Rett syndrome.
With the FDA granting priority review to the NDA, a decision from the regulatory body is expected on Mar 12, 2023.
ACAD submitted the NDA for trofinetide to treat Rett Syndrome in July 2022.
The NDA was based on data from the pivotal phase III Lavender study, which evaluated the safety and efficacy of trofinetide versus placebo for treating Rett syndrome in girls and young women aged five to 20 years.
Rett syndrome is a rare neurological disorder for girls aged between five and 20 years.
The FDA has already granted Fast Track Status and Orphan Drug Designation to trofinetide for the treatment of Rett syndrome in the United States.
Shares of Acadia have lost 23.3% this year compared with the industry’s decrease of 21.2%.
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Last December, ACAD announced positive top-line data from the pivotal phase III Lavender study evaluating trofinetide for the treatment of Rett syndrome.
The study met its co-primary endpoints by demonstrating statistically significant improvements over placebo in the Rett syndrome behavior questionnaire and the clinical global impression of progress at 12 weeks.
Acadia entered into a license agreement with Australian biopharmaceutical company, Neuren Pharmaceuticals Limited, and obtained exclusive North American rights to develop and commercialize trofinetide for Rett syndrome and other indications in 2018.
Investors must note that currently, Acadia’s top line solely comprises sales of its only marketed drug, Nuplazid (pimavanserin), in the United States. The drug is approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
Upon potential approval, trofinetide can become the second approved drug in Acadia’s portfolio of marketed drugs and lend a significant boost to the company as well as lower its sole dependence on Nuplazid for revenues.
Zacks Rank & Other Stocks to Consider
Acadia currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Aptose Biosciences Inc. APTO, Atara Biotherapeutics, Inc. ATRA and ORIC Pharmaceuticals, Inc. ORIC, all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aptose Biosciences’ loss per share estimates narrowed 15.8% for 2022 and 16% for 2023 in the past 60 days.
Earnings of Aptose Biosciences surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. APTO delivered an earnings surprise of 2.23%, on average.
Atara Biotherapeutics’ loss per share estimates narrowed 43.2% for 2022 and 31.8% for 2023 in the past 60 days.
Earnings of Atara Biotherapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. ATRA delivered an earnings surprise of 4.83%, on average.
ORIC Pharmaceuticals’ loss per share estimates narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.
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