Vanda Pharmaceuticals Inc. ((VNDA - Free Report) received a Complete Response Letter (CRL) from the FDA for the supplemental New Drug Application (sNDA) of Hetlioz (tasimelteon) to treat Jet Lag Disorder (JLD).
Hetlioz is already approved in the United States and Europe for the treatment of non-24-hour sleep-wake disorder — a serious, rare and chronic circadian rhythm disorder.
Shares of the company have slumped 41.3% year to date against the industry’s growth of 0.6%.
The company submitted the regulatory filing based on a study, which showed that JLD patients slept nearly three hours longer during the three nights, following their transatlantic trip, when treated with Hetlioz than they did when they were untreated. The results were consistent with Vanda's jet lag simulation studies, according to the company.
The CRL stated that the measures demonstrating improved sleep were of unclear clinical significance. The FDA made additional observations on various aspects of Vanda's sNDA.
Vanda intends to consider each observation as it plans for continued engagement with the FDA on this matter. . To date, there are no treatments approved by the FDA for JLD, a public health issue experienced by millions of people every year. JLD sufferers attempt to treat the condition with unapproved remedies, which do not address either the symptoms or the underlying cause of the disorder.
The label expansion of the drug would have boosted sales.
Zacks Rank & Other Stocks to Consider
Vanda currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks are Acorda Therapeutics Inc. (ACOR - Free Report) , CSL Limited (CSLLY - Free Report) and ACADIA Pharmaceuticals Inc. (ACAD - Free Report) . While Acorda and CSL Limited sport a Zacks Rank #1 (Strong Buy), ACADIA carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have narrowed from $3.59 to $2.74 for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, the average being 69.68%.
CSL Limited’s earnings per share estimates have increased from $1.75 to $2.46 for 2019 and from $1.96 to $2.75 for 2020 in the past 60 days. Shares of the company have rallied 20.9% year to date.
ACADIA’s loss per share estimates have narrowed from $1.90 to $1.78 for 2019 in the past 60 days. Shares of the company have surged 80.8% year to date.
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