We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Vanda Receives CRL From FDA for sNDA of Jet Lag Treatment
Read MoreHide Full Article
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.
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.
Legalizing THIS Could Be Even Bigger than Marijuana
Americans spend an estimated $150 billion in this industry every year… more than twice as much as they spend on marijuana. Now that 8 states have fully-legalized it (with several more states following close behind), Zacks has identified 5 stocks that could soar in response to the powerful demand. One industry insider described the future as “mind-blowing” – and early investors can still get in ahead of the surge.
Image: Bigstock
Vanda Receives CRL From FDA for sNDA of Jet Lag Treatment
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.
Vanda Pharmaceuticals Inc. Price
Vanda Pharmaceuticals Inc. price | Vanda Pharmaceuticals Inc. Quote
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.
Legalizing THIS Could Be Even Bigger than Marijuana
Americans spend an estimated $150 billion in this industry every year… more than twice as much as they spend on marijuana. Now that 8 states have fully-legalized it (with several more states following close behind), Zacks has identified 5 stocks that could soar in response to the powerful demand. One industry insider described the future as “mind-blowing” – and early investors can still get in ahead of the surge.
See these 5 “sin stocks” now >>