Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) shares dropped early to begin the week after the firm announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA).
The CRL is in regards to the ongoing review of Vanda’s supplemental New Drug Application (sNDA) for Hetlioz (tasimelteon) for the treatment of jet lag disorder (JLD).
Vanda reported in May that its JLD patients were sleeping nearly three hours longer over the three nights following their transatlantic trip when treated with Hetlioz than they did over the three nights following their untreated transatlantic trip, consistent with Vanda’s jet lag simulation studies. In the CRL, the FDA asserted that these measures demonstrating improved sleep are of unclear clinical significance.
The FDA’s conclusions regarding the clinical significance of improved sleep in JLD are not the FDA’s only observations made with respect to the sNDA. The CRL contains additional observations on various aspects of Vanda’s sNDA.
To date, there are no treatments approved by the FDA for JLD, a public health issue experienced by millions of people every year.
Mihael H. Polymeropoulos, M.D., Vanda’s president and chief executive, Commented:
We are deeply disappointed to have not received approval at this time, given our previous discussions with the FDA on this program. Vanda remains committed to obtaining FDA marketing approval for tasimelteon in Jet Lag Disorder in order to address this significant unmet medical need.
Shares of Vanda closed Friday at $15.19, in a 52-week range of $11.83 to $33.44. The consensus price target is $27.83. Following the announcement, the stock is down over 9% at $13.75 in early trading indications Monday.