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Stock Market & Financial Investment News

News Breaks
February 12, 2013
06:58 EDTVNDAVanda Pharmaceuticals to submit Tasimelteon NDA in mid-2013
In December 2012 and January 2013, Vanda announced positive results for two Phase III studies for tasimelteon in the treatment of Non-24. The SET Phase III study demonstrated that tasimelteon was able to entrain the master body clock as measured by melatonin and cortisol circadian rhythms. Vanda plans to submit an NDA to the FDA in mid-2013. Vanda will meet with the FDA in Q1 of 2013 for a pre-NDA meeting on tasimelteon in the treatment of patients with Non-24.Vanda has decided to discontinue all activities related to the MDD indication. In January, Vanda announced that the MAGELLAN Phase IIb/III clinical study in MDD did not meet the primary endpoint of a change from baseline in the Hamilton Depression Scale after 8 weeks of treatment as compared to placebo. Vanda has formally appealed the EMA's negative opinion for Fanaptum and requested a re-examination of the decision by the EMA's Committee for Medicinal Product for Human Use.
News For VNDA From The Last 14 Days
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July 2, 2015
09:07 EDTVNDAVanda has new Hetlioz patent listed in FDA Orange Book
Vanda announced that a Hetlioz patent is now listed in the FDA publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The 'patent was issued by the USPTO on June 23rd and expires in January 2033.
07:27 EDTVNDAPublic Citizen calls on FDA to correct labeling of Vanda's Hetlioz drug
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June 24, 2015
10:03 EDTVNDAHigh option volume stocks: VNDA SN ADHD UNIS
June 23, 2015
19:03 EDTVNDAOn The Fly: After Hours Movers
UP AFTER PROVIDING GUIDANCE: MeetMe (MEET), up 18.8%. ALSO HIGHER: Nektar Therapeutics (NKTR), up 4.3% after being added to S&P 600... Quidel (QDEL), up 5% after receiving FDA clearance for new Solana molecular system and assay... Vanda Pharmaceuticals (VNDA), up 4.6% after announcing positive results from REPRIEVE study... Netflix (NFLX), up 3.4% after announcing seven-for-one stock split. LOWER: Alcobra (ADHD), down 2.5% after announcing that it will host a conference call and simultaneous webcast presentation to present results from the Phase II clinical trial of MDX... Sysco (SYY), down 2.6% after bid for U.S. foods blocked was blocked by a federal judge... Boeing (BA), down marginally after announcing CEO transition.
16:32 EDTVNDAVanda announces positive results from REPRIEVE study
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07:36 EDTVNDAJMP Securities to hold a conference
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