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Vanda Pharmaceuticals Says Received Complete Response Letter From U.S. FDA
Vanda Pharmaceuticals Reports Qtrly Earnings Per Share $0.21
Vanda Pharmaceuticals FDA Update For Hetlioz In The Treatment Of Jet Lag Disorder
Vanda Pharmaceuticals Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of therapies to address unmet medical needs. Its product portfolio includes HETLIOZ (tasimelteon), Fanapt (iloperidone), Tradipitant (VLY-686), Trichostatin A and AQW051. It offers HETLIOZ for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). HETLIOZ is in clinical development for the treatment of Pediatric Non-24, Jet Lag Disorder and Smith-Magenis Syndrome. It offers Fanapt for the treatment of schizophrenia. Fanapt has potential utility in various other disorders. Tradipitant is a small molecule neurokinin-1 receptor (NK-1R) antagonist, which is in clinical development for the treatment of chronic pruritus in atopic dermatitis. Trichostatin A is a small molecule histone deacetylase (HDAC) inhibitor. AQW051 is a Phase II alpha-7 nicotinic acetylcholine receptor partial agonist. AQW051 is indicated for the treatment of central nervous system disorders.
Biotechnology & Drugs
2200 Pennsylvania Ave NW Ste 300E
H. Thomas Watkins
Independent Chairman of the Board
Mihael Hristos Polymeropoulos
President, Chief Executive Officer, Director
James Patrick Kelly
Chief Financial Officer, Executive Vice President, Treasurer
Gian Piero Reverberi
Senior Vice President, Chief Compliance Officer
Timothy I. Williams
Senior Vice President, General Counsel, Secretary
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The Humane Society of the United States is backing Vanda Pharmaceuticals Inc's fight against a U.S. Food and Drug Administration requirement that it conduct a study of a drug's risks to humans using dogs who would be euthanized at the end of the study.
A federal judge ruled on Thursday that Vanda Pharmaceuticals Inc could not proceed with a human clinical trial for its gastrointestinal drug tradipitant while the U.S. Food and Drug Administration weighs requiring months of additional animal toxicity testing.
The Food and Drug Administration is urging a judge to not allow Vanda Pharmaceuticals Inc to proceed with a human clinical drug trial while the agency reconsiders whether the drugmaker must also conduct a study on dogs who would need to be euthanized at the end of the trial.
Biopharmaceutical company Vanda Pharmaceuticals Inc has sued the U.S. Food and Drug Administration, saying the regulator is forcing it to unnecessarily conduct a study of a drug it is developing on dogs who would need to be euthanized at it conclusion.
* HETLIOZ® (TASIMELTEON) EFFECTIVE IN TREATING JET LAG DURING TRANSATLANTIC TRAVEL
* VANDA PHARMACEUTICALS REPORTS FIRST QUARTER 2018 FINANCIAL RESULTS
A federal appeals court on Friday ended a bid by West-Ward Pharmaceuticals Corp to invalidate a patent on Vanda Pharmaceutical Inc's schizophrenia drug Fanapt and bring a lower-cost generic version to market.
* U.S. FEDERAL COURT AFFIRMED U.S. COURT'S DECISION THAT WEST WARD PHARMACEUTICALS INFRINGED CO'S U.S. '610 PATENT FOR FANAPT
* VANDA PHARMACEUTICALS - ON MARCH 23, GOT PARAGRAPH IV CERTIFICATION NOTICE LETTER REGARDING ANDA BY TEVA FOR GENERIC VERSION OF 20MG HETLIOZ CAPSULE
* SALE OF 5.5 MILLION SHARES OF ITS COMMON STOCK IN AN UNDERWRITTEN PUBLIC OFFERING AT $17.00 PER SHARE Source text for Eikon: Further company coverage:
* VANDA PHARMACEUTICALS INC. PROPOSES PUBLIC OFFERING OF COMMON STOCK
* HETLIOZ® (TASIMELTEON) DEMONSTRATES EFFICACY TO TREAT JET LAG DISORDER IN AN 8 HOUR PHASE ADVANCE CLINICAL STUDY
* VANDA PHARMACEUTICALS REPORTS FOURTH QUARTER 2017 AND FULL YEAR 2017 FINANCIAL RESULTS
* Vanda receives negative opinion for marketing authorization from the European Medicines Agency on fanaptum™ for the treatment of schizophrenia
* Qtrly net loss per share $0.10 Source text for Eikon: Further company coverage: (Bengaluru Newsroom: +1 646 223 8780)
* Vanda Pharmaceuticals - On Oct 17, co reached a pricing agreement with the German National Association of Statutory Health Insurance Funds
* Vanda Pharmaceuticals Inc - announced results from randomized phase ii clinical study of Tradipitant as a monotherapy in treatment of chronic pruritus
* Vanda Pharmaceuticals Inc - total net product sales were $42.1 million in Q2 of 2017
* Vanda receives negative opinion for marketing authorization from the European Medicines Agency on Fanaptum™ for the treatment of schizophrenia
* Armistice Capital Llc reports a 5.1 percent passive stake in Vanda Pharmaceuticals Inc as of June 7 - sec filing Source text for Eikon: (http://bit.ly/2rwELbT) Further company coverage:
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