Vanda Pharmaceuticals Inc.NASDAQ
Vanda Pharmaceuticals Looks Attractive
Thu, Aug. 25, 3:54 PM
- Vanda Pharmaceuticals (VNDA +19.8%) perks up on a 10x surge in volume in response to its announcement that a U.S. district court has ruled in its favor in a patent infringement suit against Roxanne Laboratories. Roxanne filed an abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of Vanda's Fanapt (iloperidone). The judge ruled that Roxanne's ANDA infringed on Vanda's U.S. Patent Nos. RE39,198 and 8,586,610. Roxanne will be unable to launch a generic product until November 2, 2027.
Thu, Aug. 25, 12:45 PM
Wed, Jul. 27, 4:21 PM
Tue, Jul. 26, 5:35 PM
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Wed, Jun. 15, 7:50 AM
- The FDA grants three years of marketing exclusivity for Vanda Pharmaceuticals' (NASDAQ:VNDA) Fanapt (iloperidone) for the maintenance treatment of schizophrenia, an expanded use to the drug approved by the agency in May. The sNDA has been added to the Orange Book and will be effective until May 26, 2019.
- Fanapt was first approved in May 2009 for the short-term treatment of adults with schizophrenia.
- Previously: FDA OKs expended use of Vanda's Fanapt for maintenance treatment of schizophrenia; shares up 5% after hours (May 26)
Fri, May 27, 9:12 AM
Thu, May 26, 6:29 PM
- Vanda Pharmaceuticals (NASDAQ:VNDA) is up 5% after hours on increased volume in response to its announcement that the FDA has approved its supplemental New Drug Application (sNDA) for the use of Fanapt (iloperidone) as maintenance treatment for adults with schizophrenia.
- The data supporting the application was generated in the REPRIEVE study which showed 79.6% of patients treated with Fanapt remained relapse-free compared to 36.6% for placebo.
- The FDA first approved Fanapt in May 2009 for the short-term treatment of schizophrenia in adults.
Thu, May 26, 5:39 PM
Mon, May 23, 11:04 AM
- The FDA has a busy docket this week with two Ad Comm meetings and four product approval decisions.
- On Tuesday, the Circulatory System Devices Panel of the Medical Devices Advisory Committee will discuss the Premarket Approval Application (PMA) from St. Jude Medical (STJ -0.2%) seeking approval of its AMPLATZER Patent Foramen Ovale (PFO) Occluder, a permanent cardiac implant for PFO closure indicated for preventing recurrent ischemic stroke in patients who have had a cryptogenic (uncertain origin) stroke due an embolism presumed to have originated through an opening in the heart.
- On Wednesday, the Endocrinologic and Metabolic Drugs Advisory Committee will review the NDAs for Sanofi's (SNY -1.3%) fixed ratio combination of insulin glargine and lixisenatide for the treatment of adults with type 2 diabetes.
- No later than Thursday, the FDA will decide on Sarepta Therapeutics' (SRPT +2.3%) New Drug Application (NDA) seeking approval of eteplirsen for children with Duchenne muscular dystrophy amenable to skipping exon 51. Also, no later than Thursday, it will decide on AstraZeneca's (AZN -0.3%) NDA seeking approval of ZS-9 for hyperkalemia.
- No later than Friday, the agency will decide on Titan Pharmaceuticals' (TTNP +8.8%) NDA seeking approval of its Probuphine subdermal implant for the maintenance treatment of opioid addiction. Also, no later than Friday, it will decide on Vanda Pharmaceuticals' (VNDA +0.3%) supplemental NDA seeking approval of Fanapt for the maintenance (long term) treatment of schizophrenia in adults.
Wed, May 4, 4:22 PM
- Vanda Pharmaceuticals (NASDAQ:VNDA): Q1 EPS of -$0.17 beats by $0.07.
- Revenue of $33.26M (+50.2% Y/Y) beats by $0.69M.
Tue, May 3, 5:35 PM
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Thu, Feb. 11, 10:48 AM
- Vanda Pharmaceuticals (VNDA -4.9%) Q4 results: Revenues: $31.8M (+106.5%); R&D Expense: $8.7M (+81.3%); SG&A: $28.9M (+67.1%); Operating Loss: ($14.9M) (-121.4%); Net Loss: ($14.8M) (-121.2%); Loss Per Share: ($0.35) (-119.8%); Non-GAAP Loss Per Share: ($0.23) (+36.1%).
- FY2015 results: Revenues: $109.9M (+118.9%); R&D Expense: $29.1M (+51.6%); SG&A: $84.5M (-0.1%); Operating Loss: ($40.2M) (+300.0%); Net Loss: ($39.9M) (-297.5%); Loss Per Share: ($0.94) (-270.9%); Non-GAAP Loss Per Share: ($0.45) (+80.4%); Quick Assets: $143.2M (+10.3%).
- 2016 Guidance: Net product sales from both HETLIOZ and Fanapt: $143M - 153M; HETLIOZ® net product sales: $73M - 78M; Non-GAAP Operating expenses: $125M - 135M; 2016 year end cash: $123M - 143M.
Wed, Feb. 10, 4:04 PM
- Vanda Pharmaceuticals (NASDAQ:VNDA): Q4 EPS of -$0.23 beats by $0.03.
- Revenue of $31.84M (+107.2% Y/Y) beats by $0.5M.
Tue, Feb. 9, 5:35 PM
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Nov. 3, 2015, 4:56 PM
- Vanda Pharmaceuticals (NASDAQ:VNDA): Q3 EPS of -$0.11 beats by $0.09.
- Revenue of $28.3M (+91.5% Y/Y) misses by $0.54M.
Nov. 2, 2015, 5:35 PM
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