VNDA News

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that following the completion of a Type A Meeting with the U.S. Food and Drug Administration (FDA) on May 8, 2020, it has reached agreement with the FDA to resubmit its application for HETLIOZ® (tasimelteon) for the treatment of Smith-Magenis Syndrome (SMS). As previously disclosed, Vanda received a Refusal to File letter from the FDA on March 12, 2020. The Type A Meeting resolved the outstanding issues regarding the filing of the application. Vanda plans to resubmit as soon as possible, seeking approval of the solid capsule formulation of HETLIOZ® for the treatment of adults with SMS, and the liquid formulation of HETLIOZ ® for the treatment of children with SMS*.

Vanda Pharmaceuticals (NASDAQ:VNDA) shareholders are no doubt pleased to see that the share price has bounced 30% in...

No matter how much courage an investor has, investing in cheap stocks that have pending whistleblower lawsuits against them just isn't a good idea.

Companies in the news are: TSM, BK, LOVE, VNDA

Vanda Pharmaceuticals Inc. ("Vanda") (Nasdaq: VNDA), announced today that Vanda will hold its 2020 Annual Meeting of Stockholders (the "2020 Annual Meeting") in a virtual-only format due to public health concerns related to the COVID-19 pandemic and to protect the health and well-being of its stockholders, directors, employees and the public. As previously announced, the 2020 Annual Meeting will be held on June 11, 2020, at 9:00 a.m. Eastern Time.

Vanda Pharmaceuticals (NASDAQ: VNDA) may not be a household name, but it could boost your net worth. Its strategy is to expand the approved indications for those drugs and complete development of drug candidates tradipitant and VTR-297. Vanda just launched a phase 3 clinical trial with tradipitant to treat patients with COVID-19 acute respiratory distress syndrome.

Vanda Pharmaceuticals CEO Dr. Mihael Polymeropoulos joins Yahoo Finance's Seana Smith on what's next for the company's potential coronavirus treatment drug after receiving approval from the FDA for a clinical trial.

More than 4.4 million Americans filed initial unemployment claims for the week ending April 18, bringing the five-week total to about 26.5 million. Continuing unemployment claims are close to 16 million, according to data released Thursday by the Department of Labor. D.C., Maryland and Virginia saw employment claims drop compared with the previous week, but a total of nearly 140,000 residents in the three jurisdictions applied initial claims last week.

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the Federal District Court in Washington D.C. granted Vanda's motion to dismiss a False Claims Act lawsuit filed against the company.

Vanda (VNDA) and The Feinstein Institutes for Medical Research initiate enrollment in the phase III ODYSSEY study on tradipitant to treat inflammatory lung injury associated with COVID-19 infection.

U.S. doctors and others in the scientific community are calling for the release of data that convinced health regulators to authorize emergency use of Gilead Sciences Inc's antiviral drug remdesivir to treat COVID-19, so they can direct limited supplies on the right patients. Vanda Pharmaceuticals Inc Chief Executive Mihael Polymeropoulos on Wednesday published an open letter asking for a full download of the trial findings that led to emergency use authorization by the U.S. Food and Drug Administration. The FDA approved emergency use of remdesivir on May 1 based on preliminary results from a National Institute of Allergy and Infectious Diseases (NIAID) trial showing that the drug cut hospital stays by 31%, or about four days, compared with a placebo.

Vanda (VNDA) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Ladies and gentlemen, thank you for standing by, and welcome to the Q1 2020 Vanda Pharmaceuticals Inc. earnings conference call. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' first-quarter 2020 performance.

Vanda (VNDA) delivered earnings and revenue surprises of 0.00% and 0.81%, respectively, for the quarter ended March 2020. Do the numbers hold clues to what lies ahead for the stock?

Q1 2020 Vanda Pharmaceuticals Inc Earnings Call

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced it will release results for the first quarter 2020 on Wednesday, May 6, 2020, after the market closes.

The Virginia governor is asking for funding on a variety of fronts while Montgomery County is allocating some of its own money for personal protective equipment.

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today released a letter (below) from Mihael H. Polymeropoulos, M.D., President and CEO of Vanda Pharmaceuticals, proposing an approach to Clinical Trial Data Sharing in order to facilitate discovery and clinical utility of COVID-19 therapeutics. Vanda is also involved in the development of therapeutic solutions for COVID-19 and currently in Phase III studies with tradipitant for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19.

Mihael Polymeropoulos has been the CEO of Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) since 2003. This report will...

Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech stocks that hit 52-week highs April 15.) * Bio-Rad Laboratories, Inc. Class B Common Stock (NYSE: BIO) * Calithera Biosciences Inc (NASDAQ: CALA) (provided an update on the impact of COVID-19 on its ongoing clinical trials) * Eli Lilly And Co (NYSE: LLY) * Keros Therapeutics Inc (NASDAQ: KROS) (went public April 8) * Masimo Corporation (NASDAQ: MASI) * Moderna Inc (NASDAQ: MRNA (analysts hiked price targets for the shares following the company's Virtual Vaccines Day) * Pluristem Therapeutics Inc. (NASDAQ: PSTI) * Regeneron Pharmaceuticals Inc (NASDAQ: REGN)Down In The Dumps (Biotech stocks that hit 52-week lows April 15.) * Akorn, Inc. (NASDAQ: AKRX) * AxoGen, Inc Common Stock (NASDAQ: AXGN) * TherapeuticsMD Inc (NASDAQ: TXMD) * Vaccinex Inc (NASDAQ: VCNX) * Benzinga is covering every angle of how the coronavirus affects the financial world. For daily updates, sign up for our coronavirus newsletter.Stocks In Focus UroGen's Kidney Cancer Drug Gets FDA Approval Urogen Pharma Ltd (NASDAQ: URGN) said the FDA granted expedited approval for its Jelmyto for pyelocaliceal solution, indicated to treat adults with low-grade upper tract urothelial cancer. The company said the approval was granted based on positive results from a Phase 3 Olympus trial that demonstrated Jelmyto's effectiveness in this rare and difficult-to-treat cancer.Jelmyto consists of mitomycin, an established chemotherapy and sterile hydrogel, using Urogen's proprietary sustained release RTGel technology.The stock was trading more than 14% higher at $24 in Thursday's premarket session. Accelerate Diagnostics Pre-Announces In-Line Q1 Revenue Accelerate Diagnostics Inc (NASDAQ: AXDX) said it expects first-quarter net sales of $2.3 million, higher than $1.8 million in the year-ago period and in line with the consensus estimate.Citing the uncertainty surrounding the duration of the COVID-19 pandemic, the company withdrew its guidance.The stock rallied 7.89% to $9.02 in after-hours trading.Vanda To Study Impact Of Human Genetic Variations On Coronavirus Infection, Progression Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) announced the initiation of the CALYPSO program to study the role that human genetic variations play in SARS-CoV-2 infection and disease progression. The company said it will collaborate with the University of Washington School of Medicine and its Virology Lab on a pharmacogenetics study in COVID-19 patients."The study will focus on the sequencing of the genome of individual patients, as well as the COVID-19 virus, and the identification of genetic factors that correlate with disease progression and outcomes," according to Vanda. Separately, Vanda said it has enrolled the first patient in its ODYSSEY trial at Lenox Hill Hospital in New York City with Northwell Health's research arm. The ODYSSEY trial is a Phase 3 study investigating the efficacy and safety of tradipitant, a neurokinin-1 receptor antagonist, in the treatment of neurogenic inflammation of the lung secondary to SARS-CoV-2 infection.The stock was trading 8.45% higher at $11.30 in Thursday's premarket session. See also: The Week Ahead In Biotech: Urogen FDA Decision, Amarin, J&J Earnings And More COVID-19 Updates Vir Presents Positive Data For Hepatitis B Virus Drug Vir Biotechnology Inc (NASDAQ: VIR) announced additional interim data from the ongoing Phase 2 study and results from the Phase 1 trial in healthy volunteers of VIR-2218, an investigational small interfering ribonucleic acid that mediates RNA interference for the treatment of chronic hepatitis B virus infection.The company said interim results from the Phase 2 study showed VIR-2218 resulted in a significant dose-dependent and durable reduction in hepatitis B surface antigen through week 24 in patients who received two doses ranging from 20 mg to 200 mg.Vir had licensed the investigational asset from Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY). Vir said it will initiate combination trials of VIR-2218 with a shortened course of pegylated interferon, with dosing likely to begin in the second half of 2020.Vir shares were trading 0.79% higher at $29.50 in the premarket session. Co-Diagnostics Says COVID-19 Tests Validated For Use With Saliva Samples Co-Diagnostics Inc (NASDAQ: CODX) said OralDNA Labs, a CLIA-certified laboratory, recently validated a COVID-19 PCR test based on the its patented CoPrimer technology for use with saline oral rinse samples, and has notified the FDA of their intent to use the validated test in their CAP accredited high-complexity laboratory.The stock was adding 7.16% to $10.18 in premarket trading. Soligenix Licenses COVID-19 Vaccine Adjuvant From Boston Scientific Unit Soligenix, Inc. Common Stock (NASDAQ: SNGX) announced an agreement for exclusive worldwide licensing of CoVaccine HT, a novel vaccine adjuvant, from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation (NYSE: BSX), for SARS-CoV-2.View more earnings on IBBThe stock was ripping higher by 60% to $2.24 in premarket trading. Eagle Pharma Submits IND For Coronavirus Treatment Candidate Eagle Pharmaceuticals Inc (NASDAQ: EGRX) said its Ryanodex for injectable suspension inhibited the growth of SARS-CoV-2 in lab tests. The company said it submitted an IND to the FDA for a Phase 2 clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy of Ryanodex in patients infected with the virus.Inovio Nets $6.9M In Funding To Initiate South Korean Clinical Trial Of Coronavirus Vaccine Candidate Inovio Pharmaceuticals Inc (NASDAQ: INO) has been granted $6.9 million in funding by the Coalition for Epidemic Preparedness Innovations to work with the International Vaccine Institute and the Korea National Institute of Health for a Phase 1/2 clinical trial of INOVIO's COVID-19 vaccine candidate INO-4800 in South Korea, according to the IVI. The organization said it will conduct the trial in South Korea.In premarket trading Thursday, Inovio shares were advancing 7.84% to $7.70.Ascendis' Growth Hormone Deficiency Drug Granted Orphan Drug Designation Ascendis Pharma A/S (NASDAQ: ASND) said the FDA has granted Orphan Drug Designation to its TransCon hGH as a treatment for growth hormone deficiency.AEterna Warned On Nasdaq Listing Standards, Has 180-Day Grace Period To Regain Compliance AEterna Zentaris Inc. (NASDAQ: AEZS) said it has received notice from Nasdaq indicating the company is not in compliance with the minimum $1-per-share bid price requirement, having closed below $1 per share for the prior 30 consecutive business days. The company said it has been provided a grace period of 180 calendar days through Oct. 5 to regain compliance.Novavax Coronavirus Vaccine To Enter Clinics In Australia Novavax, Inc.'s (NASDAQ: NVAX) Australian development partner Nucleus Network said it is due to commence Phase 1 testing of the former's NVX-CoV2372, a SARS-CoV-2 recombinant spike protein nanoparticle vaccine, at its Melbourne and Brisbane clinics in the coming weeks.In premarket trading Thursday, Novavax shares were adding 2.51% to $17.97. Offerings Calithera said it has priced its underwritten public offering of 5 million shares at $6.25 per share. The company expects to raise gross proceeds of $31.25 million from the offering. The offering is expected to close April 20.The stock was down 1.18% to $7.51 in the premarket session. Arcturus Therapeutics Ltd (NASDAQ: ARCT), which recently issued an update on its COVID-19 vaccine development program, said it intends to sell shares of its common stock in an underwritten public offering. All the shares are to be offered by the company.The company said it intends to use the net proceeds for working capital and general corporate purposes, including capex and R&D expenses related to the advancement of its LUNAR-OTC, LUNAR-COV19 and its other product candidates and clinical trial expenditures.The stock was down 3.06% at $17.45 in the premarket session. Athersys Inc (NASDAQ: ATHX) said it intends to offer $50 million of its common stock for sale in an underwritten public offering. The company said it will use the net proceeds for working capital and general corporate purposes, including funding its acute respiratory distress syndrome clinical program, which includes initiation of a Phase 2/3 pivotal study for COVID-19-induced ARDS patients, and its process development and manufacturing projects.The stock was down 25.81% at $2.30 in the premarket session. On The Radar Clinical Readouts Moleculin Biotech Inc (NASDAQ: MBRX) is hosting a web-based investor conference call at 4:30 p.m. ET Thursday to explain the significance of the recent discovery that the active compound in its WP1122 drug candidate, which it has licensed to WPD Pharmaceuticals Inc (OTC: WCOTF), has been shown to reduce replication of SARS-CoV-2 by 100%.Earnings Thursday Abbott Laboratories (NYSE: ABT) (before the market open)Intuitive Surgical, Inc. (NASDAQ: ISRG) (after the close)Related Link:Gilead Analysts Break Down Remdesivir Data Readout From Compassionate Use See more from Benzinga * 3 Frontrunners In COVID-19 Vaccine Development: What You Need To Know * The Daily Biotech Pulse: Applied DNA Ships Vaccine Constructs For Animal Testing, Herceptin Biosimilar Now Available In US * The Daily Biotech Pulse: Amarin Reports Strong Q1 Vascepa Sales, BeiGene Aces Late-Stage Lung Cancer Study, Glaxo, Sanofi Strike COVID-19 Vaccine Partnership(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.